The document summarizes the design and statistical optimization of a pulsatile delivery system containing pantoprazole sodium. Key points include:
- The aim is to develop a pulsatile drug release tablet for pantoprazole sodium using MCC, CCS, and SSG to achieve a lag time of 5 hours followed by immediate drug release.
- A 32 factorial design is used to optimize the formulation. Preliminary studies evaluate formulations with varying levels of MCC, CCS, and SSG.
- Tablets are evaluated for pre-compression parameters, drug content, disintegration time, and dissolution profile in pH 6.8 buffer.
- The best formulation from preliminary studies will be selected for
Ideas for pharmacy students on final year project : Possible Research FieldsTareq ✅
This document provides ideas for pharmacy students' final year projects. It outlines four main research fields: pharmacy practice, pharmaceutics, chemistry, and pharmacognosy. Some potential project topics include surveys of new drugs, formulation of different dosage forms, synthesis of new medicinal drugs, and bioassays of plant extracts for biological activities. The document was prepared by Tareq Tareq, a B.Pharm student at the International Islamic University Chittagong in Bangladesh.
The document presents information on dissolution studies of solids and suspensions, including an introduction to dissolution theories, factors affecting dissolution of different dosage forms like powders, capsules, tablets, and suspensions, as well as acceptance criteria for dissolution testing as per Indian Pharmacopoeia and USP. Dissolution is defined as the process by which a solid substance solubilizes in a given solvent, and various apparatus and methods used to test dissolution of different dosage forms are discussed.
The document discusses guidelines from the International Council for Harmonisation (ICH) related to quality, safety, efficacy, and multidisciplinary aspects of pharmaceutical development. It provides an overview of ICH guidelines in four categories (Q, S, E, M) and describes some of the key guidelines within the Quality (Q) and Safety (S) categories in more detail. The Quality guidelines address issues like stability testing, impurities, biotechnology products, and good manufacturing practices. The Safety guidelines cover topics such as carcinogenicity, genotoxicity, reproductive toxicity, and non-clinical safety evaluation.
Tablets are solid oral dosage forms made by compressing powders containing active pharmaceutical ingredients and excipients. Tablets offer advantages like precise dosing, low cost, stability, and ease of production and administration. Tablet production involves blending powders, granulation to improve flow and compression properties, lubrication, and compression using tablet presses to form the final tablets. Tablet properties, types, ingredients, manufacturing processes, and equipment are described in detail in the document.
The document summarizes a study evaluating the dissolution behavior of 500mg Paracetamol tablets according to USP guidelines using the paddle method. The study found that 126.2% of the Paracetamol dissolved within 30 minutes, meeting the USP and BP standards of dissolving at least 80% within 30 minutes. The paddle apparatus and UV spectrophotometry were used to test six tablets and obtain dissolution profiles. The results indicate the tested Paracetamol tablets meet pharmacopeial standards for dissolution.
Formulation, Development and Evaluation of Uncoated Bi-layer Tablet of Anti-H...Mohanish Shah
This document presents work on developing a bilayer tablet containing metoprolol succinate and hydrochlorothiazide for the treatment of hypertension. The bilayer tablet uses Dual Release Drug Absorption System (DUREDAS) technology to provide sustained release of metoprolol from one layer and immediate release of hydrochlorothiazide from the other layer. Preliminary studies were conducted to select polymers for the sustained release layer and superdisintegrants for the immediate release layer. Calibration curves were developed for both drugs alone and in combination. Materials and equipment used in the experimental work are listed.
The document discusses India's regulatory requirements for drugs. It outlines the key regulatory bodies that oversee drug approval and quality control in India, including the Central Drugs Standard Control Organization (CDSCO) and the National Pharmaceutical Pricing Authority (NPPA). The roles of the central and state governments in drug regulation are also summarized. Processes such as new drug approval, licensing, and quality testing are explained.
This document discusses solid dosage forms known as capsules. It defines capsules as solid dosage forms where the drug is enclosed in a soluble shell, most commonly made of gelatin. There are two main types of capsules: hard gelatin capsules for solids and soft gelatin capsules for liquids. The document outlines the advantages and disadvantages of capsules, as well as methods for filling and evaluating different capsule types.
Ideas for pharmacy students on final year project : Possible Research FieldsTareq ✅
This document provides ideas for pharmacy students' final year projects. It outlines four main research fields: pharmacy practice, pharmaceutics, chemistry, and pharmacognosy. Some potential project topics include surveys of new drugs, formulation of different dosage forms, synthesis of new medicinal drugs, and bioassays of plant extracts for biological activities. The document was prepared by Tareq Tareq, a B.Pharm student at the International Islamic University Chittagong in Bangladesh.
The document presents information on dissolution studies of solids and suspensions, including an introduction to dissolution theories, factors affecting dissolution of different dosage forms like powders, capsules, tablets, and suspensions, as well as acceptance criteria for dissolution testing as per Indian Pharmacopoeia and USP. Dissolution is defined as the process by which a solid substance solubilizes in a given solvent, and various apparatus and methods used to test dissolution of different dosage forms are discussed.
The document discusses guidelines from the International Council for Harmonisation (ICH) related to quality, safety, efficacy, and multidisciplinary aspects of pharmaceutical development. It provides an overview of ICH guidelines in four categories (Q, S, E, M) and describes some of the key guidelines within the Quality (Q) and Safety (S) categories in more detail. The Quality guidelines address issues like stability testing, impurities, biotechnology products, and good manufacturing practices. The Safety guidelines cover topics such as carcinogenicity, genotoxicity, reproductive toxicity, and non-clinical safety evaluation.
Tablets are solid oral dosage forms made by compressing powders containing active pharmaceutical ingredients and excipients. Tablets offer advantages like precise dosing, low cost, stability, and ease of production and administration. Tablet production involves blending powders, granulation to improve flow and compression properties, lubrication, and compression using tablet presses to form the final tablets. Tablet properties, types, ingredients, manufacturing processes, and equipment are described in detail in the document.
The document summarizes a study evaluating the dissolution behavior of 500mg Paracetamol tablets according to USP guidelines using the paddle method. The study found that 126.2% of the Paracetamol dissolved within 30 minutes, meeting the USP and BP standards of dissolving at least 80% within 30 minutes. The paddle apparatus and UV spectrophotometry were used to test six tablets and obtain dissolution profiles. The results indicate the tested Paracetamol tablets meet pharmacopeial standards for dissolution.
Formulation, Development and Evaluation of Uncoated Bi-layer Tablet of Anti-H...Mohanish Shah
This document presents work on developing a bilayer tablet containing metoprolol succinate and hydrochlorothiazide for the treatment of hypertension. The bilayer tablet uses Dual Release Drug Absorption System (DUREDAS) technology to provide sustained release of metoprolol from one layer and immediate release of hydrochlorothiazide from the other layer. Preliminary studies were conducted to select polymers for the sustained release layer and superdisintegrants for the immediate release layer. Calibration curves were developed for both drugs alone and in combination. Materials and equipment used in the experimental work are listed.
The document discusses India's regulatory requirements for drugs. It outlines the key regulatory bodies that oversee drug approval and quality control in India, including the Central Drugs Standard Control Organization (CDSCO) and the National Pharmaceutical Pricing Authority (NPPA). The roles of the central and state governments in drug regulation are also summarized. Processes such as new drug approval, licensing, and quality testing are explained.
This document discusses solid dosage forms known as capsules. It defines capsules as solid dosage forms where the drug is enclosed in a soluble shell, most commonly made of gelatin. There are two main types of capsules: hard gelatin capsules for solids and soft gelatin capsules for liquids. The document outlines the advantages and disadvantages of capsules, as well as methods for filling and evaluating different capsule types.
Approval and Application Process involved in Investigational New Drug (IND)Nipun Gupta
1. Introduction
During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies.
2. Drug development team
3. Investigational new drug application (INDA)
4. Format and content of IND
5. Preclinical testing
6. The development process IND
application and safety
7. Clinical research
8. New drug application
9. Abbreviated new drug application
10. Changes to an approved NDA or ANDA
11. Difference between NDA and ANDA
1. Preformulation testing involves characterizing key properties of drugs and excipients to develop safe, effective, and stable dosage forms. Tests include analyzing organoleptic properties, purity, solubility, hygroscopicity, and compatibility.
2. Analytical methods are important to quantify drugs during product development and stability testing. UV and HPLC methods are often used depending on the drug's chromophores.
3. Solubility studies over the pH range of 1-8 are crucial because permeability and absorption depend on a drug's ionization state and solubility in different regions of the gastrointestinal tract.
The document discusses sterile formulations and parenteral products. It covers key topics like routes of parenteral administration, pre-formulation of sterile products, physicochemical properties, general requirements, and sterility testing. The different routes discussed are subcutaneous, intramuscular, intravenous, and others. Ideal properties of sterile dosage forms include sterility, isotonicity, being pyrogen-free and particle-free. The document also differentiates between small volume parenterals and large volume parenterals.
The document discusses the ASEAN Common Technical Dossier (ACTD) format for pharmaceutical product registration applications submitted to ASEAN regulatory authorities. The ACTD format aims to standardize applications to reduce submission time and resources while facilitating regulatory review. It includes four parts covering administrative data, quality, nonclinical, and clinical information. The ACTD guideline describes the sections within each part, including overviews, summaries, study reports, and references. The standard format seeks to provide a consistent and transparent presentation of technical information to support evaluation and understanding of registration applications.
This document provides an overview of oral disintegrating tablets (ODTs), including their development, technologies used in their production, and evaluation methods. ODTs are solid dosage forms that disintegrate rapidly in the mouth, typically within 3 minutes, without water. They offer advantages over conventional tablets for patients who have difficulty swallowing. The document reviews various ODT production technologies such as freeze drying, spray drying, mass extrusion, and direct compression. It also discusses ideal properties, advantages, and limitations of ODTs.
The document discusses invitro dissolution testing. It begins with an introduction to dissolution and BCS classification. It then covers theories of dissolution like the diffusion layer model. It describes various invitro dissolution test models including non-sink methods like the USP rotating basket and paddle apparatus and sink methods like the flow through column method. Finally, it discusses factors that can affect dissolution testing and provides a conclusion.
This document discusses quality control tests for pharmaceutical powders. It describes 7 key tests:
1) Particle size and shape determination which affects properties like weight variation and flowability. Methods include sieving and microscopy.
2) Density measurements including bulk density, tapped density and granular density which influence compressibility.
3) Granule strength and friability testing which affects changes in particle size and compressibility.
4) Flow property tests like angle of repose, compressibility index and Hausner’s ratio which indicate flow rates for uniform tablet production.
5) Moisture content testing using a moisture or IR balance to measure 2% optimal moisture for compression.
6) Percent fines testing
This document provides information about tablets, including their definition, advantages, types, and manufacturing process. It begins with definitions of tablets from pharmacopoeias and discusses how they are the most popular dosage form, comprising 70% of pharmaceutical preparations. It describes various types of tablets including compressed, sugar-coated, film-coated, enteric-coated, and effervescent tablets. The document outlines the tablet manufacturing process using tableting machines and discusses characteristics and specifications of compressed tablets.
Bio pharmaceutical classification System [BCS]Sagar Savale
The Biopharmaceutical Classification System was first developed by in 1995, by Amidon et al & his colleagues.
Definition:
“The Biopharmaceutical Classification System is a scientific framework for classifying a drug substance based on its aqueous solubility & intestinal permeability & dissolution rate”.
To saved time fast screening is required so drug substances are classified on basis of solubility and permeability. This classification is called Biopharmaceutical Classification System
Large and small volume parenterals preparationsInNo Sutnga
Small and large volume parenterals are injectable drug formulations. Small volume parenterals have volumes less than 100mL and include solutions, suspensions, emulsions, and dry powders. Large volume parenterals have volumes over 100mL and are used to provide fluids, electrolytes, and nutrition intravenously. The document discusses the classification, formulations, manufacturing, and containers used for parenteral drug products.
This document provides an overview of parenterals (injectable drugs), including:
- Definitions and routes of administration for parenterals
- General requirements like vehicles, additives, and ensuring isotonicity
- Methods for sterilization, formulation, packaging, and quality control testing of parenterals
- Considerations for facilities and production areas to ensure sterility during manufacturing
It discusses key aspects of developing parenteral drugs like pre-formulation studies, adjustment of tonicity, and precautions for aseptic work. Common sterilization techniques and packaging materials are outlined. Quality control tests evaluated include leakage, clarity, sterility, and pyrogen testing. Overall, the document serves as an introduction
The document discusses the formulation and evaluation of an artemether sustained release floating bilayer tablet. It aims to develop a floating drug delivery system for artemether to increase its gastric residence time and provide sustained release to ensure optimal drug levels in the blood and minimize side effects. The document provides background on floating drug delivery systems and reviews previous literature on developing such systems for other drugs. It then gives information on the drug artemether and outlines the objectives and methodology that will be used in the study.
This document discusses various study designs used in bioequivalence studies. It describes the objectives of such studies as determining if a test product is bioequivalent to a reference product when administered at the same molar dose under similar conditions. Some key study designs discussed include non-replicated parallel studies for long-acting drugs, multiple dose steady state studies, and clinical endpoint studies comparing therapeutic effects. Special considerations are also noted for highly variable drugs.
Control including pharmaceutical aspects, physical stability and packing of capsules. Capsules provide advantages such as masking taste and odor, ease of swallowing, and economical production. Quality control tests include physical tests like disintegration, weight variation and chemical tests like dissolution and content uniformity. Capsules are packaged in containers like plastic bottles or blister packs to protect from moisture and ensure stability. Pharmaceutical aspects of capsules include improved dissolution and bioavailability over tablets due to liquid fill formulations, as well as reduced gastric irritation potential.
The document discusses developing a chronotherapeutic drug delivery system for salbutamol sulphate to treat asthma. It aims to release the drug in a pulsatile manner at specific times corresponding to the pathophysiological needs of asthma. The objectives are to study the preformulation parameters of salbutamol sulphate and develop immediate and extended release formulations using tablet in capsule technology to achieve pulse release during midnights or early mornings. The methodology involves characterizing the drug and excipients, developing IR and ER tablet formulations, and evaluating them for micromeritic properties, drug release, and stability.
Stability indicating method development and validation for the simultaneous e...pharmaindexing
Stability indicating method development and validation for the simultaneous estimation of rabeprazole sodium and ketorolac tromethamine in bulk and synthetic mixture by RP-HPLC
Approval and Application Process involved in Investigational New Drug (IND)Nipun Gupta
1. Introduction
During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies.
2. Drug development team
3. Investigational new drug application (INDA)
4. Format and content of IND
5. Preclinical testing
6. The development process IND
application and safety
7. Clinical research
8. New drug application
9. Abbreviated new drug application
10. Changes to an approved NDA or ANDA
11. Difference between NDA and ANDA
1. Preformulation testing involves characterizing key properties of drugs and excipients to develop safe, effective, and stable dosage forms. Tests include analyzing organoleptic properties, purity, solubility, hygroscopicity, and compatibility.
2. Analytical methods are important to quantify drugs during product development and stability testing. UV and HPLC methods are often used depending on the drug's chromophores.
3. Solubility studies over the pH range of 1-8 are crucial because permeability and absorption depend on a drug's ionization state and solubility in different regions of the gastrointestinal tract.
The document discusses sterile formulations and parenteral products. It covers key topics like routes of parenteral administration, pre-formulation of sterile products, physicochemical properties, general requirements, and sterility testing. The different routes discussed are subcutaneous, intramuscular, intravenous, and others. Ideal properties of sterile dosage forms include sterility, isotonicity, being pyrogen-free and particle-free. The document also differentiates between small volume parenterals and large volume parenterals.
The document discusses the ASEAN Common Technical Dossier (ACTD) format for pharmaceutical product registration applications submitted to ASEAN regulatory authorities. The ACTD format aims to standardize applications to reduce submission time and resources while facilitating regulatory review. It includes four parts covering administrative data, quality, nonclinical, and clinical information. The ACTD guideline describes the sections within each part, including overviews, summaries, study reports, and references. The standard format seeks to provide a consistent and transparent presentation of technical information to support evaluation and understanding of registration applications.
This document provides an overview of oral disintegrating tablets (ODTs), including their development, technologies used in their production, and evaluation methods. ODTs are solid dosage forms that disintegrate rapidly in the mouth, typically within 3 minutes, without water. They offer advantages over conventional tablets for patients who have difficulty swallowing. The document reviews various ODT production technologies such as freeze drying, spray drying, mass extrusion, and direct compression. It also discusses ideal properties, advantages, and limitations of ODTs.
The document discusses invitro dissolution testing. It begins with an introduction to dissolution and BCS classification. It then covers theories of dissolution like the diffusion layer model. It describes various invitro dissolution test models including non-sink methods like the USP rotating basket and paddle apparatus and sink methods like the flow through column method. Finally, it discusses factors that can affect dissolution testing and provides a conclusion.
This document discusses quality control tests for pharmaceutical powders. It describes 7 key tests:
1) Particle size and shape determination which affects properties like weight variation and flowability. Methods include sieving and microscopy.
2) Density measurements including bulk density, tapped density and granular density which influence compressibility.
3) Granule strength and friability testing which affects changes in particle size and compressibility.
4) Flow property tests like angle of repose, compressibility index and Hausner’s ratio which indicate flow rates for uniform tablet production.
5) Moisture content testing using a moisture or IR balance to measure 2% optimal moisture for compression.
6) Percent fines testing
This document provides information about tablets, including their definition, advantages, types, and manufacturing process. It begins with definitions of tablets from pharmacopoeias and discusses how they are the most popular dosage form, comprising 70% of pharmaceutical preparations. It describes various types of tablets including compressed, sugar-coated, film-coated, enteric-coated, and effervescent tablets. The document outlines the tablet manufacturing process using tableting machines and discusses characteristics and specifications of compressed tablets.
Bio pharmaceutical classification System [BCS]Sagar Savale
The Biopharmaceutical Classification System was first developed by in 1995, by Amidon et al & his colleagues.
Definition:
“The Biopharmaceutical Classification System is a scientific framework for classifying a drug substance based on its aqueous solubility & intestinal permeability & dissolution rate”.
To saved time fast screening is required so drug substances are classified on basis of solubility and permeability. This classification is called Biopharmaceutical Classification System
Large and small volume parenterals preparationsInNo Sutnga
Small and large volume parenterals are injectable drug formulations. Small volume parenterals have volumes less than 100mL and include solutions, suspensions, emulsions, and dry powders. Large volume parenterals have volumes over 100mL and are used to provide fluids, electrolytes, and nutrition intravenously. The document discusses the classification, formulations, manufacturing, and containers used for parenteral drug products.
This document provides an overview of parenterals (injectable drugs), including:
- Definitions and routes of administration for parenterals
- General requirements like vehicles, additives, and ensuring isotonicity
- Methods for sterilization, formulation, packaging, and quality control testing of parenterals
- Considerations for facilities and production areas to ensure sterility during manufacturing
It discusses key aspects of developing parenteral drugs like pre-formulation studies, adjustment of tonicity, and precautions for aseptic work. Common sterilization techniques and packaging materials are outlined. Quality control tests evaluated include leakage, clarity, sterility, and pyrogen testing. Overall, the document serves as an introduction
The document discusses the formulation and evaluation of an artemether sustained release floating bilayer tablet. It aims to develop a floating drug delivery system for artemether to increase its gastric residence time and provide sustained release to ensure optimal drug levels in the blood and minimize side effects. The document provides background on floating drug delivery systems and reviews previous literature on developing such systems for other drugs. It then gives information on the drug artemether and outlines the objectives and methodology that will be used in the study.
This document discusses various study designs used in bioequivalence studies. It describes the objectives of such studies as determining if a test product is bioequivalent to a reference product when administered at the same molar dose under similar conditions. Some key study designs discussed include non-replicated parallel studies for long-acting drugs, multiple dose steady state studies, and clinical endpoint studies comparing therapeutic effects. Special considerations are also noted for highly variable drugs.
Control including pharmaceutical aspects, physical stability and packing of capsules. Capsules provide advantages such as masking taste and odor, ease of swallowing, and economical production. Quality control tests include physical tests like disintegration, weight variation and chemical tests like dissolution and content uniformity. Capsules are packaged in containers like plastic bottles or blister packs to protect from moisture and ensure stability. Pharmaceutical aspects of capsules include improved dissolution and bioavailability over tablets due to liquid fill formulations, as well as reduced gastric irritation potential.
The document discusses developing a chronotherapeutic drug delivery system for salbutamol sulphate to treat asthma. It aims to release the drug in a pulsatile manner at specific times corresponding to the pathophysiological needs of asthma. The objectives are to study the preformulation parameters of salbutamol sulphate and develop immediate and extended release formulations using tablet in capsule technology to achieve pulse release during midnights or early mornings. The methodology involves characterizing the drug and excipients, developing IR and ER tablet formulations, and evaluating them for micromeritic properties, drug release, and stability.
Stability indicating method development and validation for the simultaneous e...pharmaindexing
Stability indicating method development and validation for the simultaneous estimation of rabeprazole sodium and ketorolac tromethamine in bulk and synthetic mixture by RP-HPLC
ETORICOXIB AND PREGABALIN OF METHOD DEVLOPMENT IN RPHPLC BY UPEXA BAVADIYAUpexaBavadiya
Development and Validation for Simultaneous Estimation of Etoricoxib and Pregabalin in Bulk and Tablet Dosage Form by RP-HPLC 2K21 GTU MASTER IN PHARMACY BY UPEXA BAVADIYA
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.
HPLC (RP-HPLC) Method Development for simultaneous estimation of EMP & LNGLaxmanBulbule1
In this presentation, one can find out how to develop RP-HPLC method for
an antidiabetic drugs like Empagliflozin & Linagliptin by using ICH guidelines. One can also find degradation result of same drug.
UPLC refers to ultra performance liquid chromatography. It enhances speed, resolution, and sensitivity compared to HPLC by using particles less than 2μm in diameter. UPLC operates at very high pressures and provides better separation and faster analysis. It has applications in determining pesticides, analyzing pharmaceutical impurities, and more. UPLC offers advantages like reduced run time and solvent usage but also has disadvantages like higher back pressures reducing column life.
A REVIEW ON ETORICOXIB AND PREGABALIN IN METHOD VALIDATION BY RP-HPLCUpexaBavadiya
Development and Validation for Simultaneous Estimation of Etoricoxib and Pregabalin in Bulk and Tablet Dosage Form by RP-HPLC 2K20,GTU,MASTER IN PHARMACY IN QA
DESIGN AND EVALUATION OF PULSATILE DRUG DELIVERY SYSTEM CONTAINING PANTOPRAZO...Reshma Fathima .K
The document describes the design and evaluation of a pulsatile drug delivery system containing pantoprazole sodium to mimic the circadian rhythm of peptic ulcer. Six formulations of core tablets were developed using different concentrations of superdisintegrants. Tablets were then coated with Eudragit S100 to achieve a lag time of 5 hours before drug release. Evaluation showed the core tablets had acceptable hardness, friability, weight variation and drug content. No chemical interactions between the drug and polymers were observed. When coated tablets were tested, dissolution was prevented for 5 hours followed by rapid and complete drug release, indicating the system could deliver the drug during morning hours to match peptic ulcer symptoms.
Abstract:
The Chronopharmacotherapy the drug administration is synchronised with circadian rhythms Formulation development of Microspheres is more reliable formulation as compare to single type dosage formulation due to it avoids dose dumping, as per required drug release profile is achieved For microspheres many polymers are used such as albumin, gelatine, starch, Eudragit, Polyacrylamide (“PAM”) these material loading capacity is high. Micro sponges which are Spherical are called as micro-balloons. Due to its hollow structure it shows good floating properties. In these systems use of Carbon-dioxide (CO2) as gas generating system which are used for floating purpose. The objective of present investigation is to prepared and evaluate a floating pulsatile drug delivery system of Aceclofenac. The strategy adopted for microspheres containing Aceclofenac as a material were prepared by emulsion solvent diffusion technique. Drug and polymer were mixed in dichloromethane and ethanol at 1:1 ratio. The drug and polymer solution were poured in water 50% W/V polyvinyl alcohol maintained at 30-40 C and the solution was stir at 500rpm using mechanical stirrer, The microspheres obtain were washed repeatedly with water until free from poly vinyl alcohol. The developed formulations were evaluated yield of floating microspheres particle size and shape, drug entrapment efficiency in-vitro evolution of floating ability, in-vitro drug release study. On the basis of these evolution parameters it was found that optimised floating pulsatile release formulation F7 showed higher drug entrapment efficiency floating time 6.8 minutes and the drug and polymer 32 1:3 ratio the particle size was increased.
Key Words: Chronopharmacotherapy, Floating pulsatile drug delivery, Aceclofenac.
Analytical Method Development and Validation of Prednisolone Sodium Phosphate...iosrjce
IOSR Journal of Pharmacy and Biological Sciences(IOSR-JPBS) is a double blind peer reviewed International Journal that provides rapid publication (within a month) of articles in all areas of Pharmacy and Biological Science. The journal welcomes publications of high quality papers on theoretical developments and practical applications in Pharmacy and Biological Science. Original research papers, state-of-the-art reviews, and high quality technical notes are invited for publications.
Objective: The purpose of the present research investigation was to formulate sustained release (SR) formulations for
losartan potassium using 32
factorial designs. Methods: Losartan potassium is an antihypertensive agent, non-peptide
angiotensin-II receptor (type AT1) blocker, and BCS class-III agent. SR tablet formulations of losartan potassium were
formulated using variable quantities of hydroxymethyl propyl cellulose (HPMC) K100M and xanthan gum in combinations
by direct compression technique. The amount of polymers, HPMC K100M, and xanthan gum required to achieve the drug
release was selected as independent variables, X1
and X2
, respectively, whereas time required to release 10% (t10%), 50%
(t50%), 75% (t75%), and 90% (t90%) of drug from formulation was selected as dependent variables. Nine formulations were
prepared and evaluated for various pharmacopoeial tests. Results: The results reveal that all formulations were found to be
with in the pharmacopoeial limits and in vitro drug release profiles of all formulations were subjected to kinetic modeling.
The statistical parameters such as intercept, slope, and correlation coefficient were determined. Polynomial equations were
developed for dependent variables. Validity of developed polynomial equations was checked by designing two checkpoint
formulations (C1
and C2
). According to SUPAC guidelines, formulation (F4
) containing mixture of 15% HPMC K100M
and 20% xanthan gum is the most identical formulation (similarity factor f2 = 86.747, dissimilarity factor f1 = 1.760, and no
significant difference, t = 0.0477) to marketed product (LOSACAR). Conclusion: Best Formulation F4 follows the first-order,
Higuchi kinetics, and the mechanism of drug release was found to be non-Fickian diffusion anomalous transport (n = 0.825).
KEY WORDS: 32 factorial design, First-order kinetics, Hydroxymethyl propyl cellulose K100M, Losartan potassium,
Non-fickian diffusion mechanism, Sustained release tablet, Xanthan gum
When to Conduct a Renal Impairment Studyshabeel pn
This document discusses the evaluation and labeling of drug interactions mediated by drug transporters. It proposes decision trees to determine if in vitro studies suggest a drug is a substrate or inhibitor of P-glycoprotein (P-gp) and may require in vivo interaction studies. It also provides examples of labeling transporter-mediated interactions and evaluates current knowledge for interactions via other transporters. Key questions are asked about the proposed decision trees and selection of inhibitors for in vivo studies.
IOSR Journal of Pharmacy (IOSRPHR), www.iosrphr.org, call for paper, research...iosrphr_editor
1. The document describes the development and validation of an RP-HPLC method for the quantitative estimation of naproxen in tablet formulations.
2. Naproxen is a non-steroidal anti-inflammatory drug used to treat conditions like arthritis. The developed method uses a C18 column, mobile phase of phosphate buffer and methanol, and UV detection at 230nm.
3. The method was found to be linear over a concentration range of 2-20ppm with a correlation coefficient of 0.999. System suitability parameters were within acceptance criteria. The method was successfully applied to a marketed naproxen tablet formulation.
Formulation and Evaluation of Sublingual Tablet of Enalapril Maleate By 32 Fu...PRASANTAKUMARMOHAPAT3
The aim of this work was to formulate and evaluate sublingual tablets of Enalapril maleate for
rapid management of Hypertension. In the present work, the metallic taste of Enalapril maleate
was masked by using Kyron T-114 in 1:2 ratio. The Drug-Resin Complex was formulated as
sublingual tablets using Cross Povidone (X1) and Avicel PH102 (X2) by direct compression
method. The sublingual tablets were evaluated such as thickness, hardness, % Friability, Wetting
time, disintegration time, Water absorption ratio and % CDR. In this study, the fast release of
tablets depends on the concentration of Cross Povidone (X1) and Avicel PH102 (X2). The
selected formulation showed the fastest release of the tablets in 45 s. Stability study was
performed by taking an optimized formulation and it was observed stable. The sublingual tablets
showed acceptable results in all studies. The results indicate that the formulation can be used for
rapid management of Hypertension. Also, Enalapril maleate’s bioavailability may be increased
by selecting sublingual route of administration.
DEVELOPMENT AND VALIDATION OF SPECTROSCOPIC AND CHROMATOGRAPHIC METHOD FOR D...Dipak Reddy
A simple, precise & accurate UV spectroscopy & HPLC method was developed & validated as per ICH guideline.
In UV spectroscopy 0.1HCL used as diluent & in HPLC Methanol :ortho phosphoric acid (40:60%v/v) used.
Thus based on validation data it is concluded that present method is economical, less time consuming, precise , accurate for estimation of Pioglitazone in bulk drug & formulations.
This method can be used to determine the purity of the drug available from various sources by detecting the related impurities.
METHOD VALIDATION AND STABILITY METHOD OF TELMISARTAN AND EFONIDIPINE IN RPHP...godhat ankur
DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF EFONIDIPIN HYDROCHLORIDE ETHANOLATE AND TELMISARTAN IN SYNTHETIC MIXTURE
This document presents the development and validation of an RP-HPLC method for the simultaneous estimation of a muscle relaxant drug and analgesic drug in pure form and pharmaceutical dosage forms. It discusses conducting a literature review on existing methods, determining the physicochemical properties of the drugs, optimizing the analytical method, and validating the developed method as per ICH guidelines. The expected outcomes are an accurate, precise, simple, cost-effective and fast method for simultaneously analyzing the two drugs.
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
Capsules are solid dosage forms that enclose drugs within hard or soft soluble shells, usually made of gelatin. There are two main types - hard gelatin capsules and soft gelatin capsules. Hard gelatin capsules have a two-piece shell and are produced via a dipping process, while soft capsules have a one-piece shell and enclose liquids or semisolids. Capsules offer advantages like taste masking, but have disadvantages for hygroscopic or irritating drugs. They are manufactured using various filling machines from manual to automated and are filled mainly with powders, granules, pellets or tablets.
1. Preformulation studies characterize the physical and chemical properties of drug molecules to develop safe, effective, and stable dosage forms.
2. Key areas of preformulation include evaluating organoleptic properties, bulk characterization, solubility analysis, and stability analysis.
3. Important parameters studied are particle size, hygroscopicity, crystallinity, polymorphism, and powder flow properties which can impact drug dissolution, bioavailability, stability and manufacturability of dosage forms.
The document discusses the key aspects of a prescription, including:
- A prescription is a written order from a medical practitioner to a pharmacist to dispense a specific medication. It includes directions for use and administration.
- The main parts of a prescription include: date, patient information, drug names and quantities, directions for use, and prescriber information.
- When handling a prescription, pharmacists must carefully read, check ingredients, and label dispensed medications to avoid errors. Modern prescribing often involves proprietary drug names for ease of use, but official drug names are preferred. Abbreviations can introduce risks if not clearly understood.
This document discusses different dosage forms used to deliver drugs to the body. It defines dosage forms as the means of delivering active pharmaceutical ingredients (APIs) to sites of action within the body. Dosage forms contain APIs and excipients. They are classified based on route of administration and physical form. Solid dosage forms include tablets, capsules, and implants. Semi-solid forms include ointments, creams, and suppositories. Liquid forms include oral solutions, suspensions, and emulsions. The document provides examples and descriptions of various common dosage forms.
This document discusses different types of powders used in pharmacy. It describes bulk powders meant for external use which are supplied in containers designed for application. Common bulk powders include dusting powders, insufflations, snuffs, and dentifrices. Dusting powders are used on the skin and in body cavities, and contain ingredients like talc, starch, zinc oxide, and salicylic acid. Insufflations and snuffs are inhaled into body cavities and nostrils. Dentifrices contain abrasives like calcium carbonate and flavors to clean teeth. Simple and compound powders for internal use contain one or multiple ingredients wrapped in individual doses. Cachets enclose powders in shells
The document discusses factors that influence the dosage of drugs, noting that dosage cannot be fixed rigidly and must account for factors like age, health, weight, administration route, and drug interactions. It provides details on how factors like age, sex, weight, time of administration, disease states, and metabolic disturbances can impact a drug's effects and required dosage. The goal of considering these influencing factors is to determine the optimal dosage for each individual to achieve the desired therapeutic effects while avoiding toxicity.
This document discusses various pharmaceutical calculations related to dispensing medications. It covers:
- Systems of weights and measures including avoirdupois, apothecaries, metric, and imperial.
- Calculations involving density, weight, and volume.
- Methods for calculating alcohol dilutions and mixtures to achieve a target concentration.
- Conversions between percentage solutions and proof spirit units used for excise purposes.
The document provides detailed examples and step-by-step workings for various calculation types pharmacists may encounter when dispensing prescriptions.
Pharmacy education in India began in the late 19th century and was formally regulated starting in 1948 with the Pharmacy Act. The Act established the minimum educational qualification of a diploma in pharmacy to practice. Currently pharmacy education is regulated by the Pharmacy Council of India and the All India Council for Technical Education. While thousands of pharmacists graduate each year, there is no mandatory accreditation for most pharmacy programs and no regulatory body for clinical pharmacy practice.
The document discusses common defects that can occur during the tablet coating process and their potential causes and remedies. It describes defects such as blistering from overheating, chipping from high attrition, cratering from excessive coating solution, and pitting from excess core heating. Solutions include modifying drying conditions, adjusting coating formulations, and optimizing machine operating parameters. An understanding of tablet formulations and coating processes is necessary to identify and address coating defects.
The document discusses pellets, which are small spherical or semi-spherical units used to deliver pharmaceutical ingredients. Pellets offer advantages over other dosage forms like tablets, including flexibility in dosing, the ability to deliver incompatible drugs simultaneously, and different release profiles. The document describes various pelletization techniques like direct pelletizing, powder layering, extrusion-spheronization, and spray drying. It also discusses methods of assessing pellet properties and performance, such as drug content, size distribution, shape, friability, porosity, and in vitro dissolution studies. Pellets can provide controlled release of drugs and offer benefits for dosage form development, drug delivery, and manufacturing.
Parenteral products are unique dosage forms that are injected directly into the body, bypassing the gastrointestinal tract. They must be exceptionally pure and sterile to avoid contamination. Certain drugs can only be administered parenterally because they are degraded in the GI tract. Characteristics of parenteral products include being sterile, pyrogen-free, isotonic with body fluids, and stable both chemically and microbiologically throughout their shelf life. The preformulation properties of drugs and excipients used in parenterals, such as solubility, thermal profile, and particle size, must be evaluated to ensure quality, safety and efficacy.
The document discusses novel drug delivery systems (NDDS). NDDS aim to control the pharmacokinetics and pharmacodynamics of drugs to maximize efficacy and minimize toxicity. They involve interdisciplinary approaches combining polymer science, pharmaceutics, and molecular biology. Various drug carriers are under development like liposomes, nanoparticles, microparticles to minimize drug degradation and increase bioavailability. NDDS can provide controlled release of drugs over extended periods through formulations like sustained release and targeted delivery to specific sites in the body.
Normally the immune system plays an important role in protecting the body from microorganisms and other foreign substances. If the activity of the immune system is excessive or overreactive, a hypersensitivity reaction develops. The consequences of a hypersensitivity reaction may be injury to the body or death.
Teaching learning techniques for effective outcome based educationReshma Fathima .K
This document discusses traditional education versus outcome-based education (OBE). It outlines some key differences, such as traditional education being content-oriented while OBE focuses on what students learn and the outcomes of completing a program. It explains that OBE determines desired outcomes first before designing the curriculum, teaching methods, and facilities to support those outcomes. The document provides guidelines for establishing OBE, including defining program educational objectives, program outcomes, curriculum, evaluation processes, and continual improvement based on feedback. It also discusses challenges of implementing OBE and strategies for improving student performance through effective teaching and assessment activities.
A SPREADSHEET PROGRAM FOR ONE COMPARTMENT IV BOLUS ADMINISTRATIONReshma Fathima .K
This document describes the development of a spreadsheet program in Microsoft Excel to simulate a one compartment intravenous bolus administration pharmacokinetic model. Standard spreadsheet functions are used to calculate pharmacokinetic parameters like elimination rate constant, half-life, volume of distribution, clearance, and area under the curve based on input plasma drug concentration data over time. Graphs of time versus plasma concentration and time versus log plasma concentration are generated to visualize the model. The spreadsheet technique provides a simple way to model complex pharmacokinetic processes without advanced mathematics.
This document describes the design of a bilayer tablet containing atorvastatin and aspirin for the treatment of cardiovascular diseases. The bilayer tablet contains an immediate release layer of atorvastatin and an enteric-coated pulsatile release layer of aspirin. Four formulations of each layer were developed with different concentrations of excipients. The pulsatile aspirin layers were coated with Eudragit S100 to protect the drug from the acidic environment of the stomach. Evaluation of the bilayer tablets showed acceptable physicochemical properties and drug release profiles. Formulation F3 was found to be the best with one layer providing immediate release of atorvastatin to lower cholesterol and the other layer delivering aspirin at the
This document discusses the formulation and evaluation of calcium alginate beads loaded with diclofenac sodium. The objective is to develop an extended release dosage form of diclofenac sodium to reduce dosing frequency and improve patient compliance by maintaining therapeutic drug levels. Calcium alginate beads are prepared using an ionotropic gelation method by dropping sodium alginate solution containing diclofenac sodium into calcium chloride solution, resulting in crosslinking and formation of beads. The beads are evaluated for drug release using dissolution studies.
Biopharmaceutics and Pharmacokinetics Practical ManualReshma Fathima .K
The document describes an experiment to determine the partition coefficient and dissociation constant of ibuprofen. It provides background on how these properties influence drug absorption. The pH-partition hypothesis states that passive drug diffusion is governed by the drug's pKa, lipid solubility of the un-ionized form (partition coefficient), and gastrointestinal pH. The experiment involves measuring the extraction of ibuprofen into an organic phase at different buffer pH levels to calculate the apparent and true partition coefficients and dissociation constant. Plotting the results allows determining these pharmacokinetic parameters.
The document discusses the Biopharmaceutical Classification System (BCS), which classifies drug substances based on their aqueous solubility and intestinal permeability. The BCS takes into account three major factors that govern drug absorption from oral solid dosages: dissolution, solubility, and permeability. According to the BCS, drugs are classified into four classes based on being high or low solubility and permeability. Class I drugs have high solubility and permeability while Class IV drugs have low solubility and permeability. The classification can be used to predict drug absorption and bioavailability.
Pharmacokinetics is the study of how the body affects a drug after administration through the processes of absorption, distribution, metabolism and excretion. The plasma level time profile shows how drug concentrations change over time in the bloodstream or plasma after administration. The document is a YouTube video by Reshma Fathima from Grace College of Pharmacy discussing pharmacokinetics and plasma level time profiles.
How to Manage Your Lost Opportunities in Odoo 17 CRMCeline George
Odoo 17 CRM allows us to track why we lose sales opportunities with "Lost Reasons." This helps analyze our sales process and identify areas for improvement. Here's how to configure lost reasons in Odoo 17 CRM
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
A workshop hosted by the South African Journal of Science aimed at postgraduate students and early career researchers with little or no experience in writing and publishing journal articles.
How to Add Chatter in the odoo 17 ERP ModuleCeline George
In Odoo, the chatter is like a chat tool that helps you work together on records. You can leave notes and track things, making it easier to talk with your team and partners. Inside chatter, all communication history, activity, and changes will be displayed.
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.
Strategies for Effective Upskilling is a presentation by Chinwendu Peace in a Your Skill Boost Masterclass organisation by the Excellence Foundation for South Sudan on 08th and 09th June 2024 from 1 PM to 3 PM on each day.
Executive Directors Chat Leveraging AI for Diversity, Equity, and InclusionTechSoup
Let’s explore the intersection of technology and equity in the final session of our DEI series. Discover how AI tools, like ChatGPT, can be used to support and enhance your nonprofit's DEI initiatives. Participants will gain insights into practical AI applications and get tips for leveraging technology to advance their DEI goals.
हिंदी वर्णमाला पीपीटी, hindi alphabet PPT presentation, hindi varnamala PPT, Hindi Varnamala pdf, हिंदी स्वर, हिंदी व्यंजन, sikhiye hindi varnmala, dr. mulla adam ali, hindi language and literature, hindi alphabet with drawing, hindi alphabet pdf, hindi varnamala for childrens, hindi language, hindi varnamala practice for kids, https://www.drmullaadamali.com
it describes the bony anatomy including the femoral head , acetabulum, labrum . also discusses the capsule , ligaments . muscle that act on the hip joint and the range of motion are outlined. factors affecting hip joint stability and weight transmission through the joint are summarized.
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 ...
This slide is special for master students (MIBS & MIFB) in UUM. Also useful for readers who are interested in the topic of contemporary Islamic banking.
2. DESIGN AND STATISTICAL OPTIMIZATION OF PULSATILE DELIVERY SYSTEM
CONTAINING PANTOPRAZOLE SODIUM
RESHMA FATHIMA.K
GRACE COLLEGE OF PHARMACY,PALAKKAD
11-Jan-18 2
3. MAINMENU
• Introduction
• Aim and Objectives
• Review of Literature
• Plan of work
• Materials and Methods
• Results and Discussion
• Summary and Conclusion
• Bibliography
• Annexures
11-Jan-18 3
4. INTRODUCTION
• Oral control drug delivery system
• Pulsatile drug release pattern
• Circadian rhythms
• Pulsatile drug delivery system
• Chronopharmacological behavior
• GI ulcer
11-Jan-18 4
6. AIMANDOBJECTIVES
11-Jan-18 6
Background and Significance of the study
Concepts of the chronopharmacokinetics
Aim and Objectives of the study
The main aim of the research work is to develop and statistically optimize the
oral pulsatile drug release tablets containing Pantoprazole Sodium for the
treatment of peptic ulcer.
7. • The present study is to formulate pulsatile drug delivery system of
Pantoprazole sodium using newer excipient composition for the
immediate release of drug after a lag time of 5hrs.
• The specific aim of the study is to explore the influence of
microcrystalline cellulose and sodium starch glycolate on
physicochemical properties of sudden release pulsatile tablet containing
pantoprazole sodium after a lag time of 5hrs using 3² factorial design
inorder to achieve a site specific delivery system.
11-Jan-18 7
8. REVIEWOF LITERATURE
11-Jan-18 8
AUTHORS TITLE PUBLICATION CONTENTUSED
Pallab Roy et al Multiparticulate
formulation approach to
pulsatile drug delivery:
current perspectives
Journal of controlled
release (Elsevier)
2009 Vol 134 issue 2
Pulsatiledelivery, multiparticulate dosage
forms are gaining much favor over single-
unit dosage forms because of their potential
benefits like predictable gastric emptying,
no risk of dose dumping, flexible release
patterns and increased bioavailability with
less inter- and intra-subject variability.
Hong-Liang Lin et
al
Release characteristics and
in vitro–in vivo correlation
of pulsatile
pattern for a pulsatile drug
delivery system activated
by
membrane rupture via
osmotic pressure and
swelling
European Journal of
Pharmaceutics&Bio
pharmaceutics Vol
70 (2008) 289–301
This study attempted to characterize the
influence of core and coating formulations
on the release profiles to establish in
vitro/in vivo
correlations of pulsatile pattern for a
pulsatile drug delivery system activated by
membrane rupture based on three core
tablet formulations.
9. 11-Jan-18 9
AUTHORS TITLE PUBLICATION CONTENTUSED
Hyma P et al Formulation &
Evaluation of
Pulsatile Drug
Delivery System of
Venlafaxine HCL
International Journal of
Pharmacy Research and
Technology 2012,
Volume 2, Issue 4, 19-22
Pulsatile drug delivery system of Venlafaxine
Hydrochloride has been successfully prepared for
oral delivery of drug. This is a type of controlled
drug delivery system which shows sustained
therapeutic action; with lag time where there is no
release of the drug during initial lag phase of drug
administration. Venlafaxine Pulsatile formulations
were prepared using sodium alginate, pectin AS104,
and sodium bicarbonate for obtaining required lag
time.
Kommineni
veditha et al
Design and
development of
pulsatile drug
delivery systems
for Salbutamol
sulphate
International Journal of
Pharmaceutical research
and bioscience 2(4) 2013,
372-384.
Pulsatile drug delivery systems for salbutamol
sulphate were prepared with a view to release the
salbutamol around 4am with a lag time of 6 hours
after it’s administration
(10pm).
10. 11-Jan-18 10
AUTHORS TITLE PUBLICATION CONTENTUSED
Neha et al Design and Evaluation
of Chronotropic
Systems for Colon
Targeted Drug Delivery
International Journal of
Pharmacy Research and
Technology Volume 2,
Issue 3 2012 13-17
Modified Pulsincap and compression
coated tablets of aceclofenac, a non
steroidal anti-inflammatory drug used
for the treatment of rheumatoid arthritis
were developed to target drug release in
the colon.
G. Sanjana
reddy et al
Formulation and in
vitro evaluation of
colon specific drug
delivery of naproxen
sodium by using
pulsincap technology.
An International Journal
of Advances in
Pharmaceutical Sciences
Volume 5 Issue 1 2014
1751-1760
The purpose of the present study was to
design and evaluate an oral, site specific,
and pulsatile drug delivery system
containing Naproxen sodium as a model
drug, which can be targeted to colon in a
pH and time dependent manner.
11. DRUG PROFILE
Drug : Pantoprazole Sodium IP
BCS Class : Class III (high solubility, low permeability)
Category: Anti-Ulcer Agents, Proton-pump Inhibitors
Molecular weight : 383.37 gm/mol
Description: White to off- white crystalline powder and is racemic has a,
acidic and weakly basic property
11-Jan-18 11
12. Solubility: Pantoprazole sodium sesquihydrate is freely soluble in water,
Very slightly soluble in phosphate buffer at pH 7.4, and practically
insoluble in n- hexane.
Stability: Pantoprazole Sodium is not stable below pH 6.
Partition Coefficient: The partition coefficient of Pantoprazole sodium
between n-octanol and water and was found to be 1.3.
PKa: 8.35
pH: Between 9.0 & 11.5 (2% w/v solution in water)
11-Jan-18 12
13. Bioavailability: 77%
Peak plasma concentration: 2.52 mg/l
tmax: 2.5 hours (under fasting conditions)
t1/2: The mean elimination half-life is 1 hour.
Onset time : 2-4 hrs.
Volume of distribution: 0.15 l/kg
Excretion: Through renal excretion
11-Jan-18 13
14. PLAN OF WORK
Compatibility study
Construction of standard curve of Pantoprazole Sodium
Design of Pantoprazole Sodium core tablets for preliminary studies
Optimization of core tablet using 3² factorial design
Selection of optimized batch for coating
Evaluation of Pulsatile coating tablets
11-Jan-18 14
18. Methodology
Compatibility Study using FTIR
Design of Pulsatile release core tablets of Pantoprazole Sodium
Formulation of Pulsatile Pantoprazole core tablets
Evaluation of Pulsatile Pantoprazole core tablets
Preparation of standard curve of Pantoprazole Sodium in 0.1N HCl
Preparation of standard curve of Pantoprazole Sodium in pH 6.8
phosphate buffer
11-Jan-18 18
19. Pre compression parameters
Angle of repose
Bulk and tapped density
Hausner ratio
Compressibility index
Post compression parameters
Hardness test
Friability test
Weight variation test
11-Jan-18
19
20. Disintegration test for core tablet containing Pantoprazole sodium
Drug content estimation
Dissolution test for core tablet containing pantoprazole sodium
Statistical optimization
Formulation of Pulsatile Pantoprazole Sodium coated tablets
Disintegration test for coated tablet
Dissolution study for coated tablet
11-Jan-18 20
21. RESULTS ANDDISCUSSIONS
Preparation of standard plot for pantoprazole sodium in 0.1N HCl
Table 1 - Calibration curve for Pantoprazole sodium
11-Jan-18 21
Concentration(µg/ml) Absorbance
0 0
5 0.167
10 0.326
15 0.491
20 0.642
25 0.802
22. Preparation of standard plot for pantoprazole sodium in pH 6.8
phosphate buffer
Table 2 - Calibration curve for pantoprazole sodium
11-Jan-18 22
Concentration (µg/ml) Absorbance
0 0
5 0.179
10 0.368
15 0.562
20 0.744
25 0.945
23. Compatibility studies by FTIR
FTIR spectrum of Pantoprazole sodium was used to study the possible
interaction between pantoprazole sodium and its composition.
The results of the study indicates FTIR spectrum of Drug and Excipients
did not differed with major peaks of pantoprazole sodium.i.e, all the
major peaks of the drug appeared on the blend indicate that there is no
possible interaction between drug and excipients.
11-Jan-18 23
24. 11-Jan-18 24
FTIR spectrum of Pantoprazole sodium FTIR spectrum of Pantoprazole sodium, MCC, CCS,
Eudragit S 100
FTIR spectrum of Pantoprazole sodium, MCC, SSG,
Eudragit S 100
28. Weight Variation test
Table 6- Pantoprazole sodium core tablets were prepared by direct compression method.
The tablets obtained were complied with pharmacopoeial specifications
11-Jan-18 28
Average weight of tablet (mg) % Deviation
125 or less ±10
125-250 ±7.5
250 mg or more ±5
39. 11-Jan-18 39
Table 17 - Regression Coefficients for Disintegration time (sec)
Term Coefficient P
Constant 124.000 0.000
X1 2.667 0.416
X2 -1.000 0.625
X1*X1 -1.000 1.000
X2*X2 -0.000 0.727
X1*X2 0.500 -
40. 11-Jan-18 40
Term Coefficient P
Constant 86.000 0.000
X1 -2.550 0.061
X2 3.333 0.031
X1*X1 -1.350 0.435
X2*X2 1.700 0.340
X1*X2 -1.950 0.164
Table 18 - Regression Coefficients for Invitro release study
41. STATISTICAL OPTIMIZED FORMULA
A statistical model in co-operating interactive and polynomial terms was
used to evaluate the responses.
Y=b0+b1X1+b2X2+b12X1X2+b11X1X2+b22X2X2
Y= Dependent variable
b- Arithmetic mean response of 9 runs
bi - (b1,b2,b12,b11,b22) is estimated coefficient factor X1
11-Jan-18 41
43. The values of the correlation coefficient indicate a good fit shows the
plot of amount of MCC(X1) and amount of SSG (X2) versus Hardness,
Friability, Disintegration time and Invitro release of tablets respectively.
The data demonstrates that code f3 containing 180 mg of X1 and 2 mg of
X2 were optimized one based on in-vitro dissolution study (Y4).
11-Jan-18 43
44. From the above study f3 formulation was considered as a best formulation based
on evaluation parameters.
In this batch f3 show satisfactory hardness, maximum drug release and
disintegrated within 2 minute.
A pulsatile drug release, where the drug is released rapidly after a well defined
lag time.
Here the core tablet f3 show maximum drug release. So f3 formulation is
susceptible for coating.
11-Jan-18 44
45. Table 19 - Formula for coating solution
Code Ingredients Percentage(%)
f3 Eudragit S 100 20
PEG 2
Titanium dioxide 5
Acetone Q.S
Isopropyl alcohol Q.S
Tartrazine Q.S
11-Jan-18 45
46. Dissolution study of pantoprazole sodium pulsatile release tablet(f3
coated tablet)
11-Jan-18 46
48. DISCUSSION
• The Pulsatile delivery system of Pantoprazole sodium were developed.
• Statistical data
• Y=b0+b1X1+b2X2+b11X1X1+b22X2X2+b12X1X2
• Effect on Hardness
• Effect on Friability
• Effect of Disintegration and Dissolution
11-Jan-18 48
49. SUMMARY
Main aim of the study
Core tablets were prepared
Core tablets were evaluated
Best formulation (D5)
32 factorial design
Tablets were coated
Coated tablets were evaluated
11-Jan-18 49
pH 1.5-3.5
Transit time :2hrs
pH 5-6
Transit time: 5
minutes
pH 7-8 slightly
alkaline
Transit time : 2hrs
pH 7-8
Transit time : 3-6hrs
Tablet
50. CONCLUSION
The work described design of new pulsatile delivery tablets of
pantoprazole using factorial design approach for better treatment
outcome for peptic ulcer.
Preparation of Pulsatile tablets using factorial design was found to be
well suited and sound approach to obtain the successful formulations.
Inclusion of MCC and sodium starch glycolate greatly influence the
quality of formulation.
11-Jan-18 50
51. These results render the designed pantoprazole pulsatile tablets as possible
candidate for peptic ulcer patient with enhanced patient compliance.
Pantoprazole sodium is anti-ulcer drug to achieve chronotherapeutic delivery of
drug for improved patient compliance the newer device was successfully
developed and optimized.
The optimized dosage form (f3) can be taken at bedtime and released the content
in the early morning hours when ulcer symptoms are more severe.
Also the formulation suitable for large scale production.
11-Jan-18 51
52. BIBLIOGRAPHY
Geest S, Koker J, Demeester J, De Smedt S, Hennink WE. “Pulsed Invitro release
and in vivo behavior of exploding microcapsules”, J. Control. Release [2009];
135:268-73.
Dashevsky A, Mohammad A, “Development of pulsatile multiparticulate drug
delivery system coated with aqueous dispersion Aquacoat ECD” Int.J.Pharm.
[2006]; 318:124-31.
Gothoskar AV, Joshi AM ,Joshi NH., “Pulsatile drug delivery systems: A
review”, Drug Delivery Technology, [2004]; 4(5): 1-11.
11-Jan-18 52
53. Sadaphal K.P., Thakare V.M., Gandhi. B.R., “Formulation and Evaluation of
pulsatile drug delivery system for chronobiological disorder: Asthma”
International Journal of Drug Delivery 3, [2011]; 348-356
Sumit Chakraborty , Sibaji Sarkar, Sujit Kumar Debnat, “Formulation
Development and Evaluation of Pantoprazole Enteric Coated Tablets”,
International Journal of ChemTech Research, [2009], 1(3), 663-666
Haribansh Narayan Singh, Shivangi Saxena, Sunil Singh, “Pulsatile drug delivery
System : Drugs used in pulsatile formulations”, Research. J. Pharma. Dosage
forms and Tech, [2013]; 5(3), 115-121.
11-Jan-18 53
54. PUBLICATIONS
Reshma Fathima K*, Sivakumar R, Rina Parveen, “Current status on
pulsatile drug delivery systems –An overview”, Acta biomedical
Scientia, [2016]; 3(3):162-168.
Reshma Fathima K*, Sivakumar R; “Design and evaluation of Pulsatile
drug delivery system containing Pantoprazole Sodium”, AJBPR, [2016]
3(3)
11-Jan-18 54