1. Capsules are solid dosage forms that enclose one or more active ingredients in a soluble gelatin shell for oral administration. Hard capsules use gelatin and contain dry powders, while soft capsules contain oils or liquids dissolved in oils.
2. Capsules are manufactured through rotary die or reciprocating die processes that form, fill, seal and cut the gelatin shells. The gelatin used is type A or B derived from animal collagen.
3. Finished capsules are tested for attributes like size, shape, weight uniformity, content uniformity, and dissolution. Soft gelatin capsules provide benefits like protecting unstable ingredients and increasing bioavailability but have certain material limitations.
This document discusses common tablet processing problems and their remedies. It describes visual defects like capping, lamination, cracking, chipping, sticking, picking, and binding that can occur during tablet manufacturing. The causes of each defect are explained in terms of formulation issues like moisture content, binder amount, granule size, and machine issues like die wear, concavity, and speed. Solutions provided include optimizing the formulation through proper drying, lubrication, and binder selection, as well as adjusting machine settings like tapered dies, lubricated punches, and reduced speed or pressure. Overall, the document aims to help industrial pharmacists address problems in tablet manufacturing.
Soft gelatin capsules (SGCs) are hermetically sealed capsules containing liquids or semisolids without air. They are made of flexible gelatin and have gained popularity due to increased bioavailability of drugs and stability. Common manufacturing methods are rotary die and reciprocating die processes, which use gelatin ribbons to encapsulate fills. The rotary die process is most common, using rollers to converge ribbons around fills to seal and cut capsules continuously.
A detailed study on tablets, its classification, excipients, tablet granulation, methods of granulation, compression machines, equipment tooling and the problems that occur during the tablet manufacturing process. This presentation is based on the PCI syllabus for bpharm students of fifth semester.
Tablet coating serves several purposes: to mask unpleasant tastes, protect medications from environmental factors like light and moisture, control drug release, and improve appearance. There are several types of coatings including sugar, film, enteric, and press coatings. The sugar coating process involves multiple steps like sealing, sub-coating, syruping, finishing, and polishing to build up the coating and impart the desired color, texture, and shine. Skill is required during syruping to smoothly cover imperfections and apply color uniformly.
This document discusses tablet coating, which involves covering tablet surfaces with a polymeric film to provide benefits like masking taste, protecting drugs, and controlling drug release. It describes the main types of tablet coating - sugar coating, film coating, enteric coating, vacuum film coating, electrostatic coating, and dip coating. For each coating type, it outlines the basic process and materials used. The document also explains the need for tablet coating and lists the ideal characteristics of coating materials.
This document provides information about packing soft gelatin capsules. It discusses the advantages and disadvantages of soft gel capsules. The anatomy and composition of the capsule shell and content are described. The manufacturing process involves making the gelatin mass, filling the capsules, drying and packaging them. Quality is ensured through ingredient specifications, in-process testing of shell thickness, fill weight and moisture levels. Finished products are tested for appearance, assay, content uniformity and microbiology. Vegicaps are introduced as an animal-free alternative with benefits such as being natural and free of animal derivatives.
Pharmaceutical pellets are small spherical units prepared by agglomerating fine powders. They range in size from 0.5-1.5mm. Pellets can be used for both oral and injectable drug delivery and offer benefits like taste masking, immediate or sustained release, and delivery of chemically incompatible products in a single dose. Various methods are used to produce pellets including extrusion-spheronization, hot melt extrusion, fluid bed granulation, spray drying, and layering techniques. Pellets can be further processed into tablets, capsules, or other dosage forms and coated to provide modified release of drugs over an extended period.
This document discusses common tablet processing problems and their remedies. It describes visual defects like capping, lamination, cracking, chipping, sticking, picking, and binding that can occur during tablet manufacturing. The causes of each defect are explained in terms of formulation issues like moisture content, binder amount, granule size, and machine issues like die wear, concavity, and speed. Solutions provided include optimizing the formulation through proper drying, lubrication, and binder selection, as well as adjusting machine settings like tapered dies, lubricated punches, and reduced speed or pressure. Overall, the document aims to help industrial pharmacists address problems in tablet manufacturing.
Soft gelatin capsules (SGCs) are hermetically sealed capsules containing liquids or semisolids without air. They are made of flexible gelatin and have gained popularity due to increased bioavailability of drugs and stability. Common manufacturing methods are rotary die and reciprocating die processes, which use gelatin ribbons to encapsulate fills. The rotary die process is most common, using rollers to converge ribbons around fills to seal and cut capsules continuously.
A detailed study on tablets, its classification, excipients, tablet granulation, methods of granulation, compression machines, equipment tooling and the problems that occur during the tablet manufacturing process. This presentation is based on the PCI syllabus for bpharm students of fifth semester.
Tablet coating serves several purposes: to mask unpleasant tastes, protect medications from environmental factors like light and moisture, control drug release, and improve appearance. There are several types of coatings including sugar, film, enteric, and press coatings. The sugar coating process involves multiple steps like sealing, sub-coating, syruping, finishing, and polishing to build up the coating and impart the desired color, texture, and shine. Skill is required during syruping to smoothly cover imperfections and apply color uniformly.
This document discusses tablet coating, which involves covering tablet surfaces with a polymeric film to provide benefits like masking taste, protecting drugs, and controlling drug release. It describes the main types of tablet coating - sugar coating, film coating, enteric coating, vacuum film coating, electrostatic coating, and dip coating. For each coating type, it outlines the basic process and materials used. The document also explains the need for tablet coating and lists the ideal characteristics of coating materials.
This document provides information about packing soft gelatin capsules. It discusses the advantages and disadvantages of soft gel capsules. The anatomy and composition of the capsule shell and content are described. The manufacturing process involves making the gelatin mass, filling the capsules, drying and packaging them. Quality is ensured through ingredient specifications, in-process testing of shell thickness, fill weight and moisture levels. Finished products are tested for appearance, assay, content uniformity and microbiology. Vegicaps are introduced as an animal-free alternative with benefits such as being natural and free of animal derivatives.
Pharmaceutical pellets are small spherical units prepared by agglomerating fine powders. They range in size from 0.5-1.5mm. Pellets can be used for both oral and injectable drug delivery and offer benefits like taste masking, immediate or sustained release, and delivery of chemically incompatible products in a single dose. Various methods are used to produce pellets including extrusion-spheronization, hot melt extrusion, fluid bed granulation, spray drying, and layering techniques. Pellets can be further processed into tablets, capsules, or other dosage forms and coated to provide modified release of drugs over an extended period.
1. The document describes the requirements and procedures for quality control testing of pharmaceutical products and materials. It outlines the necessary facilities, equipment, personnel qualifications, and specific tests that must be conducted.
2. Quality control tests capsules for content uniformity, weight uniformity, disintegration, and dissolution. The content uniformity test assesses the quantity of drug in individual capsules, the weight uniformity test evaluates capsule weights, and the disintegration test determines how quickly capsules break down in liquid.
3. Additional responsibilities of quality control include approving or rejecting materials, monitoring production processes, conducting stability studies, and releasing finished products once all testing is completed. Quality assurance also oversees final product inspection before release.
This document discusses hard and soft gelatin capsules. It defines capsules as solid dosage forms where the drug substance is enclosed within soluble gelatin shells. Hard gelatin capsules consist of two pieces (cap and body) while soft gelatin capsules have a single flexible shell. The document describes the production process for hard capsules including dipping, drying, and filling steps. It also discusses advantages like taste masking and disadvantages like incompatibility with hygroscopic drugs. Quality control tests for capsules include disintegration, weight variation, and dissolution testing.
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.
This document discusses tablet coating defects, their causes, and remedies. It begins with an introduction to tablet coating and why it is done. Common coating defects are then described such as blistering, cratering, pitting, blooming, blushing, orange peel, sticking, picking, color variation, bridging, erosion, and twinning. The causes and remedies for each defect are provided. Critical parameters for successful tablet coating are also listed, including nozzle spacing, spray pattern, spray speed, droplet size, drying temperature, and air speed. References on tablet coating and manufacturing defects are included at the end.
The presentation deals with a detailed study of soft gelatin capsules. this involves the production of soft gelatin capsule based on the importance of base adsorption factor and minim/gram factor. also quality control studies was also elaborated.
quality control test for soft gelatin capsule and minim per gram factorSUJIT DAS
This document discusses quality control testing of soft gelatin capsules. Soft gelatin capsules contain an active pharmaceutical ingredient (API) encapsulated within an outer gelatin shell. They undergo various tests to check attributes like shape, size, color, thickness, leakage, disintegration, and content uniformity. Content uniformity involves weighing capsules individually, extracting the contents, weighing the shells to calculate net contents. Other tests described include disintegration testing in tubes, weight variation testing of random capsules, and factors that influence leakage like gelatin strength and viscosity.
Aerosol , components for aerosol formulation by mariomakhter@yahoo.commariomS7
Aerosol are the products that depend on the power of a compressed or liquefied gas to expel the contents from the container. Aerosols are termed also pressurized package.
In the manufacture of pharmaceuticals, encapsulation refers to a range of dosage forms—techniques used to enclose medicines—in a relatively stable shell known as a capsule, allowing them to, for example, be taken orally or be used as suppositories. The two main types of capsules are:
Hard-shelled capsules, which contain dry, powdered ingredients or miniature pellets made by e.g. processes of extrusion or spheronization. These are made in two halves: a smaller-diameter “body” that is filled and then sealed using a larger-diameter “cap”.
Soft-shelled capsules, primarily used for oils and for active ingredients that are dissolved or suspended in oil.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with the types of parenteral formulation including the types of parenteral route for administration along withcomponents of parenteral formulation.
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
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.
Hard gelatin capsules are manufactured using a dip-coating process. Gelatin is dissolved in hot water to create a viscous solution, which is then used to coat metal pins arranged to form either caps or bodies. The coated pins are dried and the resulting capsules are trimmed, joined, and optionally printed before packaging. Key materials used are gelatin, plasticizers to make the gelatin flexible, colorants, and sometimes opacifiers or preservatives. The production process aims to uniformly coat the pins to produce capsules with consistent thickness and strength.
Capsules are solid dosage forms that contain a drug enclosed within a hard or soft soluble shell, usually made of gelatin. There are two main types: hard gelatin capsules, which consist of two pieces that are joined, and soft gelatin capsules, which have a soft, one-piece shell. Capsules offer benefits like being tasteless, odorless, and easy to administer, and allow for flexible dosing. However, some drugs are not suitable for capsules due to stability issues. Capsules are manufactured through various processes depending on the type, including dipping, spinning, drying, filling, and sealing. They must pass quality tests like weight variation and content uniformity testing.
The document provides information on liquid oral dosage forms. It discusses monophasic and biphasic liquid dosage forms, as well as the vehicles, excipients, and formulation considerations involved in producing liquid oral medications. Specifically, it covers emulsions, suspensions, syrups, and elixirs - the main types of liquid oral dosage forms. It also addresses the advantages and disadvantages of liquid dosage forms, as well as best practices for manufacturing, evaluating, and packaging these drug formulations.
This document discusses preformulation studies and biopharmaceutical classification system (BCS) classification. It provides an introduction to preformulation studies, which characterize the physical and chemical properties of drug substances alone and with excipients. The goals and types of preformulation studies are described. Key parameters evaluated in preformulation studies include physical characteristics, chemical characteristics, organoleptic properties, polymorphism, particle size and shape, powder flow properties, hygroscopicity, solubility, pH solubility profile and common ion effects, dissolution, and permeability. Methods for various preformulation tests are also outlined.
Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of aerosol systems; formulation and manufacture of aerosols; Evaluation of aerosols; Quality control and stability studies
The document discusses the requirements and layout for producing sterile parenterals. It describes the different sections needed - cleanup, compounding, aseptic, quarantine, and packing/labeling. Specific requirements for the aseptic area are outlined, including environmental controls like particle counting, slit to agar sampling, and Rodac plates to evaluate air quality. Floors, walls, and benches must be smooth, impervious, and easy to clean. Proper ventilation and filtration of air is essential to maintain sterility. Sources of contamination and prevention methods are also covered.
The document discusses parenteral dosage forms. Parenterals are sterile solutions or suspensions of drugs administered directly into veins, muscles, or under the skin. They do not utilize the alimentary canal and must meet general requirements including stability, sterility, isotonicity, and being free of pyrogens, toxins, and foreign particles. Evaluation tests for parenterals include sterility, pyrogen, clarity, and leakage tests.
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.
In process stability control test for capsuleJinendra Jain
This document discusses quality control testing for capsules. It describes physical tests like disintegration testing, weight variation testing, and chemical tests like dissolution testing and content uniformity testing. Disintegration testing ensures capsules break down within a specified time in liquid. Weight variation testing checks that capsule weights are consistent. Dissolution testing measures how quickly the active drug is released. Content uniformity testing confirms the amount of drug in each capsule is consistent. These quality control tests are important to ensure capsules meet specifications and perform as intended.
Presentation2Non Sterile manufacturing Process Technology Capsules(hard & sof...AjayGhuge9
Non-sterile manufacturing processes are used to produce hard and soft gelatin capsules. Hard capsules consist of two pieces that fit together, while soft capsules have a flexible plasticized gelatin shell. The production process for hard capsules involves dipping pins in gelatin solution, drying and stripping the shells, trimming, filling powdered drugs, and quality control testing. Soft capsules are filled with liquid or suspension and the single-piece shells contain additional plasticizers and preservatives. Both types of capsules are packaged and stored properly to protect from moisture and ensure quality.
1. The document describes the requirements and procedures for quality control testing of pharmaceutical products and materials. It outlines the necessary facilities, equipment, personnel qualifications, and specific tests that must be conducted.
2. Quality control tests capsules for content uniformity, weight uniformity, disintegration, and dissolution. The content uniformity test assesses the quantity of drug in individual capsules, the weight uniformity test evaluates capsule weights, and the disintegration test determines how quickly capsules break down in liquid.
3. Additional responsibilities of quality control include approving or rejecting materials, monitoring production processes, conducting stability studies, and releasing finished products once all testing is completed. Quality assurance also oversees final product inspection before release.
This document discusses hard and soft gelatin capsules. It defines capsules as solid dosage forms where the drug substance is enclosed within soluble gelatin shells. Hard gelatin capsules consist of two pieces (cap and body) while soft gelatin capsules have a single flexible shell. The document describes the production process for hard capsules including dipping, drying, and filling steps. It also discusses advantages like taste masking and disadvantages like incompatibility with hygroscopic drugs. Quality control tests for capsules include disintegration, weight variation, and dissolution testing.
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.
This document discusses tablet coating defects, their causes, and remedies. It begins with an introduction to tablet coating and why it is done. Common coating defects are then described such as blistering, cratering, pitting, blooming, blushing, orange peel, sticking, picking, color variation, bridging, erosion, and twinning. The causes and remedies for each defect are provided. Critical parameters for successful tablet coating are also listed, including nozzle spacing, spray pattern, spray speed, droplet size, drying temperature, and air speed. References on tablet coating and manufacturing defects are included at the end.
The presentation deals with a detailed study of soft gelatin capsules. this involves the production of soft gelatin capsule based on the importance of base adsorption factor and minim/gram factor. also quality control studies was also elaborated.
quality control test for soft gelatin capsule and minim per gram factorSUJIT DAS
This document discusses quality control testing of soft gelatin capsules. Soft gelatin capsules contain an active pharmaceutical ingredient (API) encapsulated within an outer gelatin shell. They undergo various tests to check attributes like shape, size, color, thickness, leakage, disintegration, and content uniformity. Content uniformity involves weighing capsules individually, extracting the contents, weighing the shells to calculate net contents. Other tests described include disintegration testing in tubes, weight variation testing of random capsules, and factors that influence leakage like gelatin strength and viscosity.
Aerosol , components for aerosol formulation by mariomakhter@yahoo.commariomS7
Aerosol are the products that depend on the power of a compressed or liquefied gas to expel the contents from the container. Aerosols are termed also pressurized package.
In the manufacture of pharmaceuticals, encapsulation refers to a range of dosage forms—techniques used to enclose medicines—in a relatively stable shell known as a capsule, allowing them to, for example, be taken orally or be used as suppositories. The two main types of capsules are:
Hard-shelled capsules, which contain dry, powdered ingredients or miniature pellets made by e.g. processes of extrusion or spheronization. These are made in two halves: a smaller-diameter “body” that is filled and then sealed using a larger-diameter “cap”.
Soft-shelled capsules, primarily used for oils and for active ingredients that are dissolved or suspended in oil.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with the types of parenteral formulation including the types of parenteral route for administration along withcomponents of parenteral formulation.
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
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.
Hard gelatin capsules are manufactured using a dip-coating process. Gelatin is dissolved in hot water to create a viscous solution, which is then used to coat metal pins arranged to form either caps or bodies. The coated pins are dried and the resulting capsules are trimmed, joined, and optionally printed before packaging. Key materials used are gelatin, plasticizers to make the gelatin flexible, colorants, and sometimes opacifiers or preservatives. The production process aims to uniformly coat the pins to produce capsules with consistent thickness and strength.
Capsules are solid dosage forms that contain a drug enclosed within a hard or soft soluble shell, usually made of gelatin. There are two main types: hard gelatin capsules, which consist of two pieces that are joined, and soft gelatin capsules, which have a soft, one-piece shell. Capsules offer benefits like being tasteless, odorless, and easy to administer, and allow for flexible dosing. However, some drugs are not suitable for capsules due to stability issues. Capsules are manufactured through various processes depending on the type, including dipping, spinning, drying, filling, and sealing. They must pass quality tests like weight variation and content uniformity testing.
The document provides information on liquid oral dosage forms. It discusses monophasic and biphasic liquid dosage forms, as well as the vehicles, excipients, and formulation considerations involved in producing liquid oral medications. Specifically, it covers emulsions, suspensions, syrups, and elixirs - the main types of liquid oral dosage forms. It also addresses the advantages and disadvantages of liquid dosage forms, as well as best practices for manufacturing, evaluating, and packaging these drug formulations.
This document discusses preformulation studies and biopharmaceutical classification system (BCS) classification. It provides an introduction to preformulation studies, which characterize the physical and chemical properties of drug substances alone and with excipients. The goals and types of preformulation studies are described. Key parameters evaluated in preformulation studies include physical characteristics, chemical characteristics, organoleptic properties, polymorphism, particle size and shape, powder flow properties, hygroscopicity, solubility, pH solubility profile and common ion effects, dissolution, and permeability. Methods for various preformulation tests are also outlined.
Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of aerosol systems; formulation and manufacture of aerosols; Evaluation of aerosols; Quality control and stability studies
The document discusses the requirements and layout for producing sterile parenterals. It describes the different sections needed - cleanup, compounding, aseptic, quarantine, and packing/labeling. Specific requirements for the aseptic area are outlined, including environmental controls like particle counting, slit to agar sampling, and Rodac plates to evaluate air quality. Floors, walls, and benches must be smooth, impervious, and easy to clean. Proper ventilation and filtration of air is essential to maintain sterility. Sources of contamination and prevention methods are also covered.
The document discusses parenteral dosage forms. Parenterals are sterile solutions or suspensions of drugs administered directly into veins, muscles, or under the skin. They do not utilize the alimentary canal and must meet general requirements including stability, sterility, isotonicity, and being free of pyrogens, toxins, and foreign particles. Evaluation tests for parenterals include sterility, pyrogen, clarity, and leakage tests.
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.
In process stability control test for capsuleJinendra Jain
This document discusses quality control testing for capsules. It describes physical tests like disintegration testing, weight variation testing, and chemical tests like dissolution testing and content uniformity testing. Disintegration testing ensures capsules break down within a specified time in liquid. Weight variation testing checks that capsule weights are consistent. Dissolution testing measures how quickly the active drug is released. Content uniformity testing confirms the amount of drug in each capsule is consistent. These quality control tests are important to ensure capsules meet specifications and perform as intended.
Presentation2Non Sterile manufacturing Process Technology Capsules(hard & sof...AjayGhuge9
Non-sterile manufacturing processes are used to produce hard and soft gelatin capsules. Hard capsules consist of two pieces that fit together, while soft capsules have a flexible plasticized gelatin shell. The production process for hard capsules involves dipping pins in gelatin solution, drying and stripping the shells, trimming, filling powdered drugs, and quality control testing. Soft capsules are filled with liquid or suspension and the single-piece shells contain additional plasticizers and preservatives. Both types of capsules are packaged and stored properly to protect from moisture and ensure quality.
Non Sterile manufacturing Process Technology Capsules(hard & soft).pptxAjayGhuge9
Non-sterile manufacturing processes are used to produce hard and soft gelatin capsules. Hard capsules consist of two pieces that fit together, while soft capsules have a flexible plasticized gelatin shell. The production process for hard capsules involves dipping pins in gelatin solution, drying and stripping the shells, trimming, filling powdered drugs, and quality control testing. Soft capsules are filled with liquid or suspension and the single-piece shells contain additional plasticizers and preservatives. Both types of capsules are packaged and stored properly to protect from moisture and ensure quality.
DEFINITION
Capsules are solid preparations with hard and soft shells of various shapes and capacities, usually containing a single dose of active ingredients.
IPQC Tests for capsules As per IP, BP & USPPramod Ramane
IPQC- In Process Quality Control Tests for Capsules are
1. Uniformity Of Content
2. Disintigration Test
3. Weight Variation Test
4. Dissolution Test
The tests are with Acceptance limits/Criteria as per Indian Pharmacopoeia (IP), British Pharmacopoeia (BP) & United States Pharmacopoeia (USP)
Capsules are solid dosage forms where the drug is enclosed within a shell, typically made of gelatin. There are two main types - hard gelatin capsules which contain powders, granules, or pellets and release their contents rapidly; and soft gelatin capsules which contain liquids or pastes and provide rapid release. Capsules offer advantages like masking unpleasant tastes and smells, easy swallowing, and sustained or delayed release depending on the formulation. They are manufactured through processes like dipping, spinning, drying, stripping, trimming, and joining. Finished capsules are evaluated for content uniformity, disintegration time, moisture content, and dissolution.
This document discusses hard and soft gelatin capsules. It defines capsules as solid dosage forms where the drug substance is enclosed within soluble gelatin shells. Hard gelatin capsules consist of two pieces (cap and body) while soft gelatin capsules have a single flexible shell. The document describes the production process for hard capsules including dipping, drying, stripping, filling and quality control tests. It also covers the composition, advantages and packaging of capsules.
Capsules are solid dosage forms that contain a drug or mixture of drugs enclosed within a shell. The shell is typically made of gelatin but can also be other materials. Capsules are intended for oral administration and provide rapid release of contents unless they are modified or enteric release capsules. Capsules can be filled using various methods like auger, dosator, or dosing disc systems. Tests are conducted to ensure uniformity of contents, weight, and dissolution based on pharmacopeial standards.
This document provides information on hard gelatin capsules and the capsule manufacturing process. It discusses that capsules contain medications enclosed in either hard or soft gelatin shells, and are intended for oral administration. Hard gelatin capsules are made from two pieces - a cap and body - that are manufactured using a dipping process to coat pins in gelatin solution, then dried, trimmed, and joined. The capsules are filled either manually using punch or tray methods, or automatically using filling machines that rectify, fill, and seal the capsules.
In Process Quality Control Tests For Capsules [Autosaved].pptxSurendra Chowdary
This document discusses in-process quality control tests for capsules. It describes 7 types of tests: 1) Stability tests like shell integrity and shelf life determination, 2) Purity tests of the capsule shell, 3) Invariability tests like weight variation and content uniformity, 4) Disintegration testing, 5) Dissolution testing, 6) Moisture permeation testing of packaging, and 7) Batch release tests. The document provides details on the procedures and acceptance criteria for each of these quality control tests performed on capsules during manufacturing.
Capsules come in both hard and soft gelatin shells that enclose solid or liquid medications. Quality control tests are conducted on empty capsules and finished capsules to ensure uniformity of weight, content of active ingredients, and dissolution. Key tests include uniformity of weight, content of active ingredients, and uniformity of content. Acceptance criteria vary slightly between pharmacopeias but generally require less than 10% deviation from the average weight and 90-110% of the average active content. In-process quality checks are also important to monitor production and identify defects.
Capsules are solid dosage forms that contain a single dose of a drug enclosed in a soluble shell, typically made of gelatin. There are two main types: hard gelatin capsules and soft gelatin capsules. Capsules offer advantages like masking unpleasant tastes, ease of swallowing, and sustained release formulations. They also have some disadvantages like not being suitable for some soluble drugs. Capsules are evaluated based on weight variation, disintegration time, drug content uniformity, and dissolution testing.
This document discusses capsules as a pharmaceutical dosage form. It describes capsules as solid dosage forms where medicinal agents are enclosed within gelatin shells. The document outlines the advantages and disadvantages of capsules, as well as characteristics such as sizes, shapes, and ability to mask tastes. It also discusses the production of hard and soft gelatin capsules, including details on gelatin production, capsule filling methods, and properties of empty capsule shells.
This document discusses different types of capsules used in pharmaceutical formulations. It describes hard gelatin capsules, the process used to manufacture their shells and fill them. It also covers soft gelatin capsules, their production process, and quality control testing. Finally, it briefly mentions pellets and the requirements for their formulation and manufacturing.
Capsules are solid dosage forms that enclose a drug formulation within a shell. There are two main types - hard gelatin capsules used for powders and soft gelatin capsules used for semisolids and liquids. Quality control tests are performed during capsule manufacturing and filling to ensure specifications are met. These include in-process tests like weight variation and dissolution testing, and finished product tests such as disintegration, potency, content uniformity, and microbial testing. Capsules offer advantages like masking unpleasant tastes, easy swallowing, and protection from light, but are not suitable for hygroscopic or concentrated drugs that may irritate the stomach.
This document provides information on capsules, including definitions, advantages, disadvantages, types (hard gelatin and soft gelatin capsules), and manufacturing processes. It defines capsules as solid preparations with shells containing a single dose of active ingredients. Hard gelatin capsules are made of gelatin and can contain powders, granules, or pellets, while soft gelatin capsules contain liquids, suspensions, or semisolids. The manufacturing of both types involves processes like dipping, drying, trimming, and filling. Specifications for gelatin and requirements for capsules in compendia are also outlined.
Solid unit dosage forms the drug is enclosed within the water-soluble shell or an envelope either a hard or soft shell. Shell is typically made of gelatin primarily intended for oral delivery and provides a rapid release of contents.
Generally, the shells are formed from gelatin.
Nasopulmonary drug delivery system: Introduction to Nasal and Pulmonary routes of drug delivery, Formulation of Inhalers (dry powder and metered dose), nasal sprays, nebulizers
Tablets: a.Introduction, ideal characteristics of tablets, Classification of tablets. Excipients, Formulation of tablets, granulation methods, compression and processing problems.
Enzymes involved in rDNA technology.pptxPoonam Patil
This document discusses the key enzymes involved in recombinant DNA technology. It describes how restriction enzymes cut DNA at specific recognition sites, and DNA ligases join cut DNA fragments back together. The document outlines the process of recombinant DNA technology, including generating DNA fragments, inserting them into cloning vectors, introducing the vectors into host cells, and expressing the gene of interest. It provides details on various restriction enzymes and DNA-modifying enzymes used in genetic engineering applications.
FLUID FLOW
A fluid is a substance that continually deforms (flows) under an applied shear stress. Fluids are a subset of the phases of matter and include liquids, gases.
“Fluid flow may be defined as the flow of substances that do not permanently resist distortion”
The subject of fluid flow can be divided into-
fluid statics
fluid dynamics
Strategies for Effective Upskilling is a presentation by Chinwendu Peace in a Your Skill Boost Masterclass organisation by the Excellence Foundation for South Sudan on 08th and 09th June 2024 from 1 PM to 3 PM on each day.
हिंदी वर्णमाला पीपीटी, hindi alphabet PPT presentation, hindi varnamala PPT, Hindi Varnamala pdf, हिंदी स्वर, हिंदी व्यंजन, sikhiye hindi varnmala, dr. mulla adam ali, hindi language and literature, hindi alphabet with drawing, hindi alphabet pdf, hindi varnamala for childrens, hindi language, hindi varnamala practice for kids, https://www.drmullaadamali.com
How to Fix the Import Error in the Odoo 17Celine George
An import error occurs when a program fails to import a module or library, disrupting its execution. In languages like Python, this issue arises when the specified module cannot be found or accessed, hindering the program's functionality. Resolving import errors is crucial for maintaining smooth software operation and uninterrupted development processes.
Exploiting Artificial Intelligence for Empowering Researchers and Faculty, In...Dr. Vinod Kumar Kanvaria
Exploiting Artificial Intelligence for Empowering Researchers and Faculty,
International FDP on Fundamentals of Research in Social Sciences
at Integral University, Lucknow, 06.06.2024
By Dr. Vinod Kumar Kanvaria
This presentation was provided by Steph Pollock of The American Psychological Association’s Journals Program, and Damita Snow, of The American Society of Civil Engineers (ASCE), for the initial session of NISO's 2024 Training Series "DEIA in the Scholarly Landscape." Session One: 'Setting Expectations: a DEIA Primer,' was held June 6, 2024.
A review of the growth of the Israel Genealogy Research Association Database Collection for the last 12 months. Our collection is now passed the 3 million mark and still growing. See which archives have contributed the most. See the different types of records we have, and which years have had records added. You can also see what we have for the future.
How to Setup Warehouse & Location in Odoo 17 InventoryCeline George
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2. Definition:
“Capsules are solid dosage forms in which one or more
medicaments are enclosed in a water soluble bio-
degradable shell made up of gelatin.”
They usually contain a single dose of active ingredient(s)
and are intended for oral administration.
4. HARD SHELLED CAPSULES
“Hard Shelled Capsules, which are
typically made using gelatin and
contain dry, powdered ingredients”
These are made in two halves
• Lower diameter “body” that is
filled
• Then sealed using a higher
diameter “cap”.
6. Capsules are made fro aqueous solutions of Gelling
agents like:
Anial Protein, mainly Gelatin
Plant polysaccharides or their derivatives like
Carageenans and modified forms of starch and cellulose.
Other ingredients can be added to the gelling agent
solution like:
Plasticizers such as glycerin or sorbitol to decrease the
capsule hardness
Colouring agent
Preservatives
Disintegrants
Lubricant
surface treatment
7. COMPONENTS OF
CAPSULE
1. Gelatin
2. Certified dyes
3. Sugar
4. Water- 12 -16% but may vary depending on the
storage condition
5. Sulfur dioxide (0.15%) – Prevent decomposition
during maufacturing
6. Opaquants/ Opacifying agent- Titanium dioxide
8. Advantages:
• The drugs having unpleasant odour and taste can be
administered by enclosing them in a tasteless shell.
• They are smooth, become very slippery when moist and
can be easily swallowed.
• They are economical.
• They are easy to handle and carry.
• The capsules release the medicament as and when
desired in gastro-intestinal tract
• Capsules are made from gelatin and hence they are
therapeutically inert.
• Capsule have elegant appearance so that it enhance
patient acceptance.
• The drug in the form of solid,liquid & viscous form can be
encapsulated in capsule shell.
• Capsule formulation provide better stability of drug as
compare to uncoated tablet & liquid dosage form.
9. Disadvantages:
• Capsule are not usually used for administration of
extremely soluble materials such as potassium chloride,
potassium bromide etc. since there is sudden release of
such compound in stomach & causes irritation.
• Capsule should not used for highly efflorescent material
as material may cause the capsule to soften by losing
water molecule to shell.
• Capsule should not used for highly deliquescent powder
as powder have tendency to absorb moisture from
capsule shell & make it brittleness.
• The capsule shells can absorb water from the
environment and develop problems with drug stability and
capsule shell can become tacky.
• it unsuitable for use with liquid formulations.
10. GELATIN
• Gelatin is a translucent, colourless, brittle (when dry),
flavourless foodstuff, derived from Collagen obtained from
various animal by-products.
• Gelatin is a heterogeneous product derived by irreversible
hydrolytic extraction of treated animal collagen as it never
occurs naturally. The main source of collagen which are
required for production of gelatin are animal bones and
frozen pork /Calf skin.
• The physical & chemical properties of gelatin are the
function of parent collagen, method of extraction, pH value,
thermal degradation & electrolyte content.
• It is commonly used as gelling agent in pharmaceuticals,
photography and cosmetic industry.
11. TYPES OF GELATIN
Generally two type of gelatins are used to manufacture
capsule shell.
• Type A:
it is derived from the acid treated precursor and exhibit
isoelectric point in region of pH 9.
• Type B:
it is derived from an alkali treated precursor & exhibit
isoelectric point in region of pH 4.7.
[The isoelectric point is the pH at which a molecule carries no net
electrical charge or is electrically neutral ]
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65.
66. 1. Appearance:
Capsules produced on a small or a large scale should be
uniform in appearance. Visual or electronic inspection should be
undertaken to detect any flaws in the integrity and appearance
of the capsule.
2. Size and Shape: Hard capsules are made in a range of
sizes, the standard industrial ones in use today for human
medicines range from size from 000 (the largest) to 5 (the
smallest) are commercially available. inspection must be done
for size and shape.
3. Unique Identification Markings:
Capsule surfaces may bear symbols or other unique
identification markings for better identification.
67. 4. Uniformity of weight.:
Weigh an intact capsule. Open the capsule without losing any part of the
shell and remove the contents as completely as possible. To remove the
contents of a soft capsule the shell may be washed with ether or other
suitable solvent and the shell allowed to stand until the odour of the solvent
is no longer detectable. Weigh the shell. The weight of the contents is the
difference between the weighings. Repeat the procedure with a further 19
capsules. Determine the average weight. Not more than two of the
individual weights deviate from the average weight by more than the
percentage deviation shown in below and none deviates by more than
twice that percentage.
Average weight of capsule Contents Percentage Deviation
Less than 300 mg 10
300 mg or more 7.5
68. 5. Uniformity of content.:
This test is applicable to capsules that contain less than 10 mg or less
than 10 per cent w/w of active ingredient.
Determine the content of active ingredient in each of 10 capsules taken at
random using the method given in the monograph or by any other suitable
analytical method of equivalent accuracy and precision. The capsules
comply with the test if not more than one of the individual values thus
obtained is outside the limits 85 to 115 per cent of the average value and
none is outside the limits 75 to 125 per cent. If two or three individual
values are outside the limits 85 to 115 per cent of the average value
repeats the determination using another 20 capsules. The capsules
comply with the test if in the total sample of 30 capsules not more than
three individual values are outside the limits 85 to 115 per cent and none
is outside the limits 75 to 125 per cent of the average value
69. 6. Disintegration. The disintegration test is not applicable to Modified-release
Capsules. For those Hard Capsules and Soft Capsules for which the dissolution test is
included in the individual monograph, the test for Disintegration is not required..
a) Hard Capsules. Comply with the disintegration test in monograph , Unless
otherwise directed in the individual monograph use water as the medium. If the
capsules float on the surface of the medium, a disc may be added. If the capsules
adhere to the discs, attach a removable piece of stainless steel woven gauze with
mesh aperture of 2.00 mm to the upper plate of the basket rack assembly and carry
out the test omitting the discs. Operate the apparatus for 30 minutes unless otherwise
directed
b) Soft Capsules. Comply with the disintegration test Unless otherwise directed in the
individual monograph use water as the medium and add a disc to each tube. Operate
the apparatus for 60 minutes unless otherwise directed
c) Enteric Capsules. Use the apparatus described under disintegration test (2.5.1),
using one capsule in each tube. Operate the apparatus for 2 hours without the discs in
0.1 M hydrochloric acid. No capsule shows signs of disintegration or of rupture
permitting the escape of the contents. Replace the medium in the vessel with mixed
phosphate buffer pH 6.8, add a disc to each tube and operate the apparatus for a
further 60 minutes. Remove the apparatus from the medium and examine the
capsules. They pass the test if no residue remains on the screen or on the underside
of the discs, or, if a residue remains, it consists of fragments of shell or of a soft mass
with no palpable, unmoistened core.
70. 7. Content uniformity of drug:
A sample of 30 capsule is taken and 10 are assayed individually.
The drug content of a capsule should be within the limits of average
drug content ±15% and the drug content of none of the capsule fall
outside the average drug content ±25%.
If 1-3 capsules falls outside the average drug content ±15%, the
remaining 20 are assayed. The drug content of at least 27 out of 30
assayed should be within the average drug content ±15% limits. and
the drug content of none of the capsules falls outside the average
drug content ±25% limits. The test is prescribed for capsules when
active ingredient is <10 mg or 10% of fill weight.
71. 8. Dissolution test:
The dissolution test is carried out using the dissolution apparatus as
per U.S.P .
• The capsule is placed in a basket , and the basket is immersed in the
dissolution medium and caused to rotate at a specified speed . The
dissolution medium is held in a covered 1000ml glass vessel and
maintained at 370 c +-0.50c by means of a constant temperature
suitable water bath. The stirrer speed and type of dissolution medium
are specified in the individual monograph
Stage Number of capsule
tested
Acceptance criteria
S1 6 Each unit is not less than Q + 5%.
S2 6 Average of 12 units (S1 + S2) is equal to or greater than
Q, and no unit is less than Q – 15%.
S3 12 Average of 24 units (S1 + S2 + S3) is equal to or greater
than Q, not more than 2 units are less than Q – 15%, and
no unit is less than Q – 25%.
The quantity Q, is the specified amount of dissolved active substance,
expressed as a percentage of the labeled content.
72.
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75.
76. Advantages:
Soft gelatin capsules are in sealed form so they protect the inner fill
from oxidation and degradation.
Opaque soft gelatin capsules also protect the inner fill from UV
radiation and photo sensitive products.
It enhance patient compliance due to its elegant appearance.
Suitable for medicaments like semisolid, oils, liquid forms.
Soft gelatin capsules increase the bioavailability of API.
Disadvantages:
Few filling equipment available.
Manufacturing expensive.
Drugs from oily vehicle may pass into the shell.
Soft gelatin capsules having difficulties in dealing with water soluble
materials.
Soft gelatin capsules are highly sensitive to moisture.
Soft gelatin capsules having difficulties in dealing with efflorescent
materials.
Soft gelatin capsules having difficulties in dealing with deliquescent
material.
77.
78.
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81.
82. Nature of capsule shell:
The capsule shell is basically composed of gelatin, plasticizer
& water. Additionally it may contain preservative, colouring
agent, opacifying agent, flavor, sweetening agent to achieve
desired effect.
The gelatin is USP grade with additional specification required
by the capsule manufacture. The additional specification
concern the bloom strength, viscosity, iron content of gelatin
used.
Bloom or gel strength: is a measure of cohesive strength of
cross linking that occurs between gelatin molecule and is
proportional to the molecular weight of gelatin. Bloom is
determined by measuring the weight in gram required to move
a plastic plunger that is 0.5 inches in diameter 4mm into a 6
2/3 % gelatin gel that has been held at 10oc for 17 hours.
Bloom may vary from 150-250g.
83. Viscosity: viscosity of gelatin determined on a 6 2/3 %
conc of gelatin in water at 600 c, is a measure of
molecular chain length and determines the manufacturing
characteristics of gelatin. The viscosity for gelatin can
ranges from 25 to 45 millipoise.
Iron is always present in the raw gelatin and its
concentration usually depend on the iron content of the
large quantities of water used in its manufacture.Gelatin
used in manufacture of soft gelatin capsule should not
contain more than 15 PPM of this element.
84. Hardness
Ratio Dry
glycerin/Dry
gelatin
Usage
Hard 0.4/1 Oral,oil based or shell softening
product,designed for hot,humidity areas
Medium 0.6/1 Oral,water miscible based , shell
hardening product and designed for
temperate areas
Soft 0.8/1 Tube,vaginal,water miscible based or
shell hardening product and destined for
cold,dry areas
92. Rotary die process:
1) In this machine the soft gelatin capsules are prepared & then
filled immediately with liquid medicaments it is having two
hoppers & two rotating dies
2) Liquid mixture is placed in one hopper & the liquid
medicament in other Hooper.
3) The two rotating dies rotate in opposite directions when the
fluid gelatin mixture enters the machine from the hopper it
produces two continuous ribbons .
4) These half shell of the capsule is formed.
5) At this stage the measured quantity of the medicament is filled
in to it with the stroke of a pump with the subsequent movement
of the dies the other half capsule is formed.
6) The two halves' of the capsules are sealed together by the
heat & pressure of the rotating dies
7) As the die rolls rotate, the convergence of the matching die
pockets seals and cuts out the filled capsules
93.
94. Reciprocating die process:
This machine produces capsule completely
automatically by leading two films of gelatin between a
set of vertical dies. Rows after rows of pockets are
formed across the gelatin film, filled with medicaments
and as they process through the dies, are sealed,
shaped and cut out of the film as capsules which drop
into a cooled solvent bath
95.
96.
97.
98.
99.
100.
101. Accogel capsule filling machine:
This is another rotary process involving a measuring roll, a die roll and a
sealing roll. The measuring roll rotates directly over the die roll, and the
pockets in the two rolls are aligned with each other. The powder or
granular fill material is held in the pockets of measuring roll under
vacuum. A plasticized gelatin sheet is drawn into the die pockets of the
die roll under vacuum. As the measuring roll and die roll rotates, the
measured dose are transferred to the gelatin lined pockets of the die roll.
102.
103.
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107.
108.
109.
110.
111. For the determination of the fill weight each capsule is
weighed and the contents removed by cutting open the
capsule. The shell is then washed with petroleum ether,
and the empty shell is reweighed. If necessary,
adjustment can be made to obtain the proper fill weight.
112.
113. Finished product testing:
Test parameter almost same as hard capsule Special quality
control test on soft gelatin capsules:-
• Seal thickness:-Is measured under a microscope and it
should one half to two third of the ribbon thickness.
• Total or shell moisture test:-Moisture content is determined
by the toluene distillation method. Collecting the distillate
over a period of one hour.
• Capsule fragility or rupture test:-Force required to rupture
the capsule is determined.
• Determination of freezing and high temperature effect:-
(>450 c for 30 days) These are performed similarly to the
shell integrity test.
114.
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117.
118.
119.
120. Packaging & store of capsule:
• The main aim of packaging of filled capsule is to prevent
contamination & loss or gain of moisture during long term
storage.
• Many plastic container & various packaging technology
such as blister packaging, strip packaging are used for it.
• In some container dehydrating powder(desicants) is placed
which retard the excessive moisture absorption by capsule.
• Storage: storage of hard gelatin capsule shell for long time
period require proper maintenance of temp & humidity
121. Storage
Condition
Relative
humidity (%)
Temperature (º
C)
Minimum 35 15
Best Possible 60 20
Maximum 65 25
• Very high humidity: capsules soften, stick together and
lose shape
• Very low humidity: capsules contract in size and
become fragile
• High or fluctuated temperatures: capsule forms lumps
& condensation is seen on the surface of container.
122.
123.
124.
125. Application of soft gelatin capsule:[1]
1. They permit liquid medications to become easily portable.
2. Accuracy and uniformity of dosage ,capsule to capsule and lot to lot
predominant advantage.
3.the pharmaceutical availability of drugs formulated for this dosage form
,as measured by disintegration time or by dissolution rate often shows an
advantage over other solid dosage form
4. the physiologic availability of drug is often improved since these
capsule contain the drug in liquid form.
5. the biopharmaceutical characterstics of such formulations can altered
and adjusted more easily than those of other solid dosage form.
6. orally administered drug ,particularly if used chronically ,can be
irritating to the stomach .the dosage form of such drug can affect gastric
tolerance indicated by study.