This document discusses various visual defects that can occur during tablet processing, including capping, lamination, chipping, cracking, sticking, picking, binding, and double impression. For each defect, the document describes the causes related to formulation, processing, and machine settings, and provides potential remedies. Some common causes mentioned are insufficient or improper binders/lubricants, too dry or moist granules, deep die concavities, worn dies, and improper machine settings. Suggested remedies include modifying the formulation, drying the granules, increasing binder/lubricant amounts, adjusting machine settings, and replacing worn parts.
The document describes the process and key components of a tablet compression machine. The machine uses punches and dies to compress powder or granules into tablets. It has several stations that rotate to precisely fill the dies, compress the powder under high pressure, and eject the finished tablets. The main stages are filling the die cavity, adjusting the powder weight, compressing the powder between the punches, and ejecting the tablet. Critical parts include the hopper, feeder system, punches, dies, turret, cam tracks, and rollers which work together to automate tablet production.
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 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.
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.
The document discusses tablet disintegration testing which is an important step for tablets to dissolve and release their active ingredients. It describes the typical disintegration times for different types of tablets and the apparatus used, which consists of 6 tubes in a basket that is raised and lowered in fluid. Tablets are tested individually in each tube, and the test is repeated with additional tablets if any fail to fully disintegrate within the specified time. Enteric coated tablets are first tested in simulated gastric fluid for 1 hour to ensure no disintegration occurs, and then in intestinal fluid to confirm complete disintegration.
The document summarizes various sterilization methods used for parenterals including dry heat, moist heat, filtration, radiation, and gas sterilization. Dry heat is used to sterilize glassware and some metals by heating to temperatures between 160-180°C. Moist heat sterilization with steam under pressure is commonly used for liquids and porous materials in an autoclave. Filtration through sterile membranes can sterilize heat-labile solutions. Radiation methods include UV, gamma rays, and electrons. Gaseous methods use ethylene oxide or formaldehyde gas.
1. The document discusses quality control tests for tablets, including tests for tablet characteristics before and after compression. It describes tests for properties like hardness, friability, thickness, weight variation, drug content uniformity, and dissolution.
2. Official tests discussed include weight variation, disintegration, dissolution, and drug content/assay. Non-official tests include hardness and friability. Test conditions and acceptance criteria are provided for many of the tests.
3. The purpose of the quality control tests is to ensure tablets include the correct dose of drug, the drug is released in a controlled and reproducible manner, and the tablets have sufficient mechanical strength.
This document discusses various visual defects that can occur during tablet processing, including capping, lamination, chipping, cracking, sticking, picking, binding, and double impression. For each defect, the document describes the causes related to formulation, processing, and machine settings, and provides potential remedies. Some common causes mentioned are insufficient or improper binders/lubricants, too dry or moist granules, deep die concavities, worn dies, and improper machine settings. Suggested remedies include modifying the formulation, drying the granules, increasing binder/lubricant amounts, adjusting machine settings, and replacing worn parts.
The document describes the process and key components of a tablet compression machine. The machine uses punches and dies to compress powder or granules into tablets. It has several stations that rotate to precisely fill the dies, compress the powder under high pressure, and eject the finished tablets. The main stages are filling the die cavity, adjusting the powder weight, compressing the powder between the punches, and ejecting the tablet. Critical parts include the hopper, feeder system, punches, dies, turret, cam tracks, and rollers which work together to automate tablet production.
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 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.
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.
The document discusses tablet disintegration testing which is an important step for tablets to dissolve and release their active ingredients. It describes the typical disintegration times for different types of tablets and the apparatus used, which consists of 6 tubes in a basket that is raised and lowered in fluid. Tablets are tested individually in each tube, and the test is repeated with additional tablets if any fail to fully disintegrate within the specified time. Enteric coated tablets are first tested in simulated gastric fluid for 1 hour to ensure no disintegration occurs, and then in intestinal fluid to confirm complete disintegration.
The document summarizes various sterilization methods used for parenterals including dry heat, moist heat, filtration, radiation, and gas sterilization. Dry heat is used to sterilize glassware and some metals by heating to temperatures between 160-180°C. Moist heat sterilization with steam under pressure is commonly used for liquids and porous materials in an autoclave. Filtration through sterile membranes can sterilize heat-labile solutions. Radiation methods include UV, gamma rays, and electrons. Gaseous methods use ethylene oxide or formaldehyde gas.
1. The document discusses quality control tests for tablets, including tests for tablet characteristics before and after compression. It describes tests for properties like hardness, friability, thickness, weight variation, drug content uniformity, and dissolution.
2. Official tests discussed include weight variation, disintegration, dissolution, and drug content/assay. Non-official tests include hardness and friability. Test conditions and acceptance criteria are provided for many of the tests.
3. The purpose of the quality control tests is to ensure tablets include the correct dose of drug, the drug is released in a controlled and reproducible manner, and the tablets have sufficient mechanical strength.
This document summarizes the key components and functioning of a single punch tablet press. It discusses that a single punch tablet press is the simplest machine for tablet manufacturing, employing a single die and punch set. It describes the main components as the hopper, feeding mechanism, tooling set of die and punches, and the compression, filling and ejection processes. Some advantages are highlighted as its small size, ease of operation, high pressure capability and continuous control over loading and tablet thickness.
This document summarizes a presentation on multi-station or rotary tablet presses. It begins with an introduction explaining that rotary tablet presses use multiple tooling stations to compress powder mixtures into tablets simultaneously, unlike single punch presses. It then discusses applications in pharmaceutical and other industries. The main parts and working mechanism are described, including stages of the compression process. Advantages of high productivity and disadvantages of high costs and complexity are provided. Maintenance tips like automated cleaning and inspection are suggested to extend the life of tooling. The conclusion emphasizes the importance of choosing an appropriate tooling design for the specific tablet application.
The most common method of drug delivery is oral dosage
form of which tablet and capsule are predominant.
Tablet is more accepted as compared to capsule due to
many reason such as cost, tamper resistance, ease of
handling, ease of identification and manufacturing efficiency.
Tablet compression process understanding is resulted in
development of formulation.
Recent advances in the design of tablet compression
equipment has conducted resulted in higher efficiency,
minimized tablet variation, greater flexibility.
This document provides an overview of tablet formulation and manufacturing. It discusses the definition and advantages of tablets as a popular dosage form. It describes different types of tablets including compressed, enteric coated, and chewable tablets. The document outlines the manufacturing process for compressed tablets including preparation of granules through wet and dry granulation. It also discusses common excipients used in tablet formulations such as diluents, binders, and lubricants. Finally, it provides information on tablet coating techniques and quality evaluation tests for tablets.
This document provides an overview of compression machines used in tablet manufacturing, including single punch and rotary presses. It describes the basic working mechanisms and parts of each type of machine. Single punch presses use a single set of tooling to compress tablets in a stamping motion, while rotary presses have multiple tooling stations on a rotating turret to compress tablets between upper and lower punches in an accordion motion and achieve higher outputs. Key parts discussed include dies, punches, cam tracks, and compression rollers.
The document discusses parenterals, which are sterile preparations intended for administration through layers of skin or mucous membranes. It defines parenterals and outlines their advantages like 100% bioavailability and ability to administer to unconscious patients. The document also discusses the various routes of parenteral administration, types of parenterals like powders, solutions, and emulsions. It describes the formulation, layout, and quality control testing of parenterals. Specifically, it provides details on the areas involved in parenteral production, types of small and large volume parenterals, and common quality tests like leaker, clarity, pyrogenic, sterility, and content uniformity testing.
The document discusses various granulation techniques used in pharmaceutical manufacturing. It begins with an introduction to granules and granulation. It then covers different granulation methods including dry granulation, wet granulation and advanced techniques like fluid bed granulation, extrusion-spheronization, steam granulation and melt granulation. The document provides details on the process, equipment used, advantages and disadvantages of each method. It aims to explain why granulation is important and the various ways it can be achieved.
This document provides an introduction to fluidized bed processing, which involves coating, granulation, and drying of particulate materials. It describes the different types of spray processes in fluidized beds, including top spray, bottom spray, and tangential spray. Bottom spray processing, developed by Dr. Dale Wurster, is commonly used in pharmaceutical applications for coating uniformity. The document outlines the key components of a fluidized bed coater and discusses important process parameters like inlet temperature, spray rate, and batch size that can impact performance. Formulation factors like coating solution strength and batch size are also reviewed. Fluidized bed processing is used to improve drug properties like taste, appearance, and release characteristics.
Friability testing involves placing a sample of tablets into a drum that rotates at 25 rpm for 100 revolutions. The tablets are weighed before and after the test to determine any weight loss due to mechanical stress. An acceptable friability is less than 1% weight loss, as this ensures tablets can withstand forces during manufacturing, distribution, and handling by customers. The test is run using either a single or double drum friabilator, following procedures for sample size, rotation speed, and calculation of percentage weight loss specified in pharmacopeia.
This document discusses tablet tooling and the tablet compression process. It describes the main types of tablet tooling, including 'B', 'D', 'BB', and 'DB' tooling, and provides their dimensions and specifications. It also outlines the basic components of a tablet press, including the hopper, dies, punches, cam tracks, and feeding mechanism. Finally, it explains the three main steps of the tablet compression process: filling and dosing the dies, compressing the tablets, and ejecting and exiting the tablets from the press.
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.
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.
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
Control including pharmaceutical aspects, physical stability and packing of capsules. Capsules provide advantages such as masking taste and odor, ease of swallowing, and economical production. Quality control tests include physical tests like disintegration, weight variation and chemical tests like dissolution and content uniformity. Capsules are packaged in containers like plastic bottles or blister packs to protect from moisture and ensure stability. Pharmaceutical aspects of capsules include improved dissolution and bioavailability over tablets due to liquid fill formulations, as well as reduced gastric irritation potential.
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.
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 summarizes parenterals and their quality control testing. Parenterals are sterile dosage forms intended for administration other than orally that enter systemic circulation. Their advantages include quick onset, suitability for non-oral drugs, and use in emergencies. Disadvantages are the need for trained personnel and risks of pain, sensitivity, and expense. Quality control tests described include content uniformity, leakers, pyrogens, sterility, and particulates. Specific test methods and acceptance criteria are provided to ensure parenterals meet quality standards.
Quality control tests for Syrups and Elixirs.Umair hanif
The document discusses various quality control tests performed on syrups and elixirs, including testing the water used, visual inspection, measuring pH, testing for sucrose concentration using HPLC or UV spectroscopy, determining alcohol concentration, and measuring viscosity. Viscosity can be measured using various methods like U-tube viscometers, capillary viscometers, rotating viscometers, concentric cylinder viscometers, cone-plate viscometers, and spindle viscometers. Maintaining quality standards is important to ensure purity, appearance, stability, and proper concentration of ingredients in syrups and elixirs.
Soft gelatin capsules are solid dosage forms where the drug is enclosed in a soft soluble gelatin shell, usually formed from gelatin. There are two main types of capsules: hard gelatin capsules and soft gelatin capsules. Soft gelatin capsules are one-piece shells containing liquids, suspensions, or semisolids. They are manufactured using either a plate process or rotary die process, which simultaneously fills, seals, and cuts the capsules. Quality is ensured through testing of ingredients, in-process testing, and finished product testing.
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.
Dissolution : Official and Non official methods, Alternative methods of dissolution testing and transport models, Drug release testing, Invitro drug release testing
This document summarizes the key components and functioning of a single punch tablet press. It discusses that a single punch tablet press is the simplest machine for tablet manufacturing, employing a single die and punch set. It describes the main components as the hopper, feeding mechanism, tooling set of die and punches, and the compression, filling and ejection processes. Some advantages are highlighted as its small size, ease of operation, high pressure capability and continuous control over loading and tablet thickness.
This document summarizes a presentation on multi-station or rotary tablet presses. It begins with an introduction explaining that rotary tablet presses use multiple tooling stations to compress powder mixtures into tablets simultaneously, unlike single punch presses. It then discusses applications in pharmaceutical and other industries. The main parts and working mechanism are described, including stages of the compression process. Advantages of high productivity and disadvantages of high costs and complexity are provided. Maintenance tips like automated cleaning and inspection are suggested to extend the life of tooling. The conclusion emphasizes the importance of choosing an appropriate tooling design for the specific tablet application.
The most common method of drug delivery is oral dosage
form of which tablet and capsule are predominant.
Tablet is more accepted as compared to capsule due to
many reason such as cost, tamper resistance, ease of
handling, ease of identification and manufacturing efficiency.
Tablet compression process understanding is resulted in
development of formulation.
Recent advances in the design of tablet compression
equipment has conducted resulted in higher efficiency,
minimized tablet variation, greater flexibility.
This document provides an overview of tablet formulation and manufacturing. It discusses the definition and advantages of tablets as a popular dosage form. It describes different types of tablets including compressed, enteric coated, and chewable tablets. The document outlines the manufacturing process for compressed tablets including preparation of granules through wet and dry granulation. It also discusses common excipients used in tablet formulations such as diluents, binders, and lubricants. Finally, it provides information on tablet coating techniques and quality evaluation tests for tablets.
This document provides an overview of compression machines used in tablet manufacturing, including single punch and rotary presses. It describes the basic working mechanisms and parts of each type of machine. Single punch presses use a single set of tooling to compress tablets in a stamping motion, while rotary presses have multiple tooling stations on a rotating turret to compress tablets between upper and lower punches in an accordion motion and achieve higher outputs. Key parts discussed include dies, punches, cam tracks, and compression rollers.
The document discusses parenterals, which are sterile preparations intended for administration through layers of skin or mucous membranes. It defines parenterals and outlines their advantages like 100% bioavailability and ability to administer to unconscious patients. The document also discusses the various routes of parenteral administration, types of parenterals like powders, solutions, and emulsions. It describes the formulation, layout, and quality control testing of parenterals. Specifically, it provides details on the areas involved in parenteral production, types of small and large volume parenterals, and common quality tests like leaker, clarity, pyrogenic, sterility, and content uniformity testing.
The document discusses various granulation techniques used in pharmaceutical manufacturing. It begins with an introduction to granules and granulation. It then covers different granulation methods including dry granulation, wet granulation and advanced techniques like fluid bed granulation, extrusion-spheronization, steam granulation and melt granulation. The document provides details on the process, equipment used, advantages and disadvantages of each method. It aims to explain why granulation is important and the various ways it can be achieved.
This document provides an introduction to fluidized bed processing, which involves coating, granulation, and drying of particulate materials. It describes the different types of spray processes in fluidized beds, including top spray, bottom spray, and tangential spray. Bottom spray processing, developed by Dr. Dale Wurster, is commonly used in pharmaceutical applications for coating uniformity. The document outlines the key components of a fluidized bed coater and discusses important process parameters like inlet temperature, spray rate, and batch size that can impact performance. Formulation factors like coating solution strength and batch size are also reviewed. Fluidized bed processing is used to improve drug properties like taste, appearance, and release characteristics.
Friability testing involves placing a sample of tablets into a drum that rotates at 25 rpm for 100 revolutions. The tablets are weighed before and after the test to determine any weight loss due to mechanical stress. An acceptable friability is less than 1% weight loss, as this ensures tablets can withstand forces during manufacturing, distribution, and handling by customers. The test is run using either a single or double drum friabilator, following procedures for sample size, rotation speed, and calculation of percentage weight loss specified in pharmacopeia.
This document discusses tablet tooling and the tablet compression process. It describes the main types of tablet tooling, including 'B', 'D', 'BB', and 'DB' tooling, and provides their dimensions and specifications. It also outlines the basic components of a tablet press, including the hopper, dies, punches, cam tracks, and feeding mechanism. Finally, it explains the three main steps of the tablet compression process: filling and dosing the dies, compressing the tablets, and ejecting and exiting the tablets from the press.
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.
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.
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
Control including pharmaceutical aspects, physical stability and packing of capsules. Capsules provide advantages such as masking taste and odor, ease of swallowing, and economical production. Quality control tests include physical tests like disintegration, weight variation and chemical tests like dissolution and content uniformity. Capsules are packaged in containers like plastic bottles or blister packs to protect from moisture and ensure stability. Pharmaceutical aspects of capsules include improved dissolution and bioavailability over tablets due to liquid fill formulations, as well as reduced gastric irritation potential.
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.
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 summarizes parenterals and their quality control testing. Parenterals are sterile dosage forms intended for administration other than orally that enter systemic circulation. Their advantages include quick onset, suitability for non-oral drugs, and use in emergencies. Disadvantages are the need for trained personnel and risks of pain, sensitivity, and expense. Quality control tests described include content uniformity, leakers, pyrogens, sterility, and particulates. Specific test methods and acceptance criteria are provided to ensure parenterals meet quality standards.
Quality control tests for Syrups and Elixirs.Umair hanif
The document discusses various quality control tests performed on syrups and elixirs, including testing the water used, visual inspection, measuring pH, testing for sucrose concentration using HPLC or UV spectroscopy, determining alcohol concentration, and measuring viscosity. Viscosity can be measured using various methods like U-tube viscometers, capillary viscometers, rotating viscometers, concentric cylinder viscometers, cone-plate viscometers, and spindle viscometers. Maintaining quality standards is important to ensure purity, appearance, stability, and proper concentration of ingredients in syrups and elixirs.
Soft gelatin capsules are solid dosage forms where the drug is enclosed in a soft soluble gelatin shell, usually formed from gelatin. There are two main types of capsules: hard gelatin capsules and soft gelatin capsules. Soft gelatin capsules are one-piece shells containing liquids, suspensions, or semisolids. They are manufactured using either a plate process or rotary die process, which simultaneously fills, seals, and cuts the capsules. Quality is ensured through testing of ingredients, in-process testing, and finished product testing.
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.
Dissolution : Official and Non official methods, Alternative methods of dissolution testing and transport models, Drug release testing, Invitro drug release testing
Sree Prakash Pandey- VARIOUS DISSOLUTION TESTING METHOD.pptxSreePrakashPandey
This document provides an overview of various dissolution testing methods. It begins with definitions of dissolution and an explanation of the need for dissolution testing. It then describes the major classification of methods as official and unofficial. The official methods discussed in detail are the basket, paddle, reciprocating cylinder, flow through cell, paddle over disk, and rotating cylinder apparatuses. The unofficial methods briefly outlined include beaker, rotating/static disk, flask stirrer, peristalsis, rotating bottle, and dialysis methods. The document concludes with applications and references.
This document provides information on quality control tests for different drug dosage forms, including tablets, capsules, creams, and suspensions. It describes in detail several important tablet tests: hardness, thickness, diameter, friability, and disintegration. Hardness is tested using instruments like the Strong-Cobb or Stokes-Monsanto that measure the force required to crush a tablet. Thickness and diameter are measured with calipers and have specifications depending on the tablet strength. The friability test subjects tablets to abrasion to measure weight loss, and the disintegration test ensures tablets break down within a specified time in a basket-rack apparatus lowered up and down in fluid.
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.
This document provides an overview of a seminar presentation on tablet preparation and evaluation methods. The presentation covers various tablet types, formulation additives, preparation techniques like wet and dry granulation and direct compression, compression methods using single punch and rotary tablet presses, and quality control tests for tablets including hardness, thickness, friability, dissolution, disintegration, and content uniformity. Evaluation methods and apparatus for each quality control test are also described. The presentation was delivered by Farheen Unnisa to provide guidance on tablet manufacturing and quality testing.
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.
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.
This document discusses suppositories, including what they are, types of suppositories, trends in suppository development, and methods for evaluating suppositories. Suppositories are solid dosage forms that are inserted into body cavities like the rectum or vagina to release medication. Common types include rectal, vaginal, nasal, and ear suppositories. Evaluation methods ensure suppositories meet specifications and include tests for uniformity, disintegration, drug content, and dissolution.
This document summarizes USP dissolution testing apparatus and procedures. It describes 7 different apparatus for testing dissolution of solid oral dosage forms including baskets, paddles, cylinders and flow-through cells. Key steps are outlined for each apparatus, including preparation of the dosage form sample, equilibrating the dissolution medium, operating conditions, sampling time points and procedures. Temperatures and rotations speeds are specified. The goal is to perform dissolution testing under standardized and reproducible conditions to evaluate drug release characteristics.
in vitro dissolution and iviv correlation RoshanJain35
The document summarizes a seminar presentation on in vitro dissolution and in vitro-in vivo correlation (IVIVC). It defines key terms like dissolution, IVIVC, and discusses the significance of IVIVC including its use in reducing bioequivalence studies. The document also describes the various apparatus used for in vitro dissolution testing and the parameters and levels used to establish correlations between in vitro dissolution and in vivo absorption.
This document discusses tablet manufacturing and quality control. It begins by explaining how direct compression became the most advanced tablet manufacturing technique as it requires fewer steps and less time than older granulation methods. It then describes common excipients used in tablets and the three main manufacturing methods - direct compression, dry granulation, and wet granulation. The mechanisms and components of rotary tablet presses are outlined. Quality control tests for tablets like hardness, thickness, friability, disintegration, weight variation and dissolution are also summarized. References on pharmaceutical manufacturing and quality standards are provided.
This document provides information on the manufacturing process, flowcharts, and in-process quality control (IPQC) tests for non-sterile capsule dosage forms. It describes the manufacturing of hard and soft gelatin capsule shells using plate and rotary die processes. Key steps include dipping pins in gelatin solution, drying, stripping, and trimming shells. Capsules are filled and quality tests conducted including appearance, size, disintegration time, weight variation, moisture permeation, content uniformity, and dissolution. The document aims to provide an overview of capsule manufacturing and quality assurance.
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 in vitro dissolution, which is the process by which a solid substance dissolves in a solvent to form a solution. It describes the various processes involved in dissolution of solid dosage forms and defines intrinsic dissolution rate. It also provides the mathematical equations to describe dissolution processes under sink and non-sink conditions. The document then discusses various compendial dissolution apparatus and methods specified in different pharmacopoeias including rotating basket, paddle, reciprocating cylinder, flow-through cell methods. It also covers alternative dissolution testing methods like rotating bottle, peristalsis and Franz diffusion cell methods. Finally, the document discusses problems of variable control in dissolution testing and provides an overview of in vitro-in vivo correlation (IVIVC
This document discusses dissolution testing apparatus and methods. It defines dissolution as the process by which a solid substance enters the solvent phase to form a solution. Several theories of drug dissolution are described, including the diffusion layer theory, Danckwert's model, and the interfacial barrier model. Six common apparatus are summarized: the basket, paddle, reciprocating cylinder, flow-through cell, paddle over disk, and cylinder methods. Procedures for each apparatus are provided. Common dissolution media and factors affecting media selection are also outlined. The document provides an overview of key concepts and equipment in dissolution testing.
This document summarizes a seminar on in vitro dissolution testing models. It discusses the need for dissolution testing in evaluating bioavailability and ensuring quality. The main official dissolution apparatus described are the rotating basket, paddle, reciprocating cylinder, and flow-through cell methods. In vitro-in vivo correlation seeks to correlate dissolution results with bioavailability. Dissolution acceptance criteria and various non-official dissolution testing methods are also outlined.
Tablets are solid dosage forms that contain medicinal ingredients. They have advantages like ease of administration and stability. Tablet production involves blending active ingredients with excipients using processes like wet or dry granulation. Tablets are evaluated for properties such as uniform weight, disintegration time, dissolution rate and mechanical strength. Proper formulation and processing are necessary to minimize defects and ensure tablets have acceptable quality.
The Consumer Protection Bill, 1986 seeks to provide for better protection of the interests of consumers and for the purpose, to make provision for the establishment of Consumer councils and other authorities for the settlement of consumer disputes and for matter connected therewith. (f) right to consumer education.
Under the Indian patent law, a patent can be obtained only for an invention that is new and useful. The invention must relate to the machine, article, or substance produced by a manufacturer, or the process of manufacture of an article.
What is the "Drugs (Prices Control) Order (DPCO)" ? The Drugs Prices Control Order, 1995 is an order issued by the Government of India under Sec. 3 of Essential Commodities Act, 1955 to regulate the prices of drugs.
The Narcotics Control Bureau is the Indian central law enforcement and intelligence agency under the Ministry of Home Affairs, Government of India. The agency is tasked with combating drug trafficking and the use of illegal substances under the provisions of Narcotic Drugs and Psychotropic Substances Act.
COMPETITIVE ANALYSIS & MANAGEMENT COMMITMENT TO QUALITYANANT NAG
This document discusses competitive analysis and management commitment to quality. It outlines the steps in competitive analysis, which include identifying current and potential competitors, competitor profiling, assessing market attractiveness, and designing competitor strategies. It also introduces management commitment to quality, discussing it from the perspectives of the pharmaceutical industry/FDA and ISO-9001 standards. Management commitment to quality involves management responsibilities, quality audits, personnel requirements, and quality responsibilities as defined by ISO-9001.
Presentation of QUALITY CONTROL AND QUALITY ASSURANCE-Unit 5 (Self-selected Topics)Introduction
Sec. 211.101 charge-in of components.
Sec. 211.134 drug product inspection.
Sec. 211.115 reprocessing.
The document discusses ion exchange chromatography, including its principle of separating ions and polar molecules based on their charge affinity for the ion exchanger. It covers various aspects of ion exchange chromatography such as classifications of resins, factors affecting separations, practical requirements like column materials and dimensions, and applications in areas like biochemistry, inorganic separations, and water analysis.
The WHO plays several key roles in pharmaceutical management:
1) It issues norms and standards through expert committees and supports regulatory capacity building for drug regulation.
2) It ensures quality of essential medicines through prequalification programs.
3) It facilitates information exchange between countries on drug safety and efficacy through tools like the International Conference of Drug Regulatory Authorities and a network of national drug information officers.
Anant Nag provides personal details including his full name, date of birth, family background, and current place of residence. He completed his half schooling at Oxford Public School in Ranchi and did his matriculation from Seventh-Day Adventist High School in Ranchi. He did his Bachelor of Pharmacy from Sam Higginbottom University of Agriculture, Technology and Sciences and is currently doing his M.Pharm in Pharmaceutical Quality Assurance from Birla Institute of Technology, Mesra. His hobbies include photography, gardening, designing, vlogging, cooking, and singing.
Role of pharmacists during covid 19 pandemic pptANANT NAG
Pharmacists play an important but underutilized role during the COVID-19 pandemic. As trusted healthcare professionals with access to patients, pharmacists working in communities, hospitals, pharmaceutical industries, and regulatory authorities can help manage disease prevention, treatment, and containment. However, their full capabilities are not recognized. Integrating pharmacist services across different settings with other healthcare workers could help strengthen the response to the pandemic.
X-ray diffraction is a technique used to determine the atomic structure of crystals. When X-rays strike the regular array of atoms in a crystal, they produce a pattern of diffracted rays. By measuring the angles and intensities of these diffracted beams, the crystal structure can be analyzed. X-ray crystallography is used across many fields to determine molecular structures, crystal structures, and physical properties of materials. It works by firing X-rays at crystalline samples and observing the diffraction patterns that emerge, which can then be analyzed using Fourier transforms to reveal details about atomic positions and electron densities within the crystal. Common applications of X-ray diffraction include phase identification, structural elucidation of organic and inorganic compounds, and
Hypertension, also known as high blood pressure, is a long-term medical condition where the blood pressure in the arteries is persistently elevated. It is classified as primary (essential) hypertension, which is high blood pressure due to non-specific lifestyle and genetic factors, or secondary hypertension, which is caused by an identifiable underlying condition. Blood pressure is measured by the systolic and diastolic pressures. Normal blood pressure is below 130/80 mmHg while high blood pressure is 140/90 mmHg or higher. Lifestyle changes and medications are used to lower blood pressure and reduce health risks from hypertension.
Calibration and validation of HPLC methods involves establishing that the instrument produces accurate and reproducible results. Key aspects include:
1. Calibration involves checking parameters like flow rate accuracy, wavelength accuracy, and detector linearity using reference standards.
2. Validation establishes method performance meets requirements. It involves determining accuracy over 3 concentration levels, precision through repeatability studies, and linearity through correlation coefficients.
3. Qualification includes design, installation, operational, and performance qualification to prove equipment works correctly and leads to expected results.
Analytical method development and validationANANT NAG
This document describes the development and validation of an analytical method for Azelnidipine using UV-Visible spectroscopy. The method development involved preparation of standard stock and working solutions, selection of the analytical wavelength of 257nm from UV scanning, and generation of a calibration curve. The method validation assessed parameters such as linearity, precision, accuracy, limit of detection, limit of quantification, robustness, and assay of Azelnidipine tablets to prove that the method is suitable for use in pharmaceutical analysis. The results of the study confirmed that UV-Visible spectroscopy can accurately and reliably measure Azelnidipine concentrations in formulations.
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These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
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5-hydroxytryptamine or 5-HT or Serotonin is a neurotransmitter that serves a range of roles in the human body. It is sometimes referred to as the happy chemical since it promotes overall well-being and happiness.
It is mostly found in the brain, intestines, and blood platelets.
5-HT is utilised to transport messages between nerve cells, is known to be involved in smooth muscle contraction, and adds to overall well-being and pleasure, among other benefits. 5-HT regulates the body's sleep-wake cycles and internal clock by acting as a precursor to melatonin.
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3. WHAT IS A DISINTEGRATION TESTER
Disintegration testers are widely used to
measure the quality of the oral dosage form
like tablets and capsules.
4. A disintegration test is a procedure to
find out the time it takes for a solid
dosage form to completely
disintegrate.
If the disintegration time either varies
within a set of samples or it is too
high, it wouldn’t correspond with the
pharmacopoeial quality standards.
5. This test determines whether dosage
forms such as tablets,capsules,
boluses pessaries and suppositories
disintegrate within a prescribed time
when placed in a liquid medium under
the prescribed experimental
conditions.
For the purpose of this test,
disintegration does not imply complete
solution of the dosage unit or even of
its active constituent
6. Disintegration is defined as that state in
which no residue of the unit under test
remains on the screen of the apparatus or, if
a residue remains, it consists of fragments of
disintegrated parts of tablets component
parts such as insoluble coating of the tablets
or of capsule shells, or of any melted fatty
substance from the pessary or suppository or
is a soft mass with no palpable core.
If discs have been used with capsules, any
residue remaining on the lower surfaces of
the discs consists only of fragments of shells.
7. INSTUMENTATION
Disintegration testers are commonly
comprised of a basket, a vessel, a
water bath and the actual
disintegration unit itself (which
operates the basket motion and heats
and pumps the water in the bath).
The apparatus consists of a basket-rack
assembly, a 1-litre beaker, a thermostatic
arrangement for heating the fluid and a
mechanical device for raising and
lowering the basket in the immersion
fluid at a constant frequency rate
8. Basket-rack assembly. The basket-
rack assembly is rigid and supports six
cylindrical glass tubes, 77.5 ± 2.5 mm
long, 21.5 mm in internal diameter and
with a wall thickness of about 2 mm.
The tubes are held vertically by two
superimposed transparent plastic
plates, 90 ± 2 mm in diameter and
6.75 ± 1.75 mm thick perforated by six
holes having the same diameter as
the tubes.
9. The holes are equidistant from the centre of
the plate and are equally spaced from one
another. Attached to the under side of the
lower plate is a woven stainless steel wire
cloth with a plain square weave with 2.0 ±0.2
mm mesh apertures and with a wire diameter
of 0.615 ±0.045 mm.
The upper plate is covered with a stainless
steel disc perforated by six holes, each about
24 ± 2 mm in diameter, which fits over the
tubes and holds them between the plastic
plates. The holes coincide with those of the
upper plastic plate and the upper open ends
of the glass tubes
10. A suitable means is provided to suspend the basket-
rack assembly from the raising and lowering device
using a point on its axis.
The plates are held rigidly in position and 77.5 mm
apart by vertical metal rods at the periphery and a metal
rod is also fixed to the centre of the upper plate to
enable the assembly to be attached to the device for
raising and lowering it smoothly at a constant frequency
of between 28 and 32 cycles per minute through a
distance of 50 to 60 mm.
The time required for the upward stroke is equal to the
time required for the downward stroke, and the change
in stroke direction should be smooth and not abrupt.
There should be no appreciable horizontal motion or
movement of the axis from the vertical.
12. Discs.
A cylindrical disc for each tube, each 20.7 ±
0.15 mm thick in diameter and 9.5 ± 0.15 mm
thick, made of transparent plastic with a
relative density of 1.18 to 1.20, and pierced
with five holes, each 2 mm in diameter, one in
the centre and the other four spaced equally
on a circle of radius 6 mm from the centre of
the disc.
Four equally-spaced grooves are cut in the
lateral surface of the disc in such a way that
at the upper surface of the disc they are 9.5
mm wide and 2.55 mm deep and at the lower
surface 1.6 mm square.
13. Medium.
The assembly is suspended in the liquid
medium in a suitable vessel, preferably a 1-
litre beaker.
The volume of liquid is such that the wire
mesh at its highest point is at least 25 mm
below the surface of the liquid, and at its
lower point is at least 25 mm above the
bottom of the beaker.
At no time should the top of the basket-rack
assembly become submerged.
There is a thermostatic arrangement for
heating the liquid and maintaining the
temperature at 37º ± 2º.
14. Method.
Unless otherwise stated in the individual monograph,
introduce one tablet or capsule into each tube and, if
directed in the appropriate general monograph, add a
disc to each tube.
Suspend the assembly in the beaker containing the
specified liquid and operate the apparatus for the
specified time.
Remove the assembly from the liquid. The tablets or
capsules pass the test if all of them have disintegrated.
If 1 or 2 tablets or capsules fail to disintegrate, repeat
the test on 12 additional tablets or capsules; not less
than 16 of the total of 18 tablets or capsules tested
disintegrate.
If the tablets or capsules adhere to the disc and the
preparation under examination fails to comply, repeat
the test omitting the disc.
The preparation complies with the test if all the tablets
or capsules in the repeat test disintegrate.
15. Factors affecting the DT
1. Content : especially the quantity
and quality of the disintegrant and
lubricant (mixing condition and time of
addition of lubricant), the lubricant
increase the disintegration time by
decreasing the wettability of the
tablets due to its hydrophobicity.
16. 2. Hardness: amount of binder ,
compression force.
3. Design of granulation procedure
which will affect the physical
properties of the granules.