The document describes a study that formulated and evaluated Ofloxacin floating tablets using different grades of HPMC as polymers. Six formulations were developed using wet granulation technique. The formulations were evaluated for physicochemical properties, floating behavior, swelling index and in-vitro drug release. All formulations showed good floating properties between 8-12 hours. Drug release from the formulations ranged from 97.25% to 102.85% over 24 hours, indicating controlled release of the drug. The study demonstrated that floating tablets using HPMC can prolong gastric residence time and sustain the release of Ofloxacin.
Formulation and evaluation of Furosemide oral dispersible tabletsSriramNagarajan18
The document summarizes the formulation and evaluation of oral dispersible tablets containing the diuretic drug furosemide. Various formulations were prepared using different concentrations of superdisintegrants like crospovidone, crosscarmellose sodium, and sodium starch glycolate. Tablet properties like hardness, friability, disintegration time, and drug release were evaluated. FTIR studies showed no drug-excipient interactions. Formulation OF5 with 10mg of sodium starch glycolate was found to have the best taste and fastest disintegration time compared to other formulations.
Formulation and evaluation of tramadol using pulsincap technologySriramNagarajan18
This document describes the formulation and evaluation of tramadol pulsincaps using pulsincap technology for colon-specific delivery. Tramadol granules were prepared by blending the drug with polymers like HPMC K4M and ethyl cellulose. Hard gelatin capsules were treated with formaldehyde to make them insoluble in the stomach and small intestine. The granules were filled into the treated capsule bodies and sealed with a hydrogel plug. The formulations were evaluated for flow properties, drug content, and in vitro dissolution. Dissolution studies showed the formulations released drug in a pulsatile manner with a lag time followed by rapid release. Formulation F3 with 30% polymer showed the highest drug release of 96
B. Pharm. (Honours) Part-III Practical, Bio-Pharmaceutics-I,MANIKImran Nur Manik
a) Tablet Weight Variation Test.
b) Tablet hardness Test.
c) Tablet friability Test.
d) Tablet disintegration Test.
e) Tablet dissolution Test.
f) Leakage test of Packaging of tablets / capsules.
g) Capsule weight variation test
h) Determination of Binding Sites and Association constant.
Effervescent technique in development of floating tablets for antiviral drugsSriramNagarajan19
The purpose of this investigation was to prepare a regiospesific drug delivery system of Stavudine. Floating tablets of Stavudine were prepared by direct compression method employing different concentration of HPMC K15M by effervescent technique. Sodium bicarbonate was incorporated as a gas-generating agent. The floating tablets were evaluated for uniformity of weight, hardness, friability, drug content, swelling studies, in vitro buoyancy and dissolution studies. The effect of different concentration of HPMC K15M on drug release profile and floating properties was investigated. The prepared tablets exhibited satisfactory physico-chemical characteristics. All the prepared batches showed good in vitro buoyancy. The tablet swelled radially and axially during in vitro buoyancy studies. It was observed that the tablet remained buoyant for more than 12 hours. Increased in the HPMC K15M level, decreased the floating lag time but tablets floated for longer duration. The formulation with 1:1 drug: Polymer ratios were found to float for longer duration as compared with other formulations containing HPMC K15M. The drug release from the tablets was sufficiently sustained and non-Fickian transport of the drug from tablets was confirmed.
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
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 dissolution testing, which is an important quality control procedure for pharmaceutical dosage forms. It begins by introducing dissolution testing and explaining that it measures the rate and extent of dissolution of a drug product under specified conditions. It then describes the various apparatus used for dissolution testing according to official compendia like the USP, including the basket, paddle, reciprocating cylinder, flow-through cell, paddle-over-disk, rotating cylinder, and reciprocating disk methods. The document also discusses factors that can influence dissolution and concludes that dissolution testing is a valuable tool for evaluating batch-to-batch consistency and biological availability of drugs from formulations.
Dissolution testing conventional and controlled release productsMd Fiaz
Dissolution testing is important for quality control and predicting in vivo performance of drug products. It quantifies the rate and amount of drug released from solid oral dosage forms under standardized conditions. Key factors in designing a dissolution test include the apparatus, media, and acceptance criteria. The most common apparatuses are USP Type I (baskets), Type II (paddles), and Type IV (flow-through cells). Media include water, buffers, and simulated gastric/intestinal fluids. Acceptance criteria ensure a minimum percentage of drug dissolves within a specified time for quality batches. Dissolution testing is critical for developing and evaluating conventional and controlled-release drug products.
Formulation and evaluation of Furosemide oral dispersible tabletsSriramNagarajan18
The document summarizes the formulation and evaluation of oral dispersible tablets containing the diuretic drug furosemide. Various formulations were prepared using different concentrations of superdisintegrants like crospovidone, crosscarmellose sodium, and sodium starch glycolate. Tablet properties like hardness, friability, disintegration time, and drug release were evaluated. FTIR studies showed no drug-excipient interactions. Formulation OF5 with 10mg of sodium starch glycolate was found to have the best taste and fastest disintegration time compared to other formulations.
Formulation and evaluation of tramadol using pulsincap technologySriramNagarajan18
This document describes the formulation and evaluation of tramadol pulsincaps using pulsincap technology for colon-specific delivery. Tramadol granules were prepared by blending the drug with polymers like HPMC K4M and ethyl cellulose. Hard gelatin capsules were treated with formaldehyde to make them insoluble in the stomach and small intestine. The granules were filled into the treated capsule bodies and sealed with a hydrogel plug. The formulations were evaluated for flow properties, drug content, and in vitro dissolution. Dissolution studies showed the formulations released drug in a pulsatile manner with a lag time followed by rapid release. Formulation F3 with 30% polymer showed the highest drug release of 96
B. Pharm. (Honours) Part-III Practical, Bio-Pharmaceutics-I,MANIKImran Nur Manik
a) Tablet Weight Variation Test.
b) Tablet hardness Test.
c) Tablet friability Test.
d) Tablet disintegration Test.
e) Tablet dissolution Test.
f) Leakage test of Packaging of tablets / capsules.
g) Capsule weight variation test
h) Determination of Binding Sites and Association constant.
Effervescent technique in development of floating tablets for antiviral drugsSriramNagarajan19
The purpose of this investigation was to prepare a regiospesific drug delivery system of Stavudine. Floating tablets of Stavudine were prepared by direct compression method employing different concentration of HPMC K15M by effervescent technique. Sodium bicarbonate was incorporated as a gas-generating agent. The floating tablets were evaluated for uniformity of weight, hardness, friability, drug content, swelling studies, in vitro buoyancy and dissolution studies. The effect of different concentration of HPMC K15M on drug release profile and floating properties was investigated. The prepared tablets exhibited satisfactory physico-chemical characteristics. All the prepared batches showed good in vitro buoyancy. The tablet swelled radially and axially during in vitro buoyancy studies. It was observed that the tablet remained buoyant for more than 12 hours. Increased in the HPMC K15M level, decreased the floating lag time but tablets floated for longer duration. The formulation with 1:1 drug: Polymer ratios were found to float for longer duration as compared with other formulations containing HPMC K15M. The drug release from the tablets was sufficiently sustained and non-Fickian transport of the drug from tablets was confirmed.
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
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 dissolution testing, which is an important quality control procedure for pharmaceutical dosage forms. It begins by introducing dissolution testing and explaining that it measures the rate and extent of dissolution of a drug product under specified conditions. It then describes the various apparatus used for dissolution testing according to official compendia like the USP, including the basket, paddle, reciprocating cylinder, flow-through cell, paddle-over-disk, rotating cylinder, and reciprocating disk methods. The document also discusses factors that can influence dissolution and concludes that dissolution testing is a valuable tool for evaluating batch-to-batch consistency and biological availability of drugs from formulations.
Dissolution testing conventional and controlled release productsMd Fiaz
Dissolution testing is important for quality control and predicting in vivo performance of drug products. It quantifies the rate and amount of drug released from solid oral dosage forms under standardized conditions. Key factors in designing a dissolution test include the apparatus, media, and acceptance criteria. The most common apparatuses are USP Type I (baskets), Type II (paddles), and Type IV (flow-through cells). Media include water, buffers, and simulated gastric/intestinal fluids. Acceptance criteria ensure a minimum percentage of drug dissolves within a specified time for quality batches. Dissolution testing is critical for developing and evaluating conventional and controlled-release drug products.
Studies on development of famotidine floating tablets using three grades of M...SriramNagarajan17
This document summarizes a study on the development of floating tablets of the drug famotidine using three grades of hydroxypropyl methylcellulose (HPMC; K4M, K15M, K100M) as release-retarding polymers. Tablets were prepared using different drug-polymer ratios via wet granulation. The formulations were characterized for drug-polymer compatibility, floating behavior, swelling properties, in vitro drug release, and stability. Fourier transform infrared spectroscopy, differential scanning calorimetry, and X-ray diffraction studies indicated no drug-polymer interactions. In vitro tests showed that the type and concentration of polymer affected drug release rate and floating properties. The optimized formulation containing famotidine and HPMC K
Non sterile manufacturing process technologyPRANJAY PATIL
This document provides an overview of in-process quality control (IPQC) tests for tablets and capsules during the manufacturing process. It discusses the importance and scope of IPQC, as well as general IPQC tests such as identity, quality, purity, and potency tests. Specific IPQC tests covered for tablets include weight variation, content uniformity, hardness, thickness, friability, dissolution, disintegration, and moisture content. For capsules, content of active ingredients, weight variation, content uniformity, disintegration, dissolution, and moisture permeation are discussed. Various apparatus used to perform these tests are also described.
International Journal of Pharmaceutical Science Invention (IJPSI) is an international journal intended for professionals and researchers in all fields of Pahrmaceutical Science. IJPSI publishes research articles and reviews within the whole field Pharmacy and Pharmaceutical Science, new teaching methods, assessment, validation and the impact of new technologies and it will continue to provide information on the latest trends and developments in this ever-expanding subject. The publications of papers are selected through double peer reviewed to ensure originality, relevance, and readability. The articles published in our journal can be accessed online.
Introduction to Dissolution equipment's, Calibration of dissolution apparatus, Dissolution procedure development and validation, Dissolution method development for generic drug products.
The document discusses evaluation and stability studies of tablets. It provides details on common tablet tests performed during evaluation including general appearance, hardness, friability, weight variation, disintegration, and dissolution. It also discusses factors affecting drug stability and the various types of stability that must be considered, including chemical, physical, microbiological, therapeutic, and toxicological stability. Guidelines for stability testing from ICH, USP, FDA and other organizations are also summarized regarding testing conditions, frequency, and requirements for re-testing tablets after registration.
Design and Development of Effervescent Floating Tablet Dapagliflozinijtsrd
The objective of the present study was to formulate and evaluate Effervescent Floating Tablet of Dapagliflozin for the treatment of antidepressant agent. Tablets were prepared by direct compression using directly compressible polymers such as HPMC K4M, and Carbopol 934 were evaluated for drug excipient compatibility, density, buoyancy test, swelling study, drug content and In Vitro release profile. Sodium bicarbonate and citric acid were used producing effervescent base for buoyancy of tablets. Analysis of drug release from tablet indicates drug release by zero order, first order rate kinetics. No significant change was observed in physical appearance, drug content, floatability or in vitro dissolution pattern after storage at 450C 750C RH for three months. Samadhan Mali | Shweta Gedam | Swati Talele | Anil Jadhav "Design and Development of Effervescent Floating Tablet Dapagliflozin" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-5 , August 2020, URL: https://www.ijtsrd.com/papers/ijtsrd31674.pdf Paper Url :https://www.ijtsrd.com/pharmacy/pharmaceutics/31674/design-and-development-of-effervescent-floating-tablet-dapagliflozin/samadhan-mali
This document describes quality control tests performed on suppositories, including weight variation testing to ensure suppositories are uniformly sized, hardness testing to evaluate structural integrity, disintegration testing to assess dissolution rate, and drug content testing to verify active ingredient levels. Dissolution testing was also conducted using a basket apparatus to analyze drug release over time in vitro. Finally, short term stability studies were performed on promising formulations by storing samples at room temperature and refrigeration for 6 weeks and testing for drug content and dissolution profile.
selection of dissolution medium And dissolution study of solid dosage formAshwin Patil
The document discusses dissolution testing of solid oral dosage forms. It covers selection of dissolution media based on factors like drug solubility and formulation type. Common dissolution media include simulated gastric fluid, water and simulated intestinal fluid. Selection of parameters like rpm, time and apparatus depends on the formulation. Dissolution testing is important for quality control and bioequivalence studies. It provides insight into in vivo performance and helps product development.
Capsules come in both hard and soft gelatin shells that enclose solid or liquid medications. Quality control tests are conducted on empty capsules and finished capsules to ensure uniformity of weight, content of active ingredients, and dissolution. Key tests include uniformity of weight, content of active ingredients, and uniformity of content. Acceptance criteria vary slightly between pharmacopeias but generally require less than 10% deviation from the average weight and 90-110% of the average active content. In-process quality checks are also important to monitor production and identify defects.
This document discusses dissolution method development. It defines dissolution as a process where a solid substance enters a solvent to form a solution. The key steps in dissolution are wetting, disintegration, disaggregation, and dissolution of particles. Factors that influence dissolution are also discussed, along with the Noyes-Whitney equation. A systematic approach to method development is then outlined, including literature review, solubility studies, sink conditions, apparatus selection, media preparation, method optimization, and sample analysis investigations. The goal is to develop a successful dissolution method and analysis to characterize drug release.
Capsules are solid dosage forms that contain a drug or mixture of drugs enclosed within a shell. The shell is typically made of gelatin but can also be other materials. Capsules are intended for oral administration and provide rapid release of contents unless they are modified or enteric release capsules. Capsules can be filled using various methods like auger, dosator, or dosing disc systems. Tests are conducted to ensure uniformity of contents, weight, and dissolution based on pharmacopeial standards.
Presentatio on IPQC for Capsules by Akshay Trivedi
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality requirements".[1]
This approach places an emphasis on three aspects (enshrined in standards such as ISO 9001)[2][3]:
Elements such as controls, job management, defined and well managed processes,[4][5] performance and integrity criteria, and identification of records
Competence, such as knowledge, skills, experience, and qualifications
Soft elements, such as personnel, integrity, confidence, organizational culture, motivation, team spirit, and quality relationships.
Inspection is a major component of quality control, where physical product is examined visually (or the end results of a service are analyzed). Product inspectors will be provided with lists and descriptions of unacceptable product defects such as cracks or surface blemishes for example.[3]
The quality of the outputs is at risk if any of these three aspec
Modern humans are distinguished from other species by their extensive use of tools to control and adapt to their surroundings. Early stone tools such as anvils had no holes and were not designed as interchangeable parts. Mass production established processes for the creation of parts and system with identical dimensions and design, but these processes are not uniform and hence some customers were unsatisfied with the result. Quality control separates the act of testing products to uncover defects from the decision to allow or deny product release, which may be determined by fiscal constraints.[6] For contract work, particularly work awarded by government agencies, quality control issues are among the top reasons for not renewing a contract.[7]
The simplest form of quality control was a sketch of the desired item. If the sketch did not match the item, it was rejected, in a simple Go/no go procedure. However, manufacturers soon found it was difficult and costly to make parts be exactly like their depiction; hence around 1840 tolerance limits were introduced, wherein a design would function if its parts were measured to be within the limits. Quality was thus precisely defined using devices such as plug gauges and ring gauges. However, this did not address the problem of defective items; recycling or disposing of the waste adds to the cost of production, as does trying to reduce the defect rate. Various methods have been proposed to prioritize quality control issues and determine whether to leave them unaddressed or use quality assurance techniques to improve and stabilize production.[6]
Notable approaches
This document discusses dissolution testing of pharmaceutical dosage forms. It describes the types of dissolution apparatuses, including basket, paddle, reciprocating cylinder, flow-through cell, and transdermal cell apparatuses. The key features and uses of each apparatus are outlined. Factors that influence dissolution rate, such as formulation components, processing methods, and test conditions, are also summarized. These include vehicles, diluents, disintegrants, and processing methods like granulation and compression force.
1. The document describes the requirements and procedures for quality control testing of pharmaceutical products and materials. It outlines the necessary facilities, equipment, personnel qualifications, and specific tests that must be conducted.
2. Quality control tests capsules for content uniformity, weight uniformity, disintegration, and dissolution. The content uniformity test assesses the quantity of drug in individual capsules, the weight uniformity test evaluates capsule weights, and the disintegration test determines how quickly capsules break down in liquid.
3. Additional responsibilities of quality control include approving or rejecting materials, monitoring production processes, conducting stability studies, and releasing finished products once all testing is completed. Quality assurance also oversees final product inspection before release.
This document discusses dissolution media used for in vitro drug testing. It begins by defining dissolution as the process by which a solid substance enters the solvent phase to yield a solution. The importance of dissolution testing to confirm product quality and batch consistency is described. Common types of dissolution media discussed include simulated gastric fluid (SGF), simulated intestinal fluid (SIF), water, and biorelevant media. Key factors that can affect dissolution media and rates, such as composition, pH, viscosity, surfactants, and temperature, are also summarized.
This document discusses the design and calibration of dissolution test equipment. It provides information on the different types of dosage forms that can be tested using various dissolution apparatus, including immediate and controlled release forms. Details are given on the major pharmacopeial dissolution monographs and the six official dissolution apparatus. Factors to consider when selecting a dissolution apparatus are discussed. The document also covers qualification of the dissolution system through both mechanical calibration of parameters and chemical calibration using apparatus suitability tests with standard reference tablets. Sources of variability that can affect test reliability if not properly controlled are summarized.
The document discusses various mycotoxins produced by fungi, including their history, effects on plants and animals, and detection methods. It describes several important mycotoxins such as aflatoxins, ochratoxins, fumonisins, trichothecenes, and ergot alkaloids. For each mycotoxin, it provides details on the producing fungi, toxic effects, mechanisms of action, and historical outbreaks in humans or livestock. Detection methods like HPLC, ELISA, and lateral flow tests are also summarized. The document contains several figures and tables to illustrate fungal colonies, mycotoxin structures, and contamination levels found in studies.
This document discusses research projects for PharmD students. It emphasizes that research and problem solving are important for pharmacists and the pharmacy profession. Pharmacists can conduct research to help guide drug therapy and should understand the research process to interpret knowledge generated by others. The document provides guidance to students on formulating a research problem, including reviewing literature, developing a logical research problem statement, and considering factors like interest, magnitude, measurement and expertise when selecting a problem. It aims to help students develop skills for their PharmD research projects.
Studies on development of famotidine floating tablets using three grades of M...SriramNagarajan17
This document summarizes a study on the development of floating tablets of the drug famotidine using three grades of hydroxypropyl methylcellulose (HPMC; K4M, K15M, K100M) as release-retarding polymers. Tablets were prepared using different drug-polymer ratios via wet granulation. The formulations were characterized for drug-polymer compatibility, floating behavior, swelling properties, in vitro drug release, and stability. Fourier transform infrared spectroscopy, differential scanning calorimetry, and X-ray diffraction studies indicated no drug-polymer interactions. In vitro tests showed that the type and concentration of polymer affected drug release rate and floating properties. The optimized formulation containing famotidine and HPMC K
Non sterile manufacturing process technologyPRANJAY PATIL
This document provides an overview of in-process quality control (IPQC) tests for tablets and capsules during the manufacturing process. It discusses the importance and scope of IPQC, as well as general IPQC tests such as identity, quality, purity, and potency tests. Specific IPQC tests covered for tablets include weight variation, content uniformity, hardness, thickness, friability, dissolution, disintegration, and moisture content. For capsules, content of active ingredients, weight variation, content uniformity, disintegration, dissolution, and moisture permeation are discussed. Various apparatus used to perform these tests are also described.
International Journal of Pharmaceutical Science Invention (IJPSI) is an international journal intended for professionals and researchers in all fields of Pahrmaceutical Science. IJPSI publishes research articles and reviews within the whole field Pharmacy and Pharmaceutical Science, new teaching methods, assessment, validation and the impact of new technologies and it will continue to provide information on the latest trends and developments in this ever-expanding subject. The publications of papers are selected through double peer reviewed to ensure originality, relevance, and readability. The articles published in our journal can be accessed online.
Introduction to Dissolution equipment's, Calibration of dissolution apparatus, Dissolution procedure development and validation, Dissolution method development for generic drug products.
The document discusses evaluation and stability studies of tablets. It provides details on common tablet tests performed during evaluation including general appearance, hardness, friability, weight variation, disintegration, and dissolution. It also discusses factors affecting drug stability and the various types of stability that must be considered, including chemical, physical, microbiological, therapeutic, and toxicological stability. Guidelines for stability testing from ICH, USP, FDA and other organizations are also summarized regarding testing conditions, frequency, and requirements for re-testing tablets after registration.
Design and Development of Effervescent Floating Tablet Dapagliflozinijtsrd
The objective of the present study was to formulate and evaluate Effervescent Floating Tablet of Dapagliflozin for the treatment of antidepressant agent. Tablets were prepared by direct compression using directly compressible polymers such as HPMC K4M, and Carbopol 934 were evaluated for drug excipient compatibility, density, buoyancy test, swelling study, drug content and In Vitro release profile. Sodium bicarbonate and citric acid were used producing effervescent base for buoyancy of tablets. Analysis of drug release from tablet indicates drug release by zero order, first order rate kinetics. No significant change was observed in physical appearance, drug content, floatability or in vitro dissolution pattern after storage at 450C 750C RH for three months. Samadhan Mali | Shweta Gedam | Swati Talele | Anil Jadhav "Design and Development of Effervescent Floating Tablet Dapagliflozin" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-5 , August 2020, URL: https://www.ijtsrd.com/papers/ijtsrd31674.pdf Paper Url :https://www.ijtsrd.com/pharmacy/pharmaceutics/31674/design-and-development-of-effervescent-floating-tablet-dapagliflozin/samadhan-mali
This document describes quality control tests performed on suppositories, including weight variation testing to ensure suppositories are uniformly sized, hardness testing to evaluate structural integrity, disintegration testing to assess dissolution rate, and drug content testing to verify active ingredient levels. Dissolution testing was also conducted using a basket apparatus to analyze drug release over time in vitro. Finally, short term stability studies were performed on promising formulations by storing samples at room temperature and refrigeration for 6 weeks and testing for drug content and dissolution profile.
selection of dissolution medium And dissolution study of solid dosage formAshwin Patil
The document discusses dissolution testing of solid oral dosage forms. It covers selection of dissolution media based on factors like drug solubility and formulation type. Common dissolution media include simulated gastric fluid, water and simulated intestinal fluid. Selection of parameters like rpm, time and apparatus depends on the formulation. Dissolution testing is important for quality control and bioequivalence studies. It provides insight into in vivo performance and helps product development.
Capsules come in both hard and soft gelatin shells that enclose solid or liquid medications. Quality control tests are conducted on empty capsules and finished capsules to ensure uniformity of weight, content of active ingredients, and dissolution. Key tests include uniformity of weight, content of active ingredients, and uniformity of content. Acceptance criteria vary slightly between pharmacopeias but generally require less than 10% deviation from the average weight and 90-110% of the average active content. In-process quality checks are also important to monitor production and identify defects.
This document discusses dissolution method development. It defines dissolution as a process where a solid substance enters a solvent to form a solution. The key steps in dissolution are wetting, disintegration, disaggregation, and dissolution of particles. Factors that influence dissolution are also discussed, along with the Noyes-Whitney equation. A systematic approach to method development is then outlined, including literature review, solubility studies, sink conditions, apparatus selection, media preparation, method optimization, and sample analysis investigations. The goal is to develop a successful dissolution method and analysis to characterize drug release.
Capsules are solid dosage forms that contain a drug or mixture of drugs enclosed within a shell. The shell is typically made of gelatin but can also be other materials. Capsules are intended for oral administration and provide rapid release of contents unless they are modified or enteric release capsules. Capsules can be filled using various methods like auger, dosator, or dosing disc systems. Tests are conducted to ensure uniformity of contents, weight, and dissolution based on pharmacopeial standards.
Presentatio on IPQC for Capsules by Akshay Trivedi
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality requirements".[1]
This approach places an emphasis on three aspects (enshrined in standards such as ISO 9001)[2][3]:
Elements such as controls, job management, defined and well managed processes,[4][5] performance and integrity criteria, and identification of records
Competence, such as knowledge, skills, experience, and qualifications
Soft elements, such as personnel, integrity, confidence, organizational culture, motivation, team spirit, and quality relationships.
Inspection is a major component of quality control, where physical product is examined visually (or the end results of a service are analyzed). Product inspectors will be provided with lists and descriptions of unacceptable product defects such as cracks or surface blemishes for example.[3]
The quality of the outputs is at risk if any of these three aspec
Modern humans are distinguished from other species by their extensive use of tools to control and adapt to their surroundings. Early stone tools such as anvils had no holes and were not designed as interchangeable parts. Mass production established processes for the creation of parts and system with identical dimensions and design, but these processes are not uniform and hence some customers were unsatisfied with the result. Quality control separates the act of testing products to uncover defects from the decision to allow or deny product release, which may be determined by fiscal constraints.[6] For contract work, particularly work awarded by government agencies, quality control issues are among the top reasons for not renewing a contract.[7]
The simplest form of quality control was a sketch of the desired item. If the sketch did not match the item, it was rejected, in a simple Go/no go procedure. However, manufacturers soon found it was difficult and costly to make parts be exactly like their depiction; hence around 1840 tolerance limits were introduced, wherein a design would function if its parts were measured to be within the limits. Quality was thus precisely defined using devices such as plug gauges and ring gauges. However, this did not address the problem of defective items; recycling or disposing of the waste adds to the cost of production, as does trying to reduce the defect rate. Various methods have been proposed to prioritize quality control issues and determine whether to leave them unaddressed or use quality assurance techniques to improve and stabilize production.[6]
Notable approaches
This document discusses dissolution testing of pharmaceutical dosage forms. It describes the types of dissolution apparatuses, including basket, paddle, reciprocating cylinder, flow-through cell, and transdermal cell apparatuses. The key features and uses of each apparatus are outlined. Factors that influence dissolution rate, such as formulation components, processing methods, and test conditions, are also summarized. These include vehicles, diluents, disintegrants, and processing methods like granulation and compression force.
1. The document describes the requirements and procedures for quality control testing of pharmaceutical products and materials. It outlines the necessary facilities, equipment, personnel qualifications, and specific tests that must be conducted.
2. Quality control tests capsules for content uniformity, weight uniformity, disintegration, and dissolution. The content uniformity test assesses the quantity of drug in individual capsules, the weight uniformity test evaluates capsule weights, and the disintegration test determines how quickly capsules break down in liquid.
3. Additional responsibilities of quality control include approving or rejecting materials, monitoring production processes, conducting stability studies, and releasing finished products once all testing is completed. Quality assurance also oversees final product inspection before release.
This document discusses dissolution media used for in vitro drug testing. It begins by defining dissolution as the process by which a solid substance enters the solvent phase to yield a solution. The importance of dissolution testing to confirm product quality and batch consistency is described. Common types of dissolution media discussed include simulated gastric fluid (SGF), simulated intestinal fluid (SIF), water, and biorelevant media. Key factors that can affect dissolution media and rates, such as composition, pH, viscosity, surfactants, and temperature, are also summarized.
This document discusses the design and calibration of dissolution test equipment. It provides information on the different types of dosage forms that can be tested using various dissolution apparatus, including immediate and controlled release forms. Details are given on the major pharmacopeial dissolution monographs and the six official dissolution apparatus. Factors to consider when selecting a dissolution apparatus are discussed. The document also covers qualification of the dissolution system through both mechanical calibration of parameters and chemical calibration using apparatus suitability tests with standard reference tablets. Sources of variability that can affect test reliability if not properly controlled are summarized.
The document discusses various mycotoxins produced by fungi, including their history, effects on plants and animals, and detection methods. It describes several important mycotoxins such as aflatoxins, ochratoxins, fumonisins, trichothecenes, and ergot alkaloids. For each mycotoxin, it provides details on the producing fungi, toxic effects, mechanisms of action, and historical outbreaks in humans or livestock. Detection methods like HPLC, ELISA, and lateral flow tests are also summarized. The document contains several figures and tables to illustrate fungal colonies, mycotoxin structures, and contamination levels found in studies.
This document discusses research projects for PharmD students. It emphasizes that research and problem solving are important for pharmacists and the pharmacy profession. Pharmacists can conduct research to help guide drug therapy and should understand the research process to interpret knowledge generated by others. The document provides guidance to students on formulating a research problem, including reviewing literature, developing a logical research problem statement, and considering factors like interest, magnitude, measurement and expertise when selecting a problem. It aims to help students develop skills for their PharmD research projects.
Ideas for pharmacy students on final year project : Possible Research FieldsTareq ✅
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Dr. Babasaheb Nagurao Kumbhar discusses mycotoxins, which are toxic substances produced by fungi that grow on crops. Some key points:
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This document provides a ratio analysis of Kutwal Foods Pvt. Ltd., an Indian food manufacturing and trading company. It includes the company profile, objectives of the analysis, research methodology used, data interpretation and key findings. The analysis found that the company's gross and net profit ratios have been decreasing in recent years due to rising material costs and low sales margins. It recommends that the company improve its profitability by reducing expenses and utilizing resources more efficiently.
The document describes a final year project to develop a mobile and web application called SpringsVision Events for planning and managing social events. A team of 4 students - Syed Absar Karim, Umair Ahmed, Shafaq Yameen, and Zaid Hussain - presented their project to create an online platform for scheduling events, adding social networking features, and mobile support to the supervisor Mr. Nadeem Mahmood. The project aims to provide a useful tool for personal event management and sharing on social media.
Devlopment and in vitro evaluation of gastroretentive floating tablets of fam...srirampharma
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3) The best performing formulation was found to be M15 containing HPMC K4M, sodium bicarbonate, citric acid and PVP K30, which showed desired drug release and buoyancy time. Stability studies showed no interaction between drug and polymers.
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The document describes the design and evaluation of orodispersible tablets containing pantoprazole sodium using the sublimation method. Four formulations were developed using different concentrations of sublimation agent (camphor) and superdisintegrants. Formulation F4, containing the highest concentration of camphor and superdisintegrant, was found to have the fastest wetting time of 36 seconds and highest drug release of 87% over 9 minutes, making it the best performing formulation. The sublimation method allowed for the effective development of orodispersible tablets with high porosity, quick disintegration, and sufficient mechanical strength for pantoprazole sodium.
This document discusses in-process quality control (IPQC) and finished product quality control (FPQC) for different dosage forms. It provides details on common quality control tests for tablets, capsules, creams, ointments, and suppositories during manufacturing. For tablets, tests like hardness, friability, weight variation, and dissolution are described. For capsules, weight variation, content uniformity, and moisture permeation tests are covered. Quality tests for creams and ointments include assessment of physical properties, pH, spreadability, and microbial growth testing. Suppository quality tests include uniformity of weight, melting range, visual examination, dissolution, and disintegration.
Formulation and evaluation of omeprazole floating tabletsmedicinefda
formulation and evaluation of omeprazole floating tablets, literature review and plan of work ,methods results and discussion,conclusion sample ppt http://www.medicinefda.com/
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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.
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.
Development and evaluation of a novel twice daily cup core metformin hydrochl...SriramNagarajan19
The study was undertaken with an aim to formulate develop and evaluation of a novel twice daily core cup of Metformin hydrochloride(Antidiabetic drug) tablets using different grades and weight of HPMC polymers as release retarding agent. Granules were evaluated for tests Bulk density, tapped density, Hausner ratio before being punched as tablets. Tablets were tested for weight variation, thickness, hardness and friability as per official procedure. F-2 was found to be 73.90. From the above results and discussion it is concluded that formulation of Cup core tablet of containing Metformin hydrochloride HPMC K 4M & 215: 230 (in mg) can be taken as an ideal or optimized formulation of sustained release tablets for 12hour release as it fulfills all the requirements for sustained release tablet and our study encourages for the further clinical trials on this formulation. The core in cup tablets of Metformin hydrochloride were prepared by wet granulation method, they were evaluated for weight variation, friability, hardness, and thickness for all batches (F1 – F9). No significant difference was observed in the weight of individual tablets from the average weight. The weight variation tests were performed according to the procedure given in the pharmacopoeia. In a weight variation test, pharmacopoeial limit of tablet for percentage deviation is 5%. The average percentage deviation of all tablet formulation was found to be within the pharmacopoeial limit and hence all formulation passed the test for uniformity of weight.
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- Bilayer tablets contain two layers, one for immediate release and one for sustained release, to provide both an initial dose and prolonged maintenance dose.
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Formulation and Evaluation of Sublingual Tablets of Asenapine Maleate By 32 F...PRASANTAKUMARMOHAPAT3
Objectives: The aim of this work was to formulate and evaluate sublingual tablets of Asenapine
maleate for the treatment of schizophrenia and the treatment of manic episodes associated with
bipolar I disorder. Methods: In the present work, the bitter taste of Asenapine maleate was
masked by using Kyron T-114 in 1:1.5 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.Results: 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 54 s. Stability study
was performed by taking an optimized formulation and it was observed stable. The sublingual
tablets showed acceptable results in all studies.Conclusion: The results indicate that the
formulation can be used for the treatment of schizophrenia and the treatment of manic episodes
associated with bipolar I disorder. Moreover, Asenapine maleate as sublingual tablets may
overcome the first pass effect, gives better bioavailability, rapid onset of action and patient
compliance.
Formulation and evaluation of bi-layered floating tablets of metformin and te...SriramNagarajan17
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State of Artificial intelligence Report 2023kuntobimo2016
Artificial intelligence (AI) is a multidisciplinary field of science and engineering whose goal is to create intelligent machines.
We believe that AI will be a force multiplier on technological progress in our increasingly digital, data-driven world. This is because everything around us today, ranging from culture to consumer products, is a product of intelligence.
The State of AI Report is now in its sixth year. Consider this report as a compilation of the most interesting things we’ve seen with a goal of triggering an informed conversation about the state of AI and its implication for the future.
We consider the following key dimensions in our report:
Research: Technology breakthroughs and their capabilities.
Industry: Areas of commercial application for AI and its business impact.
Politics: Regulation of AI, its economic implications and the evolving geopolitics of AI.
Safety: Identifying and mitigating catastrophic risks that highly-capable future AI systems could pose to us.
Predictions: What we believe will happen in the next 12 months and a 2022 performance review to keep us honest.
Global Situational Awareness of A.I. and where its headedvikram sood
You can see the future first in San Francisco.
Over the past year, the talk of the town has shifted from $10 billion compute clusters to $100 billion clusters to trillion-dollar clusters. Every six months another zero is added to the boardroom plans. Behind the scenes, there’s a fierce scramble to secure every power contract still available for the rest of the decade, every voltage transformer that can possibly be procured. American big business is gearing up to pour trillions of dollars into a long-unseen mobilization of American industrial might. By the end of the decade, American electricity production will have grown tens of percent; from the shale fields of Pennsylvania to the solar farms of Nevada, hundreds of millions of GPUs will hum.
The AGI race has begun. We are building machines that can think and reason. By 2025/26, these machines will outpace college graduates. By the end of the decade, they will be smarter than you or I; we will have superintelligence, in the true sense of the word. Along the way, national security forces not seen in half a century will be un-leashed, and before long, The Project will be on. If we’re lucky, we’ll be in an all-out race with the CCP; if we’re unlucky, an all-out war.
Everyone is now talking about AI, but few have the faintest glimmer of what is about to hit them. Nvidia analysts still think 2024 might be close to the peak. Mainstream pundits are stuck on the wilful blindness of “it’s just predicting the next word”. They see only hype and business-as-usual; at most they entertain another internet-scale technological change.
Before long, the world will wake up. But right now, there are perhaps a few hundred people, most of them in San Francisco and the AI labs, that have situational awareness. Through whatever peculiar forces of fate, I have found myself amongst them. A few years ago, these people were derided as crazy—but they trusted the trendlines, which allowed them to correctly predict the AI advances of the past few years. Whether these people are also right about the next few years remains to be seen. But these are very smart people—the smartest people I have ever met—and they are the ones building this technology. Perhaps they will be an odd footnote in history, or perhaps they will go down in history like Szilard and Oppenheimer and Teller. If they are seeing the future even close to correctly, we are in for a wild ride.
Let me tell you what we see.
06-04-2024 - NYC Tech Week - Discussion on Vector Databases, Unstructured Data and AI
Discussion on Vector Databases, Unstructured Data and AI
https://www.meetup.com/unstructured-data-meetup-new-york/
This meetup is for people working in unstructured data. Speakers will come present about related topics such as vector databases, LLMs, and managing data at scale. The intended audience of this group includes roles like machine learning engineers, data scientists, data engineers, software engineers, and PMs.This meetup was formerly Milvus Meetup, and is sponsored by Zilliz maintainers of Milvus.
4th Modern Marketing Reckoner by MMA Global India & Group M: 60+ experts on W...Social Samosa
The Modern Marketing Reckoner (MMR) is a comprehensive resource packed with POVs from 60+ industry leaders on how AI is transforming the 4 key pillars of marketing – product, place, price and promotions.
Predictably Improve Your B2B Tech Company's Performance by Leveraging DataKiwi Creative
Harness the power of AI-backed reports, benchmarking and data analysis to predict trends and detect anomalies in your marketing efforts.
Peter Caputa, CEO at Databox, reveals how you can discover the strategies and tools to increase your growth rate (and margins!).
From metrics to track to data habits to pick up, enhance your reporting for powerful insights to improve your B2B tech company's marketing.
- - -
This is the webinar recording from the June 2024 HubSpot User Group (HUG) for B2B Technology USA.
Watch the video recording at https://youtu.be/5vjwGfPN9lw
Sign up for future HUG events at https://events.hubspot.com/b2b-technology-usa/
1. Research Article
FORMULATION AND EVALUATION OF OFLOXACIN FLOATING TABLETS USING HPMC
J. PADMAVATHY 1, * D. SARAVANAN 1, D. RAJESH 2
1Ratnam Institute of Pharmacy, Pidathapolur, Nellore 524346, Andhra Pradesh, India, 2Department of Pharmaceutics, SRM College of
Pharmacy, Kattankulathur, Chennai, Tamil Nadu, India, Email: devasaro@yahoo.co.in
Received: 25 Oct 2010, Revised and Accepted: 28 Nov 2010
ABSTRACT
The present study outlines a systematic approach for designing and development of Ofloxacin floating tablets to enhance the bioavailability and
therapeutic efficacy of the drug. Floating tablets of Ofloxacin have shown controlled release thereby proper duration of action at a particular site
and are designed to prolong the gastric residence time after oral administration. Different formulations were formulated by wet granulation
technique using HPMC K4M, HPMC K15M and HPMC K100M (floating agent) as polymers along with sodium bicarbonate as gas generating agent. The
formulations were evaluated for their physicochemical properties, buoyancy lag time, total floating time, swelling index and invitro drug release. It
was found that the hardness of the tablets affects the Buoyancy characteristic of the dosage form. All six formulations possessed good floating
properties with total floating time between 8 – 12 hrs. The invitro cumulative % drug release of the formulations F1A, F1B, F2A, F2B, F3A and F3B
were 102.85%, 101.32%, 100.2%, 99.98%, 99.28% and 97.25%.
Keywords: Ofloxacin, Floating tablets, HPMC, Controlled release.
INTRODUCTION
During the last decade, many studies have been performed
concerning the sustained release dosage forms of drugs, which have
been aimed at the prolongation of gastric emptying time (GET). The
GET has been reported to range from 2 to 6 hrs in humans in the fed
state.1 Retention of drug delivery systems in the stomach prolongs
the overall gastrointestinal transit time, thereby resulting in
improved bioavailability. Scintigraphic studies determining gastric
emptying rates revealed that orally administered controlled release
dosage forms are subjected to basically two complications, that is
short gastric residence time and unpredictable gastric emptying
rate.2 Depending on the mechanism of buoyancy, two distinctly
different methods viz., effervescent and non effervescent systems
have been used in the development of floating drug delivery systems
(FDDS).3 Effervescent drug delivery systems utilizes matrices
prepared with swellable polymers such as methocel or
polysaccharides and effervescent components like sodium
bicarbonate and citric or tartaric acid.
FDDS offers important advantages like they are less prone to gastric
emptying resulting in reduced intra and inter subject variability in
plasma drug levels, effective for delivery of drugs with narrow
absorption windows, reduced dosing and increased patient
compliance, reduced Cmax and prolonged drug levels above the
minimum effective concentration and improved safety profile for
drugs with side effects associated with high Cmax.
Ofloxacin is an anti‐bacterial agent that inhibits an enzyme called
DNA gyrase which is an essential component of the mechanism that
passes genetic information onto daughter cells when a cell divides.
Ofloxacin is chemically 9‐Fluoro‐2,3‐Dihydro‐3‐Methyl‐10‐[4‐
Methyl‐1‐Piperazinyl]‐7‐Oxo‐7H‐Pyrido[1,2,3‐De]‐1,4‐Benzoxazine‐
6‐Carboxylic acid hemihydrates, off white to yellow crystal,
insoluble in water, soluble in 0.1N hydro chloric acid. Ofloxacin
exhibits pH dependent solubility. It is more soluble in acidic pH and
slightly soluble in neutral or alkaline pH conditions.4 Ofloxacin is
incompletely absorbed from gastrointestinal tract, it has absorption
window confined to upper part of gastrointestinal tract. It has a half
life of 9 hours and its absolute bioavailability was reported to be
about 45‐50% of the administered dose, hence it was considered a
suitable candidate for formulation as gastroretentive floating drug
delivery system.
The present study aims in designing floating tablets of Ofloxacin
using HPMC K4M, HPMC K15M and HPMC K100M and evaluating the
prepared tablets for physicochemical properties, buoyancy lag time,
total floating time, swelling index and invitro drug release.
MATERIALS AND METHODS
Ofloxacin, Sodium bicarbonate and Lactose were procured from
Micro Labs Ltd, Bangalore, Karnataka, India. HPMC (K4M, K15M &
K100M), Hydrochloric acid and Aerosil were procured from S.D. Fine
chemical Ltd, Bombay. PVP K 90 was purchased commercially from
National Scientific Products, Mumbai. Talc and Magnesium stearate
were procured from Loba Chemie, Mumbai. All the other chemicals
used were of analytical reagent grade.
Preformulation studies
As per standard procedures, the preformulation studies including
Compatibility study, Bulk density, Tapped density, Hausner’s ratio
and Angle of repose was performed for the crude drug, Ofloxacin.
Fabrication of floating tablets
Tablets were fabricated by using wet granulation technique.
Ofloxacin (400 mg) was mixed with required amount of polymers
and other excipients as shown in Table 1. All the excipients were
passed through # 60 mesh (ASTM), mixed and granulated with 10%
solution of PVP K 90 in isopropyl alcohol. The wet mass was passed
through #16 mesh and dried at 45oC for 2 hrs. Dried granules were
passed through #24 mesh and mixed with magnesium stearate and
talc. Granules were compressed into tablets using 16 punch single
station tablet compression machine (Cadmach).5
Determination of physicochemical parameters
Hardness test
Monsanto hardness tester was used for the determination of
hardness of tablets.6
Friability
Twenty tablets were accurately weighed and placed in the friabilator
(Roche’s Friabilator) and operated for 100 revolutions. The tablets
were dedusted and reweighed. The tablets that loose less than 1%
weight were considered to be compliant.
Weight variation
10 tablets were selected randomly from the lot and weighed
individually to check for weight variation.
Disintegration test
Tablets were taken and one tablet was introduced in each tube of
(VEEGO‐microprocessor based) disintegration apparatus and placed
in 1litre beaker containing water at 370±20C and the time of
International Journal of Pharmacy and Pharmaceutical Sciences
ISSN- 0975-1491 Vol 3, Issue 1, 2011
2. Saravanan et al.
Int J Pharm Pharm Sci, Vol 3, Issue1, 170173
171
disintegration was recorded. The study was done at room
temperature without disc being added.7
Determination of drug content
10 tablets were randomly selected from the batch, weighed and
powdered. Powder equivalent to 250 mg of Ofloxacin was weighed
and was diluted with a suitable volume of 0.1M sodium hydroxide to
produce a solution containing 0.008% w/v of anhydrous Ofloxacin.
The absorbance of the resulting solution was measured
spectrophotometrically at the maximum wavelength of about 294
nm, using the solution as a blank which is prepared in the same
manner omitting the substance being examined. Calculate the
content of C18H20FN3O4 from the absorbance obtained by repeating
the operation using Ofloxacin in place of the substance being
examined and from the declared content of Ofloxacin.8
Invitro dissolution study
Invitro release studies was carried out by using United States
Pharmacopoeia (USP) 23 Dissolution Testing Apparatus II (Paddle
method). The dissolution test was performed using 900 ml of 0.1N
HCl (pH 1.2) at 37±0.5oC. 50 rpm was maintained, 5 ml of sample
was withdrawn at predetermined time intervals for 24 hours and
the same volume of the fresh medium was replaced. The absorbance
of the withdrawn sample was measured spectrophotometrically at a
wavelength of about 294 nm and cumulative percentage drug
release was calculated using an equation obtained from a standard
curve.9
Determination of floating parameter
a) Invitro buoyancy test
The invitro buoyancy was determined by observing floating lag
time, as per the method described by Rosa. The tablets were placed
in a 100 ml beaker containing 0.1N HCl. The time required for the
tablet to rise to the surface and float was considered as the floating
lag time.10
b) Swelling study
Swelling of hydrophilic polymer such as Hydroxy Propyl Methyl
Cellulose greatly depends upon the contents of the stomach and the
osmolarity of the medium. These eventually influences the release,
slowing action and the residence time.
For each formulation, one tablet was weighed and placed in a beaker
containing 200 ml of distilled water. After each hour the tablet was
removed from beaker and weighed again upto 8 hours. The
percentage weight gain by the tablet was calculated by using the
formula.
Swelling index (S.I) = {(Wt‐Wo)/Wo} x 100
Where, S.I. = swelling index
Wt = Weight of tablet at time t
Wo = Weight of tablet before immersion.
Table 1: Different floating tablets Formulations
S.No Ingredients
Quantity for 1 tablets
F1A F1B F2A F2B F3A F3B
Intra granular
1 Oflaoxacin 400 mg 400 mg 400 mg 400 mg 400 mg 400 mg
2 Polymers 175 mg
(HPMC
K4M)
210 mg
(HPMC
K4M)
175 mg
(HPMC
K15M)
210 mg
(HPMC
K15M)
175 mg
(HPMC
K100M)
210 mg
(HPMC
K100M)
3 Lactose 44.5 mg 9.5 mg 44.5 mg 9.5 mg 44.5 mg 9.5 mg
4 Sodium bi
carbonate
70.0 mg 70.0 mg 70.0 mg 70.0 mg 70.0 mg 70.0 mg
5 PVP K 90 3.5 mg 3.5 mg 3.5 mg 3.5 mg 3.5 mg 3.5 mg
6 Isopropyl
alcohol
0.1 ml 0.1 ml 0.1 ml 0.1 ml 0.1 ml 0.1 ml
Extra granular
7 Talc 2 mg 2 mg 2 mg 2 mg 2 mg 2 mg
8 Aerosol 2 mg 2 mg 2 mg 2 mg 2 mg 2 mg
9 Magnesium
stearate
3 mg 3 mg 3 mg 3 mg 3 mg 3 mg
RESULTS AND DISCUSSION
In the Preformulation studies, compatibility studies were performed
using FTIR spectrophotometer. The FTIR spectrum of pure drug and
physical mixture of drug and polymer were studied. The peaks
obtained in the spectra’s of each formulation correlated with the
peaks of pure drug spectrum. So it was concluded that no significant
difference in peak pattern in IR spectrum of drug, polymer and the
excipients exists.
The values obtained for the preformulation parameters for the
formulations F1A & B, F2A & B, F3A & B are tabulated in Table 2.
The values for the angle of repose were found to be in the range of
27˚.12΄ to 30˚.25΄. This indicates good flow property of the powder
blend. As the concentration of HPMC K4M, HPMC K15M, HPMC K100M
increases, the angle of repose also increase while the flow rate
decreases.
Compressibility index ranges between 16.33% and 21.69%
indicating that the powder blend has the required flow property for
wet granulation. Microscopic examinations of tablets from each
formulation batches have showed cylindrical shape (oval) with no
cracks.
Table 2: Preformulation studies of Ofloxacin crude drug
Batches Bulk density
(g/cm2)
Tapped density
(g/cm2)
Compressibility index Hausner’s ratio Angle of repose
(θ)
F1A 0.458 0.589 16.33 1.23 27˚.65΄
F1B 0.469 0.698 17.12 1.49 28˚.63΄
F2A 0.502 0.756 18.96 1.23 27˚.12΄
F2B 0.456 0.603 18.02 1.16 29˚.64΄
F3A 0.523 0.631 21.69 1.58 29˚.89΄
F3B 0.536 0.689 20.36 1.25 30˚.25΄
3. Saravanan et al.
Int J Pharm Pharm Sci, Vol 3, Issue1, 170173
172
Hydrodynamically balanced tablets of Ofloxacin (intra‐gastric
buoyant tablets) were prepared and evaluated to increase its local
action and bioavailability. In the present study six formulations with
variable concentration of polymer (HPMC) were prepared by wet
granulation technique and evaluated for physicochemical properties,
buoyancy lag time, total floating time, swelling index and invitro
drug release. The results indicated that on immersion in 0.1N HCl
solution at pH 1.2 at 37±0.5oC tablets float immediately and remain
buoyant upto 8‐12 hrs without disintegration. Floating property of
the tablet is governed by both the swelling (hydration) of the
polymer when it contacts with the gastric fluid, which in turn results
in increase in the bulk volume and the presence of internal voids in
the dry centre of the tablet (porosity). These two factors are
essential for the tablet to acquire bulk density < 1, so that it remains
buoyant on the gastric fluid. Hardness of the tablets was in the range
of 3.5 to 5 kg/cm2. This ensures good handling characteristics of all
the batches. % weight loss in the friability test was less than 1% in
all the cases, ensuring that the tablets were mechanically stable. All
the floating tablets prepared contained the drug within 102±5% of
the label claim. All the formulated tablets (F1A to F3B) passed the
weight variation test as the % weight variation was within the
Pharmacopoeial limits of ±5% of the average weight. The percentage
of drug content was found to be 98.27% to 101.20% of Ofloxacin,
which was within the acceptable limits. Table 3 shows the results of
physicochemical characters of Ofloxacin tablets.
In the present study, the higher degree of swelling and slow drug
release was found for tablets of F3B containing 30% HPMC K100M.
Thus, the concentration of polymer and ratio of lactose had major
influence on swelling process, matrix integrity, as well as on floating
capability. Hence from the above results it can be proved that linear
relationship exists between swelling process and concentration ratio
as shown in Table 4 and Fig. 1.
From the invitro drug profiles, it was found that drug release rate
decreased as the concentration of polymers HPMC K4M, HPMC K15M
and HPMC K100M increases as shown in Table 5 and Fig 2.
Table 3: Physicochemical evaluation data parameters of Ofloxacin tablets formulations
Batches Average
weight of
tablets (mg)
Hardness
(Kg/cm2)
Friability
(%)
% Drug
content
Buoyancy
lag Time
(sec)
Total floating
time
(hrs)
F1A 702 3.5 0.532 98.42 5.0 <12
F1B 698 3.5 0.658 99.50 4.5 <12
F2A 696 3.5 0.498 101.20 5.5 <12
F2B 704 4.0 0.456 98.27 5.0 <10
F3A 702 4.5 0.374 98.50 5.5 <10
F3B 700 5.0 0.412 98.98 6.0 <10
Table 4: Degree of swelling of Ofloxacin floating tablet formulations
Time (hrs) F1A F1B F2A F2B F3A F3B
1 78 90 86 95 90 102
2 82 98 103 116 121 138
3 90 119 116 129 144 152
4 112 125 131 156 165 176
5 129 141 156 178 185 192
6 138 156 181 250 221 236
7 156 172 198 248 256 265
8 172 191 232 268 272 294
Fig. 1: Photograph depicting degree of swelling in Ofloxacin floating tablet
Table 5: Invitro dissolution profiles of Ofloxacin floating tablets
S.No. Time in Hrs
Percentage cumulative drug release
F1A F1B F2A F2B F3A F3B
1 0 0 0 0 0 0 0
2 0.5 10.69 9.42 12.52 12.01 15.29 14.77
3 1 22.15 17.31 23.02 22.91 25.20 23.93
4 2 32.08 30.04 32.68 32.18 33.60 31.06
5 4 45.82 44.30 43.96 43.69 43.28 42.51
6 6 62.37 61.86 69.15 68.95 59.82 57.53
7 10 83.75 81.97 80.81 80.00 77.14 76.12
8 12 93.40 89.86 86.20 84.30 82.02 77.64
9 24 102.85 101.32 100.20 99.98 99.28 97.25
4. Saravanan et al.
Int J Pharm Pharm Sci, Vol 3, Issue1, 170173
173
Fig. 2: Cumulative % drug release
X‐ axis ‐ Time in hours; Y‐ axis‐ Percentage cumulative drug release
The percentage of drug release and total floating time was
comparatively good in Formulation 1A and Formulation 1B
compared with that of other formulations.
CONCLUSION
On the basis of the present study it was concluded that the floating
tablets of Ofloxacin can increase the gastric residence time as well as
bioavailability and thereby showing increased therapeutic efficacy.
REFERENCES
1. Chavanpatil M, Jain S, Chaudari S, Shear R, Vavia P.
Development of sustained release gastroretentive drug
delivery system for Ofloxacin: Invitro and invivo evaluation. Int
J Pharm 2005; 304: 178‐184.
2. Swamy PV, Bhosale UV, Hiremath SN, Shirsand SB, Raju SA.
Formulation and Optimization of Gastric Floating Drug
Delivery System of Atenolol Using 3^2 Full Factorial Design.
Indian Drugs 2008; 45: 293‐300.
3. Hilton AK, Deasy PB. Invitro and invivo evaluation of an oral
sustained‐release floating dosage form of amoxycillin
trihydrate. Int J Pharm 1992; 86: 79‐88.
4. Dumpeti Janardhan, Joginapally Sreekanth, Bharat V, Rama
Subramaniyan P.Formulation and Evaluation of Gastro
Retentive Drug Delivery System for Ofloxacin. Int J Pharma Sci
Nanotech 2009; 1: 428‐434.
5. Dilip M. Parikh. Handbook of pharmaceutical granulation
technology. Newyork: Markel Dekker INC; 1997.
6. Sreenivas SA, Gadad AP. Formulations & Evaluation of
Ondansetron HCl directly compressed mouth disintegrating
tablets. Indian drugs 2006; 43(1): 3538.
7. Ziyaur R, Mushir A, Khar RK. Design and Evaluation of bilayer
floating tablets of captopril. Acta pharm 2006; 56: 4957.
8. Rockville MK. USP. 27th revision, USP convention INC; 2004.
9. Gohel MC, Mehta PR, Dave PK, Bariya NH. More relevant
dissolution method for evaluation of PDDS. Dissolution technol
2005; 11: 22‐5.
10. Rosa M, Zia H, Rhodes T. Dosing and testing invitro of a
bioadhesive and floating drug delivery system for oral
application. Int J Pharm 1994; 105: 65‐7.