The document discusses pharmaceutical tablets, including their definition, advantages, disadvantages, ideal properties, types, ingredients, manufacturing process, and evaluation. Some key points:
- Tablets are solid oral dosage forms containing medicinal ingredients that are produced via compaction. They are the most popular dosage form, comprising 70% of medicines.
- Advantages include low cost, stability, ease of administration and identification. Disadvantages include difficulty swallowing for some patients and formulating certain drugs.
- Ingredients include active drugs and excipients like diluents, binders, disintegrants, lubricants, and colors.
- Tablets are produced via granulation and compression using tablet presses and
This document discusses sugar coating technology for tablet cores. Sugar coating is a multi-step process that involves coating the tablet core with sucrose syrup and evaporating the solvent to leave a sugar coating. The advantages of sugar coating include using widely accepted raw materials and not requiring complex equipment. The sugar coating process involves sealing the core, applying sub coatings using sucrose solution and calcium carbonate or talc, smoothing layers, coloring, polishing, and printing. Common faults are cracking, splitting, inversion causing stickiness.
Rancidity refers to the deterioration of food products due to oxidation reactions which affect quality and shelf life, making the food unfit for consumption. Rancidity occurs when food is exposed to heat, light, oxygen, or moisture and can be caused by oxidative reactions between unsaturated fatty acids and oxygen, hydrolysis of fats catalyzed by enzymes, or microbial breakdown of fats. The three main types of rancidity are oxidative, hydrolytic, and microbial. Oxidative rancidity involves lipid oxidation in initiation, propagation, and termination steps leading to formation of aldehydes and ketones. Hydrolytic and microbial rancidity involve enzymatic breakdown of fats and oils. Proper storage,
Syrups are concentrated sugar solutions used to dissolve and administer medicinal substances. They are ideal for children because the sugar masks bitter tastes. Syrups are homogeneous solutions while suspensions have unevenly dispersed particles. Syrup preparation involves dissolving ingredients in heated water or with agitation. Common ingredients include active drugs, preservatives, sweeteners, and solvents. The manufacturing process for paracetamol syrup involves dissolving the drug in a solution of glycerin and PEG 6000, then adding this to heated water and sucrose to form a transparent, flavored syrup.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive functioning. Exercise boosts blood flow, releases endorphins, and promotes changes in the brain which help enhance one's emotional well-being and mental clarity.
Pellets are small, spherical granules typically between 500-1500μm in size. They can be produced through various processes including extrusion-spheronization, suspension layering, and powder layering. Pellets offer benefits over other dosage forms like reduced variability in gastric emptying and plasma drug levels. Excipients used in pellet formulations include binders, fillers, lubricants, and coating agents. Pellets show advantages for swallowing and allow inclusion of incompatible drugs or varied release mechanisms in a single dosage form.
This document discusses tablets, lozenges, and sugar panning processes in confectionery manufacturing. It describes the basic components, manufacturing processes, and packaging methods for each. Tablets are hard confections made by compressing mixtures of ingredients like sugar, lubricants, and flavorings. Lozenges are flavored sugar doughs that are shaped, dried, and come in forms like hard candies, liquid-filled centers, or chewy bases. Sugar panning involves building up coatings on centers rotating in a pan to create hard shells or soft shells on products like sugar-coated chocolates or jelly beans. Precise control of temperature and humidity is important for drying and storing the finished confections properly.
The document discusses pharmaceutical tablets, including their definition, advantages, disadvantages, ideal properties, types, ingredients, manufacturing process, and evaluation. Some key points:
- Tablets are solid oral dosage forms containing medicinal ingredients that are produced via compaction. They are the most popular dosage form, comprising 70% of medicines.
- Advantages include low cost, stability, ease of administration and identification. Disadvantages include difficulty swallowing for some patients and formulating certain drugs.
- Ingredients include active drugs and excipients like diluents, binders, disintegrants, lubricants, and colors.
- Tablets are produced via granulation and compression using tablet presses and
This document discusses sugar coating technology for tablet cores. Sugar coating is a multi-step process that involves coating the tablet core with sucrose syrup and evaporating the solvent to leave a sugar coating. The advantages of sugar coating include using widely accepted raw materials and not requiring complex equipment. The sugar coating process involves sealing the core, applying sub coatings using sucrose solution and calcium carbonate or talc, smoothing layers, coloring, polishing, and printing. Common faults are cracking, splitting, inversion causing stickiness.
Rancidity refers to the deterioration of food products due to oxidation reactions which affect quality and shelf life, making the food unfit for consumption. Rancidity occurs when food is exposed to heat, light, oxygen, or moisture and can be caused by oxidative reactions between unsaturated fatty acids and oxygen, hydrolysis of fats catalyzed by enzymes, or microbial breakdown of fats. The three main types of rancidity are oxidative, hydrolytic, and microbial. Oxidative rancidity involves lipid oxidation in initiation, propagation, and termination steps leading to formation of aldehydes and ketones. Hydrolytic and microbial rancidity involve enzymatic breakdown of fats and oils. Proper storage,
Syrups are concentrated sugar solutions used to dissolve and administer medicinal substances. They are ideal for children because the sugar masks bitter tastes. Syrups are homogeneous solutions while suspensions have unevenly dispersed particles. Syrup preparation involves dissolving ingredients in heated water or with agitation. Common ingredients include active drugs, preservatives, sweeteners, and solvents. The manufacturing process for paracetamol syrup involves dissolving the drug in a solution of glycerin and PEG 6000, then adding this to heated water and sucrose to form a transparent, flavored syrup.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive functioning. Exercise boosts blood flow, releases endorphins, and promotes changes in the brain which help enhance one's emotional well-being and mental clarity.
Pellets are small, spherical granules typically between 500-1500μm in size. They can be produced through various processes including extrusion-spheronization, suspension layering, and powder layering. Pellets offer benefits over other dosage forms like reduced variability in gastric emptying and plasma drug levels. Excipients used in pellet formulations include binders, fillers, lubricants, and coating agents. Pellets show advantages for swallowing and allow inclusion of incompatible drugs or varied release mechanisms in a single dosage form.
This document discusses tablets, lozenges, and sugar panning processes in confectionery manufacturing. It describes the basic components, manufacturing processes, and packaging methods for each. Tablets are hard confections made by compressing mixtures of ingredients like sugar, lubricants, and flavorings. Lozenges are flavored sugar doughs that are shaped, dried, and come in forms like hard candies, liquid-filled centers, or chewy bases. Sugar panning involves building up coatings on centers rotating in a pan to create hard shells or soft shells on products like sugar-coated chocolates or jelly beans. Precise control of temperature and humidity is important for drying and storing the finished confections properly.
Gels and jellies are semi-rigid disperse systems where the movement of the dispersing medium (usually water) is restricted by a cross-linked polymer network. Jellies contain a high proportion of liquid, while gels are formed using gelling agents dispersed in a vehicle. Common gelling agents include polysaccharides like alginate, pectin, and cellulose derivatives. Gels are prepared by dissolving water-soluble components in the vehicle before slowly adding the gelling agent with stirring to prevent clumping. Gels find applications as vehicles for medication or lubricants.
This document summarizes the sieving method for separating fine and coarse powders. The sieving method involves passing powdered material through a set of sieves arranged from largest to smallest size to separate particles by size, with the smallest particles passing through to the bottom collection pan. Powder size is determined by the smallest sieve it can pass through. Sieves are shaken to allow particles to pass through while preventing clogging, though attrition may occur during shaking. The sieving method is inexpensive and easy to use but powders must be dry to prevent clogging and potential attrition from shaking.
This document discusses sheep and goat behavior. It covers various types of behaviors including feeding, social, sexual, parental, drinking, excretory, exploratory, conflict, sleep, communication, climbing, shelter-seeking, learning, aggression, fear, anomalous, and behaviors during handling and restraint. The conclusion emphasizes that animal behavior results from interactions with internal and external stimuli and that understanding behavior can help producers more efficiently manage livestock.
Cosmetics are substances used to enhance appearance without affecting the body's structure or functions. Common cosmetics include lipsticks, shampoos, cold cream, toothpastes, and hair dyes. Lipsticks contain pigments, oils, and waxes that apply color and texture to lips. Shampoos clean hair and add luster using detergents, oils, and thickeners. Cold cream and vanishing cream moisturize skin using oil-in-water or water-in-oil emulsions. Toothpastes clean teeth using abrasives while providing flavor. Hair dyes impart color to hair through temporary, semi-permanent, or permanent formulations containing dye compounds.
Cocoa butter based suppository formulationjimmmcelroy510
Rectal suppositories are bullet shaped and weigh about 2 grams for adults and 1 gram for children. Vaginal suppositories are oval or globular shaped and weigh 3 to 5 grams. Cocoa butter and triglycerides are commonly used suppository bases that require tempering to control crystal formation. Surfactants can be added to inhibit fat bloom on the suppository surface and potentially enhance drug absorption, though they may also irritate mucous membranes with prolonged use. The drug absorption route depends on whether the suppository is administered rectally or vaginally.
Quality control is about inspecting products and trying to take the defective products out. The alternative is a thing called quality assurance. This isn't about inspection, its about putting business processes in place that assure the quality of outputs. Quality control and quality assurance sounds similar but they are quite different.
This document provides a summary of capsules, including their history, types, manufacturing process, evaluation, and key details. It discusses how gelatin capsules were first developed in the 18th century and how the process has evolved. The main types - hard gelatin capsules, soft gelatin capsules, and their composition, sizes, and manufacturing processes - are outlined. Methods for evaluating capsules like uniformity of weight, drug content testing, disintegration testing, and dissolution testing are also summarized.
Lipids are a group of naturally occurring molecules that include fats, waxes, sterols, and fat-soluble vitamins. They serve important functions like energy storage, signaling, and as structural components of cell membranes. The main classes of lipids are neutral fats/triglycerides (consisting of glycerol and fatty acids), phospholipids, and sterols. Fatty acids can be saturated or unsaturated, and polyunsaturated fatty acids like omega-3 and omega-6 are essential nutrients. Lipids are insoluble in water but soluble in organic solvents, and are an important energy source in animals and plants.
Enhancement of Solubility By Solid Dispersion- Presented By Mr.Ajinkya Nikam...Ajinkya Nikam
1) Solid dispersion is a method to improve the solubility of poorly water soluble drugs by dispersing drugs in a hydrophilic carrier. It involves mixing the drug with a carrier on a molecular or microscopic level.
2) Common methods for preparing solid dispersions include fusion, solvent evaporation, spray drying, and melt extrusion. These methods aim to convert crystalline drugs into amorphous forms within hydrophilic carriers.
3) Characterization techniques like DSC, XRD, and dissolution testing are used to analyze the molecular state of drugs in solid dispersions and evaluate increases in solubility and dissolution rate compared to raw drugs.
This document discusses the development of fast dispersible tablets of aceclofenac using superdisintegrants like crospovidone, croscarmellose sodium, and sodium starch glycolate. It summarizes previous research that found these superdisintegrants can help reduce disintegration time and increase dissolution rate when included in oral fast-dissolving formulations. The objectives of this study are to select suitable superdisintegrants for developing aceclofenac tablets, prepare the tablets using suitable methods, evaluate the tablets, and test their stability according to ICH guidelines.
This document discusses tablets as a dosage form for delivering medications. It defines tablets and outlines their advantages such as precise dosing, low cost, and stability. Various types of tablets are described based on where they are administered and how they release the drug. The key ingredients used in tablets called excipients are explained. Granulation techniques for tablet manufacturing like wet and dry granulation are summarized. The document also covers tablet processing problems that can occur and ways to control the manufacturing process.
OINTMENT ASEPTIC MANUFACTURING, IPQC & PROCESS AUTOMATION IN SEMISOLIDSAkanksha Puri
The document discusses process automation in semisolids like ointments. It describes various types of equipment used in manufacturing processes like mixing and milling. The key stages of ointment production including trituration, emulsification and fusion methods are outlined. Quality control tests for ointments are then summarized, including universal tests like description, identification and assay, as well as specific tests such as pH, homogeneity, spreadability and sterility. The membrane filtration method for microbial content and sterility testing is also briefly described.
The document discusses guidelines for stability testing of pharmaceutical products. It defines stability testing as evaluating how environmental factors affect a drug substance or product's properties over time. This helps determine shelf life, proper storage conditions, and labeling instructions. Stability testing evaluates many factors like active ingredient stability, excipient interactions, manufacturing process, dosage form, and storage conditions. It also considers degradation reactions and how they are impacted by conditions. Stability testing parameters and timepoints are described for various dosage forms like tablets, capsules, solutions, injections etc. The document also discusses ICH guidelines for stability testing and recommendations for climatic zones III and IV.
Preformulation studies for bulk characterizationmangu3107
The document discusses preformulation studies, which generate information to help formulate stable and effective drug dosage forms. The overall goals of preformulation are to improve drug stability, bioavailability, and reduce incompatibility. Some key tests described include determining the drug's physical properties like color, odor, taste, purity, and thermal behavior. Melting point analysis can provide information on a drug's identity and purity. Preformulation studies are important to identify suitable drug candidates and formulations before clinical development.
The document discusses quality control parameters for ointments. It describes different types of ointments and bases and methods of preparation. Key quality control tests are outlined including physical appearance, particle size, weight variation, solubility, pH, spreadability, viscosity and microbial limits. Evaluation tests assess rate of absorption, non-irritancy, and rate of penetration to ensure uniform content and stability over time. Maintaining quality control is important for ointments to effectively deliver drugs to affected areas as a stable semi-solid dosage form.
The document provides information on various quality control tests performed during the aseptic processing and manufacturing of different dosage forms including ointments, suspensions, emulsions, powders, and parenterals. Some key tests mentioned are particle size determination, viscosity testing, weight variation, clarity testing, sterility testing, and assays to check for active ingredients and check for uniform drug content. The tests help monitor the quality of products during manufacturing to ensure sterile and stable products are produced.
This document provides information on aseptic processing and in-process quality control tests for various dosage forms including ointments, suspensions, emulsions, powders, and parenterals. It describes how sterile products are manufactured through aseptic processing to ensure sterility. It also outlines various quality tests done during manufacturing to monitor product quality, such as appearance, viscosity, particle size, moisture content, clarity, pH, and microbial limits.
This document discusses preformulation stability studies. It outlines the key factors that affect drug stability like temperature, moisture, and light. The objectives of stability testing are to determine shelf life and provide better storage conditions. The main types of stability are chemical, physical, microbiological, therapeutic, and toxicological. Various methods for stability testing include real-time testing, accelerated testing, and retained sample testing. Guidelines for long-term stability testing from ICH are presented. Common dosage forms that undergo stability testing are discussed.
Process validation- This guidance incorporates principles and approaches that...Sanchit Dhankhar
This guidance incorporates principles and approaches that all manufacturers can use to validate manufacturing processes.
It is the process of establishing, through documented evidence, a high degree of assurance that a specific process will consistently produce a product that meets its predetermined specifications and quality characteristics.
The document discusses validation of processing techniques for wet granulation. It outlines key parameters that must be considered and validated at each stage of wet granulation including blending, wet granulation, drying, and tablet compression. Parameters like mixing time and speed, binder concentration, granulation endpoint, drying temperature and moisture content, and compression force must be optimized and shown to consistently produce tablets meeting quality standards. Equipment used at each stage must also be validated to ensure it is suitable for the processing steps.
Effective process validation contributes significantly to assuring drug quality. The basic
principle of quality assurance is that a drug should be produced that is fit for its intended use.
This principle incorporates the understanding that the following conditions exist:
• Quality, safety, and efficacy are designed or built into the product.
• Quality cannot be adequately assured merely by in-process and finished-product
inspection or testing
Gels and jellies are semi-rigid disperse systems where the movement of the dispersing medium (usually water) is restricted by a cross-linked polymer network. Jellies contain a high proportion of liquid, while gels are formed using gelling agents dispersed in a vehicle. Common gelling agents include polysaccharides like alginate, pectin, and cellulose derivatives. Gels are prepared by dissolving water-soluble components in the vehicle before slowly adding the gelling agent with stirring to prevent clumping. Gels find applications as vehicles for medication or lubricants.
This document summarizes the sieving method for separating fine and coarse powders. The sieving method involves passing powdered material through a set of sieves arranged from largest to smallest size to separate particles by size, with the smallest particles passing through to the bottom collection pan. Powder size is determined by the smallest sieve it can pass through. Sieves are shaken to allow particles to pass through while preventing clogging, though attrition may occur during shaking. The sieving method is inexpensive and easy to use but powders must be dry to prevent clogging and potential attrition from shaking.
This document discusses sheep and goat behavior. It covers various types of behaviors including feeding, social, sexual, parental, drinking, excretory, exploratory, conflict, sleep, communication, climbing, shelter-seeking, learning, aggression, fear, anomalous, and behaviors during handling and restraint. The conclusion emphasizes that animal behavior results from interactions with internal and external stimuli and that understanding behavior can help producers more efficiently manage livestock.
Cosmetics are substances used to enhance appearance without affecting the body's structure or functions. Common cosmetics include lipsticks, shampoos, cold cream, toothpastes, and hair dyes. Lipsticks contain pigments, oils, and waxes that apply color and texture to lips. Shampoos clean hair and add luster using detergents, oils, and thickeners. Cold cream and vanishing cream moisturize skin using oil-in-water or water-in-oil emulsions. Toothpastes clean teeth using abrasives while providing flavor. Hair dyes impart color to hair through temporary, semi-permanent, or permanent formulations containing dye compounds.
Cocoa butter based suppository formulationjimmmcelroy510
Rectal suppositories are bullet shaped and weigh about 2 grams for adults and 1 gram for children. Vaginal suppositories are oval or globular shaped and weigh 3 to 5 grams. Cocoa butter and triglycerides are commonly used suppository bases that require tempering to control crystal formation. Surfactants can be added to inhibit fat bloom on the suppository surface and potentially enhance drug absorption, though they may also irritate mucous membranes with prolonged use. The drug absorption route depends on whether the suppository is administered rectally or vaginally.
Quality control is about inspecting products and trying to take the defective products out. The alternative is a thing called quality assurance. This isn't about inspection, its about putting business processes in place that assure the quality of outputs. Quality control and quality assurance sounds similar but they are quite different.
This document provides a summary of capsules, including their history, types, manufacturing process, evaluation, and key details. It discusses how gelatin capsules were first developed in the 18th century and how the process has evolved. The main types - hard gelatin capsules, soft gelatin capsules, and their composition, sizes, and manufacturing processes - are outlined. Methods for evaluating capsules like uniformity of weight, drug content testing, disintegration testing, and dissolution testing are also summarized.
Lipids are a group of naturally occurring molecules that include fats, waxes, sterols, and fat-soluble vitamins. They serve important functions like energy storage, signaling, and as structural components of cell membranes. The main classes of lipids are neutral fats/triglycerides (consisting of glycerol and fatty acids), phospholipids, and sterols. Fatty acids can be saturated or unsaturated, and polyunsaturated fatty acids like omega-3 and omega-6 are essential nutrients. Lipids are insoluble in water but soluble in organic solvents, and are an important energy source in animals and plants.
Enhancement of Solubility By Solid Dispersion- Presented By Mr.Ajinkya Nikam...Ajinkya Nikam
1) Solid dispersion is a method to improve the solubility of poorly water soluble drugs by dispersing drugs in a hydrophilic carrier. It involves mixing the drug with a carrier on a molecular or microscopic level.
2) Common methods for preparing solid dispersions include fusion, solvent evaporation, spray drying, and melt extrusion. These methods aim to convert crystalline drugs into amorphous forms within hydrophilic carriers.
3) Characterization techniques like DSC, XRD, and dissolution testing are used to analyze the molecular state of drugs in solid dispersions and evaluate increases in solubility and dissolution rate compared to raw drugs.
This document discusses the development of fast dispersible tablets of aceclofenac using superdisintegrants like crospovidone, croscarmellose sodium, and sodium starch glycolate. It summarizes previous research that found these superdisintegrants can help reduce disintegration time and increase dissolution rate when included in oral fast-dissolving formulations. The objectives of this study are to select suitable superdisintegrants for developing aceclofenac tablets, prepare the tablets using suitable methods, evaluate the tablets, and test their stability according to ICH guidelines.
This document discusses tablets as a dosage form for delivering medications. It defines tablets and outlines their advantages such as precise dosing, low cost, and stability. Various types of tablets are described based on where they are administered and how they release the drug. The key ingredients used in tablets called excipients are explained. Granulation techniques for tablet manufacturing like wet and dry granulation are summarized. The document also covers tablet processing problems that can occur and ways to control the manufacturing process.
OINTMENT ASEPTIC MANUFACTURING, IPQC & PROCESS AUTOMATION IN SEMISOLIDSAkanksha Puri
The document discusses process automation in semisolids like ointments. It describes various types of equipment used in manufacturing processes like mixing and milling. The key stages of ointment production including trituration, emulsification and fusion methods are outlined. Quality control tests for ointments are then summarized, including universal tests like description, identification and assay, as well as specific tests such as pH, homogeneity, spreadability and sterility. The membrane filtration method for microbial content and sterility testing is also briefly described.
The document discusses guidelines for stability testing of pharmaceutical products. It defines stability testing as evaluating how environmental factors affect a drug substance or product's properties over time. This helps determine shelf life, proper storage conditions, and labeling instructions. Stability testing evaluates many factors like active ingredient stability, excipient interactions, manufacturing process, dosage form, and storage conditions. It also considers degradation reactions and how they are impacted by conditions. Stability testing parameters and timepoints are described for various dosage forms like tablets, capsules, solutions, injections etc. The document also discusses ICH guidelines for stability testing and recommendations for climatic zones III and IV.
Preformulation studies for bulk characterizationmangu3107
The document discusses preformulation studies, which generate information to help formulate stable and effective drug dosage forms. The overall goals of preformulation are to improve drug stability, bioavailability, and reduce incompatibility. Some key tests described include determining the drug's physical properties like color, odor, taste, purity, and thermal behavior. Melting point analysis can provide information on a drug's identity and purity. Preformulation studies are important to identify suitable drug candidates and formulations before clinical development.
The document discusses quality control parameters for ointments. It describes different types of ointments and bases and methods of preparation. Key quality control tests are outlined including physical appearance, particle size, weight variation, solubility, pH, spreadability, viscosity and microbial limits. Evaluation tests assess rate of absorption, non-irritancy, and rate of penetration to ensure uniform content and stability over time. Maintaining quality control is important for ointments to effectively deliver drugs to affected areas as a stable semi-solid dosage form.
The document provides information on various quality control tests performed during the aseptic processing and manufacturing of different dosage forms including ointments, suspensions, emulsions, powders, and parenterals. Some key tests mentioned are particle size determination, viscosity testing, weight variation, clarity testing, sterility testing, and assays to check for active ingredients and check for uniform drug content. The tests help monitor the quality of products during manufacturing to ensure sterile and stable products are produced.
This document provides information on aseptic processing and in-process quality control tests for various dosage forms including ointments, suspensions, emulsions, powders, and parenterals. It describes how sterile products are manufactured through aseptic processing to ensure sterility. It also outlines various quality tests done during manufacturing to monitor product quality, such as appearance, viscosity, particle size, moisture content, clarity, pH, and microbial limits.
This document discusses preformulation stability studies. It outlines the key factors that affect drug stability like temperature, moisture, and light. The objectives of stability testing are to determine shelf life and provide better storage conditions. The main types of stability are chemical, physical, microbiological, therapeutic, and toxicological. Various methods for stability testing include real-time testing, accelerated testing, and retained sample testing. Guidelines for long-term stability testing from ICH are presented. Common dosage forms that undergo stability testing are discussed.
Process validation- This guidance incorporates principles and approaches that...Sanchit Dhankhar
This guidance incorporates principles and approaches that all manufacturers can use to validate manufacturing processes.
It is the process of establishing, through documented evidence, a high degree of assurance that a specific process will consistently produce a product that meets its predetermined specifications and quality characteristics.
The document discusses validation of processing techniques for wet granulation. It outlines key parameters that must be considered and validated at each stage of wet granulation including blending, wet granulation, drying, and tablet compression. Parameters like mixing time and speed, binder concentration, granulation endpoint, drying temperature and moisture content, and compression force must be optimized and shown to consistently produce tablets meeting quality standards. Equipment used at each stage must also be validated to ensure it is suitable for the processing steps.
Effective process validation contributes significantly to assuring drug quality. The basic
principle of quality assurance is that a drug should be produced that is fit for its intended use.
This principle incorporates the understanding that the following conditions exist:
• Quality, safety, and efficacy are designed or built into the product.
• Quality cannot be adequately assured merely by in-process and finished-product
inspection or testing
This presentation includes introduction of validation, types of validation,process validation of dosage forms[ solids(tablets),liquids(emulsions and suspensions),semisolids.
This document discusses stability testing and guidelines for conducting stability studies. It provides definitions and purposes of stability testing, including determining a product's shelf life and suitable storage conditions. Key points:
- Stability testing involves studying how a drug's quality changes over time under environmental factors like temperature, humidity, and light.
- Studies are conducted according to ICH guidelines and involve long-term, accelerated, and intermediate storage conditions on multiple batches.
- Results provide evidence for a retest period or shelf life. Significant changes observed during testing may require adjusting the proposed shelf life.
- Guidelines cover topics like selection of batches, containers, testing frequency, evaluation of results, and data presentation required in applications. Matrix
This document discusses preformulation testing, which involves investigating the physical and chemical properties of a new drug substance alone and when combined with excipients. The overall objective is to generate information to help formulate stable and bioavailable dosage forms. Key aspects covered include organoleptic properties, purity, particle size and surface area. Common methods for analyzing these parameters, such as chromatography, microscopy, and gas adsorption, are also summarized. The goals are to provide critical data for developing optimized dosage forms that can be mass produced.
This document provides an overview of pilot plant scale manufacturing of oral solid dosage forms like tablets and capsules. It discusses various unit operations involved like material handling, blending, granulation, drying, size reduction, compression, coating, and capsule filling. It explains that the purpose of a pharmaceutical pilot plant is to transform a lab-scale formula into a viable product by developing reliable manufacturing procedures. Key steps like blending, granulation, drying, milling and compression are described along with the equipment used in each step and important process parameters. Capsule manufacturing processes like dipping, drying, trimming and filling are also summarized.
IPQC of Pharmaceutical Dosage Form at Pharmaceutical Industry mahbub tanim
This slides contents some details on In Process Quality Control (IPQC) of pharmaceutical dosage form (tablet, capsule, syrups, sterile etc.) at pharmaceuticals before sent them to Quality Control (QC) department.
Introduction to Dissolution equipment's, Calibration of dissolution apparatus, Dissolution procedure development and validation, Dissolution method development for generic drug products.
In-process quality control (IPQC) tests are checks carried out during the manufacturing process to monitor and ensure the process complies with specifications. Some key IPQC tests include physical, chemical, microbiological, and biological testing of in-process materials to check for identity, strength, quality, and purity. IPQC tests help minimize errors, provide accurate procedures, identify issues, and ensure proper flow and compliance during production. Common IPQC tests for tablets include weight variation, disintegration, dissolution, drug content, hardness, and friability testing. For suspensions and emulsions, important IPQC tests include checks of appearance, particle size, viscosity, pH, and stability.
This document provides an overview of coating technology and problems encountered in coating processes. It discusses the objectives of coating, including masking taste and odor, providing physical and chemical protection for drugs, and protecting drugs from gastric environments. The key coating techniques of film coating, sugar coating, and enteric coating are described. Common coating equipment like coating pans and fluidized bed coaters are also outlined. Finally, potential coating defects are defined and causes and remedies are provided.
Similar to Quality control tests of suppository ... (20)
BIOLOGICAL ASSAY OF ANTIBIOTICS , VITAMIN D , DIGOXIN & INSULINHasnat Tariq
This document provides information about biological assays. It begins by defining an assay and describing different types including chemical, immuno, and biological assays. It then focuses on biological assays, explaining that they measure the effect of a substance on a living organism or tissue. The key advantages of biological assays are that they determine actual biological activity rather than just concentration, and can assess compounds when chemical structure is unknown. However, biological assays are generally less precise and more time-consuming than chemical assays. The document provides details about how biological assays are performed and standardized, including the use of standard preparations and units of activity. It also discusses quantitative, graded, and characterized bioassays as well as the principles, techniques, applications, and limitations of biological assays
QUALITY CONTROL OF SOLID DOSAGE FORMS (TABLETS , CAPSULES & POWDERS)Hasnat Tariq
This document discusses quality control tests for solid dosage forms, specifically tablets. It describes common tests like hardness, thickness and diameter, friability, weight variation, and disintegration. Hardness tests the force required to break a tablet and can affect other properties. Thickness and diameter are important for specifications and uniform dosing. Friability tests the tablets' ability to withstand abrasion and breakage from handling. Weight variation ensures uniform tablet weights. Disintegration tests how long it takes a tablet to break down, which correlates to drug release. The document provides details on procedures, equipment, and specifications for each test.
This document provides an overview of statistical quality control and different types of control charts. It discusses descriptive and inferential statistics, parameters of descriptive statistics like mean and distribution shape. It also covers variables, sources of variation, and quality aspects. Control charts are presented as a statistical tool to monitor process variation over time. Different types of control charts for variables and attributes are explained, including X-bar and R charts, P charts, and C charts. Process acceptance control charts are also introduced.
The document discusses rapid release granulation technology for improving the dissolution and bioavailability of poorly water-soluble drug compounds. It describes how formulation factors like the drug form, particle size, polymorphism, and additives as well as granulation factors like liquid binder quantity and equipment can be manipulated to produce rapid release granules. The goal is to enhance dissolution by increasing surface area, solubilization, wettability and disintegration. Rapid dissolution leads to higher absorption and bioavailability for Class II drugs with high permeability but low solubility.
Fungal infection of skin (Dermatophytosis , yeast infection)Hasnat Tariq
This document discusses various fungal infections affecting humans. It describes superficial infections like athlete's foot, ringworm, and jock itch which are caused by dermatophytes. Deep fungal infections that enter the body are also discussed. Common dermatophyte infections are described in detail including symptoms, transmission, risk factors and treatment. Pityriasis versicolor and vaginal yeast infections are also summarized. The document provides an overview of common fungal infections and dermatophytosis.
Monoclonal antibody production by hybridoma technologyHasnat Tariq
Monoclonal antibodies are identical antibodies produced by a single clone of B cells that recognize a specific epitope. They are produced through the hybridoma technology which involves fusing antibody producing B cells with myeloma cells to form a hybridoma cell line. This allows for the mass production of antibodies that recognize a single epitope. Monoclonal antibodies have various applications including use in biochemical analysis through techniques like ELISA and RIA. They can also be used for diagnostic imaging by labeling them with radioisotopes.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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1. QUALITY CONTROL OF SUPPOSITORIES CHAPTER NO 4
HASNAT TARIQ (GDIP) 1
4.QUALITY CONTROL OF SUPPOSITORIES
Rectal route for drug administration
The patient is unable to use the oral route (infection in GIT, nausea, unconscious, post operation and young an old
and mentally disturbed patients). The drug is less suited for oral route (causes GI side effects, insufficiently stable
at pH or GIT, susceptible to enzymatic degradation, has first-pass effect, with unacceptable taste)
Drawbacks of rectal route
• Slow and incomplete absorption
• Inter and intra subject variation.
• Development of proctitis.
• Problems with large scale production of suppositories and of achievement of a suitable shelf life.
• Demanding straight storage conditions.
Therapy with the rectal route
i) Local effect
• In case of pain itching or haemorrides.
• Locally active drugs include astringents, antiseptics, antifungal, local anesthetics, vasoconstrictors,
anti-inflammatory compounds, soothing and protective agents and some laxatives.
ii) Systemic effect
Anti-asthmatics, anti-rheumatics, and analgesics.
iii) Mechanical effect
To increase the bowel evacuation in constipation.
Suppository
Suppositories are medicated solid bodies of various sizes and shapes suitable for introduction into body cavities
for their local and systemic effect.
The medicament is incorporated into the base such as coca butter that melts at body temperature or into one such
as glycerol gelatin or PEG which slowly dissolve into the mucous secretions. Suppositories are suited particularly
for producing local action, but may also be used to produce a systemic effect or exert a mechanical effect to
facilitate emptying the lower bowel
Suppository bases:
As with ointment bases, suppository base composition plays an important role in both the rate and extent of
release of medications. Suppository base may be classified according to their composition and physical properties;
1. Oleaginous base 2. Water soluble or miscible base
Tests of suppository bases
2. QUALITY CONTROL OF SUPPOSITORIES CHAPTER NO 4
HASNAT TARIQ (GDIP) 2
The specifications of suppository bases are mentioned below;
1.Melting range
Since fats don’t have sharp melting point, their melting characteristics are expressed as a range indicating the
temperature at which the fat start to melt and the temperature at which it is completely melted.
2. Solidification point
This value indicates the time required for the base solidification when it is chilled in the mold. If the interval
between the melting range and solidification point is 10 0
C or more, the time require for solidification may have to
be shortened for more efficient manufacturing procedure by augmenting refrigeration.
3. Saponification value
The number of milligrams of potassium hydroxide require to neutralize the free acids and to saponify the esters
contained in 1 g of fat is an indication of the type of glyceride (mono or tri) as well as the amount of glyceride
present.
4. Iodine value
The value expresses the number of grams of iodine that react with 100 g of fat or other unsaturated material. The
possibility of the decomposition by moisture, acid, or oxygen (leads to rancidity in fats) increases with high iodine
values.
5. Water number
The amount of water in grams which can be incorporated in 100 gram of fat is expressed by this value. The water
number can be increased by addition of surface-active agents (surfactants).
6. Acid value
The number of milligrams of potassium hydroxide required to neutralize the free acid in 1 gram of substance is
expressed by this value. Low acid values or complete absence of acid are important for good suppository base.
Free acids complicate formulation work, because they react with other ingredients and can also cause irritation
when in contact with mucous membranes.
Types of suppositories:
3. QUALITY CONTROL OF SUPPOSITORIES CHAPTER NO 4
HASNAT TARIQ (GDIP) 3
Quality control test for suppository
Stability considerations in dispensing practice for suppositories include observations on excessive softening and
oil stains on packaging.
Compounded suppositories can be checked for calculations of actual or theoretical weight, and weight variation,
shape, color, hardness, surface texture, and overall appearance.
Suppository quality control includes physical and chemical aspects of the product.
• Physical analysis includes visual examination (physical appearance), uniformity of weight,
uniformity of texture, melting point, liquefaction time, melting and solidification time and mechanical
strength.
• Chemical analysis includes analysis of the activity and dissolution testing. The uniformity of texture
can be accessed by sectioning a suppository longitudinally and laterally and ensuring that each
section presents a smooth uniform surface
PHYSICAL ANALYSIS
1.VISUAL EXAMINATION:
Visual evaluation of suppositories is necessary and important to check for the absence of fissuring, pitting, fat
blooming, exudation, sedimentation and migration of active ingredient. Suppositories can be observed as intact
unit and also by splitting them longitudinally. The use of color chats is advisable.
I. Shape
It is advisable to check the shape of the suppository to see if it is
consistent, irrespective of whether the suppository is ogive or torpedo
shape. Suppositories must be of proper shape and size because change in
shape affects the suppositories. Change in shape can affect the
formulation
II. Surface conditions
The following can be checked; brilliance, dullness, mottling, cracks, dark
regions, axial cavities, bursts, air bubble, holes etc.
III. Stability
Check the stability there should be no crack and bubbles in the
suppositories.
IV. Color
The intensity, nature and homogeneity of the color should be verified.
The use of color chart is advisable
V. Odor
Verification of order can prevent confusion when similar suppositories are being processed. Must be of
desired odour because change in odour indicate the degradation process.
2. WEIGHT UNIFORMITY
Procedure:
1. Weigh 20 suppositories individually. w1, w2, w3…. w20
2. Weigh all the suppositories together
3. Calculate the average weight = W/20.
Limit:
Not more than 2 suppositories differ from the average weight by more than
5%, and no suppository differs from the average weight by more than 10%
4. QUALITY CONTROL OF SUPPOSITORIES CHAPTER NO 4
HASNAT TARIQ (GDIP) 4
NOTE
• If the weight is found to be too small, it is advisable to check whether the mold is being well filled and whether
there are axial cavities or air bubbles caused by badly adjusted mechanical stirring or the presence of an
undesirable surfactant.
• If the weight is found to be too high, check that scraping has been carried out correctly, and also that the mixture
is homogeneous
3. Melting range test (melting point, melting zone, macro-melting range test)
Melting range or melting zone is the term often preferred by some rather than melting point. Many suppositories
and medicated suppositories are mixtures and so don’t have a precise melting point. Routinely though we
continue to call the physical phenomenon obtained under rigorous conditions the melting point.
The release rate of the suppository is related to its melting point. It is therefore critical that this test be evaluated
using a non-destructive method.
Techniques:
• A number of different techniques are used to study melting behavior including the open capillary tube, U-
tube and the drop point method. One shortcoming is the use of limited data to describe the continuous
complex melting process occurring in successive steps including various molecular weight triglycerides
polymers or other ingredients. The methods used are similar in principle but include different steps and
techniques.
• In general, they include the set-up of the equipment placement of the suppository dosage unit in the
apparatus followed by the application of heat and observation for a change in the system such as melting
or movement. The results obtained using different methods don’t always agree so it is important to use a
consistent method. In general, the melting point should be equal to or less than 37 0
C.
• A nondestructive method must be used because if the suppository is melted before a measurement is made
the suppository constituents may be transformed into a metastable state. The melting test consist of
placing a suppository on the surface of water thermostatically controlled at 37oC and verifying the
complete melting of the suppository in the few minutes.
Melting point determination
The determination methods are discussed below;
1) The use of U – shaped capillary tube to determine the melting point provides precise information for excipient
control and consistency in production for those suppositories containing soluble active principals. The method is
not suitable when the suppositories have a high powder content, which prevents the fat from sliding inside the
capillary tube to give the end point determination.
2) When there are more numerous controls and where studies with a greater precision can be undertaken, an
apparatus can be used consisting of microscope, a heated deck and a recorder. This provides for a more detailed
observation and recording of the melting process.
3) The melting point can also be determined by placing a small diameter wire into the mold containing the
suppository melt before the form solidifies. The form is then immersed in water held by the wire and the
temperature of the liquid is raised slowly (about 1oC every 2 – 3 minutes) until the suppository slips of the wire,
this is the melting point of the suppository.
6. QUALITY CONTROL OF SUPPOSITORIES CHAPTER NO 4
HASNAT TARIQ (GDIP) 6
4. Breaking Test (Hardness test)
Purpose:
This test applied to suppositories and passeries based on fatty
excipients. It is not suited to suppositories and passeries based on
hydrophilic excipients such as gelatin-glycerol mixture.
Hardness indicates the maximum force which the suppository can
withstand during storage, packaging and hardening.
This test is design to check:
Hardness Fragility Brittleness
Apparatus
A thermostated chamber closed in front by a glass window and
containing a device that is to hold the suppository or passery.
Two opposite jaws, the upper jaw descending vertically toward
the lower jaw. The crushing surfaces of the jaw are flat
perpendicular, to the direction of movement and larger than zone
of contact with the suppository or passery.
A plastic sample holder is fixed in the center of the jaw (half a holder in each jaw).
The upper jaw (top pressure block) is connected to suspension to which can be added each of which weight
200g. The initial mass of the device is 600g. Crushing of the sample is carried out by successive adding 200g disc
to the initial mass of 600g.
Procedure
1. The suppository is placed in the instrument.
2. Add 600 g; leave it for one min. (use a stop watch).
3. If not broken, add 200 g every one min. until the suppository is broken.
Calculations: The hardness of the suppository is calculated by adding the weights together.
if the suppository is broken before the end of the last min. the last weight is canceled
Limit: 1.8- 2kg
5. Liquefaction time (Softening time test)
“The conversion of solid or gas into liquid is called Liquefaction.” Liquefaction testing provides information on
the behavior of a suppository when subjected to the maximum temperature of 37Co
and pressure to release API.
The test commonly used is Krowzynski’s method, which measure the time required for the suppository to
liquefy under pressure similar to those found in the rectum (approx. 30g) in the presence of water at 37oC.
In general, the liquefaction should take no longer than 30 minutes.
Krowzynski’s method
Apparatus I
The apparatus consists of a 16 mm diameter glass tube, 235 mm long with an approximately 6 mm diameter
reduction at the base.
One end is blocked with a small rubber stopper to facilitate cleaning after use.
A thermostat graduated in lengths of a centigrade is used.
The tube and thermometer are held in place by means of a large rubber stopper with two holes in a 225 mm long
tube with a 50 mm diameter, filled with lateral tubes to allow the water at 37oC from a constant temperature water
bath to circulate.
Apparatus II
Another apparatus equipped with a 30g glass stem 180mm long and 9mm wide. The base has a ring form with a
14mm diameter.
The ring of the stem has a cuneiform shape opening to allow the melted excipient to escape upwards during the
test.
At a distance of approximately 100mm from the ring, three glass projections supports the stem in a vertical
position in a tube.
7. QUALITY CONTROL OF SUPPOSITORIES CHAPTER NO 4
HASNAT TARIQ (GDIP) 7
The stem is also marked with a dash corresponding to its position with respect to the upper level of the tube
Procedure
1. Obtain a constant temperature in the circulating water bath at 37oC.
2. Pour approx. 5ml of water down the tube so that all the tube is filled below the narrowed part (and so that the
suppository to be tested is relatively humid conditions similar to those in the rectum.
3. After 5 minutes (the time necessary to bring the 5ml of water at 37oC) insert the suppository with the end
pointed downward into the glass tube, insert the glass stem so that it is resting on top of the suppository and start
the timer.
4. Note the time required for the mark of the glass stem to drop and come in line of the upper edge of the tube.
5. Repeat it for two more suppositories.
6. If the difference among the three times readings is greater than 105 seconds start again on two more
suppositories (making a total of 5 suppositories.
7. Determine the average liquefaction time.
Apparatus III (CellophaneTube method)
Apparatus using a cellophane bag consist of a glass cylinder with an external diameter of 50mm narrowing down
to 22mm at either end for a length of 30mm.
Procedure
1. The cylinder is filled with two connections through which water that is maintained at 37oC can circulate in
such a manner that the lower half of cellophane collapse and upper part widen.
2. A 34 – 35 cm length of cellulose dialyzer tubing, size inflated diameter of 1.12 inch (2.8cm) is moistened,
opened and placed in the cylinder.
3. The tube is drawn out of either end of the cylinder and secured with two elastic bands.
4. Tubing is attached to allow the warm water to circulate maintaining the temperature.
5. As a result of water pressure the upper part of the tubing widens and the lower half collapse exerting pressure
on suppository.
6... When the appropriate temperature is reached, the suppository is placed in the dialysis tubing and the time of
liquefaction is measured.
8. QUALITY CONTROL OF SUPPOSITORIES CHAPTER NO 4
HASNAT TARIQ (GDIP) 8
The apparatus can also be used to measure the melting point of suppositories made with both water soluble and
water insoluble bases. This can be accomplished by increasing the temperature of the water at a set rate. For
example; one degree every 10 minutes until the suppository melts.
6.Melting and solidification time
There is a relation between melting and solidification time that is important to characterize. The release of the API
from the vehicle is related to the melting point of the vehicle and the solubility of the drug in the vehicle.
Suppositories undergo three changes in phase during their “life.”
i) First, they are melted ii) Secondly, they are solidified iii) Third they are again
melted
An understanding of these factors and their relationships is critical for evaluating the bioavailability of the final
suppository formulation. Melting and solidification is a complex process and difficulties in measurements can
arise leading to different results obtained using different methods. The higher the melting point the later the drug
effects appear. If too high the effect of the drug will not appear.
Solidification time is defined as the highest temperature occurring during the solidification of a supercooled
liquid.
a) Various methods are available to measure it including Shukoff’s method, in which the liquid is shaken in an
evacuated flask until turbid and the temperature noted at which a transitory rise in temperature occurs during
cooling
b) The European pharmacopoeia also describes a procedure that involves heating the material, then allowing it to
cool slowly while stirring. The temperature is recorded at 1-minute intervals. The cooling curve normally passes
through a minimum which indicates a supercooled melt. Heat is liberated during crystallization and the
temperature time curve rises. The maximum in this phase is the solidification temperature
Thermometer
Suppositories
Dialyzing tube
Glass cylinder
Water
inlet Collapsed part
Widen part
9. QUALITY CONTROL OF SUPPOSITORIES CHAPTER NO 4
HASNAT TARIQ (GDIP) 9
7. Disintegration test for suppositories and pessaries
The disintegration test determines whether the suppositories or pessaries soften or disintegrate within the
prescribed time when placed in a liquid medium in the experimental conditions described below;
Disintegration is considered to be achieved when;
a) Dissolution is complete
b) The components of the suppository or pessary have separated; melted fatty substance collect on the surface
of the liquid, insoluble powder fall on the bottom and soluble components may be distributed in one or
more of these ways.
c) There is softening of the sample that may be accomplished by appreciable change of shape without
complete separation of the components, the softening is such that the suppository or pessary no longer has a
solid core offering resistance to pressure of a glass rod.
d) Rupture of the gelatin shell of rectal or vaginal capsule occurs allowing release of the contents.
e) No residue remains on the perforated disc or if a residue remains, it consists only of a soft or frothy mass
having no solid core offering resistance to pressure of a glass rod (vaginal tablets).
Apparatus Dimensions:
The apparatus consists of a cylinder of glass or suitable transparent plastic of appropriate thickness. To the
interior of which is attached by means of three hooks a metal device consisting of two perforated stainless metal
discs each containing 39 holes, 4mm in diameter. The diameter of the disc is similar to that of the interior of the
cylinder; the discs are about 30mm apart. Consist of 60mm long and 52 mm diameter cylinder of glass.
Metal device
2 perforated
metal disc
HOOK
Glass cylinder
10. QUALITY CONTROL OF SUPPOSITORIES CHAPTER NO 4
HASNAT TARIQ (GDIP) 10
Methodology:
The test is carried out using three such apparatuses each containing a single sample. Each apparatus is placed in
a beaker with a capacity of at least 4 liters filled with water maintained at 36oC – 37oC unless otherwise
prescribed. The apparatus may also be placed together in a vessel with a capacity of at least 12 liters. The
beaker is fitted with a slow stirrer and a device that will hold the cylinders vertically not less than 90 mm below
the surface of the water and allow them to be inverted without emerging from the water.
Acceptance criteria:
Fat base = 30 mins
Water soluble base= 60 mins
Procedure
1. Use three suppositories or passries
2. Place each one on the lower disc of a device place the latter in the cylinder and secure
3. Invert the apparatuses every 10 minutes.
4. Examine the samples after the period prescribed in the monograph.
5. T0 pass the test all the samples must have disintegrated.
Method of operation for vaginal tablets
Use the apparatus described above, arranged so as to rest on the hooks.
Procedure
1. Place it in a beaker of suitable diameter containing water maintained at 37oC with a level just below the
upper perforated disc.
2. Using a pipette, adjust the level with the water at 37oC until a uniform film covers the perforations of the
disc.
3. Use three vaginal tablets.
4. Place each one on the upper plate of an apparatus and cover the latter with a glass plate to maintain
appropriate conditions of humidity.
5. Examine the state of the sample after the period prescribed in the monograph.
6. To pass the test all the samples must have disintegrated
8. Penetration time
A suppository penetration test can be used to determine the temperature at which the suppository becomes
sufficiently soft for a penetrating rod to drop through its length.
Apparatus
The apparatus used is shown;
11. QUALITY CONTROL OF SUPPOSITORIES CHAPTER NO 4
HASNAT TARIQ (GDIP) 11
Procedure
1. The temperature is adjusted to that required for the test generally
about, 37oC.
2. The suppository is placed in the device and the penetration rod
gently moved into place.
3. The devise holding the suppository and penetration rod is lowered
into the constant temperature bath and a stopwatch is started.
4. When the penetration rod drops through the softened suppository,
the time is recorded.
CHEMICAL ANALYSIS
1. Dissolution testing
One of the most important quality control tools available for in vitro assessment is dissolution testing.
Purpose:
Dissolution testing is often required for suppositories to test for hardening and polymorphic transitions of active
ingredients and suppository bases.
However, unlike for tablets and capsule dosage forms, there are not enough dissolution testing methods or
validations for suppositories. This can be partly attributable to the immiscibility of some of the suppository
vehicles in water.
Dissolution testing methods include the paddle method, basket method, membrane diffusion, Suppository
penetration apparatus. method/dialysis method, and the continuous flow/bead method.
12. QUALITY CONTROL OF SUPPOSITORIES CHAPTER NO 4
HASNAT TARIQ (GDIP) 12
2. STABILITY TESTING
• Cocoa butter suppositories on storage, “bloom”; i.e., they form a white powdery deposit on the surface.
This can be avoided by storing the suppositories at uniform cool temperatures and by wrapping them in
foils.
• Fat based suppository harden on storage
• There is an upward shift in melting range due to slow crystallization to the more stable polymeric forms
of the base.
• The softening time test and differential scanning calorimetry can be used as stability indicating test
methods. if we store the suppositories at an elevated temperature, just below its melting range,
immediately after manufacture, the aging process is speeded
3. Assay of Active ingredient
Determine the amount of active ingredient by the method prescribed in the assay; calculate, if necessary,
the amount of active ingredient in the suppositories taken for the assay and divide by the no of
suppositories. The result lies within the range for the content of active ingredient stated in the monograph.