The solubility behavior of drugs remains one of the most exigent aspects in formulation development. With the advent of combinatorial chemistry and high throughput screening, the number of poorly water soluble compounds has dramatically increased. Among all the newly discovered chemical entities, about 40 45 drugs fail to reach market due to their poor water solubility. Because of solubility problem, bioavailability of drugs gets affected and hence solubility enhancement becomes necessary. In present study the attempts have been made to increase the dissolution of BCS class 2 drug Piroxicam using hydrophilic polymers namely polyethylene glycol PEG 6000 and sodium lauryl sulphate as a surfactant by using solid dispersion technique. In solid dispersion microwave induced solid dispersion and conventional fusion method is compared. Drug polymer complex was prepared using batch method. Maximum dissolution rate was obtained of the complex prepared from Piroxicam PEG6000 SLS . A successful solubility enhancement of drug complex was confirmed by taking drug release in phosphate buffer pH 6.8. The drug was characterized according to different compendial methods, on the basis of identification by UV spectroscopy, organoleptic properties and other tests. After that among the all formulation batches, solid dispersion F16 was selected for further tablet formulation batches, nine formulations were developed and studied. The values of pre compression parameters was evaluated, results were within prescribed limits and indicated good free flowing properties. The data obtained of post compression parameters such as weight variation, hardness, friability, wetting time, water absorption ratio, content uniformity, disintegration time and dissolution was found to superior over conventional formulation. The F9 batch with disintegrating time 10 ± 0.52 second and dissolution 93.20 ± 0.61 was selected as optimized formulation and was found superior over other formulation. Batch F9 was also subjected to stability studies for three months and was tested for its disintegrating time, drug contents and dissolution behavior monthly. F9 formulation after stability study was found to be stable. Mr. Yennuwar Dhiresh Pramod | Mr. Sujit Kakade | Mrs. Trusha Shangrapawar | Dr. Ashok Bhosale "Formulation, Development and Evaluation of Fast Disintegrating Tablet of Piroxicam using Solid Dispersion Technique" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-5 , August 2022, URL: https://www.ijtsrd.com/papers/ijtsrd50422.pdf Paper URL: https://www.ijtsrd.com/pharmacy/pharmaceutics/50422/formulation-development-and-evaluation-of-fast-disintegrating-tablet-of-piroxicam-using-solid-dispersion-technique/mr-yennuwar-dhiresh-pramod
This document discusses drug-excipient compatibility studies. It begins by explaining the importance of these studies in maximizing dosage form stability and avoiding formulation problems. It then describes the goals of compatibility studies and various mechanisms of drug-excipient interactions including physical, chemical, and physiological interactions. Finally, it outlines several analytical methods used in compatibility studies, including thermal techniques like DSC, spectroscopic techniques like vibrational spectroscopy, and chromatographic techniques like HPLC.
Formulation development and evalution of matrix tablet ofGajanan Ingole
The document describes the development of a matrix tablet for oral delivery of an antihypertensive drug (NSL) using pH dependent and independent polymers. It includes sections on introduction, literature review, drug and excipient profiles, aim and objectives, rationale, materials and equipment, experimental work, results, discussion, and references. The key steps involved preformulation studies, formulation of matrix tablets, optimization studies to match the in vitro dissolution profile of a marketed reference product, and stability studies. The optimized formulation was found to release the drug in a controlled manner for 24 hours.
Pharmacosomes are lipid-based vesicular drug delivery systems where drugs are covalently bound to lipids. They can incorporate both hydrophilic and lipophilic drugs and deliver them in a targeted manner. Pharmacosomes have advantages like high drug loading, direct delivery to the site of action, and reduced toxicity. They are formulated using techniques like solvent evaporation, ether injection, and lyophilization. Pharmacosomes show potential for improving drug absorption, transport, and therapeutic effects. Evaluation methods include assessing solubility, drug content, surface morphology, thermal behavior, and in vitro drug release.
Microspheres are spherical particles ranging from 1 nm to 200 μm that can be used to deliver drugs in a sustained or controlled release manner. They are typically made of biodegradable polymers and can be prepared using various methods like single/double emulsion, polymerization, phase separation, or spray drying. Drugs are encapsulated or absorbed onto the microspheres and released over time as the polymer degrades. Microspheres find applications in areas like vaccines, targeted drug delivery, and imaging due to their advantages of sustained release, increased drug stability and reduced toxicity.
This document provides an overview of ion exchange resins (IER) and their use in drug delivery systems. IER are water-insoluble polymers that contain ionizable functional groups used to exchange ions. They are classified based on these functional groups as strong/weak cation or anion exchangers. The document discusses the advantages and limitations of IER drug complexes, how to select resins based on properties, preparation methods, and factors affecting drug loading. Applications described include stabilization, extended release, taste masking, and use as antacids or disintegrants. Recent patents involving IER for drug delivery are also mentioned. In conclusion, the document reviews the role of IER in modifying drug release and their effective use in
Niosomes are non-ionic surfactant-based vesicles that can be used for drug delivery. They consist of a nonionic surfactant bilayer enclosing an aqueous core. This document discusses the definition, structure, advantages, preparation methods and evaluation of niosomes. Niosomes can be prepared using methods like ether injection, film hydration, sonication, heating and extrusion. Their stability and ability to encapsulate and release drugs can be evaluated by measuring vesicle size, drug content, entrapment efficiency and in vitro drug release over time. Niosomes offer targeted drug delivery and improved oral absorption compared to other formulations.
DISSOLUTION
Dissolution is a process in which solid substance solubilizes in a given solvent
DISSOLUTION TESTING
A dissolution test uses an apparatus with specific test conditions in combination with acceptance criteria to evaluate the performance of the product. In-vitro test must predict the in-vivo behaviour
Factors in design of dissolution tests:
Factors relating to dissolution apparatus
Factors relation to dissolution fluid
Process parameters
Need of Dissolution Testing:
Development and optimisation of dosage forms
Batch to batch drug release uniformity
Quality, safety, efficacy and stability of the product
IVIV Correlation
Bioequivalence
Assessing pre and post approval changes
DISSOLUTION APPARATUS
Dissolution apparatus evolved to prepare a sample under controlled conditions thereby making the test repeatable.
Principle types of dissolution apparatus-
Close-compartment apparatus
Open-compartment apparatus
Dialysis systems
Ideal features of Dissolution Apparatus:
The fabrication, dimensions, and positioning of all components must be precisely specified and reproducible
Simple in design, easy to operate and useable
Sensitive
Nearly perfect sink conditions
Provide an easy means of introducing the dosage form into the dissolution medium
Provide minimum mechanical abrasion
Easy withdrawal of samples
Elimination of evaporation of solvent medium
DISSOLUTION METHODS
The Standard Dissolution Methods Database has been prepared by the Division of Bioequivalence, Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA).
Official methods:
Rotating Basket
Rotating Paddle
Reciprocating Cylinder
Flow-Through Cell
Paddle Over Disc
Rotating Cylinder
Reciprocating Disc
Non-official methods:
Static Disc Method
Beaker Method
Flask Stirrer Method
Peristalsis Method
Rotating Bottle Method
Dialysis Method
Diffusion Cell Method
Dissolution Apparatus Types and their Applications
Problems associated with dissolution apparatus
USP Performance Verification Test (PVT):
The USP Performance Verification Test (PVT) assesses the suitable performance of apparatus used in dissolution testing.
Responsible for detecting problems associated with the dissolution apparatus that are found to be within mechanical tolerances.
REFERENCES
This document discusses drug-excipient compatibility studies. It begins by explaining the importance of these studies in maximizing dosage form stability and avoiding formulation problems. It then describes the goals of compatibility studies and various mechanisms of drug-excipient interactions including physical, chemical, and physiological interactions. Finally, it outlines several analytical methods used in compatibility studies, including thermal techniques like DSC, spectroscopic techniques like vibrational spectroscopy, and chromatographic techniques like HPLC.
Formulation development and evalution of matrix tablet ofGajanan Ingole
The document describes the development of a matrix tablet for oral delivery of an antihypertensive drug (NSL) using pH dependent and independent polymers. It includes sections on introduction, literature review, drug and excipient profiles, aim and objectives, rationale, materials and equipment, experimental work, results, discussion, and references. The key steps involved preformulation studies, formulation of matrix tablets, optimization studies to match the in vitro dissolution profile of a marketed reference product, and stability studies. The optimized formulation was found to release the drug in a controlled manner for 24 hours.
Pharmacosomes are lipid-based vesicular drug delivery systems where drugs are covalently bound to lipids. They can incorporate both hydrophilic and lipophilic drugs and deliver them in a targeted manner. Pharmacosomes have advantages like high drug loading, direct delivery to the site of action, and reduced toxicity. They are formulated using techniques like solvent evaporation, ether injection, and lyophilization. Pharmacosomes show potential for improving drug absorption, transport, and therapeutic effects. Evaluation methods include assessing solubility, drug content, surface morphology, thermal behavior, and in vitro drug release.
Microspheres are spherical particles ranging from 1 nm to 200 μm that can be used to deliver drugs in a sustained or controlled release manner. They are typically made of biodegradable polymers and can be prepared using various methods like single/double emulsion, polymerization, phase separation, or spray drying. Drugs are encapsulated or absorbed onto the microspheres and released over time as the polymer degrades. Microspheres find applications in areas like vaccines, targeted drug delivery, and imaging due to their advantages of sustained release, increased drug stability and reduced toxicity.
This document provides an overview of ion exchange resins (IER) and their use in drug delivery systems. IER are water-insoluble polymers that contain ionizable functional groups used to exchange ions. They are classified based on these functional groups as strong/weak cation or anion exchangers. The document discusses the advantages and limitations of IER drug complexes, how to select resins based on properties, preparation methods, and factors affecting drug loading. Applications described include stabilization, extended release, taste masking, and use as antacids or disintegrants. Recent patents involving IER for drug delivery are also mentioned. In conclusion, the document reviews the role of IER in modifying drug release and their effective use in
Niosomes are non-ionic surfactant-based vesicles that can be used for drug delivery. They consist of a nonionic surfactant bilayer enclosing an aqueous core. This document discusses the definition, structure, advantages, preparation methods and evaluation of niosomes. Niosomes can be prepared using methods like ether injection, film hydration, sonication, heating and extrusion. Their stability and ability to encapsulate and release drugs can be evaluated by measuring vesicle size, drug content, entrapment efficiency and in vitro drug release over time. Niosomes offer targeted drug delivery and improved oral absorption compared to other formulations.
DISSOLUTION
Dissolution is a process in which solid substance solubilizes in a given solvent
DISSOLUTION TESTING
A dissolution test uses an apparatus with specific test conditions in combination with acceptance criteria to evaluate the performance of the product. In-vitro test must predict the in-vivo behaviour
Factors in design of dissolution tests:
Factors relating to dissolution apparatus
Factors relation to dissolution fluid
Process parameters
Need of Dissolution Testing:
Development and optimisation of dosage forms
Batch to batch drug release uniformity
Quality, safety, efficacy and stability of the product
IVIV Correlation
Bioequivalence
Assessing pre and post approval changes
DISSOLUTION APPARATUS
Dissolution apparatus evolved to prepare a sample under controlled conditions thereby making the test repeatable.
Principle types of dissolution apparatus-
Close-compartment apparatus
Open-compartment apparatus
Dialysis systems
Ideal features of Dissolution Apparatus:
The fabrication, dimensions, and positioning of all components must be precisely specified and reproducible
Simple in design, easy to operate and useable
Sensitive
Nearly perfect sink conditions
Provide an easy means of introducing the dosage form into the dissolution medium
Provide minimum mechanical abrasion
Easy withdrawal of samples
Elimination of evaporation of solvent medium
DISSOLUTION METHODS
The Standard Dissolution Methods Database has been prepared by the Division of Bioequivalence, Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA).
Official methods:
Rotating Basket
Rotating Paddle
Reciprocating Cylinder
Flow-Through Cell
Paddle Over Disc
Rotating Cylinder
Reciprocating Disc
Non-official methods:
Static Disc Method
Beaker Method
Flask Stirrer Method
Peristalsis Method
Rotating Bottle Method
Dialysis Method
Diffusion Cell Method
Dissolution Apparatus Types and their Applications
Problems associated with dissolution apparatus
USP Performance Verification Test (PVT):
The USP Performance Verification Test (PVT) assesses the suitable performance of apparatus used in dissolution testing.
Responsible for detecting problems associated with the dissolution apparatus that are found to be within mechanical tolerances.
REFERENCES
Introduction
Structure
Niosomes Vs. Liposome
Advantages & Disadvantages
Properties of Niosomes
Method of Manufacturing
Evaluation of Niosomes
Applications
Marketed products
Niosomes are non-ionic surfactant-based vesicles that can be used to deliver drugs. They are divided into small unilamellar vesicles, large unilamellar vesicles, and multi-lamellar vesicles based on their size and number of bilayers. Niosomes can be used for controlled drug release, to improve drug stability and bioavailability, and for targeted drug delivery to tissues like the liver, spleen, and tumors. They have applications in drug delivery via various routes of administration like oral, topical, and intravenous delivery.
Product Stability Studies & Stability Testing Amit Attri
This presentation provides an overview of pharmaceutical stability testing. It discusses the different types of stability studies including formal stability studies, stress stability studies, and abbreviated stability studies. Key factors that influence drug stability are also explained such as temperature, humidity, pH, and light exposure. Common degradation pathways for drugs like hydrolysis, oxidation, and photodegradation are summarized. The presentation emphasizes the importance of stability testing for determining a drug's shelf life and appropriate storage conditions. It provides examples of stability issues for several drugs.
The document discusses the requirements and contents of an Investigational Medicinal Product Dossier (IMPD) which provides information on the quality, manufacture, and control of investigational medical products (IMPs) used in clinical trials in the European Union. An IMPD includes summaries of nonclinical and clinical data and is required for authorization to perform clinical trials in EU member states. It must provide an overall risk-benefit assessment of the proposed trial based on nonclinical and clinical analyses. A simplified IMPD may be acceptable in some cases such as if the IMP is already authorized. The IMPD covers quality data, nonclinical pharmacology and toxicology data, previous clinical experience, and an overall risk assessment.
This document discusses post-approval regulatory affairs for drugs and medical devices. It explains that the FDA may require post-approval studies to ensure continued safety and effectiveness of approved products. Sponsors must comply with post-approval requirements or approval can be withdrawn. Post-approval changes are categorized as major, moderate, or minor depending on their potential effect. Major changes generally require prior approval from the FDA, while moderate changes require notification 30 days before distribution. Minor changes are reported annually. The document provides recommendations for common post-approval changes including components, manufacturing sites, processes, specifications, packaging, and labeling.
This document provides an overview of osmotic drug delivery systems. It discusses the basic components and principles of osmosis that osmotic drug delivery systems utilize. The key components discussed include the drug, osmogen, semipermeable membrane, and factors that affect drug release such as solubility, osmotic pressure, delivery orifice size, and membrane type. A variety of osmotic pump designs are also briefly mentioned.
The document discusses drug product performance evaluation through in vitro dissolution testing. It provides details on factors that influence drug dissolution like drug substance properties, formulation composition, manufacturing process, and dissolution test conditions. The key goals of in vitro drug product testing are to characterize drug potency and release rate from oral dosage forms, provide information for formulation development, and ensure quality, comparability and stability over time. Common tests include disintegration testing and dissolution testing using apparatus specified in pharmacopeias to simulate gastrointestinal conditions. The results of in vitro testing aid product development and assessment of shelf-life and quality.
Scale up and post approval changes (SUPAC) involve changes made after drug approval to manufacturing processes, equipment, batch size, or sites. Changes are classified as minor, moderate, or major. Site changes include those within a single facility or between adjacent facilities (Level 1) or different campuses (Level 3). Batch size changes up to 10 times the initial size are Level 1, and beyond that are Level 2. Equipment changes include automated vs non-automated (Level 1) or different designs (Level 2). Process changes include altered parameters within validated ranges (Level 1).
Post marketing surveillance monitors drug safety after approval and includes adverse event reporting, re-examination of drugs, and re-evaluation of risk-benefit profiles
This document discusses gastroretentive drug delivery systems (GRDDS), which are oral dosage forms designed to remain in the stomach for an extended period of time to prolong drug release. It covers the rationale for using GRDDS, factors controlling gastric residence time, and various approaches for prolonging gastric retention including floating systems, high-density systems, and bioadhesive or magnetic systems. Floating systems include non-effervescent and effervescent types that float due to low density or gas generation. High-density systems do not float but remain in the stomach through bioadhesion, magnetic forces, swelling to a large size, or raft formation on gastric fluids.
This document discusses various types of documentation required in the pharmaceutical industry, including master formula records (MFR), drug master files (DMF), and generic drug development. It defines MFRs as approved master documents that describe the full manufacturing process for a specific batch size. It provides details on the content required for MFRs based on guidelines from WHO, Health Canada, and the US CFR. It also discusses the purpose and types of DMFs submitted to the FDA, including Type 1 for manufacturing facilities, Type 2 for drug substances/products, and others. Finally, it briefly mentions the Hatch-Waxman Act as it relates to generic drug development.
Nanostructured lipid carriers (NLCs) were presented as a topical drug delivery system. NLCs consist of a blend of solid and liquid lipids which can incorporate drugs at high loading capacities. They were summarized to have advantages over solid lipid nanoparticles including avoidance of drug expulsion and unpredictable gelation. Methods for producing NLCs like high pressure homogenization were described. NLCs were said to increase skin permeation of drugs while providing occlusive and moisturizing properties beneficial for skin care. Several drug-loaded NLC formulations were presented including ones for flurbiprofen, minoxidil, and tacrolimus to improve their topical delivery and stability.
Mucoadhesive drug delivery systems aim to increase drug bioavailability by keeping formulations in close contact with mucus membranes. There are three main stages of mucoadhesion: wetting and swelling, interpenetration of polymer chains with the mucus layer, and formation of chemical bonds. Several theories explain mucoadhesion, including electronic, adsorption, wetting, diffusion, and fracture theories. Key factors affecting mucoadhesion are related to the polymer properties, such as molecular weight, concentration, flexibility, and spatial conformation, as well as environmental and physiological factors. Mucoadhesive systems can provide benefits like prolonged drug residence at the site of action and increased drug absorption.
This document discusses different types of rate controlled drug delivery systems. It begins by introducing controlled release drug delivery and distinguishing it from sustained release. It then classifies controlled release systems into three main categories: rate programmed, activation modulated, and feedback regulated systems. Within each category it describes several examples of systems, identifying how drug release is controlled in each case. Key factors that can affect controlled release are also listed. The document aims to provide an overview of controlled drug delivery technologies with classifications and examples.
Dissolution apparatus, invivo-invitro corelation, factor affecting,BCS classification ..
Complete dissolution topic in this slide & easy way to write..
Cheak it now and give feedback
FORMULATION AND EVALUATION OF GEL LOADED MICROSPONGES OF DICLOFENAC SODIUM FO...SriramNagarajan18
This document describes the formulation and evaluation of diclofenac sodium-loaded microsponges for topical delivery. Microsponges were prepared using ethyl cellulose polymer by a quasi-emulsion solvent diffusion method. The microsponges were spherical and porous in structure as seen under SEM. Particle size ranged from 23.9-45.9 μm depending on the drug:polymer ratio. Yield increased from 10.85-41.03% with increasing polymer content. Drug content was highest for formulation M4 at 74.03% and decreased with higher polymer ratios. The microsponges were then dispersed in a carbopol gel and evaluated for properties like pH, viscosity and spreadability. In vitro drug
Regulatory affairs is a profession that developed to ensure public health by regulating product safety. Regulatory affairs professionals work with regulatory agencies and internal departments to register products, track legislation changes, and provide strategic advice. They must understand both internal manufacturing processes and requirements from agencies like CDSCO in India or the USFDA.
A Master Formula Record (MFR) is a key document that contains all information about manufacturing a pharmaceutical product, including starting materials, packaging, and processing instructions. It is prepared by R&D as the standard reference for making Batch Manufacturing Records. The MFR must include product details, a procedure description, and all ingredients and their quantities. It ensures consistent manufacturing of batches according to the standard process.
Dissolution : Official and Non official methods, Alternative methods of dissolution testing and transport models, Drug release testing, Invitro drug release testing
Solubility and dissolution enhancement of BCS class ii drug Piroxicam by soli...Makrani Shaharukh
The Present study was conducted to improve solubility and dissolution of poor water soluble drug Piroxicam. In this research work, Piroxicam Solid Dispersion was prepared kneading method by using, Guar Gum as a carrier. Drug and carriers weight ratio were1:1 to 1:5. The properties of solid were evaluated using Fourier Transform Infra red (FTIR) Spectroscopy, differential scanning calorimetry (DSC), scanning electron microscopy (SEM), and solubility and dissolution studies. The FTIR Spectroscopy showed no chemical interaction between Piroxicam and carrier. DSC studies indicated their no change of melting point of Piroxicam in Solid Dispersion. SEM result showed that Piroxicam was dispersed and was present as amorphous state in the solid dispersions. Solubility of Solid dispersions was highest at Ratio 1:5 is 0.319±0.02 mg/mL. The drug release data of solid dispersion revealed that formulation F5 exhibited more than 95 % drug release after 60 min. Finally we conclude that the solubility & dissolution enhancement is depend on nature and amount of the carrier and when increases the carrier increase the solubility of Piroxicam. Solid dispersion system of Piroxicam and carriers used could improve the solubility and dissolution rate of Piroxicam.
Investigating the Effect of Molecular Weight of Polyvinylpyrrolidone and Hydr...Smruti Chaudhari, Ph.D.
This document summarizes a study investigating the effect of molecular weight of polyvinylpyrrolidone (PVP) and hydroxypropyl methyl cellulose (HPMC) polymers on maintaining supersaturation of the weakly acidic drug indomethacin. Non-formulated methods like solvent shift and solvent casting were used to screen the ability of different PVP and HPMC grades to generate and maintain indomethacin supersaturation. Solid dispersions of indomethacin with PVP and HPMC were also prepared using spray drying. Results showed that higher molecular weight PVP generated greater supersaturation while higher molecular weight HPMC generated lower supersaturation. Solid dispersions with high molecular weight P
Introduction
Structure
Niosomes Vs. Liposome
Advantages & Disadvantages
Properties of Niosomes
Method of Manufacturing
Evaluation of Niosomes
Applications
Marketed products
Niosomes are non-ionic surfactant-based vesicles that can be used to deliver drugs. They are divided into small unilamellar vesicles, large unilamellar vesicles, and multi-lamellar vesicles based on their size and number of bilayers. Niosomes can be used for controlled drug release, to improve drug stability and bioavailability, and for targeted drug delivery to tissues like the liver, spleen, and tumors. They have applications in drug delivery via various routes of administration like oral, topical, and intravenous delivery.
Product Stability Studies & Stability Testing Amit Attri
This presentation provides an overview of pharmaceutical stability testing. It discusses the different types of stability studies including formal stability studies, stress stability studies, and abbreviated stability studies. Key factors that influence drug stability are also explained such as temperature, humidity, pH, and light exposure. Common degradation pathways for drugs like hydrolysis, oxidation, and photodegradation are summarized. The presentation emphasizes the importance of stability testing for determining a drug's shelf life and appropriate storage conditions. It provides examples of stability issues for several drugs.
The document discusses the requirements and contents of an Investigational Medicinal Product Dossier (IMPD) which provides information on the quality, manufacture, and control of investigational medical products (IMPs) used in clinical trials in the European Union. An IMPD includes summaries of nonclinical and clinical data and is required for authorization to perform clinical trials in EU member states. It must provide an overall risk-benefit assessment of the proposed trial based on nonclinical and clinical analyses. A simplified IMPD may be acceptable in some cases such as if the IMP is already authorized. The IMPD covers quality data, nonclinical pharmacology and toxicology data, previous clinical experience, and an overall risk assessment.
This document discusses post-approval regulatory affairs for drugs and medical devices. It explains that the FDA may require post-approval studies to ensure continued safety and effectiveness of approved products. Sponsors must comply with post-approval requirements or approval can be withdrawn. Post-approval changes are categorized as major, moderate, or minor depending on their potential effect. Major changes generally require prior approval from the FDA, while moderate changes require notification 30 days before distribution. Minor changes are reported annually. The document provides recommendations for common post-approval changes including components, manufacturing sites, processes, specifications, packaging, and labeling.
This document provides an overview of osmotic drug delivery systems. It discusses the basic components and principles of osmosis that osmotic drug delivery systems utilize. The key components discussed include the drug, osmogen, semipermeable membrane, and factors that affect drug release such as solubility, osmotic pressure, delivery orifice size, and membrane type. A variety of osmotic pump designs are also briefly mentioned.
The document discusses drug product performance evaluation through in vitro dissolution testing. It provides details on factors that influence drug dissolution like drug substance properties, formulation composition, manufacturing process, and dissolution test conditions. The key goals of in vitro drug product testing are to characterize drug potency and release rate from oral dosage forms, provide information for formulation development, and ensure quality, comparability and stability over time. Common tests include disintegration testing and dissolution testing using apparatus specified in pharmacopeias to simulate gastrointestinal conditions. The results of in vitro testing aid product development and assessment of shelf-life and quality.
Scale up and post approval changes (SUPAC) involve changes made after drug approval to manufacturing processes, equipment, batch size, or sites. Changes are classified as minor, moderate, or major. Site changes include those within a single facility or between adjacent facilities (Level 1) or different campuses (Level 3). Batch size changes up to 10 times the initial size are Level 1, and beyond that are Level 2. Equipment changes include automated vs non-automated (Level 1) or different designs (Level 2). Process changes include altered parameters within validated ranges (Level 1).
Post marketing surveillance monitors drug safety after approval and includes adverse event reporting, re-examination of drugs, and re-evaluation of risk-benefit profiles
This document discusses gastroretentive drug delivery systems (GRDDS), which are oral dosage forms designed to remain in the stomach for an extended period of time to prolong drug release. It covers the rationale for using GRDDS, factors controlling gastric residence time, and various approaches for prolonging gastric retention including floating systems, high-density systems, and bioadhesive or magnetic systems. Floating systems include non-effervescent and effervescent types that float due to low density or gas generation. High-density systems do not float but remain in the stomach through bioadhesion, magnetic forces, swelling to a large size, or raft formation on gastric fluids.
This document discusses various types of documentation required in the pharmaceutical industry, including master formula records (MFR), drug master files (DMF), and generic drug development. It defines MFRs as approved master documents that describe the full manufacturing process for a specific batch size. It provides details on the content required for MFRs based on guidelines from WHO, Health Canada, and the US CFR. It also discusses the purpose and types of DMFs submitted to the FDA, including Type 1 for manufacturing facilities, Type 2 for drug substances/products, and others. Finally, it briefly mentions the Hatch-Waxman Act as it relates to generic drug development.
Nanostructured lipid carriers (NLCs) were presented as a topical drug delivery system. NLCs consist of a blend of solid and liquid lipids which can incorporate drugs at high loading capacities. They were summarized to have advantages over solid lipid nanoparticles including avoidance of drug expulsion and unpredictable gelation. Methods for producing NLCs like high pressure homogenization were described. NLCs were said to increase skin permeation of drugs while providing occlusive and moisturizing properties beneficial for skin care. Several drug-loaded NLC formulations were presented including ones for flurbiprofen, minoxidil, and tacrolimus to improve their topical delivery and stability.
Mucoadhesive drug delivery systems aim to increase drug bioavailability by keeping formulations in close contact with mucus membranes. There are three main stages of mucoadhesion: wetting and swelling, interpenetration of polymer chains with the mucus layer, and formation of chemical bonds. Several theories explain mucoadhesion, including electronic, adsorption, wetting, diffusion, and fracture theories. Key factors affecting mucoadhesion are related to the polymer properties, such as molecular weight, concentration, flexibility, and spatial conformation, as well as environmental and physiological factors. Mucoadhesive systems can provide benefits like prolonged drug residence at the site of action and increased drug absorption.
This document discusses different types of rate controlled drug delivery systems. It begins by introducing controlled release drug delivery and distinguishing it from sustained release. It then classifies controlled release systems into three main categories: rate programmed, activation modulated, and feedback regulated systems. Within each category it describes several examples of systems, identifying how drug release is controlled in each case. Key factors that can affect controlled release are also listed. The document aims to provide an overview of controlled drug delivery technologies with classifications and examples.
Dissolution apparatus, invivo-invitro corelation, factor affecting,BCS classification ..
Complete dissolution topic in this slide & easy way to write..
Cheak it now and give feedback
FORMULATION AND EVALUATION OF GEL LOADED MICROSPONGES OF DICLOFENAC SODIUM FO...SriramNagarajan18
This document describes the formulation and evaluation of diclofenac sodium-loaded microsponges for topical delivery. Microsponges were prepared using ethyl cellulose polymer by a quasi-emulsion solvent diffusion method. The microsponges were spherical and porous in structure as seen under SEM. Particle size ranged from 23.9-45.9 μm depending on the drug:polymer ratio. Yield increased from 10.85-41.03% with increasing polymer content. Drug content was highest for formulation M4 at 74.03% and decreased with higher polymer ratios. The microsponges were then dispersed in a carbopol gel and evaluated for properties like pH, viscosity and spreadability. In vitro drug
Regulatory affairs is a profession that developed to ensure public health by regulating product safety. Regulatory affairs professionals work with regulatory agencies and internal departments to register products, track legislation changes, and provide strategic advice. They must understand both internal manufacturing processes and requirements from agencies like CDSCO in India or the USFDA.
A Master Formula Record (MFR) is a key document that contains all information about manufacturing a pharmaceutical product, including starting materials, packaging, and processing instructions. It is prepared by R&D as the standard reference for making Batch Manufacturing Records. The MFR must include product details, a procedure description, and all ingredients and their quantities. It ensures consistent manufacturing of batches according to the standard process.
Dissolution : Official and Non official methods, Alternative methods of dissolution testing and transport models, Drug release testing, Invitro drug release testing
Solubility and dissolution enhancement of BCS class ii drug Piroxicam by soli...Makrani Shaharukh
The Present study was conducted to improve solubility and dissolution of poor water soluble drug Piroxicam. In this research work, Piroxicam Solid Dispersion was prepared kneading method by using, Guar Gum as a carrier. Drug and carriers weight ratio were1:1 to 1:5. The properties of solid were evaluated using Fourier Transform Infra red (FTIR) Spectroscopy, differential scanning calorimetry (DSC), scanning electron microscopy (SEM), and solubility and dissolution studies. The FTIR Spectroscopy showed no chemical interaction between Piroxicam and carrier. DSC studies indicated their no change of melting point of Piroxicam in Solid Dispersion. SEM result showed that Piroxicam was dispersed and was present as amorphous state in the solid dispersions. Solubility of Solid dispersions was highest at Ratio 1:5 is 0.319±0.02 mg/mL. The drug release data of solid dispersion revealed that formulation F5 exhibited more than 95 % drug release after 60 min. Finally we conclude that the solubility & dissolution enhancement is depend on nature and amount of the carrier and when increases the carrier increase the solubility of Piroxicam. Solid dispersion system of Piroxicam and carriers used could improve the solubility and dissolution rate of Piroxicam.
Investigating the Effect of Molecular Weight of Polyvinylpyrrolidone and Hydr...Smruti Chaudhari, Ph.D.
This document summarizes a study investigating the effect of molecular weight of polyvinylpyrrolidone (PVP) and hydroxypropyl methyl cellulose (HPMC) polymers on maintaining supersaturation of the weakly acidic drug indomethacin. Non-formulated methods like solvent shift and solvent casting were used to screen the ability of different PVP and HPMC grades to generate and maintain indomethacin supersaturation. Solid dispersions of indomethacin with PVP and HPMC were also prepared using spray drying. Results showed that higher molecular weight PVP generated greater supersaturation while higher molecular weight HPMC generated lower supersaturation. Solid dispersions with high molecular weight P
Background: The main objective of present research work is to formulate the Carbamazepine Fast Dissoving tablets. Carbamazepine, an
antiepileptic, belongs to BCS Class-II and used to control some types of seizures in the treatment of epilepsy and Neuropathic Pain by
blocking use-dependent sodium channels. Methods: The Fast Dissoving tablets of Carbamazepine were prepared employing different
concentrations of Crospovidone and Croscarmellose sodium in different combinations as a Sperdisintegrants by Direct Compression technique
using 32
factorial design. The concentration of Crospovidone and Croscarmellose sodium was selected as independent variables, X1
and X2 respectively whereas, wetting time, Disintegration time, t
50% ,t90%were selected as dependent variables. Results and Discussion:
Totally nine formulations were designed and are evaluated for hardness, friability, thickness, Assay, Wetting time, Disintegration time, Invitro
drug release. From the Results concluded that all the formulation were found to be with in the Pharmacopoeial limits and the In-vitro
dissolution profiles of all formulations were fitted in to different Kinetic models, the statistical parameters like intercept (a), slope (b) &
regression coefficient (r) were calculated. Polynomial equations were developed for Wetting time, Disintegration time, t50%, t90%. Validity of
developed polynomial equations were verified by designing 2 check point formulations (C1
, C2
). According to SUPAC guidelines the
formulation (F5
) containing combination of 9.375% Crospovidone and 9.375% Croscarmellose, is the most similar formulation (similarity factor
f
2
=82.675, dissimilarity factor f1
= 2.049 & No significant difference, t= 0.041) to marketed product (TEGRETOL-100). Conclusion: The
selected formulation (F5
) follows First order, Higuchi’s kinetics, mechanism of drug release was found to be Non-Fickian Diffusion (n= 0.665).
KEYWORDS: Carbamazepine, 3
2Factorial Design, Crospovidone , croscarmellose Sodium, Wetting Time, Disintegration Time.
DESIGN AND ASSESSMENT OF COLON SPECIFIC DRUG DELIVERY OF CELECOXIB USING PU...Lakshmi
The document summarizes the design and assessment of a colon-specific drug delivery system for celecoxib using pulsincap technique. Celecoxib microcrystals were prepared using a rapid solvent change method and evaluated. The microcrystals were then used to prepare pulsincaps containing hydrogel plugs to provide a lag time before drug release. In vitro drug release studies were conducted on the pulsincaps to assess their ability to deliver celecoxib in a pulsatile manner to the colon. The aim was to improve solubility, target delivery to the colon, and minimize dosing frequency for the treatment of rheumatoid arthritis.
SOLID DISPERSION
Definition: The technology is the science of dispersing one or more active ingredients in an inert matrix in the solid stage.
Need of solid dispersion:
Increases Oral bioavailability of a drug
Increased dissolution rate.
Enhanced release of drugs from ointment.
Improved the solubility & stability.
The concept of solid dispersion was originally proposed by Sekiguchi & obi.
Increasing the dissolution, absorption & therapeutic efficacy of drugs in dosage forms.
Increasing solubility in water.
Improving the oral absorption and bioavailability of BCS Class II drugs.
Formulation and Evaluation of Nimodipine Tablet by Liquisolid Techniqueijtsrd
Liquisolid technique is novel concept of the drug delivery via the oral route. This technique is applied to poorly water soluble , water insoluble or lipophilic drugs. According to the new formulation method of liquisolid compact, liquid medication such as solution or suspensions of water insoluble drug in suitable non volatile solvent can be converted into acceptably flowing and compressible powders by blending with selected powder excipients. The present work endeavour is directed towards the development of liquisolid compact for production of immediate release tablet of water insoluble Nimodipine. Liquisolid compacts were prepared by using polyethylene glycol 300 as the liquid vehicle or non volatile solvent. Crospovidone was used as a superdisintegrating agent and PVP K30 as a binder. Microcrystalline cellulose was used as a absorbing carrier and silicone dioxide as adsorbing coating material. The prepared liquisolid system were evaluated for their micromeretic properties and possible drug excipients interaction . The FTIR spectra study ruled out any interaction between the drug and excipients in preparation of Nimodipine liquisolid compact. The in vitro dissolution study confirmed enhance drug release from liquisolid compacts by using USP type I basket in 0.5 SLS in water. The selected optimal formula released 93.86 of its content in 30 min which is showing immediate release. The results showed that use of superdisintegrants had remarkable impact on the release rate of Nimodipine from Liquisolid compact, enhancing the release rate of the drug from liquisolid compact. Neha Durge | Kirti Parida ""Formulation and Evaluation of Nimodipine Tablet by Liquisolid Technique"" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-3 | Issue-4 , June 2019, URL: https://www.ijtsrd.com/papers/ijtsrd23863.pdf
Paper URL: https://www.ijtsrd.com/pharmacy/pharmaceutics/23863/formulation-and-evaluation-of-nimodipine-tablet-by-liquisolid-technique/neha-durge
Enhancement of Aqueous Solubility of Piroxicam Using Solvent Deposition SystemAI Publications
Piroxicam is a non-steroidal anti-inflammatory drug that is characterized by low solubility-high permeability. The present study was designed to improve the dissolution rate of piroxicam at the physiological pH's through its increased solubility by using solvent deposition system.
This document provides a synopsis for a Master's thesis project titled "Formulation and Evaluation of Fast Dissolving Films of Lisinopril". The project aims to develop fast dissolving films of the hypertension drug Lisinopril to improve patient compliance. Literature on fast dissolving drug delivery systems and films has been reviewed. The planned work involves preparing Lisinopril films using natural and synthetic polymers through various techniques and evaluating the films for properties like drug content, dissolution, and pharmacodynamics. If successful, the fast dissolving Lisinopril films could provide quick action and ease of administration benefits for hypertension patients.
Formulation and Evaluation of Fast Disintegrating Tablet of Solid Dispersion ...ijtsrd
This document describes the formulation and evaluation of fast-disintegrating tablets containing a solid dispersion of the poorly water-soluble drug carvedilol. Solid dispersions of carvedilol with PEG6000 and PVP K30 in various ratios were prepared using the kneading method and evaluated for solubility, drug content, and in vitro drug release. The F3 formulation with PEG6000 in a 1:3 ratio showed the highest drug release of 96.61% within 40 minutes. This optimized solid dispersion was then used to prepare fast-disintegrating tablets by direct compression. The tablets were evaluated for disintegration time, drug release, and other parameters. Tablet FD6 was selected as the optimized formulation as it
Dissolution Enhancement of BCS Class 4 Dssrugs Using Quality by Design Approa...inventionjournals
Solid dispersion is one of the vastly accepted and practically economical processes in bioavailability enhancement study. The present investigation deals mostly with increase in solubility and dissolution rate of BCS class 4 drugs for enhancement of oral bioavailability. For the same solid dispersion were prepared and analyzed for appropriate concentration of drug polymer ratio by phase solubility analysis. The solvent evaporation study widely accepted due to its efficient solid dispersion in lesser efforts. The study designs were prepared with specific concentration of drug and polymer ratio with the help of high throughput model i.e. Central Composite Design (by Design Expert trial copy) by specific design of experiment with full factorial design (DOE). The fixed variables were concentration of polymers and dependant variables were dissolution and permeability across bio-membrane in in-vitro model. The prepared dispersion investigated for dissolution and permeability improvement using USP Type II apparatus and modified everted gut sac model which leads to improvement of quality of whole formulation with Quality by design efficiently.
Formulation development and invitro evaluation of lamotrigine fast dissolving...SriramNagarajan19
The present study was to formulate and evaluate oral fast dissolving Oral tablet containing Lamotrigine. Present study reveals that all the nine formulated tablet showed satisfactory tablet parameters. It can be concluded that, Oral fast dissolving tablet -containing Lamotrigine can be prepared by direct compression method. 10% CCS (FV) tablet exhibited required disintegration time and dissolution time. The drug release was about 98.7 % in 15min. The accelerated stability studies of the optimized F5 formulation indicates that the formulated oral fast dissolving tablet were unaffected after 3 months storage under accelerated conditions as there were no signs of visually distinguishable changes in appearance, disintegration time and cumulative percentage of drug release. From the present investigation it can be concluded that oral fast dissolving tablet formulation can be a potential novel drug dosage form for pediatric, geriatric and also for general population.
PREFORMULATION STUDY IN DESIGNING OF TABLET DOSAGES FORM.pptxSWASTIKPATNAIK1
Preformulation studies are important for determining the physicochemical properties of new drug substances before developing dosage forms. This document outlines preformulation studies conducted for omeprazole magnesium and carbamazepine to aid in the development of enteric coated tablets and buccal mucoadhesive tablets, respectively. Key tests included solubility analysis, stability analysis, particle size characterization, and in vitro drug release studies. The results of these preformulation studies provided guidance on suitable excipients and helped establish formulation designs and processing parameters to achieve the desired drug delivery profiles.
The document discusses a study on enhancing the solubility of loratadine, a class II drug with low solubility and high permeability, through solid dispersion techniques. Loratadine's solubility decreases with increasing pH. The study prepares solid dispersions of loratadine with β-cyclodextrin, HPC, and PEG-6000 and finds their solubility is greatly improved, especially at higher pH levels. Solubility is tested in buffers from pH 1.2 to 7.4. The co-precipitation method provides better solubility results than physical mixing for the dispersions tested.
Formulation Development and Evaluation of Mouth Dissolving Film of Ziprasidon...ijtsrd
The primary objective of this work was to develop a mouth dissolving film with Ziprasidone HCI, along with bioenhancer quercetin and basic ingredients like polymers, plasticizers, sweetener, saliva stimulating agent and flavor. The films were prepared by solvent casting I method. Quercetin enhances dissolution of drug which results in increase in CDR upto 99 . HPMC E5 cps, which was not able to impart thickness to the film, HPMC E15 shown good flexibility. The plasticizer propylene glycol which was not able to impart flexibility and folding endurance to the film. PEG 400 produced good folding endurance, tensile strength and percent elongation. The optimized formulation F3 was shown good mouth feel, folding endurance, instant drug release as well as good mechanical properties. The F3, shown less disintegration time of 31 seconds and 95 drug released within 3 minutes. Therefore it was concluded that rapid drug release was achieved for immediate onset of action using quercetin as natural bioenhancer which is beneficial and gives maximum drug release when compared to conventional dosage form. Jaydeep Jadhav "Formulation Development and Evaluation of Mouth Dissolving Film of Ziprasidone Using Natural Bioenhancer" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-5 , August 2022, URL: https://www.ijtsrd.com/papers/ijtsrd50464.pdf Paper URL: https://www.ijtsrd.com/pharmacy/pharmaceutics/50464/formulation-development-and-evaluation-of-mouth-dissolving-film-of-ziprasidone-using-natural-bioenhancer/jaydeep-jadhav
This document summarizes the development and evaluation of an in situ gelling system for the treatment of periodontitis using tinidazole as the model drug. Tinidazole was incorporated into gellan gum and poloxamer 407 polymer matrices using a 32 full factorial design to optimize the formulation variables. Nine formulations were developed varying the concentration of gellan gum (0.5-1.5% w/v) and poloxamer 407 (10-20% w/v). The formulations were characterized for appearance, gelling capacity, pH, viscosity, gelation temperature, drug content, syringeability and in vitro drug release. The optimized formulation with maximum desirability contained 0.5% w/
ABSTRACT The purpose of this study was to prepare and evaluate immediate release itraconazole pellets and comprehensive studies of the same. The itraconazole pellets is prepared using fluid bed processer with different concentration of HPMC (Hydroxy Propyl Methyl Cellulose). The physicochemical compatibility of the drug and the excipient studied by differential scanning calorimetry. The prepared pellets were physically evaluated with size, shape, bulk density, tapped density, compressibility index, hausners ratio, angle of repose, sieve analysis, surface roughness, density, moisture content, assay and drug release etc. The in vitro drug release profile from pellets shows that all the formulation release more than 75% drug within 90min. Optimized formulations were found to have HPMC concentration 2-5% of total weight of pellets to maximize high-quality surface, desired release, and size distribution within the range. These results indicate that pellets containing 10 % HPMC of total weight of pellets give better quality of itraconazole pellets for immediate release. Key Words: Itraconazole, Hydroxyl propyl methyl cellulose and Immediate release.
The oral route is the most favorable route for administration of drugs because of accurate dosage, low cost of therapy, self medication, non-invasive method, and ease of administration leading to a high level of patient compliance. Of the oral Dosage forms, solid dosage form is the preferred class of product as tablet represents a unit dosage form in which one dose of drug is placed accurately.
Formulation and evaluation of buccal disintegrating tablet of anticonvulsant ...AkshayAkotkar
This document discusses the formulation and evaluation of buccal disintegrating tablets of an anticonvulsant drug. It begins with an introduction to buccal drug delivery and the advantages of buccal disintegrating tablets over conventional dosage forms. The document then covers topics like permeability of drugs through oral mucosa, theories of adhesion, basic formulation components, and mechanisms of buccal disintegrating tablets. Nine formulations of gabapentin buccal tablets were developed and evaluated for characteristics like hardness, friability, drug content uniformity, disintegration time, and in-vitro drug release. Formulation F5 was found to have the highest drug release of 99.99% and was concluded to be the
The document discusses the liquisolid technique for enhancing drug dissolution and delivery. Liquisolid systems convert liquid drugs or drug suspensions into dry, flowable powders by mixing the liquid with select carrier and coating materials. This improves drug release characteristics and oral bioavailability. The key steps are: (1) dissolving the drug in a non-volatile solvent, (2) mixing this liquid medication with carrier material to absorb the liquid internally and externally, (3) adding a coating material to produce a dry, free-flowing powder, and (4) compressing the powder into tablets or filling capsules. Evaluation studies showed the liquisolid tablets had higher drug release and bioavailability compared to commercial formulations.
The document discusses preformulation studies for solids. The objectives are to develop a stable, safe and effective dosage form with maximum bioavailability. Preformulation testing characterizes the physical, chemical and other properties of a new drug to aid in dosage form development. Studies include analyzing the drug's crystallinity, polymorphism, particle size, solubility, stability and compatibility with excipients. Analytical techniques used include microscopy, spectroscopy, chromatography and thermal analysis to understand the drug's properties and develop an optimal dosage form.
Similar to Formulation, Development and Evaluation of Fast Disintegrating Tablet of Piroxicam using Solid Dispersion Technique (20)
‘Six Sigma Technique’ A Journey Through its Implementationijtsrd
The manufacturing industries all over the world are facing tough challenges for growth, development and sustainability in today’s competitive environment. They have to achieve apex position by adapting with the global competitive environment by delivering goods and services at low cost, prime quality and better price to increase wealth and consumer satisfaction. Cost Management ensures profit, growth and sustainability of the business with implementation of Continuous Improvement Technique like Six Sigma. This leads to optimize Business performance. The method drives for customer satisfaction, low variation, reduction in waste and cycle time resulting into a competitive advantage over other industries which did not implement it. The main objective of this paper ‘Six Sigma Technique A Journey Through Its Implementation’ is to conceptualize the effectiveness of Six Sigma Technique through the journey of its implementation. Aditi Sunilkumar Ghosalkar "‘Six Sigma Technique’: A Journey Through its Implementation" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64546.pdf Paper Url: https://www.ijtsrd.com/other-scientific-research-area/other/64546/‘six-sigma-technique’-a-journey-through-its-implementation/aditi-sunilkumar-ghosalkar
Edge Computing in Space Enhancing Data Processing and Communication for Space...ijtsrd
Edge computing, a paradigm that involves processing data closer to its source, has gained significant attention for its potential to revolutionize data processing and communication in space missions. With the increasing complexity and data volume generated by modern space missions, traditional centralized computing approaches face challenges related to latency, bandwidth, and security. Edge computing in space, involving on board processing and analysis of data, offers promising solutions to these challenges. This paper explores the concept of edge computing in space, its benefits, applications, and future prospects in enhancing space missions. Manish Verma "Edge Computing in Space: Enhancing Data Processing and Communication for Space Missions" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64541.pdf Paper Url: https://www.ijtsrd.com/computer-science/artificial-intelligence/64541/edge-computing-in-space-enhancing-data-processing-and-communication-for-space-missions/manish-verma
Dynamics of Communal Politics in 21st Century India Challenges and Prospectsijtsrd
Communal politics in India has evolved through centuries, weaving a complex tapestry shaped by historical legacies, colonial influences, and contemporary socio political transformations. This research comprehensively examines the dynamics of communal politics in 21st century India, emphasizing its historical roots, socio political dynamics, economic implications, challenges, and prospects for mitigation. The historical perspective unravels the intricate interplay of religious identities and power dynamics from ancient civilizations to the impact of colonial rule, providing insights into the evolution of communalism. The socio political dynamics section delves into the contemporary manifestations, exploring the roles of identity politics, socio economic disparities, and globalization. The economic implications section highlights how communal politics intersects with economic issues, perpetuating disparities and influencing resource allocation. Challenges posed by communal politics are scrutinized, revealing multifaceted issues ranging from social fragmentation to threats against democratic values. The prospects for mitigation present a multifaceted approach, incorporating policy interventions, community engagement, and educational initiatives. The paper conducts a comparative analysis with international examples, identifying common patterns such as identity politics and economic disparities. It also examines unique challenges, emphasizing Indias diverse religious landscape, historical legacy, and secular framework. Lessons for effective strategies are drawn from international experiences, offering insights into inclusive policies, interfaith dialogue, media regulation, and global cooperation. By scrutinizing historical epochs, contemporary dynamics, economic implications, and international comparisons, this research provides a comprehensive understanding of communal politics in India. The proposed strategies for mitigation underscore the importance of a holistic approach to foster social harmony, inclusivity, and democratic values. Rose Hossain "Dynamics of Communal Politics in 21st Century India: Challenges and Prospects" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64528.pdf Paper Url: https://www.ijtsrd.com/humanities-and-the-arts/history/64528/dynamics-of-communal-politics-in-21st-century-india-challenges-and-prospects/rose-hossain
Assess Perspective and Knowledge of Healthcare Providers Towards Elehealth in...ijtsrd
Background and Objective Telehealth has become a well known tool for the delivery of health care in Saudi Arabia, and the perspective and knowledge of healthcare providers are influential in the implementation, adoption and advancement of the method. This systematic review was conducted to examine the current literature base regarding telehealth and the related healthcare professional perspective and knowledge in the Kingdom of Saudi Arabia. Materials and Methods This systematic review was conducted by searching 7 databases including, MEDLINE, CINHAL, Web of Science, Scopus, PubMed, PsycINFO, and ProQuest Central. Studies on healthcare practitioners telehealth knowledge and perspectives published in English in Saudi Arabia from 2000 to 2023 were included. Boland directed this comprehensive review. The researchers examined each connected study using the AXIS tool, which evaluates cross sectional systematic reviews. Narrative synthesis was used to summarise and convey the data. Results Out of 1840 search results, 10 studies were included. Positive outlook and limited knowledge among providers were seen across trials. Healthcare professionals like telehealth for its ability to improve quality, access, and delivery, save time and money, and be successful. Age, gender, occupation, and work experience also affect health workers knowledge. In Saudi Arabia, healthcare professionals face inadequate expert assistance, patient privacy, internet connection concerns, lack of training courses, lack of telehealth understanding, and high costs while performing telemedicine. Conclusions Healthcare practitioners telehealth perceptions and knowledge were examined in this systematic study. Its collection of concerned experts different personal attitudes and expertise would help enhance telehealths implementation in Saudi Arabia, develop its healthcare delivery alternative, and eliminate frequent problems. Badriah Mousa I Mulayhi | Dr. Jomin George | Judy Jenkins "Assess Perspective and Knowledge of Healthcare Providers Towards Elehealth in Saudi Arabia: A Systematic Review" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64535.pdf Paper Url: https://www.ijtsrd.com/medicine/other/64535/assess-perspective-and-knowledge-of-healthcare-providers-towards-elehealth-in-saudi-arabia-a-systematic-review/badriah-mousa-i-mulayhi
The Impact of Digital Media on the Decentralization of Power and the Erosion ...ijtsrd
The impact of digital media on the distribution of power and the weakening of traditional gatekeepers has gained considerable attention in recent years. The adoption of digital technologies and the internet has resulted in declining influence and power for traditional gatekeepers such as publishing houses and news organizations. Simultaneously, digital media has facilitated the emergence of new voices and players in the media industry. Digital medias impact on power decentralization and gatekeeper erosion is visible in several ways. One significant aspect is the democratization of information, which enables anyone with an internet connection to publish and share content globally, leading to citizen journalism and bypassing traditional gatekeepers. Another aspect is the disruption of conventional media industry business models, as traditional organizations struggle to adjust to the decrease in advertising revenue and the rise of digital platforms. Alternative business models, such as subscription models and crowdfunding, have become more prevalent, leading to the emergence of new players. Overall, the impact of digital media on the distribution of power and the weakening of traditional gatekeepers has brought about significant changes in the media landscape and the way information is shared. Further research is required to fully comprehend the implications of these changes and their impact on society. Dr. Kusum Lata "The Impact of Digital Media on the Decentralization of Power and the Erosion of Traditional Gatekeepers" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64544.pdf Paper Url: https://www.ijtsrd.com/humanities-and-the-arts/political-science/64544/the-impact-of-digital-media-on-the-decentralization-of-power-and-the-erosion-of-traditional-gatekeepers/dr-kusum-lata
Online Voices, Offline Impact Ambedkars Ideals and Socio Political Inclusion ...ijtsrd
This research investigates the nexus between online discussions on Dr. B.R. Ambedkars ideals and their impact on social inclusion among college students in Gurugram, Haryana. Surveying 240 students from 12 government colleges, findings indicate that 65 actively engage in online discussions, with 80 demonstrating moderate to high awareness of Ambedkars ideals. Statistically significant correlations reveal that higher online engagement correlates with increased awareness p 0.05 and perceived social inclusion. Variations across colleges and a notable effect of college type on perceived social inclusion highlight the influence of contextual factors. Furthermore, the intersectional analysis underscores nuanced differences based on gender, caste, and socio economic status. Dr. Kusum Lata "Online Voices, Offline Impact: Ambedkar's Ideals and Socio-Political Inclusion - A Study of Gurugram District" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64543.pdf Paper Url: https://www.ijtsrd.com/humanities-and-the-arts/political-science/64543/online-voices-offline-impact-ambedkars-ideals-and-sociopolitical-inclusion--a-study-of-gurugram-district/dr-kusum-lata
Problems and Challenges of Agro Entreprenurship A Studyijtsrd
Noting calls for contextualizing Agro entrepreneurs problems and challenges of the agro entrepreneurs and for greater attention to the Role of entrepreneurs in agro entrepreneurship research, we conduct a systematic literature review of extent research in agriculture entrepreneurship to overcome the study objectives of complications of agro entrepreneurs through various factors, Development of agriculture products is a key factor for the overall economic growth of agro entrepreneurs Agro Entrepreneurs produces firsthand large scale employment, utilizes the labor and natural resources, This research outlines the problems of Weather and Soil Erosions, Market price fluctuation, stimulates labor cost problems, reduces concentration of Price volatility, Dependency on Intermediaries, induces Limited Bargaining Power, and Storage and Transportation Costs. This paper mainly devoted to highlight Problems and challenges faced for the sustainable of Agro Entrepreneurs in India. Vinay Prasad B "Problems and Challenges of Agro Entreprenurship - A Study" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64540.pdf Paper Url: https://www.ijtsrd.com/other-scientific-research-area/other/64540/problems-and-challenges-of-agro-entreprenurship--a-study/vinay-prasad-b
Comparative Analysis of Total Corporate Disclosure of Selected IT Companies o...ijtsrd
Disclosure is a process through which a business enterprise communicates with external parties. A corporate disclosure is communication of financial and non financial information of the activities of a business enterprise to the interested entities. Corporate disclosure is done through publishing annual reports. So corporate disclosure through annual reports plays a vital role in the life of all the companies and provides valuable information to investors. The basic objectives of corporate disclosure is to give a true and fair view of companies to the parties related either directly or indirectly like owner, government, creditors, shareholders etc. in the companies act, provisions have been made about mandatory and voluntary disclosure. The IT sector in India is rapidly growing, the trend to invest in the IT sector is rising and employment opportunities in IT sectors are also increasing. Therefore the IT sector is expected to have fair, full and adequate disclosure of all information. Unfair and incomplete disclosure may adversely affect the entire economy. A research study on disclosure practices of IT companies could play an important role in this regard. Hence, the present research study has been done to study and review comparative analysis of total corporate disclosure of selected IT companies of India and to put forward overall findings and suggestions with a view to increase disclosure score of these companies. The researcher hopes that the present research study will be helpful to all selected Companies for improving level of corporate disclosure through annual reports as well as the government, creditors, investors, all business organizations and upcoming researcher for comparative analyses of level of corporate disclosure with special reference to selected IT companies. Dr. Vaibhavi D. Thaker "Comparative Analysis of Total Corporate Disclosure of Selected IT Companies of India" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64539.pdf Paper Url: https://www.ijtsrd.com/other-scientific-research-area/other/64539/comparative-analysis-of-total-corporate-disclosure-of-selected-it-companies-of-india/dr-vaibhavi-d-thaker
The Impact of Educational Background and Professional Training on Human Right...ijtsrd
This study investigated the impact of educational background and professional training on human rights awareness among secondary school teachers in the Marathwada region of Maharashtra, India. The key findings reveal that higher levels of education, particularly a master’s degree, and fields of study related to education, humanities, or social sciences are associated with greater human rights awareness among teachers. Additionally, both pre service teacher training and in service professional development programs focused on human rights education significantly enhance teacher’s knowledge, skills, and competencies in promoting human rights principles in their classrooms. Baig Ameer Bee Mirza Abdul Aziz | Dr. Syed Azaz Ali Amjad Ali "The Impact of Educational Background and Professional Training on Human Rights Awareness among Secondary School Teachers" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64529.pdf Paper Url: https://www.ijtsrd.com/humanities-and-the-arts/education/64529/the-impact-of-educational-background-and-professional-training-on-human-rights-awareness-among-secondary-school-teachers/baig-ameer-bee-mirza-abdul-aziz
A Study on the Effective Teaching Learning Process in English Curriculum at t...ijtsrd
“One Language sets you in a corridor for life. Two languages open every door along the way” Frank Smith English as a foreign language or as a second language has been ruling in India since the period of Lord Macaulay. But the question is how much we teach or learn English properly in our culture. Is there any scope to use English as a language rather than a subject How much we learn or teach English without any interference of mother language specially in the classroom teaching learning scenario in West Bengal By considering all these issues the researcher has attempted in this article to focus on the effective teaching learning process comparing to other traditional strategies in the field of English curriculum at the secondary level to investigate whether they fulfill the present teaching learning requirements or not by examining the validity of the present curriculum of English. The purpose of this study is to focus on the effectiveness of the systematic, scientific, sequential and logical transaction of the course between the teachers and the learners in the perspective of the 5Es programme that is engage, explore, explain, extend and evaluate. Sanchali Mondal | Santinath Sarkar "A Study on the Effective Teaching Learning Process in English Curriculum at the Secondary Level of West Bengal" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd62412.pdf Paper Url: https://www.ijtsrd.com/humanities-and-the-arts/education/62412/a-study-on-the-effective-teaching-learning-process-in-english-curriculum-at-the-secondary-level-of-west-bengal/sanchali-mondal
The Role of Mentoring and Its Influence on the Effectiveness of the Teaching ...ijtsrd
This paper reports on a study which was conducted to investigate the role of mentoring and its influence on the effectiveness of the teaching of Physics in secondary schools in the South West Region of Cameroon. The study adopted the convergent parallel mixed methods design, focusing on respondents in secondary schools in the South West Region of Cameroon. Both quantitative and qualitative data were collected, analysed separately, and the results were compared to see if the findings confirm or disconfirm each other. The quantitative analysis found that majority of the respondents 72 of Physics teachers affirmed that they had more experienced colleagues as mentors to help build their confidence, improve their teaching, and help them improve their effectiveness and efficiency in guiding learners’ achievements. Only 28 of the respondents disagreed with these statements. With majority respondents 72 agreeing with the statements, it implies that in most secondary schools, experienced Physics teachers act as mentors to build teachers’ confidence in teaching and improving students’ learning. The interview qualitative data analysis summarized how secondary school Principals use meetings with mentors and mentees to promote mentorship in the school milieu. This has helped strengthen teachers’ classroom practices in secondary schools in the South West Region of Cameroon. With the results confirming each other, the study recommends that mentoring should focus on helping teachers employ social interactions and instructional practices feedback and clarity in teaching that have direct measurable impact on students’ learning achievements. Andrew Ngeim Sumba | Frederick Ebot Ashu | Peter Agborbechem Tambi "The Role of Mentoring and Its Influence on the Effectiveness of the Teaching of Physics in Secondary Schools in the South West Region of Cameroon" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64524.pdf Paper Url: https://www.ijtsrd.com/management/management-development/64524/the-role-of-mentoring-and-its-influence-on-the-effectiveness-of-the-teaching-of-physics-in-secondary-schools-in-the-south-west-region-of-cameroon/andrew-ngeim-sumba
Design Simulation and Hardware Construction of an Arduino Microcontroller Bas...ijtsrd
This study primarily focuses on the design of a high side buck converter using an Arduino microcontroller. The converter is specifically intended for use in DC DC applications, particularly in standalone solar PV systems where the PV output voltage exceeds the load or battery voltage. To evaluate the performance of the converter, simulation experiments are conducted using Proteus Software. These simulations provide insights into the input and output voltages, currents, powers, and efficiency under different state of charge SoC conditions of a 12V,70Ah rechargeable lead acid battery. Additionally, the hardware design of the converter is implemented, and practical data is collected through operation, monitoring, and recording. By comparing the simulation results with the practical results, the efficiency and performance of the designed converter are assessed. The findings indicate that while the buck converter is suitable for practical use in standalone PV systems, its efficiency is compromised due to a lower output current. Chan Myae Aung | Dr. Ei Mon "Design Simulation and Hardware Construction of an Arduino-Microcontroller Based DC-DC High-Side Buck Converter for Standalone PV System" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64518.pdf Paper Url: https://www.ijtsrd.com/engineering/mechanical-engineering/64518/design-simulation-and-hardware-construction-of-an-arduinomicrocontroller-based-dcdc-highside-buck-converter-for-standalone-pv-system/chan-myae-aung
Sustainable Energy by Paul A. Adekunte | Matthew N. O. Sadiku | Janet O. Sadikuijtsrd
Energy becomes sustainable if it meets the needs of the present without compromising the ability of future generations to meet their own needs. Some of the definitions of sustainable energy include the considerations of environmental aspects such as greenhouse gas emissions, social, and economic aspects such as energy poverty. Generally far more sustainable than fossil fuel are renewable energy sources such as wind, hydroelectric power, solar, and geothermal energy sources. Worthy of note is that some renewable energy projects, like the clearing of forests to produce biofuels, can cause severe environmental damage. The sustainability of nuclear power which is a low carbon source is highly debated because of concerns about radioactive waste, nuclear proliferation, and accidents. The switching from coal to natural gas has environmental benefits, including a lower climate impact, but could lead to delay in switching to more sustainable options. “Carbon capture and storage” can be built into power plants to remove the carbon dioxide CO2 emissions, but this technology is expensive and has rarely been implemented. Leading non renewable energy sources around the world is fossil fuels, coal, petroleum, and natural gas. Nuclear energy is usually considered another non renewable energy source, although nuclear energy itself is a renewable energy source, but the material used in nuclear power plants is not. The paper addresses the issue of sustainable energy, its attendant benefits to the future generation, and humanity in general. Paul A. Adekunte | Matthew N. O. Sadiku | Janet O. Sadiku "Sustainable Energy" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64534.pdf Paper Url: https://www.ijtsrd.com/engineering/electrical-engineering/64534/sustainable-energy/paul-a-adekunte
Concepts for Sudan Survey Act Implementations Executive Regulations and Stand...ijtsrd
This paper aims to outline the executive regulations, survey standards, and specifications required for the implementation of the Sudan Survey Act, and for regulating and organizing all surveying work activities in Sudan. The act has been discussed for more than 5 years. The Land Survey Act was initiated by the Sudan Survey Authority and all official legislations were headed by the Sudan Ministry of Justice till it was issued in 2022. The paper presents conceptual guidelines to be used for the Survey Act implementation and to regulate the survey work practice, standardizing the field surveys, processing, quality control, procedures, and the processes related to survey work carried out by the stakeholders and relevant authorities in Sudan. The conceptual guidelines are meant to improve the quality and harmonization of geospatial data and to aid decision making processes as well as geospatial information systems. The established comprehensive executive regulations will govern and regulate the implementation of the Sudan Survey Geomatics Act in all surveying and mapping practices undertaken by the Sudan Survey Authority SSA and state local survey departments for public or private sector organizations. The targeted standards and specifications include the reference frame, projection, coordinate systems, and the guidelines and specifications that must be followed in the field of survey work, processes, and mapping products. In the last few decades, there has been a growing awareness of the importance of geomatics activities and measurements on the Earths surface in space and time, together with observing and mapping the changes. In such cases, data must be captured promptly, standardized, and obtained with more accuracy and specified in much detail. The paper will also highlight the current situation in Sudan, the degree to which survey standards are used, the problems encountered, and the errors that arise from not using the standards and survey specifications. Kamal A. A. Sami "Concepts for Sudan Survey Act Implementations - Executive Regulations and Standards" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63484.pdf Paper Url: https://www.ijtsrd.com/engineering/civil-engineering/63484/concepts-for-sudan-survey-act-implementations--executive-regulations-and-standards/kamal-a-a-sami
Towards the Implementation of the Sudan Interpolated Geoid Model Khartoum Sta...ijtsrd
The discussions between ellipsoid and geoid have invoked many researchers during the recent decades, especially during the GNSS technology era, which had witnessed a great deal of development but still geoid undulation requires more investigations. To figure out a solution for Sudans local geoid, this research has tried to intake the possibility of determining the geoid model by following two approaches, gravimetric and geometrical geoid model determination, by making use of GNSS leveling benchmarks at Khartoum state. The Benchmarks are well distributed in the study area, in which, the horizontal coordinates and the height above the ellipsoid have been observed by GNSS while orthometric heights were carried out using precise leveling. The Global Geopotential Model GGM represented in EGM2008 has been exploited to figure out the geoid undulation at the benchmarks in the study area. This is followed by a fitting process, that has been done to suit the geoid undulation data which has been computed using GNSS leveling data and geoid undulation inspired by the EGM2008. Two geoid surfaces were created after the fitting process to ensure that they are identical and both of them could be counted for getting the same geoid undulation with an acceptable accuracy. In this respect, statistical operation played an important role in ensuring the consistency and integrity of the model by applying cross validation techniques splitting the data into training and testing datasets for building the geoid model and testing its eligibility. The geometrical solution for geoid undulation computation has been utilized by applying straightforward equations that facilitate the calculation of the geoid undulation directly through applying statistical techniques for the GNSS leveling data of the study area to get the common equation parameters values that could be utilized to calculate geoid undulation of any position in the study area within the claimed accuracy. Both systems were checked and proved eligible to be used within the study area with acceptable accuracy which may contribute to solving the geoid undulation problem in the Khartoum area, and be further generalized to determine the geoid model over the entire country, and this could be considered in the future, for regional and continental geoid model. Ahmed M. A. Mohammed. | Kamal A. A. Sami "Towards the Implementation of the Sudan Interpolated Geoid Model (Khartoum State Case Study)" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63483.pdf Paper Url: https://www.ijtsrd.com/engineering/civil-engineering/63483/towards-the-implementation-of-the-sudan-interpolated-geoid-model-khartoum-state-case-study/ahmed-m-a-mohammed
Activating Geospatial Information for Sudans Sustainable Investment Mapijtsrd
Sudan is witnessing an acceleration in the processes of development and transformation in the performance of government institutions to raise the productivity and investment efficiency of the government sector. The development plans and investment opportunities have focused on achieving national goals in various sectors. This paper aims to illuminate the path to the future and provide geospatial data and information to develop the investment climate and environment for all sized businesses, and to bridge the development gap between the Sudan states. The Sudan Survey Authority SSA is the main advisor to the Sudan Government in conducting surveying, mappings, designing, and developing systems related to geospatial data and information. In recent years, SSA made a strategic partnership with the Ministry of Investment to activate Geospatial Information for Sudans Sustainable Investment and in particular, for the preparation and implementation of the Sudan investment map, based on the directives and objectives of the Ministry of Investment MI in Sudan. This paper comes within the framework of activating the efforts of the Ministry of Investment to develop technical investment services by applying techniques adopted by the Ministry and its strategic partners for advancing investment processes in the country. Kamal A. A. Sami "Activating Geospatial Information for Sudan's Sustainable Investment Map" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63482.pdf Paper Url: https://www.ijtsrd.com/engineering/information-technology/63482/activating-geospatial-information-for-sudans-sustainable-investment-map/kamal-a-a-sami
Educational Unity Embracing Diversity for a Stronger Societyijtsrd
In a rapidly changing global landscape, the importance of education as a unifying force cannot be overstated. This paper explores the crucial role of educational unity in fostering a stronger and more inclusive society through the embrace of diversity. By examining the benefits of diverse learning environments, the paper aims to highlight the positive impact on societal strength. The discussion encompasses various dimensions, from curriculum design to classroom dynamics, and emphasizes the need for educational institutions to become catalysts for unity in diversity. It highlights the need for a paradigm shift in educational policies, curricula, and pedagogical approaches to ensure that they are reflective of the diverse fabric of society. This paper also addresses the challenges associated with implementing inclusive educational practices and offers practical strategies for overcoming barriers. It advocates for collaborative efforts between educational institutions, policymakers, and communities to create a supportive ecosystem that promotes diversity and unity. Mr. Amit Adhikari | Madhumita Teli | Gopal Adhikari "Educational Unity: Embracing Diversity for a Stronger Society" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64525.pdf Paper Url: https://www.ijtsrd.com/humanities-and-the-arts/education/64525/educational-unity-embracing-diversity-for-a-stronger-society/mr-amit-adhikari
Integration of Indian Indigenous Knowledge System in Management Prospects and...ijtsrd
The diversity of indigenous knowledge systems in India is vast and can vary significantly between different communities and regions. Preserving and respecting these knowledge systems is crucial for maintaining cultural heritage, promoting sustainable practices, and fostering cross cultural understanding. In this paper, an overview of the prospects and challenges associated with incorporating Indian indigenous knowledge into management is explored. It is found that IIKS helps in management in many areas like sustainable development, tourism, food security, natural resource management, cultural preservation and innovation, etc. However, IIKS integration with management faces some challenges in the form of a lack of documentation, cultural sensitivity, language barriers legal framework, etc. Savita Lathwal "Integration of Indian Indigenous Knowledge System in Management: Prospects and Challenges" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63500.pdf Paper Url: https://www.ijtsrd.com/management/accounting-and-finance/63500/integration-of-indian-indigenous-knowledge-system-in-management-prospects-and-challenges/savita-lathwal
DeepMask Transforming Face Mask Identification for Better Pandemic Control in...ijtsrd
The COVID 19 pandemic has highlighted the crucial need of preventive measures, with widespread use of face masks being a key method for slowing the viruss spread. This research investigates face mask identification using deep learning as a technological solution to be reducing the risk of coronavirus transmission. The proposed method uses state of the art convolutional neural networks CNNs and transfer learning to automatically recognize persons who are not wearing masks in a variety of circumstances. We discuss how this strategy improves public health and safety by providing an efficient manner of enforcing mask wearing standards. The report also discusses the obstacles, ethical concerns, and prospective applications of face mask detection systems in the ongoing fight against the pandemic. Dilip Kumar Sharma | Aaditya Yadav "DeepMask: Transforming Face Mask Identification for Better Pandemic Control in the COVID-19 Era" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd64522.pdf Paper Url: https://www.ijtsrd.com/engineering/electronics-and-communication-engineering/64522/deepmask-transforming-face-mask-identification-for-better-pandemic-control-in-the-covid19-era/dilip-kumar-sharma
Streamlining Data Collection eCRF Design and Machine Learningijtsrd
Efficient and accurate data collection is paramount in clinical trials, and the design of Electronic Case Report Forms eCRFs plays a pivotal role in streamlining this process. This paper explores the integration of machine learning techniques in the design and implementation of eCRFs to enhance data collection efficiency. We delve into the synergies between eCRF design principles and machine learning algorithms, aiming to optimize data quality, reduce errors, and expedite the overall data collection process. The application of machine learning in eCRF design brings forth innovative approaches to data validation, anomaly detection, and real time adaptability. This paper discusses the benefits, challenges, and future prospects of leveraging machine learning in eCRF design for streamlined and advanced data collection in clinical trials. Dhanalakshmi D | Vijaya Lakshmi Kannareddy "Streamlining Data Collection: eCRF Design and Machine Learning" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63515.pdf Paper Url: https://www.ijtsrd.com/biological-science/biotechnology/63515/streamlining-data-collection-ecrf-design-and-machine-learning/dhanalakshmi-d
Physiology and chemistry of skin and pigmentation, hairs, scalp, lips and nail, Cleansing cream, Lotions, Face powders, Face packs, Lipsticks, Bath products, soaps and baby product,
Preparation and standardization of the following : Tonic, Bleaches, Dentifrices and Mouth washes & Tooth Pastes, Cosmetics for Nails.
A Strategic Approach: GenAI in EducationPeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
A review of the growth of the Israel Genealogy Research Association Database Collection for the last 12 months. Our collection is now passed the 3 million mark and still growing. See which archives have contributed the most. See the different types of records we have, and which years have had records added. You can also see what we have for the future.
বাংলাদেশের অর্থনৈতিক সমীক্ষা ২০২৪ [Bangladesh Economic Review 2024 Bangla.pdf] কম্পিউটার , ট্যাব ও স্মার্ট ফোন ভার্সন সহ সম্পূর্ণ বাংলা ই-বুক বা pdf বই " সুচিপত্র ...বুকমার্ক মেনু 🔖 ও হাইপার লিংক মেনু 📝👆 যুক্ত ..
আমাদের সবার জন্য খুব খুব গুরুত্বপূর্ণ একটি বই ..বিসিএস, ব্যাংক, ইউনিভার্সিটি ভর্তি ও যে কোন প্রতিযোগিতা মূলক পরীক্ষার জন্য এর খুব ইম্পরট্যান্ট একটি বিষয় ...তাছাড়া বাংলাদেশের সাম্প্রতিক যে কোন ডাটা বা তথ্য এই বইতে পাবেন ...
তাই একজন নাগরিক হিসাবে এই তথ্য গুলো আপনার জানা প্রয়োজন ...।
বিসিএস ও ব্যাংক এর লিখিত পরীক্ষা ...+এছাড়া মাধ্যমিক ও উচ্চমাধ্যমিকের স্টুডেন্টদের জন্য অনেক কাজে আসবে ...
The simplified electron and muon model, Oscillating Spacetime: The Foundation...RitikBhardwaj56
Discover the Simplified Electron and Muon Model: A New Wave-Based Approach to Understanding Particles delves into a groundbreaking theory that presents electrons and muons as rotating soliton waves within oscillating spacetime. Geared towards students, researchers, and science buffs, this book breaks down complex ideas into simple explanations. It covers topics such as electron waves, temporal dynamics, and the implications of this model on particle physics. With clear illustrations and easy-to-follow explanations, readers will gain a new outlook on the universe's fundamental nature.
How to Fix the Import Error in the Odoo 17Celine George
An import error occurs when a program fails to import a module or library, disrupting its execution. In languages like Python, this issue arises when the specified module cannot be found or accessed, hindering the program's functionality. Resolving import errors is crucial for maintaining smooth software operation and uninterrupted development processes.
Exploiting Artificial Intelligence for Empowering Researchers and Faculty, In...Dr. Vinod Kumar Kanvaria
Exploiting Artificial Intelligence for Empowering Researchers and Faculty,
International FDP on Fundamentals of Research in Social Sciences
at Integral University, Lucknow, 06.06.2024
By Dr. Vinod Kumar Kanvaria
Main Java[All of the Base Concepts}.docxadhitya5119
This is part 1 of my Java Learning Journey. This Contains Custom methods, classes, constructors, packages, multithreading , try- catch block, finally block and more.
2. International Journal of Trend in Scientific Research and Development @ www.ijtsrd.com eISSN: 2456-6470
@ IJTSRD | Unique Paper ID – IJTSRD50422 | Volume – 6 | Issue – 5 | July-August 2022 Page 158
two components the drug and the polymer matrix.
Hence, this approach is expected to form a basis for
the commercialization of many poorly water-soluble
and water-insoluble drugs in their solid-dispersion
formulations in the near future. These poorly water
soluble drugs i.e. BCS class II drugs absorption from
the gastrointestinal tract can be limited by a number
of factors; most significant contributors are poor
aqueous solubility & poor membrane permeability of
the drug molecule. Therefore, the improvement of
drug solubility thereby its oral bioavailability remains
one of most challenging aspects of drug development
process especially for oral drug delivery system. Out
of many categories, Non steroidal anti-inflammatory
drugs, Analgesic drugs are the most widelyprescribed
medication. Piroxicam is an Analgesic and non
steroidal anti inflamatory drug commonly used to
relieve the pain and inflammation. Piroxicam belongs
to BCS class II drugs which has low solubility and
high permeability. Piroxicam mostly permeable
through stomach but due to its solubility limitation it
can’t enter into systemic circulation. After this time
Piroxicam goes in to small intestine where it is
solubilized but can’t permeate through its membrane
(Piroxicam having pH depended solubility and
permeability). So, to improve dissolution of such drug
is challenging and rational. Recently a totally unique
approach supported the use of microwave
irradiation has been proposed for the preparation of
SD. Microwaves irradiation (MW) could also be a
well-known method for heating and drying
materials. Microwaves, with their ability to
penetrate any substance, allow the assembly of
heat in any point of the sample at the same time
this is often because of the presence in it of
molecules characterized by a dipolar moment able
to absorb microwave energy and convert it into
heat. This phenomenon occurs when the
microwave frequency is on the brink of the
resonance frequency of the polar molecules. The
efficient heating of materials by microwaves
depends on the capacity of a selected material to
soak up microwave energy. Microwave energy has
been employed to vary the crystalline state of a
drug, instead of conventional heating. [1, 2]
MATERIALS AND METHODS
Materials
All materials used in present research were
commercial samples. Active pharmaceutical
ingredient: Piroxicam (Aarti Pharma, Mumbai)
Hydrophilic polymers: Polyethylene glycol 6000,
Sodium lauryl sulphate (Research lab Fine chem.
Industry, Mumbai), Excipients: Sodium starch
glycolate, Croscarmellose Sodium, Crospovidone,
(Research lab fine chem. Islampur), Microcrystalline
cellulose, Magnesium stearate, Mannitol, Talc
(Research lab fine chem. Mumbai).
Preformulation Studies of Piroxicam
Organoleptic Evaluation, Melting point, Solubility
profile and Loss on drying of Piroxicam drug for
identification and authentication of received sample
for further formulation studies of solid dispersion [3, 4]
Scanning of Piroxicam in Phosphate Buffer pH6.8
Solution
The standard solution (10ug/mL) was scanned from
200-400 nm on UV spectrophotometer (Shimadzu
UV-1800). Primary standard solution of Piroxicam
was prepared by dissolving 10 mg of Piroxicam in
100 mL of the phosphate buffer pH 6.8 solutions to
obtain a solution of 100 ug/mL Aliquot of 0.5 mL, 1.0
mL, 1.5 mL, 2.0 mL and 2.5 mL from the standard
stock solution were transferred to 10mL volumetric
flask and the volume was adjusted up to the mark
with phosphate buffer pH 6.8 to obtain a
concentration of 5ug/mL, 10ug/mL, 15ug/mL,
20ug/mL and 25ug/mL The absorbance was
determined at 354 nm against blank. The calibration
curve is shown in Figure (2) and absorbances of
different concentration of Piroxicam are reported in
Table (4) [7, 8, 9, 17]
Drug Excipient Compatibility Studies by using
FTIR Spectroscopy of Piroxicam and PEG 6000
and SLS
Piroxicam, polymer and solid dispersion was
prepared and mixed with suitable quantity of
Potassium bromide. About 100mg of this sample was
compressed to form a transparent pellet using a
hydraulic press at 10 tons pressure. It was scanned
from 4000 to 600 cm-1
FTIR Spectrophotometer. The
interaction between drug-excipients was observed
from IR spectral studies by observing any shift in
peaks of drug in the spectrum of physical mixture of
drug. [11, 12, 13]
Formulation and Development of Solid Dispersion
of Piroxicam
Solid dispersion of drug and polymer was prepared by
using Microwave induced fusion method and
conventional fusion method in various ratios such as
Piroxicam + PEG 6000 (1:1), Piroxicam + PEG 6000
+ SLS (1:1:0.75), Piroxicam + PEG6000 (1:2),
Piroxicam+PEG6000 + SLS (1:2:0.75), Piroxicam +
PEG 6000 (1:3), Piroxicam + PEG 6000 + SLS
(1:3:0.75) Piroxicam + PEG 6000 (1:4), Piroxicam +
PEG 6000 + SLS (1:4:0.75) and Solid dispersion
prepared by conventional fusion method were F1, F2,
F3, F4, F5, F6, F7, F8 and solid dispersion prepared
by microwave induced fusion method F9, F10, F11,
F12, F13, F14, F15 and F16 respectively.[11]
3. International Journal of Trend in Scientific Research and Development @ www.ijtsrd.com eISSN: 2456-6470
@ IJTSRD | Unique Paper ID – IJTSRD50422 | Volume – 6 | Issue – 5 | July-August 2022 Page 159
Table 1 Formulation of Drug and Polymer
Formulations / Batches Composition Method Ratio
F1 Piroxicam+ PEG 6000 Conventional Fusion Method 1:1
F2 Piroxicam +PEG 6000 +SLS Conventional Fusion Method 1:1:0.75
F3 Piroxicam + PEG 6000 Conventional Fusion Method 1:2
F4 Piroxicam +PEG 6000 +SLS Conventional Fusion Method 1:2:0.75
F5 Piroxicam +PEG 6000 Conventional Fusion Method 1:3
F6 Piroxicam + PEG 6000+SLS Conventional Fusion Method 1:3:0.75
F7 Piroxicam +PEG 6000 Conventional Fusion Method 1:4
F8 Piroxicam + PEG 6000+SLS Conventional Fusion Method 1:4:0.75
F9 Piroxicam+ PEG 6000 Microwave Induced Fusion Method 1:1
F10 Piroxicam +PEG 6000 +SLS Microwave Induced Fusion Method 1:1:0.75
F11 Piroxicam + PEG 6000 Microwave Induced Fusion Method 1:2
F12 Piroxicam +PEG 6000 +SLS Microwave Induced Fusion Method 1:2:0.75
F13 Piroxicam +PEG 6000 Microwave Induced Fusion Method 1:3
F14 Piroxicam +PEG 6000 +SLS Microwave Induced Fusion Method 1:3:0.75
F15 Piroxicam +PEG 6000 Microwave Induced Fusion Method 1:4
F16 Piroxicam + PEG 6000+SLS Microwave Induced Fusion Method 1:4:0.75
Conventional Fusion Method
In conventional fusion method the polymer was heated to molten mass and to this weighed amount of Piroxicam
was added with continuous stirring with or without SLS until mixture get melt completely and drug molecules
are get dispersed uniformly in polymer occur. Solidification was allowed to occur at room temperature. The
product was stored in a dessicator for 24 h and then pulverized using a porcelain mortar and pestle. The
pulverized powder was passed through 100# sieve to get uniform particle size. [11]
Microwave Induced Fusion Method
In microwave induced fusion method microwave energy used to prepare solid dispersion. The drug and
hydrophilic polymer will get fused together to form solid dispersion. Solid dispersion is prepared by placing the
mixture of drug and polymer in porcelain dish and subjected to microwave radiation. Only one sample is place at
a time inside the microwave oven. Only one sample is placed at a time inside the microwave oven. Porcelain
dish is place in room temperature to solidify molten mass. The solid dispersion is placed in desiccators for 24 hr.
and then product is pulverize using a porcelain mortar and pestle. The pulverize powder is pass through 100#
sieve. [11]
Comparative Solubility and Dissolution Study to Select the Optimum Batch of Solid Dispersion
Comparative solubility and dissolution study of Piroxicam and Solid dispersion batches to select the optimum
batch of solid dispersion for further studies.
Solubility study of Solid Dispersion and Piroxicam
Solubility measurement of Piroxicam were performed according to a published method. The amount of solid
dispersion powder containing 2.5mg equivalent Piroxicam was weighed accurately in volumetric flask was
dissolved 5ml distilled water by sonication for 15 min subsequently, the solutions were filtered through a
Whatman filter paper no. 1 Filtered solution was diluted properly with distilled water. The diluted solution was
analyzed for the Piroxicam in UV at 354nm.[11]
In vitro Dissolution Study of Pure Drug and Solid Dispersion Using Conventional Fusion Method and
Microwave Induced Fusion Method.
Dissolution profiles of Piroxicam and solid dispersion were determined using the USP Type II Dissolution test
apparatus (Electrolab Model TDT-08L) set with a paddle speed of 50 rpm. Dissolution was performed in 900 ml
of phosphate buffer pH 6.8 maintained at 370
± 0.50
C. The 20 mg of Piroxicam, and The solid dispersion
containing equivalent of 20mg of Piroxicam and PEG 6000 (1:1, 1:0.75, 1:2, 1:2:0.75, 1:3, 1:3:0.75, 1:4,
1:4:0.75) Conventional Fusion Method and Microwave Induced Fusion Method batches of solid dispersion from
F1 to F16 was taken in a muslin cloth and tied to the rotating paddle kept in vessel of dissolution apparatus the
paddle was rotated at 50 rpm. Aliquot of dissolution medium, 5 ml was withdrawn at specified time and filtered
through Whatmann filter paper. The amount of drug dissolved was determined by UV-Visible
spectrophotometer by measuring the absorbance of the sample at 354 nm. An equal volume of fresh medium,
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prewarmed at 370
C was replaced into the dissolution medium after each sampling to maintain the constant
volume throughout the test. Three trials for each batch were performed and average percentage drug release.[11]
Comparative Dissolution Study of Piroxicam and solid dispersion
The dissolution of pure drug is compare with solid dispersion by conventional fusion method (F8) and
microwave induced fusion method (F16) which is shown in Table 12 and graph was plotted to show % drug
release which was represented in Figure 10
Selection of Optimum Batch of Solid Dispersion for formulation of Fast Disintegrating Tablet
For Selection of the optimum batch Solid Dispersion Technique, the dissolution of the pure drug Piroxicam and
its Solid Dispersion by Conventional Fusion Method and Microwave Induced Fusion Method is compare.
EVALUATION OF SOLID DISPERSION [11, 13]
Physical appearance
Visual inspection of all batches of solid dispersions such as color and appearance.
Percentage yield Study of Solid Dispersion
Percentage yield was calculated with respect to dry product. Based on the practical yield (P.Y) obtained a0nd the
calculated theoretical yield (T.Y), % yield was calculated by using the following formula:
PY (%) = [Practical weight/Theoretical weight (Drug +Carrier)] ×100 ......Eqn
1
Where,
a = Practical weight of solid dispersion obtained
b = Theoretical weight of solid dispersion preparation.
Drug Content
Determination of drug content in solid dispersion powder solid dispersion equivalent to 20 mg of Piroxicam was
accurately weighed and transferred to a 100 ml volumetric flask. About 30 ml of distilled water was added and
flask was shaken to dissolve the contents completely and the volume was made up to the mark with distilled
water. The concentration of this resulting solution was 100µg/ml. From this solution, 1 ml of solution was taken
in another 10 ml volumetric flask, and volume was made up to 10 ml with distilled water. The solution was
analyzed spectrophotometric at 354 nm against corresponding reagent blank. The analysis was carried out in
triplicate and drug contents were determined. [11, 14]
Characterization of Microwave Induced Solid Dispersion
FT-IR Spectroscopy
Infrared spectra matching approach was used for the detection of any possible chemical reaction between the
drug and the excipients. Piroxicam, polymer and solid dispersion was prepared and mixed with suitable quantity
of Potassium bromide. The interaction between drug-excipients was observed from IR spectral studies by
observing any shift in peaks of drug in the spectrum of mixture of drug. [14]
Differential Scanning Calorimetry (DSC)
In drug formulation it is essential to evaluate the possible interactions between the active principle and the
excipients, as the choice of the excipients should be performed in relation to the drug delivery, to their
compatibility with the same drug and to the stability of the final product. Piroxicam powder was mixed with
various excipient and the resulting mixture was kept in sealed glass vials. Mixture should be examined under
Nitrogen to eliminate oxidative and pyrolytic effect at a standard heating rate (2, 5 or 100
C per minute) on DSC.
Thermograms of pure drug are used as a reference. [14]
XRD STUDIES
X-ray powder diffractometry was carried out to investigate the effect of complexation process on crystallinityof
drug. Powder X-ray diffractometry were carried out using a D8 Advance (Bruker) scanner with filter Ni, Cu, Kα
radiation, voltage 40kV and a current of 20 mA. The scanning rate employed was 1°/min over the 5° to 50°
diffraction angle (2θ) range. The XRPD patterns of drug powder and drug-polymer complex were recorded. The
comparative XRPD patterns of pure drug and drug- polymer complex were given in Figures 14 and 15 [11, 14]
FORMULATION OF FAST DISINTEGRATING TABLET OF PIROXICAM USING SOLID
DISPERSION TECHNIQUE
After evaluation of solid dispersion of Piroxicam prepared by conventional fusion method and microwave
induced fusion method, fast dissolving tablets were prepared according to formula given in Table 2 [15, 16]
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Table 2 Formulation of Fast Disintegrating Tablet
Formulations F1 F2 F3 F4 F5 F6 F7 F8 F9
Ingredient Unit Formula (mg per tablet)
Solid Dispersion complex
equivalent to 20 mg Piroxicam
118.55 118.55 118.55 118.55 118.55 118.55 118.55 118.55 118.55
Sodium starch glycolate 6 10.5 15 - - - - - -
Crosscarmellose sodium - - - 6 10.5 15 - - -
Crospovidone - - - - - - 6 10.5 15
Microcrystalline cellulose 120 115.5 111 120 115.5 111 120 115.5 111
Mannitol 50 50 50 50 50 50 50 50 50
Magnesium Stearate 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5
Talc 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5
Total 300 300 300 300 300 300 300 300 300
EVALUATION OF POWDER BLEND FOR FAST DISINTEGRATING TABLET
Method: Accurate quantity of drug and all ingredients were weighed according to formula and powder except
mannitol and magnesium sterate was blended homogeneously in mortar and pestle for 15 minutes. Prepared
powder blend was passed through sieve No. #60. Finally, mannitol and magnesium sterate passed through sieve
No. #30 was added and further mixed for 10 minutes. The powder blend was evaluated for angle of repose, bulk
density, Tapped density, Compressibility Index and Hausner’s ratio. [7, 11]
MANUFACTURING OF FAST DISINTEGRATING TABLET OFPIROXICAMCONTAININGSOLID
DISPERSION BY DIRECT COMPRESSION METHOD
The fast disintegrating tablets were prepared by direct compression method with the use of different
superdisintegrants namely Croscarmellose sodium, Sodium starch glycolate, Crospovidone. Microcrystalline
cellulose, Mannitol was used as a diluents and Mg. Stearate was used as lubricant.. Accurate quantity of drug
and all ingredients were weighed according to formula and powder except mannitol and Magnesium sterate was
blended homogeneously in mortor and pestle for 15 minutes. Prepared powder blend was passed through sieve
no. #60. Finally, mannitol and Magnesium sterate passed from sieve no. #30 added and was further mixed for10
minutes. Accurately weighed 300 mg homogeneously mixed powder blend was fed manually and compressed
with constant compression force and hardness on 16 stations tablet compression machine with 5 mm,
breakthrough, and flat faced punches. Total nine formulations were prepared.
EVALUATION OF FAST DISINTEGRATING TABLET
The prepared tablets of piroxiam were evaluated for post cimression parameters like
Appearance
The tablets were visually observed for capping, chipping and lamination. [11,17]
Thickness
Three tablets were selected randomly from each batch and thickness was measured by using Vernier Caliper.
[11,17]
Hardness
Hardness or tablet crushing strength (Fo) the force required to break a tablet in a diametric compression was
measured using Pfizer Hardness Tester. For each formulation, the hardness of 6 tablets was determined using the
Pfizer hardness tester. The tablet was held along its oblong axis in between the two jaws of the tester. At this
point, reading should be zero kg/cm2
. Then constant force was applied until the tablet fractured. The value at this
point was noted in kg/cm2
. [7,11,17]
Friability
Friability of the tablets was determined using Roche Friabilator. This device subjects the tablets to the combined
effect of abrasions and shock in a plastic chamber revolving at 25 rpm and roping the tablets height of 6 inches
in each revolution. [7]
Previously weighed sample of tablets was placed in the riabilator and were subjected to 25 revolutions. Tablets
were dedusted using a soft muslin cloth and reweighed, the friability (F) is given by the formula.
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Drug Content
Content uniformity test is used to ensure that every tablet contains the amount of drug substance intended with
little variation among tablets within a batch. Five tablets were selected randomly and average weight was
calculated. Tablets were crushed in a mortar and accurately weighed and the amount of average tablet was taken
from the crushed blend. then, the sample was transferred to the 100ml volumetric flask and was diluted up to the
mark with pH 6.8 phosphate buffer. the content was shaken periodically and kept for 24 hours for dissolution of
drug completely. The solution was filtered and appropriate dilutions were made. The drug content in each tablet
was estimated at 354nm against pH 6.8 phosphate buffer as a blank reference and reported. [11, 17, 18]
Weight Variation Method
Twenty tablets were randomly selected from each batch and individually weighed. The average weight and
standard deviation of 20 tablets was calculated. The batch passes the test for weight variation test if not more
than two of the individual tablet weight deviate from the average weight. [7, 17]
% F = (Initial wt. - Final wt. / Initial wt.) × 100. ………..Eqn
2
Disintegration time Method
The disintegration time of tablet was determined by using Disintegration test apparatus. Tablets were placed in
disintegration test assembly and disc was placed was placed on tablets in each glass tube of assembly. The
assembly was dipped in a vessel containing 900ml phosphate buffer pH 6.8 at 370
C.The time for disappearance
of tablet residue above mesh was noted as disintegration time. [7]
Wetting time of water absorption Ratio
Wetting Time: wetting time of dosage form is related with the contact angle. wetting time of the mouth
dissolving tablets is another Important parameter, which needs to be assessed to give an insight into the
disintegration properties of the tablets; a lower wetting time cause faster disintegration of the tablet can be
measured using a simple procedure. [7, 17, 18]
Method: five circular tissue papers of 10 cm diameter were placed in a petri dish. 10ml of water was added to
petri dish, a tablet was carefully placed on the surface of the tissue paper. the time required for water to reach
upper surface of the tablet was noted as wetting time.
Water absorption ratio(R): the weight of the tablet before keeping in the petri dish was noted (Wb). The wetted
ablet from the petri dish was taken and re weighed (Wa) using the same.
R=100×Wa- Wb/Wb ………………Eqn
3
Where,
Wb =Weight of tablet before water absorption
Wa = Weight of tablet after water absorption
In-vitro Dissolution studies
Dissolution profiles of piroxicam tablets were determined using the USP Type II Dissolution test apparatus set
with a paddle speed of 100 rpm. Dissolution was performed in 900 ml of maintained at 370
± 0.50
C. Aliquot of
dissolution medium, 5 ml was withdrawn at 5, 10, 15, 20, 25, 30 and 40 min with 5 minutes interval, and filtered
through Whatmann filter paper. The amount of drug dissolved was determined by UV-Visible
spectrophotometer by measuring the absorbance of the sample at 354 nm. An equal volume of fresh medium,
prewarmed at 370
C was replaced into the dissolution medium after each sampling to maintain the constant
volume throughout the test. Three trials for each batch were performed and average percentage drug release was
calculated by using disso software. [7, 11, 13]
STABILITY STUDY
Stability of a formulation can be defined as the time from date on manufacture of the formulation until its
chemical or biological activity is not less than a predetermined level of labeled potency and its physical
characteristics have not changed appreciably or deleteriously. Formulation and the development of a
pharmaceutical product are not complete without proper stability analysis, carried out on it to assess the physical
and chemical stability and the safety. The purpose of stability testing is to provide evidence on how the quality
of a drug substance or drug product varies with time. Under the influence of a variety of environmental factors
such as temperature, humidity and light, enabling recommended storage conditions, re-test periods and shelf
lives. Generally, the observation of the rate at which the product degrades under normal room temperature
requires a long time. To avoid the undesirable delay, the principles of accelerated stability studies are adopted.
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The International Conference on Harmonization (ICH) Guidelines titled “Stabilitytesting of new drug substance
and products” (QIA) describes the stability test requirements for drug registration application in the European
Union, Japan and United States of America. ICH specifies the length of study and storage conditions.
Long-term testing 250
C ± 20
C/60 % RH ± 5% for 12 months.
Short term testing 300
C ± 20
C/65 % RH ± 5% for 1 month.
Accelerated testing 400
C ± 20
C/75 % RH ± 5% for 6 months.
Stability studies for the present work carried out at 400
C ± 20
C/75% ± 5% RH for the selected formulation for 3
months.
Method
The selected formulations were packed in tightly closed container which were tightly plugged with cotton and
capped. They were then stored at 400
C ± 20
C /75 % RH ± 5% for 3 months and evaluated for their physical
appearance, hardness, disintegrate time, dissolution testing and drug content at specified intervals of time. The
drug solutions were further scanned to observe any possible spectral change. [11]
Result and Discussion
Preformulation Studies of Piroxicam
Organoleptic properties received sample of piroxicam oduorless, fine off white to light yellow powder. The
melting point of piroxicam was found to be 199-2010
C. The reported melting point of Piroxicam was 198-2000
C.
The Piroxicam is practically insoluble in water and freely soluble in methanol and chloroform. The percentage
loss on drying after 4 hours was found to be 0.5%. The sample passes test for loss on drying as per the limits
specified in I.P. (N.M.T. 0.4%) all results are complies as per I.P.
Scanning of Piroxicam in Phosphate Buffer pH 6.8 Solution
The absorption maxima were found to be at 354 nm in phosphate buffer pH 6.8.
Figure 1 Scanning of Piroxicam in Phosphate Buffer pH 6.8 Solution
Calibration Curve of Piroxicam in Phosphate Buffer pH 6.8
Standard curve of Piroxicam was determined by plotting absorbance Vs concentration at 354nm. Using solution
prepared in Phosphate Buffer pH 6.8 at 354nm; it follows Beer’s law. The R2
value was found to be 0.9992.
Absorbance value were depicted in Table 3
Table 3 Calibration Curve of Piroxicam in Phosphate Buffer pH 6.8
Sr.no. Concentration (µg/ml) Absorbance
1 5 0.203
2 10 0.389
3 15 0.587
4 20 0.751
5 25 0.965
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Figure 2: Standard Graph of Piroxicam in Phosphate Buffer pH 6.8
Calibration Curve of Piroxicam in Distilled Water
Standard curve of Piroxicam was determined by plotting absorbance Vs concentration at 354nm. Using solution
prepared in Distilled water at 354nm; it follows Beer’s law. The R2
value was found to be 0.998. Absorbance
value were depicted in Table 4
Table 4 Calibration Curve of Piroxicam in Distilled Water
Sr.no. Concentration (µg/ml) Absorbance
1 5 0.016
2 10 0.031
3 15 0.042
4 20 0.057
5 25 0.071
Figure 3 Calibration Curve of Piroxicam in Distilled Water
Drug Excipient Compatibility Studies Using Fourier Transform Infra red Spectroscopy of Piroxicam and
PEG 6000 and SLS
Major functional groups present in Piroxicam show characteristic peaks in IR spectrum. Table 5 shows peaks
observed at different wave numbers and the functional group associated with these peaks. The major peaks are
identical to functional group of Piroxicam. Hence, the sample was confirmed as Piroxicam.
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FTIR Studies of Piroxicam
Figure 4 FTIR Spectrum of Piroxicam
Table 5 Interpretation of FTIR Spectrum of Piroxicam
Sr.no.
Reference Peak
Wavenumber(cm-1
)
Reported Peak
Wavenumber(cm-1
)
Functional Group
1 773.45 771.55 Ortho-di substituted ring
2 1149.57 1149.61 SO2-NH group
3 1300.02 1303.92 Pyridine
4 1435.04 1435.09 Methyl
5 1525.69 1527.67 Tertiary amine group
6 1629.85 1627.97 Amide carbonyl
7 3338.78 3340.82 Cubic polymorphic form
FTIR Studies PEG 6000
Figure 5 FTIR Spectrum of PEG 6000
Table 6 Interpretation of FTIR Spectrum of PEG 6000
Sr.no.
Reference Peak
Wavenumber(cm-1
)
Observed Peak
Wavenumber(cm-1
)
Functional Group
1 3500-3000 3502.85 O-H Stretching
2 3000-2500 2885.60 OH Bending
3 2000-1500 1350.22 C-H stretching
4 1500-1000 1141.90 C=O Stretching
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FTIR Studies Sodium lauryl Sulphate
Figure 6 FTIR Spectrum of SLS
Table 7 Interpretation of FTIR Spectrum of SLS
Sr.no.
Reference Peak
Wavenumber(cm-1
)
Observed Peak
Wavenumber(cm-1
)
Functional Group
1 1350-1140 1216.64 S=O Sulphate
2 1375-1450 1372.1 C=N Stretching of pyridine
3 3000-2800 2916.96 C-H Stretching
4 1300-1000 1078.26 O-H (Alcohol H-bonded) stretching
5 1465 1466.67 C-H Alkane stretching
Mixture of Piroxicam, PEG 6000 and SLS
Figure 7 FTIR Spectrum of Piroxicam, PEG 6000 and SLS Mixture
Table 8 Interpretation of FTIR Spectrum of Piroxicam, PEG 6000 and SLS Mixture
Sr.no.
Reference Peak
Wavenumber(cm-1
)
Reported Peak
Wavenumber(cm-1
)
Functional Group
1 773.45 771.55 Ortho-di substituted ring
2 1149.57 1149.61 SO2-NH group
3 1300.02 1342.50 Pyridine ring
4 1435.04 1465.09 Methyl group
5 1525.69 1527.67 Tertiary amine group
6 1629.85 1627.97 Amide carbonyl
7 3338.78 3340.82 Cubic polymorphic form
In spectrum of pure drug and polymer is showed in figure 4 - 7. In above IR spectra the peak of drug and
polymer are showed in Table 5 - 8. All these peaks have appeared in physical mixture indicating no chemical
interaction between Piroxicam and polymer.
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The formulation of solid dispersion prepared by both methods i.e., Conventional Fusion Method and Microwave
induced Fusion method in various ratios such as Piroxicam and PEG with and without SLS (1:1, 1:1:0.75, 1:2,
1:2:0.75, 1:3, 1:3:0.75 1:4, 1:4:0.75) Solid dispersion prepared by conventional Fusion Method were F1, F2, F3,
F4, F5, F6, F7, F8 and solid dispersion prepared by microwave Induced Fusion Method F9, F10, F11, F12, F13,
F14, F15 and F16 respectively.
Solubility study of various solid dispersion trial batches was performed. Solid dispersion prepared by microwave
induced fusion method improved solubility of Piroxicam as compared to pure drug and solid dispersion prepared
by conventional fusion method. The batch F16 was more soluble than pure drug and other formulation batches.
Table 9 Solubility Study of Solid Dispersion
Formulations Drug: Carrier Solubility (µg/ml)
Pure drug Pure drug 2.285
F1 Piroxicam + PEG 6000 (1:1) 9.428
F2 Piroxicam + PEG 6000 (1:1:0.75) 20.85
F3 Piroxicam + PEG6000 (1:2) 17.28
F4 Piroxicam + PEG 6000 + SLS (1:2:0.75) 29.42
F5 Piroxicam + PEG6000 (1:3) 25.14
F6 Piroxicam + PEG 6000 + SLS (1:3:0.75) 40.14
F7 Piroxicam + PEG 6000 (1:4) 34.42
F8 Piroxicam + PEG 6000 (1:4:0.75) 51.57
F9 Piroxicam + PEG 6000 (1:1) 13.714
F10 Piroxicam + PEG 6000 (1:1:0.75) 28.71
F11 Piroxicam + PEG6000 (1:2) 24.42
F12 Piroxicam + PEG 6000 + SLS (1:2:0.75) 37.28
F13 Piroxicam + PEG6000 (1:3) 31.57
F14 Piroxicam + PEG 6000 + SLS (1:3:0.75) 47.91
F15 Piroxicam + PEG 6000 (1:4) 42.28
F16 Piroxicam + PEG 6000 + SLS (1:4:0.75) 63.71
Out of eight formulations F8 shown maximum drug release i.e., 85.47±0.19%. Solid dispersion (F8) of
Piroxicam, PEG 6000 with and without SLS prepared by conventional fusion method significantly improved its
solubility and dissolution rate.
Table 10 Dissolution profile of solid dispersions prepared by conventional fusion Method
Time
(min)
Cumulative % Drug Release
F1 F2 F3 F4 F5 F6 F7 F8
0 00 00 00 00 00 00 00 00
5
11.35 ±
0.81
19.94 ±
1.22
18.24 ±
0.73
32.89 ±
1.21
26.45 ±
1.14
39.63 ±
1.24
31.39 ±
1.19
42.48 ±
0.93
10
22.06 ±
0.63
33.57 ±
1.13
31.89 ±
0.62
43.52 ±
0.64
36.44 ±
0.93
50.23 ±
1.15
40.35 ±
0.75
54.77 ±
0.64
15
30.63 ±
0.44
41.21 ±
0.96
39.23 ±
0.26
50.36 ±
0.49
43.83 ±
0.52
58.92 ±
1.29
51.46 ±
0.82
63.54 ±
1.04
20
39.09 ±
0.36
51.60 ±
0.56
48.73 ±
0.84
59.41 ±
0.52
55.54 ±
0.63
65.46 ±
1.65
59.46 ±
0.95
70.19 ±
1.14
25
47.26 ±
0.59
57.21 ±
0.66
54.19 ±
0.63
65.12 ±
0.47
62.16 ±
0.67
71.46 ±
1.33
67.28 ±
0.61
76.56 ±
0.85
30
53.11 ±
1.09
64.57 ±
0.75
61.23 ±
0.34
71.45 ±
0.71
67.64 ±
0.83
77.63 ±
0.23
72.69 ±
0.91
81.26 ±
0.98
40
59.22 ±
0.26
70.89 ±
0.64
68.47 ±
1.05
76.32 ±
0.33
72.88 ±
1.34
82.12 ±
0.44
78.29 ±
1.13
85.47 ±
0.79
*Result are mean of three determinations
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Figure 8 Dissolution Profile of Solid Dispersions Prepared by Conventional Fusion Method
*Result are mean of three determinations
Out of eight formulations F16 showed maximum drug release i.e., 96.24±0.04 %. Solid dispersion (F16) of
Piroxicam with polymer PEG 6000 and surfactant SLS prepared by microwave induced fusion method
significantly improved its solubility and its dissolution rate.
Table 11 Dissolution profile of solid dispersion prepared by microwave induced fusion method.
Time
(min)
Cumulative % Drug Release
F9 F10 F11 F12 F13 F14 F15 F16
0 00 00 00 00 00 00 00 00
5
16.28 ±
0.66
23.14 ±
1.12
22.17 ±
0.69
34.17 ±
0.80
30.11 ±
0.62
46.05 ±
1.44
37.03 ±
0.96
54.33 ±
0.82
10
26.99 ±
0.63
37.40 ±
0.80
34.30 ±
0.46
46.61 ±
0.72
41.86 ±
1.23
56.44 ±
0.41
48.36 ±
0.77
63.12 ±
0.64
15
34.36 ±
0.52
48.39 ±
0.46
42.78 ±
1.13
55.96 ±
0.64
52.63 ±
0.73
65.97 ±
1.07
57.21 ±
1.25
72.55 ±
0.44
20
43.87 ±
1.14
56.89 ±
1.06
49.53 ±
1.21
63.41 ±
0.75
60.63 ±
1.14
73.19 ±
1.06
66.59 ±
1.27
79.88 ±
0.95
25
52.69 ±
0.61
63.59 ±
1.11
57.01 ±
1.04
70.55 ±
0.61
68.74 ±
0.44
78.51 ±
1.15
73.42 ±
0.60
84.57 ±
1.02
30
61.47 ±
1.32
71.23 ±
0.63
66.79 ±
1.17
78.60 ±
1.33
73.99 ±
0.92
83.48 ±
1.26
79.34 ±
1.35
89.11 ±
1.28
40
68.77 ±
0.94
76.09 ±
1.21
74.56 ±
0.94
81.20 ±
0.92
79.24 ±
0.83
87.96 ±
0.72
84.44 ±
1.29
96.24 ±
0.84
*Result are mean of three determinations
Figure 9 Dissolution Profile of Solid Dispersions Prepared by Microwave Induced Fusion Method
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Table 12 Percent drug release of Piroxicam and solid dispersion by conventional fusion method (F8)
and microwave induced fusion method (F16)
Time
(Min)
Cumulative % Drug Release
Pure Drug F8 F16
0 0.00 00 00
5 06.21 ± 0.34 42.48 ± 0.93 54.33 ± 0.82
10 08.91 ± 0.52 54.77 ± 0.64 63.12 ± 0.64
15 11.75 ± 0.63 63.54 ± 1.04 72.55 ± 0.44
20 13.38 ± 0.92 70.19 ± 1.14 79.88 ± 0.95
25 15.92 ± 0.45 76.56 ± 0.85 84.57 ± 1.02
30 17.51 ± 0.61 81.26 ± 0.98 89.11 ± 1.28
40 18.95 ± 0.95 85.47 ± 0.79 96.24 ± 0.84
*Result are mean of three determination
Figure 10 Comparative Dissolution Profile of Piroxicam, F8 and F16
It was concluded that the F16 formulation gives highest drug release i.e. 96.24% in 40 min, in Phosphate Buffer
pH 6.8 whereas the F8 formulation and pure drug was found to be 81.26% and 18.95% drug release in Phosphate
Buffer pH 6.8 in 40 min. In that comparative study microwave induced solid dispersion exhibit significant
improvement in solubility and dissolution rate compared to that of pure drug.
Selection of Optimum Batch of Solid Dispersion for formulation of Fast Disintegrating Tablet
From solubility and dissolution studies all batches of microwave induced fusion method shows improved drug
solubility and dissolution rate than conventional fusion method, Hence F16 formulation of microwave induced
fusion method is selected for further formulation of fast disintegrating tablet.as shown in table no 10, 11, 12.
All batches of Piroxicam solid dispersion are off white colored and amorphous powder in nature. It is further
confirmed by x ray diffraction studies.
Different trial batches of solid dispersion show % practical yield from range 86.79 to 97.63%. Batch F16
Showed 97.63 % practical yield.
Table 13 Percentage Practical Yield of Solid Dispersion
Formulation Ratio Initial weight (mg) Final Weight (mg) % Practical Yield
F1 1:1 2000 1.899 94.96
F2 1:1:0.75 2.750 2.6367 95.88
F3 1:2 3000 2.883 96.11
F4 1:2:0.75 3.750 3.517 93.80
F5 1:3 5000 4.722 94.44
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F6 1:3:0.75 4.750 4.745 95.31
F7 1:4 5000 4.804 96.09
F8 1:4:0.75 5.750 5.543 96.40
F9 1:1 2000 1.952 97.63
F10 1:1:0.75 2.750 2.697 98.09
F11 1:2 3000 2.896 96.56
F12 1:2:0.75 3.750 3.646 97.23
F13 1:3 4000 3.873 96.83
F14 1:3:0.75 4.750 4.689 97.89
F15 1:4 5000 4.868 97.36
F16 1:4:0.75 5.750 5.529 98.16
(Drug is taken in 1000 mg)
The drug Content of Solid Dispersion of Piroxicam optimized formulation F16 Piroxicam + PEG 6000 + SLS
(1:4:0.75) was found to be 97.00 % indicating good content in solid dispersion.
In spectrum of pure drug and microwave induced solid dispersion is showed in figure 4 and 11 In above IR
spectra the peak of drug and polymer are showed in Table 5 - 8. All these peaks have appeared in formulation
and physical mixture indicating no chemical interaction between Piroxicam and polymer.
Figure 11 FTIR Studies of Microwave Induced Fusion Solid Dispersion
Table 14 Interpretation of FTIR Spectrum of Microwave Induced Fusion Method
Sr.no.
Reference Peak
Wavenumber(cm-1
)
Reported Peak
Wavenumber(cm-1
)
Functional Group
1 773.45 771.55 Ortho-di substituted ring
2 1149.57 1149.61 SO2-NH group
3 1300.02 1303.92 Pyridine ring
4 1435.04 1435.09 Methyl group
5 1525.69 1527.67 Tertiary amine group
6 1629.85 1627.97 Amide carbonyl
7 3338.78 3340.82 Cubic polymorphic form
The DSC of Piroxicam shown in Figure 12 Piroxicam showed a characteristic sharp endothermic peak at
203.33°C which is near to its standard reported melting point. From this it is confirms that given drug sample is
of Piroxicam is in pure form.
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Figure 12 DSC Studies of Piroxicam
The DSC curve of pure piroxicam exhibited a single endothermic response corresponding to the melting of drug.
Onset of melting was observed at 203.33°C, where as pure PEG 6000 showed a melting endotherm at 55.22°C.
Thermograms of SDs showed the absence of a piroxicam peak, suggesting that piroxicam is completely soluble
in the liquid phase of polymer or absence of crystalline nature of piroxicam. However, the melting peak of PEG
6000 in SDs was observed at slightly lower temperature (52-57°C) than that of pure PEG 6000. The Formulation
of piroxicam, SLS and PEG 6000 also showed no endothermic peak of piroxicam. It is speculated that piroxicam
dissolved in PEG 6000 during the DSC measurement, only one endothermic peak at 55.22°C corresponding to
PEG 6000 was observed. The crystalline piroxicam is converted to its amorphous form which is confirmed by
DSC and further by XRD study. (Fig.15
Figure 13 DSC Studies of Microwave Induced Fusion Solid Dispersion
X-ray diffraction of piroxicam displayed five major peaks shows at diffraction angles (2Ø0
) 14.46°, 17.65°,
19.690
, 26.68°and 27.32° were observed with intense peak at 17.650
and 27.320
indicating thecrystalline nature
of Piroxicam. (Fig-14)
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Figure 14 XRD Studies of Piroxicam
The absence of sharp peaks in the solid dispersion indicates the crystalline nature of Piroxicam is converted into
amorphous nature absence of a piroxicam peak, suggesting that Piroxicam is completely soluble in the liquid
phase of polymer or absence of crystalline nature of Piroxicam. It is confirmed that piroxicam is solubilized or
fused with polymer and also confirms the amorphous nature of Piroxicam. (Fig.14)
Figure 15 XRD Studies of Microwave Induced Fusion Solid Dispersion
EVALUATION OF POWDER BLEND FOR FAST DISINTEGRATING TABLETS
The characterization of mixed blend was done for determination of mass-volume relationship parameter. The
evaluated parameter angle of repose, bulk density, tapped density, hausner’s ratio and compressibility index was
reported in Table 15.
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Table 15 Evaluation of powder blend for fast disintegrating tablets
Formulations
Angle of
repose (Ɵ)
Bulk Density
(gm/cm3
)
Tapped Density
(gm/cm3
)
Hausner’s
Ratio (HR)
Carr’s Compressibility
index (%)
F1 25.58 ± 0.63 0.44 ± 0.010 0.51 ± 0.043 1.15 ± 0.42 13.72 ± 0.20
F2 27.67 ± 0.65 0.47 ± 0.019 0.53 ± 0.029 1.12 ± 0.32 11.32 ± 0.39
F3 25.53 ± 0.49 0.45 ± 0.023 0.51 ± 0.016 1.13 ± 0.38 13.72 ± 0.45
F4 26.42 ± 0.45 0.44 ± 0.029 0.52 ± 0.014 1.16 ± 0.20 15.38 ± 0.42
F5 25.78 ± 0.23 0.46 ± 0.078 0.53 ± 0.031 1.15 ± 0.16 15.21 ± 0.36
F6 28.04 ± 0.57 0.44 ± 0.096 0.52 ± 0.039 1.18 ± 0.22 13.20 ± 0.16
F7 26.65 ± 0.13 0.47 ± 0.056 0.54 ± 0.010 1.14 ± 0.71 12.96 ± 0.47
F8 27.66 ± 0.49 0.44 ± 0.063 0.51 ± 0.021 1.15 ± 0.38 13.72 ± 0.67
F9 25.79 ± 0.39 0.46 ± 0.076 0.52 ± 0.026 1.13 ± 0.28 11.53 ± 0.41
* Result are mean of three dimensions
MANUFACTURING OF FAST DISINTEGRATING TABLET OFPIROXICAMCONTAININGSOLID
DISPERSION BY DIRECT COMPRESSION METHOD
EVALUATION OF FAST DISINTEGRATING TABLETS
All the formulations were subjected for weight variation, thickness, hardness, friability, drug content, in vitro
disintegration time, wetting time, water absorption ratio, in vitro dissolution studies were carried out. All the
formulations were passed the parameter which was reported in Table 16
Table 16 Evaluation of Fast Disintegrating Tablets
Formulations
Thickne
ss
(mm)
Hardness
(Kg/cm2
)
Friability
(%)
Drug
Content
(%)
Weight
variations
(mg)
Disintegr
ation
time (sec)
Wettin
g time
(sec)
% Water
absorptio
n ratio
F1
4.39 ±
0.02
3.26 ±
0.31
0.72 ±
0.25
95.85 ±
0.89
300 ± 1.51 59 ± 0.3
24 ±
0.57
81.26 ±
1.08
F2
4.44 ±
0.03
3.36 ±
0.55
0.81 ±
0.34
96.21 ±
0.44
302 ± 1.02 48 ± 0.5
20 ±
0.41
90.28 ±
0.69
F3
4.30 ±
0.03
3.24 ±
0.44
0.69±
0.33
96.25 ±
0.56
300 ± 0.93 37 ± 0.6
17 ±
0.33
114.40 ±
1.015
F4
4.32±
0.01
3.36 ±
0.86
0.63±
0.18
95.89 ±
0.96
298 ± 1.15 42 ± 0.3
49 ±
0.56
78.45 ±
0.96
F5
4.36 ±
0.05
3.33 ±
0.45
0.79±
0.22
96.50 ±
0.11
303 ± 0.89 34 ± 0.2
43 ±
0.41
84.34 ±
0.61
F6
4.49 ±
0.1
3.22 ±
0.92
0.72±
0.31
96.83 ±
0.63
299 ± 0.96 26 ± 0.4
38 ±
0.22
93.12 ±
1.55
F7
4.38 ±
0.05
3.30 ±
0.59
0.62±
0.42
96.40 ±
0.56
301 ± 0.65 23 ± 0.2
22 ±
0.47
84.24 ±
093
F8
4.41 ±
0.05
3.39 ±
0.43
0.50±
0.26
96.15 ±
0.23
300 ± 0.96 16 ± 0.5
18 ±
0.42
96.66 ±
0.85
F9
4.40 ±
0.03
3.25 ±
0.71
0.71 ±
0.29
97.00 ±
0.11
300 ± 0.49 10 ± 0.6
13 ±
0.52
119.80 ±
0.76
*Results are mean of three determinations.
In vitro % Drug Release of Drug from Tablet
All the nine formulations were subjected for the in vitro dissolution studies using tablet dissolution apparatus
(USP). Phosphate Buffer pH 6.8 was used as dissolution medium. The sample were withdrawn at different time
intervals, Filter and analyzed at 354nm. Cumulative % drug release was calculated on the basis of mean amount
of Piroxicam present in respective table. The result obtained in the in vitro drug release for all formulations F1 to
F9 are tabulated in Table 17 The plots are presented in figure no 10.17. The superdisintrgrants such as
crospovidone (2%, 3.5% and 5%), SSG (2%, 3.5% and 5%), and CCS (2%, 3.5% and 5%), were used in
different proportions.
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Table 17 In vitro Cumulative % Drug Release from Tablets
Time
(min)
Cumulative % Drug Release
F1 F2 F3 F4 F5 F6 F7 F8 F9
0 00 00 00 00 00 00 00 00 00
5
25.24 ±
0.76
28.74 ±
1.21
31.12
±0.71
35.02 ±
1.12
38.42 ±
0.94
41.23 ±
0.76
43.76 ±
0.79
48.12 ±
0.7 4
52.36 ±
0.81
10
39.26 ±
0.65
43.92 ±
1.02
48.22 ±
0.66
49.78 ±
0.64
53.75 ±
0.65
58.63 ±
0.69
58.49 ±
0.65
62.26 ±
0.89
66.22 ±
0.36
15
48.25±
0.91
52.47 ±
0.66
57.02 ±
0.86
61.36 ±
0.96
64.81 ±
0.89
67.84 ±
0.81
68.45 ±
0.66
72.55 ±
0.65
75.98 ±
0.85
20
53.66 ±
0.63
58.81 ±
0.42
63.44 ±
0.94
67.47 ±
0.41
70.48 ±
0.65
73.45 ±
0.99
75.18 ±
0.71
79.01 ±
0.62
82.61 ±
0.92
25
58.44±
0.59
62.47±
0.97
68.55 ±
1.27
71.42 ±
1.18
75.64 ±
0.64
78.64 ±
1.02
79.22 ±
0.69
83.47 ±
0.93
87.06 ±
0.69
30
61.56 ±
0.48
66.56 ±
0.62
71.85 ±
1.26
75.64 ±
0.69
77.63 ±
0.92
81.24 ±
1.5
83.03 ±
0.46
86.17 ±
0.73
91.02 ±
0.72
40
68.77±
0.74
71.73 ±
1.31
73.25 ±
1.10
77.32 ±
0.89
80.12 ±
1.22
83.63
±1.23
86.34 ±
0.91
90.11 ±
0.49
93.20 ±
0.61
*Results are mean of three dimensions
The rapid dissolution was observed in formulation F9 releases 93.20% ± 0.61 at the end of 40 minutes. Rapid
dissolution might be due to fast breakdown of particles and rapid absorption of drugs. The drug release was
completely achieved in shorter duration of time. In all the formulations the drug release within 40 minutes. High
dissolution may occur due to faster breakdown.
Figure 16 Cumulative % drug release of F1-F9 formulations
In comparative study F9 formulation gives higher percent drug release compare to other remaining eight
formulations at the end of 40 minutes and graphical representation is shown in Figure 16 Therefore, it was
concluded that the best optimized batch was found to be F9 because of lesser disintegration time and highest
percentage drug release at the end of 40 min among all the formulations. Because it containing crosspovidone
superdisintegrant with fast wetting time and highest swelling property.
STABILITY STUDY
The Fast disintegrating tablet of solid dispersion of Piroxicam, F9 batch were subjected to stability study at
temperature 40°C ± and relative humidity 75% ± for three months. After each month tablet were analyzed for
hardness, friability, disintegration time, dissolution time and drug content. The results are as follows.
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Table 18 Stability Study of Fast Disintegrating Tablets of Optimized Formulation
F9 at 400
C ± 20
C /75 % RH ± 5%
Formulation
Parameters
Evaluated
Initial
After 1
Month
After 2
Month
After 3
Month
F9
Hardness (Kg/Cm2
) 3.25 ± 0.71 3.23 ± 0.89 3.18 ± 0.68 3.12 ± 0.41
Friability (%) 0.71± 0.29 0.71 ± 0.79 0.83 ± 0.25 0.69 ± 0.89
Disintegration Time (sec) 10 ± 0.6 10 ± 0.4 11 ± 0.5 11 ± 0.3
Content Uniformity (%) 97.00 ± 0.11 97.00 ± 0.30 96.36 ± 0.23 96.22 ± 0.75
Cumulative % Drug Release 93.20 ± 0.61 93.14 ± 0.39 92.42 ± 0.36 92.11 ± 0.56
*Results are the mean of three determinations
From the results of Table 18 it is concluded that, the fast disintegrating tablets of solid dispersion of Piroxicam
from tablet F9 batch are physically stable and retained their original properties when stored at temperature 400
C
± 20
C, 75 % RH ± 5% and after three months there was no significant difference in disintegration time,
cumulative % drug release, hardness, friability and drug content.
Conclusion
Overall, the results concluded that suitable formulated
solid dispersion F9 of Piroxicam with polymer
Polyethylene glycol 6000 and surfactant as sodium
lauryl sulphate prepared by microwave induced
fusion method in the ratio (1:4:0.75), improved its
solubility and dissolution rate. Alteration of surface
property of drug particles may be responsible for
enhanced dissolution rate of Piroxicam from solid
dispersion compared to pure Piroxicam. It was
decided to prepare fast dissolving tablets of solid
dispersion of Piroxicam by direct compression
method. In the formulation of tablets, sodium starch
glycolate, and croscarmellose, crospovidone were
used as super disintegrants. Prior to compression, the
powder blend were evaluated for angle of repose,
bulk density, tapped density, compressibility index,
Hausner's ratio. The compressed tablets were also
evaluated for weight variation, hardness, friability,
drug content, disintegration time, wetting time, in
vitro drug release and stability studies In the above
studies, F9 formulation showed promising results.
The stability studies were carried out for the
optimized batch F9 for 90 days and it showed
acceptable results. So F9 formulation was considered
as the optimized formulation. Among F1 to F16
batches of solid dispersions prepared, F16 was found
to be optimized. The study shows that the dissolution
rate of Piroxicam can be enhanced to a great extent by
solid dispersion technique using microwave induced
fusion method in the ratio (1:4:0.75) Hence,
Piroxicam sodium starch glycolate, croscarmellose &
crospovidine systems can be considered for
formulating fast disintegrating tablets of Piroxicam.
The fast disintegrating tablets of Piroxicam batch (F9)
shows highest drug release as compared to other
formulations. From above results it can be concluded
that the solid dispersion technique can be used to
enhance the solubility, dissolution rate and oral
bioavailability of water insoluble drugs.
Acknowledgements
The authors express their sincere thanks to Aarti
pharma (Mumbai, India) for providing drug sample
and Research lab Fine chem. Industry, (Mumbai,
India) for providing polymers. The authors also
acknowledge P.D.E.A’s Shankarrao Ursal College of
Pharmaceutical Sciences and Research Center,
Kharadi for providing facilities to carry out the
research work
References
[1] Singh MC, Sayyad AB, Sawant SD. Review on
various techniques of solubilityenhancement of
poorly soluble drugs with special emphasis on
solid dispersion. J Pharm Res. 2010 Oct; 3(10):
249-50.
[2] Kadam SV, Shinkar DM, Saudagar RB. Review
on solubility enhancement techniques. Int J
Pharm Biol Sci. 2013; 3(3): 462-75.
[3] Indian Pharmacopoeia 2010. Government of
India, ministry of health and family welfare's.
Volume-III. Published by the controller of
publications, The Indian pharmacopoeia
commission Ghaziabad: 142-143. 1926-1928P.
[4] The United State Pharmacopoeia national
formulary asjan. 25t edition, Volume-1&11 30
(24). 616. 1179-1182.
[5] British Pharmacopoeia (2009). Dept. of health.
social services and public safety, Published by
Medicines & Healthcare Products regulatory
agency, Vol-I&ll: 4490-4488.
[6] https://go.drugbank.com/drugs/DB00554.
[7] Gowthamy Priya G. Formu-lation,
Development and Evaluation of Fast
Disintegrating Piroxicam Tablets. Intl J Phar-
ma Scie. 2020; 7-1.
[8] Sachan AK, Tripathi K, Vishnoi G, Rasheed A,
Sharma R, Gangwar SS. Formulation
20. International Journal of Trend in Scientific Research and Development @ www.ijtsrd.com eISSN: 2456-6470
@ IJTSRD | Unique Paper ID – IJTSRD50422 | Volume – 6 | Issue – 5 | July-August 2022 Page 176
development and characterization of Piroxicam
fast dissolving tablets approved for the
treatment of arthritis. IJDR. 2015 Feb: 5 (2):
3440-46.
[9] Darade SC, Patil PB, Kalkotwar RS.
Formulation and evaluation of orodispersible
tablet containing piroxicam by sublimation
method. Indian Journal of Pharmacy and
Pharmacology. 2017; 4(2): 82-77.
[10] Carr, R. L., Evaluating flow properties of
solids. Chem. Eng, 1965. 72(2): p. 168-163.
[11] Ms. Garudkar AB, Dr. Bhosale AV, Ms. Trusha
Y. Puttewar, design, development and
evaluation of immediate release tablet of
ibuprofen solid dispersion. Int J Curr Res.
August 2016; 08 (08): 36048-61.
[12] A, Siddiqi & Gj, Khan & Si, Makrani &
Khalifa, Mahmadasif & Yunus, & Shaoor,
Ahmed & Jadhav, Rahul. (2020). Solubilityand
dissolution enhancement of BCS class II drug
piroxicam by solid dispersion. Pharmaceutica
Analytica Acta. 1442-1434.
[13] Mansuk AG, Deshmukh D, Maheshwari RK,
Pachpute T. Formulation optimization and
characterization of solid dispersion of
piroxicam prepared by novel application of
mixed solvency concept. Pharmaceutical
Resonance. 2020; 2 (2): 41-6.
[14] Modasiya MK, Lala II, Prajapati BG, Patel
VM, Shah DA. Design and characterization of
fast disintegrating tablets of piroxicam.
International Journal of PharmTech Research.
2009; 1(2): 353-7.
[15] Raymond C. Rowe. Paul J. Sheskey and Sian
C. Owen. 6' edition, Handbook of
pharmaceutical excipients. Published by the
Pharmaceutical Press, (2009); 506-509, 178-
180, 754-755, 283-281.
[16] N. k. Jain Pharmaceutical Product
developement, CBS Publication; 2nd edition, 1
January 2011; 56-49.
[17] Kumar I, Chaudhary D, Thakur B, Pandit V.
Formulation and Evaluation of Piroxicam Fast
Dissolving Tablets Using Direct Compression
and Sublimation Method. Journal of Drug
Delivery and Therapeutics. 2020 Jun 15; 10(3-
s): 17-25.
[18] Panchal DM, Tiwari AK. A research on
improvisation in dissolution of olmesartan
medoxomil by enhancing its solubility using
solid dispersion techniques. World J Pharm
Res. 2013; 2(5): 1793-816.
[19] Kuchekar BS, Mahajan HS, Badhan AC. Mouth
dissolve tablets of sumatriptan succinate. Indian
J Pharm Sci. 2004; 2: 238-40.
[20] Jafar M. Improving dissolution of meloxicam
using solid dispersions. " (2006): 238-231.
[21] Kuchekar BS, Desai SA, Karande SV, Petkar
KC. Orodissolving tablet of promethazine
hydrochloride. Indian J Pharm Educ Res. July–
September 2006; 40(3). 271-250.
[22] Arunprasad K, Narayanan N, Rajalakshmi G.
Preparation and evaluation of solid dispersion
of terbinafine hydrochloride. Int J Pharm Sci
Rev Res. 2010 Jul; 3(1): 130-4.
[23] Kiran NR, Palanichamy S, Rajesh M, Rajadhas
TG, Anusha V, Parasakthi N, Thirupathi AT.
Formulation and evaluation of orodispersible
piroxicam tablets. Journal of Pharmaceutical
Sciences and Research. 2010 Oct 1; 2(10): 621-
615.
[24] Maurya D, Belgamwar V, Tekade A.
Microwave induced solubility enhancement of
poorly water soluble atorvastatin calcium.
Journal of Pharmacy and Pharmacology. 2010
Nov; 62(11): 1599-606.
[25] Nagar SS. Taste masking o Piroxicam by spray
drying technique. Vol 3/Issue 4/Apr 2011: 12-
4.
[26] Dave RH, Patel AD, Donahue E, Patel H. To
evaluate the effect of addition of an anionic
surfactant on solid dispersion using model drug
indomethacin. Drug Development and
Industrial Pharmacy. 2012 Aug 1; 38(8): 930-9.
[27] Ganure Ashok L, Dangi AA, Kumar PP, Rai
MK, Aravadiya JP. Preparation and evaluation
of tramadol hydrochloride fast dispersible tablet
by using compression technique, IJPI’s. J
Pharm Cosmetol. 2011; 1: 2. 160-140.