This presentation pertains to the in-process tests performed during the manufacturing process of the solid dosages form (tablets).
The presentation covers the methods and the permissible limits for the tests performed.
These tests are of great importance as these not only ensure quality product but also upholds the cGMP.
Hardness, friability, thickness, disintegration, weight variation, content uniformity, and dissolution are important quality control tests conducted on tablets. Hardness ensures tablets can withstand handling and processing, while friability measures how well tablets withstand abrasion. Disintegration tests how long it takes for tablets to break down, and weight variation and content uniformity ensure all tablets contain the intended amount of active drug. Dissolution testing determines how quickly the drug is released from the tablet in the body. Documentation of all quality control test results is necessary.
In Process Quality Control Tests (IPQC) for Solid Dosage FromSagar Savale
This document discusses in-process quality control tests that are performed during the manufacturing of solid oral dosage forms such as tablets and capsules. It provides details about common tests like weight variation, hardness, friability, disintegration and dissolution. The tests help to identify any issues during production so that corrective actions can be taken. Specific test methods, acceptance criteria and instruments used for tests are outlined for various types of oral dosage forms including immediate release tablets, sustained release tablets, capsules and suppositories. Maintaining quality during manufacturing is important to deliver consistent drug levels in patients.
In Process Quality Control (IPQC) of pharmaceutical dosage form in Pharmaceut...Saad Ahmed Sami
A brief description of in process quality control (IPQC) definition, factors affecting the process and IPQC process in solid, liquid and sterile dosage form . IPQC cover the entire chain of operations from the receipt of raw material in the warehouse to the release of finished products from the warehouse for distribution and or sale. IPQC is a process where quality of a product is ensured that it meets the standard according to regulatory authority guideline.
This document discusses in-process quality control tests for liquid dosage forms, including sterile and non-sterile formulations. For sterile dosage forms like parenterals and ophthalmics, it describes tests for drug content, clarity, pyrogens, sterility, stability, leakage, and dye penetration. For non-sterile syrups and suspensions, it outlines testing drug content, active ingredient assays, pH, weight per ml, and particle size. The document provides details on procedures for each test and references for further information.
IPQC?
Its Need
In-Process Quality Control tests for Tablets
Hardness
Friability
Thickness
Disintegration Time
Weight variation
Content uniformity
Dissolution test
Leakage testing for strip and blister packaging
In process quality control of suspensions and emulsionsceutics1315
This document discusses in-process quality control of suspensions and emulsions. It defines in-process quality control as controlling manufacturing procedures from raw materials to final product packaging. Key tests for suspensions include appearance, particle size, zeta potential, viscosity, sedimentation rate and redispersibility. Maintaining proper pH, drug content uniformity and monitoring manufacturing areas are also important. Tests for emulsions include appearance, droplet size, viscosity, creaming index and phase separation. Proper documentation of quality control procedures and parameters is necessary to ensure batch uniformity and quality.
In Process Quality Control Tests (IPQC) For Parenteral or Sterile Dosage FormsSagar Savale
These are the tests performed between QA and QC and provides for the authorization of approved raw materials for manufacturing based on actual laboratory testing generally called as IPQC such as physical, chemical, microbiologic and biologic tests.
IPQC and FPQC tests are important quality control steps for creams from raw materials to finished product. Creams are topical semisolid preparations used to deliver drugs to the skin. They can be oil-in-water or water-in-oil emulsions. Evaluation of creams includes tests for physical properties, pH, viscosity, spreadability, irritancy, microbial growth, and preservative efficacy. Creams are packaged in jars or tubes and stored properly to ensure stability.
Hardness, friability, thickness, disintegration, weight variation, content uniformity, and dissolution are important quality control tests conducted on tablets. Hardness ensures tablets can withstand handling and processing, while friability measures how well tablets withstand abrasion. Disintegration tests how long it takes for tablets to break down, and weight variation and content uniformity ensure all tablets contain the intended amount of active drug. Dissolution testing determines how quickly the drug is released from the tablet in the body. Documentation of all quality control test results is necessary.
In Process Quality Control Tests (IPQC) for Solid Dosage FromSagar Savale
This document discusses in-process quality control tests that are performed during the manufacturing of solid oral dosage forms such as tablets and capsules. It provides details about common tests like weight variation, hardness, friability, disintegration and dissolution. The tests help to identify any issues during production so that corrective actions can be taken. Specific test methods, acceptance criteria and instruments used for tests are outlined for various types of oral dosage forms including immediate release tablets, sustained release tablets, capsules and suppositories. Maintaining quality during manufacturing is important to deliver consistent drug levels in patients.
In Process Quality Control (IPQC) of pharmaceutical dosage form in Pharmaceut...Saad Ahmed Sami
A brief description of in process quality control (IPQC) definition, factors affecting the process and IPQC process in solid, liquid and sterile dosage form . IPQC cover the entire chain of operations from the receipt of raw material in the warehouse to the release of finished products from the warehouse for distribution and or sale. IPQC is a process where quality of a product is ensured that it meets the standard according to regulatory authority guideline.
This document discusses in-process quality control tests for liquid dosage forms, including sterile and non-sterile formulations. For sterile dosage forms like parenterals and ophthalmics, it describes tests for drug content, clarity, pyrogens, sterility, stability, leakage, and dye penetration. For non-sterile syrups and suspensions, it outlines testing drug content, active ingredient assays, pH, weight per ml, and particle size. The document provides details on procedures for each test and references for further information.
IPQC?
Its Need
In-Process Quality Control tests for Tablets
Hardness
Friability
Thickness
Disintegration Time
Weight variation
Content uniformity
Dissolution test
Leakage testing for strip and blister packaging
In process quality control of suspensions and emulsionsceutics1315
This document discusses in-process quality control of suspensions and emulsions. It defines in-process quality control as controlling manufacturing procedures from raw materials to final product packaging. Key tests for suspensions include appearance, particle size, zeta potential, viscosity, sedimentation rate and redispersibility. Maintaining proper pH, drug content uniformity and monitoring manufacturing areas are also important. Tests for emulsions include appearance, droplet size, viscosity, creaming index and phase separation. Proper documentation of quality control procedures and parameters is necessary to ensure batch uniformity and quality.
In Process Quality Control Tests (IPQC) For Parenteral or Sterile Dosage FormsSagar Savale
These are the tests performed between QA and QC and provides for the authorization of approved raw materials for manufacturing based on actual laboratory testing generally called as IPQC such as physical, chemical, microbiologic and biologic tests.
IPQC and FPQC tests are important quality control steps for creams from raw materials to finished product. Creams are topical semisolid preparations used to deliver drugs to the skin. They can be oil-in-water or water-in-oil emulsions. Evaluation of creams includes tests for physical properties, pH, viscosity, spreadability, irritancy, microbial growth, and preservative efficacy. Creams are packaged in jars or tubes and stored properly to ensure stability.
The document discusses in-process quality control (IPQC) for parenteral products. IPQC involves controlling manufacturing procedures from raw materials to finished product release. Key IPQC tests for parenterals include clarity testing to detect particulate matter using visual or automated methods, leakage testing of packaging, testing fill volume and pH, and sterility testing. The document outlines various physical, chemical, biological, and microbiological tests performed during IPQC to ensure product quality.
This document discusses capsules as a dosage form of medication. It provides an introduction to capsules, describing them as solid dosage forms that contain one or more ingredients enclosed in a gelatin shell. The document outlines the advantages of capsules, such as masking unpleasant tastes and being easy to swallow. Disadvantages include some drugs or solutions being unsuitable for capsules. The document also describes various quality control tests for capsules, such as appearance, size, disintegration testing, weight variation, and content uniformity testing. It provides details on procedures for several of these tests.
IPQC Tests for capsules As per IP, BP & USPPramod Ramane
IPQC- In Process Quality Control Tests for Capsules are
1. Uniformity Of Content
2. Disintigration Test
3. Weight Variation Test
4. Dissolution Test
The tests are with Acceptance limits/Criteria as per Indian Pharmacopoeia (IP), British Pharmacopoeia (BP) & United States Pharmacopoeia (USP)
This document provides information about tablets, including their definition, categories, in-process tests, and testing methods. Tablets are solid oral dosage forms containing medicaments. There are several categories including uncoated, film coated, sugar coated, and modified release tablets. In-process tests include uniformity of contents, weight, dissolution, and disintegration. Dissolution and disintegration tests are described for different tablet types using specified apparatus, media, and time/acceptance criteria. Modified and prolonged release tablets have additional dissolution testing methods and criteria for acid and buffer stages.
Ipqc tests for sterile formulations are as follows :
Leakage Test
Clarity Test
pH
Particulate Matter Injection
SterilityTest
Pyrogen Test
Content Uniformity & Weight
Volume Filled
The tests For Sterile products are as per IP, BP & USP
Ipqc tests for suspension & emulsion pptXenChisti
This document discusses in-process quality control of suspensions and emulsions. It outlines the importance of in-process quality control to minimize variability, ensure quality, and monitor process variables. Key in-process quality control tests for suspensions include appearance, particle size measurement, drug content uniformity, and redispersibility. Important tests for emulsions include appearance, particle size distribution, phase separation, creaming, coalescence, and breaking. Proper in-process quality control ensures a stable, uniform final product is produced.
Ipqc and fpqc test for pharmaceuticals semi solidsArpitSuralkar
This document discusses quality control tests for semisolid dosage forms like creams, pastes, jellies and ointments. It outlines 11 tests: appearance, spreadability, pH, rate of absorption, irritancy, rate of penetration, consistency, sensitivity, drug content, rheology/viscosity, and rate of release of the active medication. These tests evaluate various physical properties and ensure safety, stability and appropriate release of the drug.
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 summarizes the standards and testing methods for different types of tablets according to the Indian Pharmacopoeia. It describes 10 types of tablets and the standards that apply to all tablets, including content uniformity, weight variation, disintegration, friability, and dissolution testing. The document provides details on the acceptance criteria and testing procedures for each of these standards.
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.
Quality Control Tests For Tablets and Capsules(QC)mdpavel
This document discusses quality control tests for tablets and capsules. It describes tests for general appearance, size, shape, thickness, color, and odor. It then compares quality control tests from the British, Indian, and United States Pharmacopoeias, including tests for content of active ingredients, disintegration, uniformity of content and weight, and labeling. Specific tests are described for different types of tablets, including uncoated, enteric coated, dispersible, and modified release tablets. Common non-official tests like hardness and friability are also summarized.
The Rapid Mixer Granulator is a multi-purpose machine that can blend powders, granulate wet masses, and produce effervescent and melt pelletized products using mechanical agitation and shearing forces. Validation of the Rapid Mixer Granulator involves qualification of installation, operation, and performance to verify it can produce granules within specified parameters. Tests are conducted at different mixing speeds and times to ensure content uniformity and granule consistency meet acceptance criteria.
The document discusses the importance of in-process quality control (IPQC) testing for pharmaceuticals. IPQC aims to monitor and control the manufacturing process at various stages to ensure quality products. It involves physical, chemical, biological and microbiological testing of raw materials and samples taken during production. Tests are done before, during and after manufacturing to check identity, purity, potency and meet specifications. IPQC is essential for tablets and involves tests such as hardness, friability, disintegration and dissolution to evaluate quality.
This document discusses quality control tests for suppositories. It describes the different types of suppositories and various tests conducted during quality control, including visual examination, uniformity of weight and texture, melting point determination, breaking strength, dissolution testing, content uniformity, and disintegration testing. The goals of these tests are to ensure suppositories meet specifications for attributes like appearance, consistency, and ability to dissolve or disintegrate properly when administered.
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized.
This document provides guidance on validating a liquid filling and sealing machine. It discusses the key stages of validation including user requirement specification, design qualification, installation qualification, operational qualification, and performance qualification. The performance qualification section provides specific tests to validate the machine's weight variation, filling volume accuracy, particle contamination levels, leak testing, and oxygen content. Requalification of the machine is recommended on a defined schedule or after any changes to ensure continued proper operation.
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.
This document evaluates various properties of tablets including size, shape, thickness, friability, weight variation, disintegration, and dissolution. It describes common tests used to analyze these properties, including friability testing to measure how easily tablets crumble, weight variation testing to check consistency of tablet weights, disintegration testing using glass tubes in fluid, and dissolution testing using apparatus 1 (basket type) or apparatus 2 (paddle type) to measure how quickly drugs dissolve. The document provides details on procedures, equipment, and standards used for these pharmaceutical quality control tests.
2. Quality Control of Solid Dosage Forms.pptxashfaq22
This document discusses quality control tests for solid oral dosage forms, specifically tablets. It describes common physical tests like weight variation, hardness, thickness and diameter, friability, and disintegration time. It also covers important chemical tests like assay, content uniformity, and dissolution. Test procedures and acceptance criteria are provided for each test. Different test procedures are described for uncoated, coated, enteric-coated, buccal, and sublingual tablets. A variety of apparatus and equipment used in the tests are also illustrated.
This document provides an overview of dissolution testing and the factors that influence drug dissolution. It defines dissolution and describes the intrinsic dissolution process. It also discusses the various apparatus used for dissolution testing according to pharmacopeial specifications, including the basket, paddle, reciprocating cylinder, and flow-through cell. The key factors affecting dissolution are also summarized, such as drug properties, apparatus parameters, and media properties.
Tablet friability,harness and dissolution testingdonjacob81
Tablet friability, hardness, and dissolution are important quality control tests. Friability tests measure a tablet's ability to withstand abrasion without breaking, with less than 1% weight loss indicating it can withstand manufacturing and shipping stresses. Hardness tests measure a tablet's resistance to breaking, with 4-10 kg generally considered a minimum. Dissolution tests evaluate how quickly an active ingredient is released from a tablet, which affects how well it can be absorbed in the body.
The document discusses in-process quality control (IPQC) for parenteral products. IPQC involves controlling manufacturing procedures from raw materials to finished product release. Key IPQC tests for parenterals include clarity testing to detect particulate matter using visual or automated methods, leakage testing of packaging, testing fill volume and pH, and sterility testing. The document outlines various physical, chemical, biological, and microbiological tests performed during IPQC to ensure product quality.
This document discusses capsules as a dosage form of medication. It provides an introduction to capsules, describing them as solid dosage forms that contain one or more ingredients enclosed in a gelatin shell. The document outlines the advantages of capsules, such as masking unpleasant tastes and being easy to swallow. Disadvantages include some drugs or solutions being unsuitable for capsules. The document also describes various quality control tests for capsules, such as appearance, size, disintegration testing, weight variation, and content uniformity testing. It provides details on procedures for several of these tests.
IPQC Tests for capsules As per IP, BP & USPPramod Ramane
IPQC- In Process Quality Control Tests for Capsules are
1. Uniformity Of Content
2. Disintigration Test
3. Weight Variation Test
4. Dissolution Test
The tests are with Acceptance limits/Criteria as per Indian Pharmacopoeia (IP), British Pharmacopoeia (BP) & United States Pharmacopoeia (USP)
This document provides information about tablets, including their definition, categories, in-process tests, and testing methods. Tablets are solid oral dosage forms containing medicaments. There are several categories including uncoated, film coated, sugar coated, and modified release tablets. In-process tests include uniformity of contents, weight, dissolution, and disintegration. Dissolution and disintegration tests are described for different tablet types using specified apparatus, media, and time/acceptance criteria. Modified and prolonged release tablets have additional dissolution testing methods and criteria for acid and buffer stages.
Ipqc tests for sterile formulations are as follows :
Leakage Test
Clarity Test
pH
Particulate Matter Injection
SterilityTest
Pyrogen Test
Content Uniformity & Weight
Volume Filled
The tests For Sterile products are as per IP, BP & USP
Ipqc tests for suspension & emulsion pptXenChisti
This document discusses in-process quality control of suspensions and emulsions. It outlines the importance of in-process quality control to minimize variability, ensure quality, and monitor process variables. Key in-process quality control tests for suspensions include appearance, particle size measurement, drug content uniformity, and redispersibility. Important tests for emulsions include appearance, particle size distribution, phase separation, creaming, coalescence, and breaking. Proper in-process quality control ensures a stable, uniform final product is produced.
Ipqc and fpqc test for pharmaceuticals semi solidsArpitSuralkar
This document discusses quality control tests for semisolid dosage forms like creams, pastes, jellies and ointments. It outlines 11 tests: appearance, spreadability, pH, rate of absorption, irritancy, rate of penetration, consistency, sensitivity, drug content, rheology/viscosity, and rate of release of the active medication. These tests evaluate various physical properties and ensure safety, stability and appropriate release of the drug.
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 summarizes the standards and testing methods for different types of tablets according to the Indian Pharmacopoeia. It describes 10 types of tablets and the standards that apply to all tablets, including content uniformity, weight variation, disintegration, friability, and dissolution testing. The document provides details on the acceptance criteria and testing procedures for each of these standards.
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.
Quality Control Tests For Tablets and Capsules(QC)mdpavel
This document discusses quality control tests for tablets and capsules. It describes tests for general appearance, size, shape, thickness, color, and odor. It then compares quality control tests from the British, Indian, and United States Pharmacopoeias, including tests for content of active ingredients, disintegration, uniformity of content and weight, and labeling. Specific tests are described for different types of tablets, including uncoated, enteric coated, dispersible, and modified release tablets. Common non-official tests like hardness and friability are also summarized.
The Rapid Mixer Granulator is a multi-purpose machine that can blend powders, granulate wet masses, and produce effervescent and melt pelletized products using mechanical agitation and shearing forces. Validation of the Rapid Mixer Granulator involves qualification of installation, operation, and performance to verify it can produce granules within specified parameters. Tests are conducted at different mixing speeds and times to ensure content uniformity and granule consistency meet acceptance criteria.
The document discusses the importance of in-process quality control (IPQC) testing for pharmaceuticals. IPQC aims to monitor and control the manufacturing process at various stages to ensure quality products. It involves physical, chemical, biological and microbiological testing of raw materials and samples taken during production. Tests are done before, during and after manufacturing to check identity, purity, potency and meet specifications. IPQC is essential for tablets and involves tests such as hardness, friability, disintegration and dissolution to evaluate quality.
This document discusses quality control tests for suppositories. It describes the different types of suppositories and various tests conducted during quality control, including visual examination, uniformity of weight and texture, melting point determination, breaking strength, dissolution testing, content uniformity, and disintegration testing. The goals of these tests are to ensure suppositories meet specifications for attributes like appearance, consistency, and ability to dissolve or disintegrate properly when administered.
Documentation is an integral part of good manufacturing practices. It defines a system of information and control so that risks so inherent in misinterpretation and/or error in oral communication are minimized.
This document provides guidance on validating a liquid filling and sealing machine. It discusses the key stages of validation including user requirement specification, design qualification, installation qualification, operational qualification, and performance qualification. The performance qualification section provides specific tests to validate the machine's weight variation, filling volume accuracy, particle contamination levels, leak testing, and oxygen content. Requalification of the machine is recommended on a defined schedule or after any changes to ensure continued proper operation.
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.
This document evaluates various properties of tablets including size, shape, thickness, friability, weight variation, disintegration, and dissolution. It describes common tests used to analyze these properties, including friability testing to measure how easily tablets crumble, weight variation testing to check consistency of tablet weights, disintegration testing using glass tubes in fluid, and dissolution testing using apparatus 1 (basket type) or apparatus 2 (paddle type) to measure how quickly drugs dissolve. The document provides details on procedures, equipment, and standards used for these pharmaceutical quality control tests.
2. Quality Control of Solid Dosage Forms.pptxashfaq22
This document discusses quality control tests for solid oral dosage forms, specifically tablets. It describes common physical tests like weight variation, hardness, thickness and diameter, friability, and disintegration time. It also covers important chemical tests like assay, content uniformity, and dissolution. Test procedures and acceptance criteria are provided for each test. Different test procedures are described for uncoated, coated, enteric-coated, buccal, and sublingual tablets. A variety of apparatus and equipment used in the tests are also illustrated.
This document provides an overview of dissolution testing and the factors that influence drug dissolution. It defines dissolution and describes the intrinsic dissolution process. It also discusses the various apparatus used for dissolution testing according to pharmacopeial specifications, including the basket, paddle, reciprocating cylinder, and flow-through cell. The key factors affecting dissolution are also summarized, such as drug properties, apparatus parameters, and media properties.
Tablet friability,harness and dissolution testingdonjacob81
Tablet friability, hardness, and dissolution are important quality control tests. Friability tests measure a tablet's ability to withstand abrasion without breaking, with less than 1% weight loss indicating it can withstand manufacturing and shipping stresses. Hardness tests measure a tablet's resistance to breaking, with 4-10 kg generally considered a minimum. Dissolution tests evaluate how quickly an active ingredient is released from a tablet, which affects how well it can be absorbed in the body.
The document discusses disintegration and dissolution tests for tablets. The disintegration test uses 6 glass tubes with tablets placed in baskets that move up and down in fluid to check if tablets break down within a specified time. Factors like hardness and excipients affect disintegration time. The dissolution test uses apparatus like baskets or paddles that rotate tablets in fluid to determine the drug release rate over time and ensure bioequivalence. Proper conditions like sink volume and agitation are needed. Dissolution is important to show drug availability and batch consistency.
This Powerpoint presentation summarizes in-process quality control (IPQC) procedures for pharmaceutical manufacturing. It discusses how IPQC monitors the manufacturing process from raw materials to finished products to ensure quality. Specific IPQC tests are described for different dosage forms like tablets, capsules, suspensions, and parenterals. Common problems encountered during manufacturing of these dosage forms are also outlined along with recommended troubleshooting steps. The importance of IPQC during packaging operations to check for defects is also highlighted.
ANTI HYPERTENSIVE AGENTS [MEDICINAL CHEMISTRY] BY P.RAVISANKAR, HYPERTENSION,...Dr. Ravi Sankar
ANTI HYPERTENSIVE AGENTS [MEDICINAL CHEMISTRY] BY P.RAVISANKAR, HYPERTENSION,TYPES,CAUSES OF HYPERTENSION, CLASSIFICATION, MECHANISM OF ACTION, SAR, ACE INHIBITORS, ARB , DIURETICS(WATER PILLS), TIPS TO STOP SILENT KILLER.
BY P. RAVISANKAR, VIGNAN PHARMACY COLLEGE, VADLAMUDI, GUNTUR,A.P, INDIA.
Hypertension is defined as a sustained high blood pressure that makes the heart work harder to pump blood through the arteries. It has two main components: systolic and diastolic blood pressure. There are several classes of drugs used to treat hypertension, including diuretics, beta blockers, ACE inhibitors, calcium channel blockers, and alpha blockers. Lifestyle changes such as exercise, weight loss, reducing salt and alcohol intake, and quitting smoking can also help control blood pressure. The goals of treatment are to prevent complications like heart attacks, strokes, and kidney disease.
The document discusses the heart and hypertension. It defines normal blood pressure and describes the types and causes of hypertension. Hypertension usually has no symptoms, but can sometimes cause headaches, confusion or vision changes. Untreated hypertension can damage blood vessels and the heart over time, so treatment is important even in asymptomatic cases. Treatment includes diuretics, ACE inhibitors, calcium channel blockers, and other drugs that work to lower blood pressure by various mechanisms.
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.
This document discusses antihypertensive agents used to treat hypertension. It describes different categories of agents including adrenergic agents, ACE inhibitors, angiotensin II receptor blockers, calcium channel blockers, diuretics, and vasodilators. For each category, the document outlines mechanisms of action, examples of medications, therapeutic uses, and potential side effects. It emphasizes the importance of monitoring blood pressure during therapy and avoiding abruptly stopping medications.
The document discusses various quality control tests that are performed on tablets during manufacturing, including tests for general appearance, hardness, friability, weight variation, content uniformity, disintegration and dissolution. It provides details on procedures and limits for these tests according to pharmacopoeial standards like the British Pharmacopoeia, Indian Pharmacopoeia and United States Pharmacopoeia. The tests are important to ensure tablets meet requirements for reproducibility, stability and accurate dosing of the active drug.
The document discusses different types of antihypertensive drugs, their mechanisms of action, uses, and side effects. It defines hypertension and guidelines for initiating treatment. The main drug classes covered are diuretics, beta blockers, calcium channel blockers, ACE inhibitors, angiotensin II receptor antagonists, alpha blockers, vasodilators, and central acting agents. Factors such as age, comorbidities, and resistant hypertension are addressed in principles of treatment.
The document discusses in-process quality control for pharmaceutical manufacturing. It outlines that the purpose of in-process quality control is to ensure batch uniformity and integrity. It describes that procedures for in-process quality control should specify in-process controls and limits, required tests and examinations, and sampling procedures for each batch during both manufacturing and packaging operations. The document provides examples of key process parameters that should be evaluated and optimized as part of in-process quality control.
1) Hypertension is defined as a systolic blood pressure over 140 mm Hg or a diastolic over 90 mm Hg. Antihypertensive drugs are used to reduce high blood pressure.
2) There are several classes of antihypertensive drugs, including ACE inhibitors, calcium channel blockers, beta blockers, diuretics, and angiotensin receptor blockers.
3) The document provides details on the mechanisms of several classes of antihypertensive drugs and examples of drugs within each class, such as ACE inhibitors decreasing angiotensin II and calcium channel blockers inhibiting calcium influx into vascular smooth muscle cells.
This document discusses quality control of medicinal products. It defines quality control as procedures to ensure identity and purity of pharmaceuticals, ranging from simple chemical tests to complex pharmacopoeial standards. The document outlines types of counterfeit medicines that may have incorrect ingredients or dosages. It also discusses analytical processes for quality control, including standard methods, field tests, and ensuring precision and accuracy. Quality assurance involves four phases from evaluating new methods to external audits.
The document provides information on quality control testing for pharmaceutical tablets. It defines quality control as the process of monitoring quality during manufacturing to ensure standards are met. It describes several important quality control tests conducted on tablets, including weight variation, thickness, hardness, friability, disintegration, dissolution, and content uniformity tests. These tests are essential to ensure tablets are safe, effective, and meet specifications for attributes like drug content, stability and patient acceptability. The document provides details on procedures, equipment and acceptance criteria for each quality control test.
IPQC checks are carried out during the manufacturing process to monitor critical variables that can impact product quality. In-process materials are tested for identity, strength, and purity, and any rejected materials are quarantined. The objectives are quality control, process control, and ensuring final product quality through continuous monitoring and implementation of good manufacturing practices. IPQC involves establishing and documenting controls to ensure output falls within acceptable standard ranges.
Industrial Pharmacy, Quality control of tablets.pdfAlishaKhatun4
This document discusses quality control testing for tablets. It begins by defining quality control as procedures taken during manufacturing to ensure a product meets requirements and is reproducible. It then describes various types of quality control tests for tablets, including weight variation, drug content, disintegration, dissolution, thickness, hardness, friability, and organoleptic characteristics. The document provides details on testing procedures and equipment for these analyses. It concludes that quality control of tablets requires various tests to be performed during production and after to ensure product standards are met.
Everyone requires a product of the best quality, be it in case of medicines or any other edibles or services. Hence, the presentation deals with the quality control of tablets
This document discusses important quality control tests that are conducted on tablets during production. It outlines tests for hardness, friability, thickness, disintegration, weight variation, content uniformity, dissolution, and leak testing of packaging. Specific procedures and acceptance criteria are provided for each test to ensure the tablets meet standards for quality, stability, and ability to deliver the intended dose of medication. Routine quality control testing plays a key role in pharmaceutical manufacturing.
Quality control tests are important to ensure tablets meet standards for safety, efficacy and patient acceptability. Key tests include weight variation, hardness, friability, disintegration and dissolution. Weight variation tests if individual tablet weights match the average weight. Hardness ensures tablets can withstand manufacturing and handling stresses. Friability tests surface strength and disintegration confirms how quickly tablets break down in fluid. Dissolution determines the rate of drug release.
Non sterile manufacturing process technologyPRANJAY PATIL
This document provides an overview of in-process quality control (IPQC) tests for non-sterile pharmaceutical tablets and capsules. It discusses the importance of IPQC in minimizing errors and enforcing manufacturing standards. Common IPQC tests described for tablets include weight variation, content uniformity, hardness, thickness, friability, dissolution, disintegration, and moisture content. For capsules, discussed tests include content of active ingredients, weight variation, content uniformity, disintegration, and dissolution. A variety of apparatus used in conducting these tests are also outlined.
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.
QUALITY CONTROL OF TABLETS IPQC stands for in process quality control. These are checks that are carried out before the manufacturing process is completed.
The document provides details on quality control tests conducted on tablets, including physical tests like hardness, thickness, friability, and chemical tests like content uniformity and dissolution. It describes the purpose, equipment, and procedures for tests like hardness, thickness and diameter, friability, disintegration, weight variation, content uniformity, assay, and dissolution. The tests are essential to ensure tablets meet specifications for attributes like strength, thickness, ability to withstand abrasion, breakdown time, uniform drug content, and drug release rate.
This document summarizes various quality control tests performed on tablets during the manufacturing process, known as in-process quality control (IPQC). It describes tests of tablet thickness, weight variation, hardness, friability, drug content, disintegration time, and dissolution. Acceptance criteria are provided for each test according to pharmacopeial standards. The purpose of IPQC testing is to ensure tablets meet specifications for identity, strength, quality and purity before the manufacturing process is complete.
This document discusses evaluation parameters for tablets, including non-official and official tests. It provides details on tablet size, shape, color, markings and organoleptic properties. Official tests covered include weight variation, hardness, friability, disintegration and dissolution. Weight variation ensures uniform tablet weights. Hardness and friability test tablet strength and stability. Disintegration and dissolution tests simulate how tablets break down in the body. Content uniformity also evaluates active ingredient amounts in tablets.
In Process Quality Control Tests For Capsules [Autosaved].pptxSurendra Chowdary
This document discusses in-process quality control tests for capsules. It describes 7 types of tests: 1) Stability tests like shell integrity and shelf life determination, 2) Purity tests of the capsule shell, 3) Invariability tests like weight variation and content uniformity, 4) Disintegration testing, 5) Dissolution testing, 6) Moisture permeation testing of packaging, and 7) Batch release tests. The document provides details on the procedures and acceptance criteria for each of these quality control tests performed on capsules during manufacturing.
Quality control tests ensure tablets meet specifications for drug content, release properties, and physical characteristics. The document outlines official quality control tests from pharmacopeias including uniformity of content to ensure consistent drug dose between tablets, dissolution testing to ensure controlled drug release, and disintegration testing to confirm tablets break down within defined limits. Additional common tests described are hardness, thickness, and friability testing to ensure tablets can withstand manufacturing and handling forces. Special tests are specified for effervescent, soluble, and enteric coated tablets tailored to their drug release mechanisms.
This document discusses in-process quality control tests that are carried out during pharmaceutical manufacturing to ensure quality. It describes tests for general appearance including size, shape, color and odor. It also discusses thickness variation, content uniformity, weight variation, hardness, friability, disintegration time and dissolution tests. Specific test parameters and acceptance criteria are provided for each test to ensure tablets meet standards. In-process quality control helps guarantee that tablets are manufactured correctly and meet specifications before the process is complete.
IPQC is concerned with providing accurate , specific, & definite descriptions of the procedures to be employed, from, the receipt of raw materials to the release of the finished dosage forms
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.
Quality Control Tests Of Capsules dosage form.
1. Weight Variation Test
2. Content Uniformity Test
3. Dissolution Test
4. Disintegration Test
5. Leak Test
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In Process Quality Control System (IPQC) for Solid Dosages Form (Tablets)
1. IPQC TESTS FOR TABLETS
Krupanidhi College of Pharmacy (Q.A)
Gaurav Kumar
M.Pharm (Q.A)
2. What Do You Mean By “IPQC”…?
IPQC is concerned with providing accurate , specific, & definite descriptions of the
procedures to be employed, from, the receipt of raw materials to the release of the finished
dosage forms.
“INSPECTION
”
“TESTING”
Krupanidhi College of Pharmacy (Q.A)
3. In process Quality Control
In process Quality Control, IPQC tests are mostly performed within the production
area.
They should not carry any risk for the quality of product.
In process testing enables easier identification of problems. It some time identifies a
defective product batch that can be corrected by rework, whereas once that batch
has been completed, this may not be possible.
Failure to meet In process control specification indicates either that procedure were
not followed or some factor(S) out of control.
Krupanidhi College of Pharmacy (Q.A)
4. Various instrument used in IPQC department:
Disintegration apparatus
Dissolution apparatus
Analytical balance Muffle furnace
Friability testing apparatus
Bulk density apparatus
Tablet hardness tester
Infra red moisture content measuring apparatus
U.V Spectroscopy
Abbe Refractometer
T.L.C. kit
Karl fisher Titrimeter
Krupanidhi College of Pharmacy (Q.A)
5. Official and unofficial tests for evaluation of tablets
Official Tests:
1. Weight variation
2. Disintegration
3. Dissolution
4. Drug content
Non-Official Tests:
1. Hardness
2. friability
Evaluation of Tablet
Krupanidhi College of Pharmacy (Q.A)
6. 1. General Appearance:
The general appearance of a tablet, its identity and general elegance is essential for consumer acceptance, for control of
lot-to-lot uniformity and tablet-to-tablet uniformity. The control of general appearance involves the measurement of size,
shape, color, presence or absence of odor, taste etc.
2. Size & Shape:
It can be dimensionally described & controlled. The thickness of a tablet is only variables. Tablet thickness can be
measured by micrometer or by other device. Tablet thickness should be controlled within a ± 5 % variation of standard
value.
Krupanidhi College of Pharmacy (Q.A)
7. 3. Unique identification marking:
These marking utilize some form of embossing, engraving or printing. These markings include company name or symbol,
product code, product name etc.
4. Organoleptic properties:
Color distribution must be uniform with no mottling. For visual color comparison compare the color of sample against standard
color.
5. Hardness :
Tablet requires a certain amount of strength or hardness and resistance to friability to withstand mechanical shocks of handling in
manufacture, packaging and shipping. Hardness generally measures the tablet crushing strength.
Krupanidhi College of Pharmacy (Q.A)
8. Hardness (crushing strength):
It is the load required to crush the tablet when placed on its edge.
Why do we measure hardness?
To determine the need for pressure adjustments on the tableting machine.
Hardness can affect the disintegration.
So if the tablet is too hard, it may not disintegrate in the required period of time. And if the tablet is too soft, it will not withstand the
handling during subsequent processing such as coating or packaging.
In general, if the tablet hardness is too high, we first check its disintegration before rejecting the batch.
If the disintegration is within limit, we accept the batch.
If Hardness is high + disintegration is within a time accept the batch.
Factors Affecting the Hardness:
• Compression of the tablet and compressive force.
• Amount of binder. (More binder à more hardness)
• Method of granulation in preparing the tablet (wet method gives more hardness than direct method, Slugging method gives the best
hardness).
Limits: 5 kilograms minimum and 8 kilograms maximum.
Make hardness test on 5 tablets and then take the average hardness.
Krupanidhi College of Pharmacy (Q.A)
10. 6.Friability:
Friability of a tablet can determine in laboratory by Roche friabilator. This consist of a plastic chamber that revolves at 25 rpm,
dropping the tablets through a Distance of six inches in the friabilator, which is then operate for 100 revolutions. The tablets are
reweighed. Compress tablet that lose less than 0.5 to 1.0 % of the Tablet weigh are consider acceptable.
Krupanidhi College of Pharmacy (Q.A)
11. It is the tendency of tablets to powder, chip, or fragment and this can affect the elegance appearance, consumer acceptance of the
tablet, and also add to tablet’s weight variation or content uniformity problems.
Friability is a property that is related to the hardness of the tablet.
An instrument called Roche friabilator is used to evaluate the ability of the tablet to withstand abrasion in packaging, handling, and
shipping.
Procedure:
1. Weigh 20 tablets together = W1
2. Put these tablets in the friabilator and adjust the instrument at 100 rpm (i.e. = 25 rpm for 4 min)
3. Weigh the 20 tablets (only the intact ones) = W2
Friability (% loss) = W1 - W2/100
It must be less than or equal to1 % but if more we do not reject the tablets as this test is non-official.
Perform this test using 20 tablets that were used first in the weight variation test.
Krupanidhi College of Pharmacy (Q.A)
12. 7. Thickness test
Thickness is an unofficial test .
Thickness of the tablet is inversely proportional to hardness i.e. increase in hardness decrease the thickness & vice
versa.
Thickness of tablet is measured by Vernier caliper/screw gauge.
It is determined for 10tablets.
Krupanidhi College of Pharmacy (Q.A)
Vernier caliper
13. 8.Weight variation test (uniformity of weight)
Weigh 20 tablet selected at random, each one individually . X1, X2, X3… Xz
Determine the average weight. X= (X1+X2 +X3+…+ Xz)/20
Limit:
Upper limit = average weight + (average weight * % error)
Lower limit = average weight - (average weight * % error)
The individual weights are compared with the upper and lower limits.
Not more than two of the tablets differ from the average weight by more than the % error listed, and no tablet
differs by more than double that percentage.
Krupanidhi College of Pharmacy (Q.A)
14. Sr.
No
Average wt. of tablet(mg) Max. % difference
allowed
1 130 or Less 10%
2 130-324 7.5%
3 More than 324 5%
Krupanidhi College of Pharmacy (Q.A)
WEIGHT VARIATION TOLERANCES FOR UNCOATED TABLETS
USP XX-NF STANDARDS
IP STANDARDS
Sr.
No
Average wt. of tablet(mg) Max. % difference
allowed
1 84 or Less 10%
2 84- 250 7.5%
3 More than 250 5%
15. 9. Content Uniformity Test:
It is an official test.
Randomly select 30 tablets. 10 of these assayed individually. The Tablet pass the test if 9 of the 10 tablets must
contain not less than 85% and not more than 115% of the labeled drug content and the 10th tablet may not contain
less than 75% and more than125 % of the labeled content. If these conditions are not met, remaining 20 tablet
assayed individually and none may fall out side of the 85 to 115 % range.
10. Disintegration test (U.S.P.) :
Disintegration test is an official test.
It is the time required for the tablet to break into particles, the disintegration test is a measure only of the time
required under a given set of conditions for a group of tablets to disintegrate into particles
It is performed to identify the disintegration of tablet in particular time period.
Disintegration test is not performed for controlled & sustained release tablets.
Krupanidhi College of Pharmacy (Q.A)
16. The U.S.P. device to test disintegration uses 6 glass tubes that are 3” long; open at the top and 10 mesh screen at the bottom end.
To test for disintegration time, one tablet is placed in each tube and the basket rack is positioned in a 1-L beaker of water,
simulated gastric fluid or simulated intestinal fluid at 37 ± 20 C such that the tablet remain 2.5 cm below the surface of liquid on
their upward movement and not closer than 2.5 cm from the bottom of the beaker in their downward movement. Move the basket
containing the tablets up and down through a distance of 5-6 cm at a frequency of 28 to 32 cycles per minute. Floating of the
tablets can be prevented by placing perforated plastic discs on each tablet.
Krupanidhi College of Pharmacy (Q.A)
17. According to the test the tablet must disintegrate and all particles must pass through the 10 mesh screen in the time
specified. If any residue remains, it must have a soft mass.
Liquids used in disintegration
Water,
Simulated gastric fluid (pH = 1.2 HCl),
or Simulated intestinal fluid (pH = 7.5, KH2PO4 (phosphate buffer) + pancreatic enzyme + NaOH)
Disintegration test apparatusKrupanidhi College of Pharmacy (Q.A)
18. Sr no. Type of tablets Medium Temperature limit
1 Compressed uncoated 37 ± 2 0C 15 minutes or as per
individual monograph
2 Sugar coated
If 1 or 2 tablets fail
Water
0.1 N HCL
37 ± 2 0C 60 minutes or as per
individual monograph
3 Film coated water 37 ± 2 0C 30 minutes or as per
individual monograph
4 Enteric coated 0.1 N HCL &
Phosphate
buffer pH 6.8
37 ± 2 0C 1 hr or as per individual
monograph
5 Dispersible/
Effervescent
water 37 ± 2 0C LST < 3 minutes or as
per individual
monograph
6 Buccal 37 ± 2 0C 4 hr or as per individual
monograph
DISINTEGRATION TESTING CONDITIONS AND INTERPRETATION
Krupanidhi College of Pharmacy (Q.A)
19. U.S.P. method for uncoated tablets:
Start the disintegration test on 6 tablets.
If one or two tablets from the 6 tablets fail disintegrate completely within 30min repeat the same test on another 12 tablet. (i.e. the whole
test will consume 18 tablets).
Not less then 16 tablets disintegrate completely within the time
if more then two tablets (from the 18) fail to disintegrate, the batch must be rejected.
For Coated tablets:
1. To remove or dissolve the coat, immerse the tablet in distilled water for 5min.
Put the tablet in the apparatus in water or HCL for 30 min at 37oC (according to the U.S.P). If not disintegrated, put in intestinal fluid.
If one or two tablets fail to disintegrate, repeat on 12 tablets. So 16 tablets from the 18 must completely disintegrate within the time, if
two or more not disintegrated the batch is rejected.
U.S.P. and B.P Method for Enteric coated tablets:
1. Put in distilled water for five minutes to dissolve the coat.
2. Then put in simulated gastric fluid (0.1M HCL) for one hour.
3. Then put in simulated intestinal fluid for two hours.
If one or two tablets fail to disintegrate, repeat this test on another 12 tablets. So 16 tablets from 18 should completely disintegrate. If
more than two fail to disintegrate the Batch must be rejected.
Krupanidhi College of Pharmacy (Q.A)
20. 11. Dissolution Test
Dissolution is an official test.
Dissolution is performed to check the percentage release from the dosage forms.i.e.tablet.
Tablet breaks down into small particles which offers a greater surface area to the dissolving media.
Disintegration test does not give assurance that particles will release drug in solution at an appropriate rate, that’s
why dissolution tests & it’s specifications developed for all tablet products.
1. USP Dissolution apparatus I ( Basket method)
A single tablet is placed in a small wire mesh basket attached to the bottom of the shaft connected to a variable
speed motor. The basket is immersed in a dissolution medium (as specified in monograph) contained in a 1000 ml
flask. The flask is cylindrical with a hemispherical bottom. The flask is maintained at 37 ± 0.50C by a constant
temperature bath. The motor is adjusted to turn at the specified speed and sample of the fluid are withdrawn at
intervals to determine the amount of drug in solutions.
Krupanidhi College of Pharmacy (Q.A)
21. 2. USP Dissolution apparatus II ( Paddle method)
It is same as apparatus-1, except the basket is replaced by a paddle. The dosage form is allowed to sink to the bottom of
the flask before stirring. For dissolution test U.S.P. specifies the dissolution test medium and volume, type of apparatus to
be used, rpm of the shaft, time limit of the test and assay procedure for. The test tolerance is expressed as a % of the
labeled amount of drug dissolved in the time limit.
Krupanidhi College of Pharmacy (Q.A)
22. Sr.no. Quantity
Stage/level
Number of tablets
tested
Acceptance criteria
1 S1 6 Each unit is < D* + 5 percent**
2 S2 6 Average of 12 units (S1 +S2) is equal to or greater than
(> )D, and no unit is less than D - 15 percent**
3 S3 12 Average of 24 units (S1+S2+S3) is equal to or greater
than (> )D, not more than 2 units are less than d-15
percent** and no unit is less than d-25 percent**
DISSOLUTION TESTING AND INTERPRETATION IP STANDARDS
*D is the amount of dissolved active ingredient specified in the individual monograph, expressed as a percentage
of the labelled content.
** Percentages of the labelled content.
Krupanidhi College of Pharmacy (Q.A)
23. CONTENTS
Evaluation of Precompressional Characteristics of tablets
or
Rheological Characteristics of granules
1. Particle Size & Shape Determination.
2. Surface area.
3. Density
i. Bulk density
ii. True density
iii. Granular density
4. Granule strength & friability.
5. Flow properties.
i. Angle of repose
ii. Percentage Compressibility Index
iii. Hausner’s ratio
6. Moisture content.
7. Percentage fines(% fines).
Krupanidhi College of Pharmacy (Q.A)
24. EVALUATION OF COMPRESSIONAL CHARACTERISTICS OF TABLETS
1. General Appearance
2. Size & Shape
3. Unique identification marking
4. Organoleptic properties
5. Hardness test
6. Friability.
7. Thickness test
8. Weight variation.
9. Disintegration test.
10. Drug Content Uniformity
11. Dissolution test.
Krupanidhi College of Pharmacy (Q.A)
25. CHARACTERIZATION OF GRANULES
1) Particle Size & Shape Determination
Size affects the average weight of tablet, Disintegration Time, weight variation, friability, flowability & drying
rate.
The size & shape depends upon processing requirements & during granulation.
The methods for determining size & shape are
1. Sieving
2. Sedimentation rate.
3. Microscopy (SEM)
4. By Light Scattering
Krupanidhi College of Pharmacy (Q.A)
26. 2. SURFACE AREA
It is not commonly used for granules but generally used for drug substances.
If required particle size is measured & from this surface area is measured.
Most method used is gas absorption & air permeability.
In gas absorption, gas is absorbed as monolayer on particles this is in term of calculated & converted to surface area.
In air permeability method the rate of air permeates a bed of powder ,is used to calculate surface area of powder
sample.
Krupanidhi College of Pharmacy (Q.A)
27. 3. Density
Density may influence compressibility, tablet porosity & dissolution.
Dense hard granules may require higher load to produce cohesive compact to reduce free granules seen on the surface of
tablets.
↑ compressibility ↑ DT, Dissolution, if DT is slower dissolution is indirectly hampered.
Dense granules have less friability but cause a problem in releasing the drug.
Three Methods to determine density
i. Bulk Density –
Bulk density is given by equation,
ρb = M / Vb
Where, ρb- bulk density of granules,
M is mass of granules in gm,
Vb – volume of granules in measuring cylinder in ml.
More compressible bed of particulate - less flowable powder or granules.
If less dense/compressible - more flowable powder or granules.
Krupanidhi College of Pharmacy (Q.A)
28. ii. True/tapped density –
Tapped/true density is given by equation,
ρt = M / Vb
Where, ρt- bulk density of granules,
M is mass of granules in gm,
Vt – volume of granules in measuring cylinder after tapping in ml.
iii. Granular density
It is determined by Pycnometer method.
Two methods are used to determined granular density.
In one intrusion fluid used-Mercury, and other
Any solvent of low surface tension e.g. Benzene
The accuracy of these method depends upon ability of intrusion fluid to penetrate the pores of granules.
Liquids should not masks granules solubilies in it, & having property to penetrate the pores.
Density is then determine from volume of intrusion fluid displaced in pycnometer by giving mass of granulation.
It is calculated by using equation,
Granular Density (D) = M / Vp -Vi
Where, Vp-Total volume of Pycnometer, Vi- Volume of intrusion fluid (ml) containing Mass (gm) (M) of granules required to fill
pycnometer.
Krupanidhi College of Pharmacy (Q.A)
29. 4. Granule Strength & Friability
They are important because they affect:-
1.changes in particle size distributions of granulations.
2.compressibility into cohesive tablets.
Granule strength & friability are measured by:-
1.Compressive Strength/hardness.
2.Using Friability measurements/apparatus.
5. Flow properties.
It is an ability of the granule to flow from hopper to die cavity for tablet uniformity.
Flow property of granule are not uniform we are not getting tablet of uniform
size.
Flow property of material results from many forces
1.Frictional force
2.Surface tension force
3.Mechanical force caused by interlocking of irregular shape particles
4.Electrostatic forces
5.Cohesive/ vander Waals forces
Krupanidhi College of Pharmacy (Q.A)
30. Forces also affect granule property such as particle size, particle size distribution, particle shape, surface texture, roughness &
surface area.
If particle size of powder is ≤ 150 µm the magnitude of frictional & vander waals force predominate.
When particle size↑ mechanical & physical properties become more important with packing properties.
Flow properties of granules are determined by measuring three parameters-
i. Angle of repose – It is measured by two methods
a. Static angle of repose
b. Dynamic angle of repose.
Equation is , tan θ = h/r.
Where, θ - angle of repose, h – height of pile, r – radius of pile.
Krupanidhi College of Pharmacy (Q.A)
31. Fig(1)
Fixed height
Fig(2)
fixed base cone
Fig (3)
Tilting angle
Fig (4)
Rotating cylinder
Methods of determination of angle of repose
Krupanidhi College of Pharmacy (Q.A)
32. In fig.(1) height is constant & powder is added through the hopper until powder reaches tip of funnel.
In fig.(2) height is varied & base cone is fixed, powder is added until height reaches at max.
In fig.(3) rectangle box is filled with powder & tipped until content begins to slide.
In fig.(4) revolving cylinder with transparent end is made to revolve horizontally when half filled with powder.
The max. angle that the plane of powder makes with horizontal surface on rotation is taken as the angle of repose..
(1),(2) & (3) gives static angle of repose. While (4) gives kinetic or dynamic angle of repose.
Krupanidhi College of Pharmacy (Q.A)
Sr no. Angle of repose (o) Type of flow
1 < 25 Excellent
2 25-30 Good
3 30-40 passable
4 > 40 Poor
33. ii. Percentage compressibility Index
It is directly related to the relative flow rate cohesiveness & particle size.
It is simple fast & popular method of presiding powder flow characters.
It can be obtained from bulk density measurements is the % Compressibility index (C).
% Compressibility index = Tapped density - Bulk density / Tapped density X 100.
OR
I = (1 – V/ Vo ) x 100
Where, I – % Compressibility index,
V – volume occupied by powder/ granules after tapping, Vo - volume of powder/granules before tapping.
Krupanidhi College of Pharmacy (Q.A)
SR.NO. % Compressibility index Type of flow
1 5-15 Excellent
2 12-16 Very good
3 18-21 Good
4 23-25 Passable
5 33-38 Poor
6 > 40 Very poor
34. iii. Hausner's Ratio
• Hausner’s ratio was related to interparticulate friction and as such could be used to predict powder flow characteristics.
• It showed that powder with low particular friction such as coarse sphere had ratio of approximately 1.2, where as more as
cohesiveness- less free flowing powders such as flaks have Hausner’s ratio greater than 1.6.
FORMULA:
Hausner’s ratio = Tapped density / Bulk density
6. Moisture content
The amount of moisture present in the granule is called moisture content.
Generally the granules contain 2% moisture. It is required for the binding of the powder or granules during compression in
die cavity.
Percentage of moisture is calculated by using “moisture Balance” or “IR Balance”.
IR Balance consist of simple balance which is placed I to the casing in which the IR bulb is attached which produce heat
inside the chamber.
The small amount of sample taken from oven to measure moisture content & place in the moisture balance..
Krupanidhi College of Pharmacy (Q.A)
35. Initial reading should be note down after that we are initiated the IR Bulb as IR bulb is initiated the moisture is removed
from the granules via heating after that note down the reading.
% of moisture is calculated by,
% moisture content = Initial wt.- Final wt./ initial weight X 100
Krupanidhi College of Pharmacy (Q.A)
Moisture analyzer
IR moisture balanceSarotorious MA-100
36. 7. Percentage Fines (% Fines)
% fines means the amount of powder remain in the granule.
Generally the amount is 15% of fines.
It is necessary for the tablet compression because if we are using 100% granules then it is difficult to maintain hardness of
tablet because they having free space in the die cavity after compression the tablet is crack due to air.
% fine can be calculated by using Sieve method.
% fine should not be more than 15%.
Krupanidhi College of Pharmacy (Q.A)
37. IPQC/Official Standards as per B.P. /I.P./ U.S.P. for tablets
COMPARISON OF DIFFERENT PHARMACOPOEIAL QUALITY CONTROL TESTS
BRITISH PHARMACOPOEIA
FOR ALL TABLETS:
Content of active ingredients
Disintegration
Uniformity of content
Labeling.
Uncoated tablet:
-Disintegration test
-Uniformity of weight
Effervescent tablet:
-Disintegration test
-Uniformity of weight
Coated tablet:
-Disintegration test
-Uniformity of weight
Krupanidhi College of Pharmacy (Q.A)
38. Gastro resistant tablet:
-Disintegration test
Modified release tablet:
-Uniformity of weight.
Dispersible tablet:
-Disintegration test
-Uniformity of dispersion
-Uniformity of weight
Krupanidhi College of Pharmacy (Q.A)
39. INDIAN PHARMACOPOEIA
Uncoated tablet:
-Uniformity of container content
-Content of active ingredient
-Uniformity of weight
-Uniformity of content
-Disintegration test
Enteric coated tablet:
-Disintegration test
Dispersible tablet:
-Uniformity of dispersion
-Disintegration
Soluble tablet:
-Disintegration test
Effervescent tablet:
-Disintegration/ Dissolution / Dispersion test.
Krupanidhi College of Pharmacy (Q.A)
40. UNITED STATES PHARMACOPOEIA
Physical tests applicable to tablet formulation:
-Bulk density / Tapped density of powder
-Powder fineness
-Loss on drying
-Disintegration test
-Tablet friability
-Dissolution test
-Drug release testing
-Uniformity of dosage form
-Container permeation test
-Labeling of inactive ingredients
Krupanidhi College of Pharmacy (Q.A)
41. References
1. Leon Lachman, The theory and practice of Industrial pharmacy,3rd edition, Varghese
publishing house, page no.67-68,77-78,315-317,296-303.
2. Indian Pharmacopoeia-2010,Govt.Of India ministry of health & family welfare,6th
edition, page no.187-198.
Krupanidhi College of Pharmacy (Q.A)
42. Process control by means of in-process controls
Krupanidhi College of Pharmacy (Q.A)
43. Example of an IPQC structure
Krupanidhi College of Pharmacy (Q.A)
50. Krupanidhi College of Pharmacy (Q.A)
“All the in-process controls, including those made in the production area by
production personnel, should be performed according to methods approved by
Quality Control and the results recorded.“ (6.18 EU-GMP-Guide, see chapter C.4).
AQL lists (AQL = Acceptance Quality Limit)
51. Krupanidhi College of Pharmacy (Q.A)
The parameters and experiences
accumulated during the process validation determine the scope of the
tests as well as the limits.
52. Krupanidhi College of Pharmacy (Q.A)
“In-process controls may be carried out within the production area provided they
do not carry any risk for the production.” (3.17 EU-GMP-Guide, see chapter C.4).
This means that particular care must be taken when carrying out sampling or testing.
Examples of possible influences of in-process control methods on production
are shown below:
• Particle measurements (influence on air flow pattern)
• Direct contact tests (matrix residues on surface)
• Disintegration tests (influence on room humidity)
• Leak test on blisters (blue bath with microbial contamination risk)
Tests are therefore normally carried out in a segregated area and not directly at
the manufacturing location.
53. Krupanidhi College of Pharmacy (Q.A)
As a first step, a sampling plan has to be established, which identifies process
steps and/or locations for sampling, as well as number and amount of samples.
When defining the amount to be sampled, statistical criteria should be considered
and justified, e.g.
• Component variability
• Confidence levels
• Degree of precision
• Quantity needed for analysis
• Reserve amount needed
The sampling plan should also contain precise instructions on the sampling procedure,
54. TESTING
Samples are tested to verify conformance with specifications:
• Identity
• Component conformity to written specifications
• Container/Closure conformity to written specifications
• Examination for contamination
As a result, components, containers or closures will be approved or rejected.
The tests to be performed and the methods to be used have to be defined.
A list of specifications has to be established.
Krupanidhi College of Pharmacy (Q.A)
55. Krupanidhi College of Pharmacy (Q.A)
CONCLUSION
In-process control not only provides a means of controlling production. It also performs a quality assurance
function.
The in-process control group personnel may be assigned to production or quality control depending on the
relevant company structure. In each case, autonomy in relation to the production process must be ensured.
The in-process control methods that are part of the manufacturing formula are compiled and validated under
the supervision of quality control.
Statistical evaluation and periodic review of in-process data contributes to the general assessment of process
performance and product quality.