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.
This document describes several key pieces of equipment used in the pharmaceutical manufacturing process. It discusses the Rapid Mixer Granulator, which performs fast mixing and wet granulation in a single step. It then describes the fluidized bed dryer, which dries granules using hot air in a fluidized bed. Tablet compression machines are also summarized, explaining how they compress granules into tablets using dies and punches. Finally, the document discusses coating machines, which apply coatings to tablets through a spraying process while tumbling and drying them using heated air.
This document provides information on soft and hard gelatin capsules. It discusses the classification of capsules, the components and production process of soft gelatin capsules, and the structure, manufacturing, filling principles, and sealing of hard gelatin capsules. Soft gelatin capsules are one-piece and can encapsulate liquids, while hard gelatin capsules have a separate cap and body that are filled and then sealed. The production processes aim to precisely control factors like thickness, moisture levels, and fill weight to produce high quality capsules.
1. The document discusses different types of capsules including hard gelatin capsules and soft gelatin capsules.
2. Hard gelatin capsules contain medicaments in dry powder form enclosed in a hard shell, while soft gelatin capsules contain liquids, suspensions, or semisolids in a soft soluble shell.
3. The production, filling, finishing, and quality control testing of hard gelatin capsules is described in detail. Methods for ensuring uniformity of weight and content are outlined.
This document provides information on tablets, including their definition, ingredients, manufacturing methods, and equipment used. Tablets are solid preparations made by compressing particles into various shapes and sizes, consisting of one or more active ingredients. The main ingredients used are fillers, binders, disintegrants, lubricants, glidants, antiadherents, colors, flavors, and sweeteners. The three main manufacturing methods are wet granulation, direct compression, and dry granulation. Wet granulation involves mixing, granulating, drying, and milling steps while direct compression is a two-step process of screening/milling and mixing. Dry granulation uses roller compaction. Final blending is done to ensure content uniform
Hard gelatin capsules are solid dosage forms where medicaments are enclosed in gelatin shells. They have advantages like easy swallowing, taste masking, and rapid drug release. Capsules are filled using semi-automatic or automatic machines that employ various techniques like piston tamping or vibratory filling. After filling, capsules are polished, evaluated for quality parameters like weight variation and content uniformity, and packaged and stored properly. Modern filling machines can fill thousands of capsules per hour.
Capsules are a solid dosage form with a drug substance enclosed in a water soluble shell made of gelatin. They come in both hard and soft forms. Capsules have advantages like masking unpleasant tastes and smells, allowing sustained release, and being economical and easy to handle. However, hygroscopic drugs cannot be filled in capsules as they may absorb water and break. Capsules come in various standard sizes depending on their capacity. Soft gelatin capsules can have different shapes and their contents include liquids or solids dissolved in excipients to form a paste. They are sealed during the combined filling and sealing operation on machines.
This document defines soft gelatin capsules and describes their anatomy, manufacturing process, quality considerations, and types. Soft gelatin capsules have a soft gelatin shell containing liquids, suspensions, or semisolids. The shell is made of gelatin, plasticizer, and water. The content can be liquids, solutions, or suspensions. The manufacturing process involves making the gel and content mixtures, encapsulating using machinery, drying, inspecting, and packaging. Quality is ensured through ingredient and in-process testing and finished product testing. Vegicaps are an alternative animal-free soft capsule with a seaweed and starch shell.
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.
This document describes several key pieces of equipment used in the pharmaceutical manufacturing process. It discusses the Rapid Mixer Granulator, which performs fast mixing and wet granulation in a single step. It then describes the fluidized bed dryer, which dries granules using hot air in a fluidized bed. Tablet compression machines are also summarized, explaining how they compress granules into tablets using dies and punches. Finally, the document discusses coating machines, which apply coatings to tablets through a spraying process while tumbling and drying them using heated air.
This document provides information on soft and hard gelatin capsules. It discusses the classification of capsules, the components and production process of soft gelatin capsules, and the structure, manufacturing, filling principles, and sealing of hard gelatin capsules. Soft gelatin capsules are one-piece and can encapsulate liquids, while hard gelatin capsules have a separate cap and body that are filled and then sealed. The production processes aim to precisely control factors like thickness, moisture levels, and fill weight to produce high quality capsules.
1. The document discusses different types of capsules including hard gelatin capsules and soft gelatin capsules.
2. Hard gelatin capsules contain medicaments in dry powder form enclosed in a hard shell, while soft gelatin capsules contain liquids, suspensions, or semisolids in a soft soluble shell.
3. The production, filling, finishing, and quality control testing of hard gelatin capsules is described in detail. Methods for ensuring uniformity of weight and content are outlined.
This document provides information on tablets, including their definition, ingredients, manufacturing methods, and equipment used. Tablets are solid preparations made by compressing particles into various shapes and sizes, consisting of one or more active ingredients. The main ingredients used are fillers, binders, disintegrants, lubricants, glidants, antiadherents, colors, flavors, and sweeteners. The three main manufacturing methods are wet granulation, direct compression, and dry granulation. Wet granulation involves mixing, granulating, drying, and milling steps while direct compression is a two-step process of screening/milling and mixing. Dry granulation uses roller compaction. Final blending is done to ensure content uniform
Hard gelatin capsules are solid dosage forms where medicaments are enclosed in gelatin shells. They have advantages like easy swallowing, taste masking, and rapid drug release. Capsules are filled using semi-automatic or automatic machines that employ various techniques like piston tamping or vibratory filling. After filling, capsules are polished, evaluated for quality parameters like weight variation and content uniformity, and packaged and stored properly. Modern filling machines can fill thousands of capsules per hour.
Capsules are a solid dosage form with a drug substance enclosed in a water soluble shell made of gelatin. They come in both hard and soft forms. Capsules have advantages like masking unpleasant tastes and smells, allowing sustained release, and being economical and easy to handle. However, hygroscopic drugs cannot be filled in capsules as they may absorb water and break. Capsules come in various standard sizes depending on their capacity. Soft gelatin capsules can have different shapes and their contents include liquids or solids dissolved in excipients to form a paste. They are sealed during the combined filling and sealing operation on machines.
This document defines soft gelatin capsules and describes their anatomy, manufacturing process, quality considerations, and types. Soft gelatin capsules have a soft gelatin shell containing liquids, suspensions, or semisolids. The shell is made of gelatin, plasticizer, and water. The content can be liquids, solutions, or suspensions. The manufacturing process involves making the gel and content mixtures, encapsulating using machinery, drying, inspecting, and packaging. Quality is ensured through ingredient and in-process testing and finished product testing. Vegicaps are an alternative animal-free soft capsule with a seaweed and starch shell.
This document provides an overview of tablets, including their definition, advantages, disadvantages, types, additives, granulation processes, equipment used, tableting procedure, and evaluation. Tablets are defined as a compressed solid dosage form containing medicaments with or without excipients. Their advantages include dose precision, low cost, stability, and masking of taste, while disadvantages can include difficulty swallowing and formulation challenges for some drugs. The document discusses various tablet types, additives used, granulation technologies and equipment, the tableting process, and methods for evaluating tablets.
This document provides an overview of tablets, including their advantages and disadvantages, types, excipients used, manufacturing process, coating methods, and evaluation. Tablets are the most popular oral solid dosage form, comprising 70% of total medicines. They are easy to administer and stable, but some drugs are not suitable due to solubility or stability issues. Tablet types include immediate and sustained release, as well as those for oral, buccal, vaginal, and other routes of administration. Excipients like diluents, binders, and lubricants are necessary for tablet production. Granulation and compression are the main manufacturing steps. Tablet coating helps mask taste and protects the drug.
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
Capsules can be hard or soft gelatin shells containing medications. Hard capsules have 13-16% moisture and are easier to swallow than soft capsules with over 16% moisture. Capsules offer benefits like precise dosing and packaging but may be difficult for some to swallow. They are manufactured by dipping plates in gelatin solutions to form shells, filling powder or liquid into the shells, and sealing. Quality is ensured through testing size, dissolution, and content uniformity during production.
Small scale and large scale capsule filling machineceutics1315
This document summarizes small and large scale capsule filling machines. It describes the components and manufacturing of hard and soft gelatin capsules. Various filling methods are discussed including direct, indirect, and vacuum-assisted techniques. Specific machines from companies like Lilly, Farmatic, Hofliger & Karg, Macofar, mG2, Osaka, and Zanasi are outlined with their models and capacities. Capsule sealing and recent filling equipment are also briefly covered. In summary, the document provides an overview of capsule manufacturing processes and machinery used at different production scales.
This document defines tablet diluents and describes the properties and purposes of common diluents lactose and calcium phosphate. It states that diluents are used to increase tablet bulk and weight while allowing direct compression manufacturing. Key properties of diluents include being inert, non-toxic, and not affecting drug bioavailability. Common diluents are classified as organic like lactose or inorganic like calcium phosphate. Lactose is the most widely used diluent and comes in several forms with different properties for tableting. Calcium phosphate and tribasic calcium phosphate are also described as inexpensive inorganic diluents.
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.
The document provides information on quality control testing for pharmaceutical tablets. It defines quality control as the process of monitoring quality during manufacturing to ensure standards are met. It describes several important quality control tests conducted on tablets, including weight variation, thickness, hardness, friability, disintegration, dissolution, and content uniformity tests. These tests are essential to ensure tablets are safe, effective, and meet specifications for attributes like drug content, stability and patient acceptability. The document provides details on procedures, equipment and acceptance criteria for each quality control test.
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.
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.
Capsules are solid dosage forms that enclose the drug substance within a soluble shell or envelope, primarily for oral delivery. There are two main types: hard gelatin capsules that contain solid medicines, and soft gelatin capsules that contain liquid or semi-solid medicines. Hard gelatin capsules are manufactured through a dipping, spinning, drying, and joining process to form two-piece capsules. Soft gelatin capsules are produced through plate or rotary die processes that fill and seal liquid-filled shells simultaneously. Both types require drying and may be polished before storage.
Tablets are solid dosage forms usually obtained by single or multiple compression of powders or granules. In certain cases tablets may be obtained by molding or extrusion techniques. They are uncoated or coated. Tablets are normally right circular solid cylinders, the end surfaces of which are flat or convex and the edges of which may be bevelled. They may have lines or break-marks (scoring), symbols or other markings.Tablets contain one or more active ingredients. They may contain excipients such as diluents, binders, disintegrating agents, glidants, lubricants, substances capable of modifying the behaviour of the dosage forms and the active ingredient(s) in the gastrointestinal tract, colouring matter authorized by the appropriate national or regional authority and flavouring substances. When such excipients are used it is necessary to ensure that they do not adversely affect the stability, dissolution rate, bioavailability, safety or efficacy of the active ingredient(s); there must be no incompatibility between any of the components of the dosage form.
Tablets are single-dose preparations intended for oral administration. Some are intended to be swallowed whole, some after being chewed and some after being crushed, some are intended to be dissolved or dispersed in water before being taken and some are intended to be retained in the mouth where the active ingredient(s) is/are liberated.
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 causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
Everyone requires a product of the best quality, be it in case of medicines or any other edibles or services. Hence, the presentation deals with the quality control of tablets
These are the sterile preparation intended to administered other than intestinal route to bypass first pass metabolism and directly goes to systemic circulation.
These preparation give quick onset of action and site specific activity.
Suitable for drugs which are inactive in GIT environment.
Can be given unconscious or vomiting or diarrheal patient.
These are the sterile preparation intended to administered other than intestinal route to bypass first pass metabolism and directly goes to systemic circulation.
These preparation give quick onset of action and site specific activity.
Suitable for drugs which are inactive in GIT environment.
Can be given unconscious or vomiting or diarrheal patient.
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.
selection of packaging material for parentralsNilesh Utpure
This document discusses packaging materials for parenteral dosage forms. It describes the key requirements for parenteral packaging, including being sufficiently strong, not allowing product loss, not reacting with contents, withstanding heat sterilization, and protecting light-sensitive products. It then discusses various packaging materials - glass, plastic, and metal - and their advantages and limitations for parenteral dosage forms. Glass is widely used for ampules and vials due to its non-toxicity, non-reactivity, and ability to withstand heat sterilization. The document also outlines the types of glass and plastic materials approved for parenteral packaging according to pharmacopeial standards.
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.
Hard and soft gelatin capsules are two types of capsules used for drug delivery. Hard capsules contain dry ingredients and disintegrate quickly once swallowed. They are made by dipping pins in gelatin solutions to form two-piece shells. Soft capsules contain liquids or semi-solids and have plasticized gelatin shells that are manufactured using plate, rotary die, or reciprocating processes. Both types of capsules are evaluated for stability, content uniformity, and disintegration time.
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.
This document provides an overview of tablets, including their definition, advantages, disadvantages, types, additives, granulation processes, equipment used, tableting procedure, and evaluation. Tablets are defined as a compressed solid dosage form containing medicaments with or without excipients. Their advantages include dose precision, low cost, stability, and masking of taste, while disadvantages can include difficulty swallowing and formulation challenges for some drugs. The document discusses various tablet types, additives used, granulation technologies and equipment, the tableting process, and methods for evaluating tablets.
This document provides an overview of tablets, including their advantages and disadvantages, types, excipients used, manufacturing process, coating methods, and evaluation. Tablets are the most popular oral solid dosage form, comprising 70% of total medicines. They are easy to administer and stable, but some drugs are not suitable due to solubility or stability issues. Tablet types include immediate and sustained release, as well as those for oral, buccal, vaginal, and other routes of administration. Excipients like diluents, binders, and lubricants are necessary for tablet production. Granulation and compression are the main manufacturing steps. Tablet coating helps mask taste and protects the drug.
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
Capsules can be hard or soft gelatin shells containing medications. Hard capsules have 13-16% moisture and are easier to swallow than soft capsules with over 16% moisture. Capsules offer benefits like precise dosing and packaging but may be difficult for some to swallow. They are manufactured by dipping plates in gelatin solutions to form shells, filling powder or liquid into the shells, and sealing. Quality is ensured through testing size, dissolution, and content uniformity during production.
Small scale and large scale capsule filling machineceutics1315
This document summarizes small and large scale capsule filling machines. It describes the components and manufacturing of hard and soft gelatin capsules. Various filling methods are discussed including direct, indirect, and vacuum-assisted techniques. Specific machines from companies like Lilly, Farmatic, Hofliger & Karg, Macofar, mG2, Osaka, and Zanasi are outlined with their models and capacities. Capsule sealing and recent filling equipment are also briefly covered. In summary, the document provides an overview of capsule manufacturing processes and machinery used at different production scales.
This document defines tablet diluents and describes the properties and purposes of common diluents lactose and calcium phosphate. It states that diluents are used to increase tablet bulk and weight while allowing direct compression manufacturing. Key properties of diluents include being inert, non-toxic, and not affecting drug bioavailability. Common diluents are classified as organic like lactose or inorganic like calcium phosphate. Lactose is the most widely used diluent and comes in several forms with different properties for tableting. Calcium phosphate and tribasic calcium phosphate are also described as inexpensive inorganic diluents.
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.
The document provides information on quality control testing for pharmaceutical tablets. It defines quality control as the process of monitoring quality during manufacturing to ensure standards are met. It describes several important quality control tests conducted on tablets, including weight variation, thickness, hardness, friability, disintegration, dissolution, and content uniformity tests. These tests are essential to ensure tablets are safe, effective, and meet specifications for attributes like drug content, stability and patient acceptability. The document provides details on procedures, equipment and acceptance criteria for each quality control test.
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.
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.
Capsules are solid dosage forms that enclose the drug substance within a soluble shell or envelope, primarily for oral delivery. There are two main types: hard gelatin capsules that contain solid medicines, and soft gelatin capsules that contain liquid or semi-solid medicines. Hard gelatin capsules are manufactured through a dipping, spinning, drying, and joining process to form two-piece capsules. Soft gelatin capsules are produced through plate or rotary die processes that fill and seal liquid-filled shells simultaneously. Both types require drying and may be polished before storage.
Tablets are solid dosage forms usually obtained by single or multiple compression of powders or granules. In certain cases tablets may be obtained by molding or extrusion techniques. They are uncoated or coated. Tablets are normally right circular solid cylinders, the end surfaces of which are flat or convex and the edges of which may be bevelled. They may have lines or break-marks (scoring), symbols or other markings.Tablets contain one or more active ingredients. They may contain excipients such as diluents, binders, disintegrating agents, glidants, lubricants, substances capable of modifying the behaviour of the dosage forms and the active ingredient(s) in the gastrointestinal tract, colouring matter authorized by the appropriate national or regional authority and flavouring substances. When such excipients are used it is necessary to ensure that they do not adversely affect the stability, dissolution rate, bioavailability, safety or efficacy of the active ingredient(s); there must be no incompatibility between any of the components of the dosage form.
Tablets are single-dose preparations intended for oral administration. Some are intended to be swallowed whole, some after being chewed and some after being crushed, some are intended to be dissolved or dispersed in water before being taken and some are intended to be retained in the mouth where the active ingredient(s) is/are liberated.
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 causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
Everyone requires a product of the best quality, be it in case of medicines or any other edibles or services. Hence, the presentation deals with the quality control of tablets
These are the sterile preparation intended to administered other than intestinal route to bypass first pass metabolism and directly goes to systemic circulation.
These preparation give quick onset of action and site specific activity.
Suitable for drugs which are inactive in GIT environment.
Can be given unconscious or vomiting or diarrheal patient.
These are the sterile preparation intended to administered other than intestinal route to bypass first pass metabolism and directly goes to systemic circulation.
These preparation give quick onset of action and site specific activity.
Suitable for drugs which are inactive in GIT environment.
Can be given unconscious or vomiting or diarrheal patient.
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.
selection of packaging material for parentralsNilesh Utpure
This document discusses packaging materials for parenteral dosage forms. It describes the key requirements for parenteral packaging, including being sufficiently strong, not allowing product loss, not reacting with contents, withstanding heat sterilization, and protecting light-sensitive products. It then discusses various packaging materials - glass, plastic, and metal - and their advantages and limitations for parenteral dosage forms. Glass is widely used for ampules and vials due to its non-toxicity, non-reactivity, and ability to withstand heat sterilization. The document also outlines the types of glass and plastic materials approved for parenteral packaging according to pharmacopeial standards.
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.
Hard and soft gelatin capsules are two types of capsules used for drug delivery. Hard capsules contain dry ingredients and disintegrate quickly once swallowed. They are made by dipping pins in gelatin solutions to form two-piece shells. Soft capsules contain liquids or semi-solids and have plasticized gelatin shells that are manufactured using plate, rotary die, or reciprocating processes. Both types of capsules are evaluated for stability, content uniformity, and disintegration time.
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.
This document discusses the history, definition, manufacturing process, advantages, and quality control testing of gelatin capsules. It begins by outlining the 1834 patent for gelatin capsules and patient preferences for capsules versus tablets. Key points include:
- Gelatin capsules consist of a soluble shell enclosing a drug substance and are commonly made from type A or B gelatin.
- Hard gelatin capsules have separate body and cap pieces while soft gelatin capsules form a single shell during manufacturing.
- Quality is ensured through testing weight variation between capsules and uniformity of drug content.
This document discusses capsules, including definitions, types (hard gelatin and soft gelatin), and manufacturing processes. It notes that capsules enclose medicinal substances within a shell, usually made of gelatin. Hard gelatin capsules are made through a dipping process where gelatin is used to form two halves that are later joined. Soft gelatin capsules use a concentric nozzle process to simultaneously form the shell and fill it. The document provides details on quality control and the various sizes of capsules used for humans.
This document discusses hard shell and soft shell capsules. It defines capsules as solid dosage forms containing medicinal agents enclosed in gelatin shells. Hard shell capsules are made of two rigid gelatin shells joined together, while soft shell capsules contain plasticizers like glycerin added to the gelatin. The document describes the manufacturing processes of both types of capsules and compares their advantages and disadvantages as drug delivery systems.
In the changing scenario of pharmacy practice in India, for successful practice of
Hospital Pharmacy, the students are required to learn various skills like drug distribution,
drug dispensing, manufacturing of parenteral preparations, drug information, patient
counselling, and therapeutic drug monitoring for improved patient care
Capsules are solid dosage forms in which the drug or a mixture of drugs with or without excipients is enclosed in Hard Gelatin Capsule Shells, in soft, soluble shells of gelatin, or in hard or soft shells of any other suitable material, of various shapes and capacities. They usually contain a single dose of active ingredient(s) and are intended for oral administration.
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.
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 is unsuitable for use with liquid formulations.
The mechanism involved for production of hard gelatin capsule shell are
The Capsule shell contains :
Dry Gelatin (Type A or B)
Plasticizer – Glycerine
Solvent – Demineralised water
Preparation of the gelatin solution (dipping solution): A concentrated solution of gelatin (35- 40%) is prepared by dissolving the gelatin in demineralized water which has been heated to 60– 70°C in jacketed pressure vessels. This is stirred until the gelatin has dissolved and vacuum is applied to removed entrapped air bubbles. At this stage, other processing aids may be added like plasticizer, colourant, opaquing agent etc. The viscosity of gelatin preparation has to be controlled as it may affect downstream manufacturing process & very importantly thickness of shell. cap Body.
Dipping
Spinning
Drying
Stripping & Trimming
Joining
The mechanism involved for production of hard gelatin capsule shell are
The Capsule shell contains :
Dry Gelatin (Type A or B)
Plasticizer – Glycerine
Solvent – Demineralised water
Preparation of the gelatin solution (dipping solution): A concentrated solution of gelatin (35- 40%) is prepared by dissolving the gelatin in demineralized water which has been heated to 60– 70°C.
Hard and soft gelatin capsules are solid oral dosage forms where the drug is enclosed within a soluble shell made of gelatin. Hard gelatin capsules have a two-piece design where the body and cap are joined, while soft gelatin capsules are one-piece shells containing liquids or semisolids. Some key advantages of capsules are taste masking, ease of administration and manufacture, and ability to incorporate both solid and liquid drugs. The document discusses the history, components, manufacturing processes, sizes, and storage conditions of hard and soft gelatin capsules.
1. Capsules are solid dosage forms that enclose medications within gelatin shells. They can contain powders, liquids, or semisolids.
2. There are two main types - hard gelatin capsules that have two pieces joined together, and soft gelatin capsules that are one solid piece.
3. Capsules offer advantages like masking taste, easy administration, and low manufacturing costs. Their main disadvantage is that some liquids or solutions can dissolve the gelatin shell.
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The document discusses hard gelatin capsules and soft gelatin capsules. It provides details on the production of hard gelatin capsule shells including the key components of gelatin, plasticizers, water and other additives. It describes the size of capsules and methods of filling capsules, including manual filling and using semi-automatic and fully automatic capsule filling machines. The document also differentiates between hard gelatin capsules and soft gelatin capsules and discusses their applications.
This document discusses capsule dosage forms, including hard gelatin capsules and soft gelatin capsules. It covers the definition of capsules, types of capsules and gelatin, manufacturing processes, sizes, filling techniques, and evaluation parameters. Capsules are solid dosage forms that enclose medicaments in a soluble gelatin shell. Hard capsules contain dry powders while soft capsules contain oils or active ingredients dissolved in oil. The manufacturing process for hard capsules involves dipping pins in gelatin solution to form shells, which are then dried, trimmed, and filled.
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.
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.
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.
Capsules are solid dosage forms that enclose drug substances within hard or soft soluble shells, usually made of gelatin. There are two main types - hard gelatin capsules, which have two pieces, and soft gelatin capsules, which are one-piece and hermetically sealed. Capsules offer advantages like being tasteless, odorless, and easy to administer, and allow for flexible dosing. Key steps in production include dipping, spinning, drying, stripping, trimming, joining, and filling. Capsules are evaluated for weight variation, content uniformity, and dissolution.
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.
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Capsule, manufacturing of capsule,Soft gelatin capsule, preparation methods, Evaluation of capsule, package and storage
1. CAPSULE
G A N A P A T H I N A Y A K
P H A R M . D
J A Y A M U K H I C O L L E G E O F
P H A R M A C Y
2.
3. DEFINITIONS
❖Capsules are solid dosage form in which the drug
substance is enclosed in a water soluble shell or an
envelope
❖ a capsule shell is made up of gelatin
❖Primary intended for oral delivery
4. ADVANTAGES DISADVANTAGES
➢The drug having unpleasant taste
and odour can be administered by
enclosing them in a tasteless shell
➢They are smooth become slippery
when moist and can be easily
swallowed
➢The ready solubility of gelatin at
gastric PH provides rapid release
of medicament in the stomach
➢They are attractive in appearence
➢The Hygroscopic drugs can’t be filled in
capsules
➢The concentrated preparations which
need previous dilutionare unsuitable for
capsule because it may lead to irritation
in stomach if administers as such
5. ❖ Gelatin is heterogenous product derived by hydrolyte
extraction of animal collagen
❖ The sources of gelatin including animal bones and
frozen pork skin
❖ Type – A : gelatin is mainly derived from pork skin by
acid treatment
❖ Type – B : gelatin is derived from bones and animal skin
by alkaline process
GELATIN
6. Manufacture of Empty Gelatin Capsule
Steps involvedin making empty gelatin capsule :-
1. DIPPING :
▪ pairs of the stainless steel pins are dipped into the dipping
solution to simultaneouslyfrom the caps and bodies.
▪ The dipping solution is maintained at a temperatureof
about 50 degrees centigrade in a heated jacketed dipping
pan.
2. SPINNING :
▪ The pins are rotated to distribute the gelatin over the pins
uniformly and to avoid the formation of a bead at the
capsule ends.
7. Manufacture of Empty Gelatin Capsule
Steps involvedin making empty gelatin capsule :-
3. DRYING :
▪ The capsule is dried by a blast of cool air to form a hard
shells. The pins are moved through a series of air drying kilns
to remove water
4. STRIPPING :
▪ A series of bronze jaws strip the cap and body portions of the
capsules from the pins
8. Manufacture of Empty Gelatin Capsule
Steps involvedin making empty gelatin capsule :-
5. TRIMMING AND JOINING :
▪ The stripped cap and body portions are trimmed to the
required length by stationary knives
6. POLISHING :
▪ Pan polishing – Aceta – cota pan is used to dust &
polish
▪ Cloth dusting – capsule are rubbed with cloth
▪ Brushing – capsule are feed under soft rotating
brush
9. ADJUVENTS
▪ In large scale or small preparation of filled Hard gelatin capsule
divided into following steps :
- Developing the capsule shell
- Filling the capsule shell
- Capsule sealing
- Cleaning and polishing the filled capsule
▪ Diluents and fillers : lactose, micro crystalline cellulose,
starch.
▪ Disintegrants : sodium starch , pregelatinizedstarch
▪ Glidants and Lubricants : silicon dioxide , magnesium
stearate,calcium stearate.
▪ Wetting agents : SLS
10. HARD GELATIN CAPSULE
➢ These are used for administration of solid medicaments
➢ The capsule shell is prepared from gelatin ,It consists of two parts i.e.,
body and cap
➢ The powdered material is filled into the cylindrical body of the capsules
and then the cap is placed over it.
➢ Contain 12 – 16 % moisture
➢ Typically filled with dry solids – powers, granules, pellets, tablets
Filling of Hard Gelatin Capsules :
1. Punch method or Manual Filling
2. Hand Filling or Semi Automatic Capsules Devices
3. Automatic Filling Machine
11. Preparation Methods
1. PUNCH METHOD :
❑Powder is placed on a shut of a clean paper or
porcelain plate using spatula which is formed
into a cake having a depth of approx. – one
fourth to one third the level of the capsule
body.
❑Then empty capsule body is held b/w the
thumb and fore finger, punched vertically into
the powder cake repeatedly until filled
12. Preparation Methods
2. Capsule Filling Machine :
❑It consists of…
❑A bed having 200 – 300 holes
❑A loading tray having 200 – 300 holes
❑A power tray
❑A pin plate having a rubber top
❑A lever
❑A cam handle
13. Preparation Methods
3. Automatic capsule Filling Machine :
❑It has been designed and developed to fill Hard
Gelatin capsule with powder or pellets
❑It can be applicable to the widest range of
capsule at all sizes and guarantee the integrity
of all capsule
❑Capsule of filling, 6 capsules at a time with
operation from 10 stations . Accurate operation
for orientation opening, filling, joining and
ejecting of the capsule
14. Finishing of Capsule
➢Cloth dusting :capsule are rubbed with cloth
➢Polishing :
➢Pan polishing – aceta – cola pan is used to dust and
polish which is lined with cheese or a polyurethane
cloth
➢Brushing :capsule are feed under soft rotating brush
➢Sorting :
➢Rotosort – 1,50,000 capsules/ hr
15. SOFT GELATIN CAPSULE
• Soft gelatin capsule are one piece, hermetically sealed, soft gelatin shells
containing a liquid, a suspension, or a semisolid.
Composition of shell of Soft gel Capsule :
• The capsule shell is basically composed of gelatin,
a plasticizer and water. It may contain additional
ingredients such as preservative, coloring and
opacifying agents, flavoring agents, sugars, acids
and medicaments to achieve desired effects.
16. SOFT GELATIN CAPSULE
1. capsule shell water :
• NMT 45% w/w the ratio by weight of water to
dry gelatin can vary from 0.7% to 1.3[water] to
1.0 [dry gelatin] depending on the viscosity of
the gelatin being used.
2. Plasticizer :
• Used to make the soft gel shell elastic & pliable
• Ratio used is b/w 0.3 to 1.8 for soft to hard
shell on dry basis Ex :- glycerin, sorbitol.
17. SOFT GELATIN CAPSULE
3. Color :
• Used in shell has to be darker than color of encapsulating
material color may be natural or synthetic
4. Opacifier :
• Usually titanium dioxide, may be added to produce an
opaque shell.
• When the fill formation is a suspension or to prevent photo
degradationof light sensitive fill ingredients
18. SOFT GELATIN CAPSULE
5. Chelating agent :
• Iron is always present in raw gelatin,
should not contain iron more than
15ppm
• Additionally chelating agent may be
used for preventing the reaction of
iron with materials or colors.
19. Manufacture of soft gelatin capsule
1. Plate process :
❖A warm sheet of gelatin is placed on the bottom plate of
mold
❖The liquid medicament is poured on it
❖Then the 2nd sheet of the prepared gelatin is carefully laid in
place on top of the medicament, and the top plate of the
mold is put in place
❖The entire mold is then subjected to a press where pressure is
applied to form fill and seal the capsule simultaneously
❖Then the capsule is removed
20. Manufacture of soft gelatin capsule
2. Rotatory Machine :
❖ In this process the die cavities are machined into the outer
surface of the two rollers
❖ Gelatin is properly weighed & dispensed in melting
temperature under vacuum of 93’c
❖ Two plasticizedgelatin ribbons are continuously and fed
with the liquid or paste fill b/w the rollers of the rotatory
die mechanism
❖ As the die rolls rotate, the convergence of the matching die
packets seals & cuts out the filled capsules
21. Manufacture of soft gelatin capsule
3. Accogel capsule Machine :
❖ It consists of 3 parts : 1. measuring roll
2. die roll
3. sealing roll
❖ As the measuring roll and die rolls rotate, the measured doses
are transferred to the gelatin – linked pocket of the die roll.
❖ The continued rotation of the filled die converges with the
rotating sealing roll where a 2nd gelatin sheet is applied to form
the other half of the capsule
❖ Pressure developed b/w the die roll and sealing roll seals and
cuts out the capsules