Capsules
Capsules are solid medication forms in which the drug is contained in an outer coating. Both the active and inactive ingredients are held together by the coating.
The most common type of coating is a gelatine shell. The gelatine shells are made of protein from animals. The smooth surface of the gelatine shells allow for easier swallowing. Gelatine shells are classified into two types: hard a soft. Soft gelatine shells have had ingredients added to the shell to give it a soft, elastic consistency. This allows the capsule to be flexible during administration. The two halves of the soft capsules are sealed together and cannot be broken apart. The shape of soft capsules can vary from round to oblong. They are filled with powdered, pasty, or liquid medications. The soft gelatine capsule is broken apart in the body during absorption to allow the medication to
Be distributed to the body. Hard gelatine capsules are characterized by two oblong halves joined together. These capsules are filled with a powdered substance and often intended for oral administration. They are to be swallowed whole. One advantage of a hard gelatine capsule is that it can be broken open and its contents sprinkled over a food substance or into water before administration. This is helpful for patients who are not able to swallow a whole capsule. The ingredients will be dissolved more quickly outside the gelatine shell
Capsules are solid preparations with hard or soft shells of various shapes and capacities, usually containing a single dose of active ingredient. They are intended for oral administration.The capsule shells are made of gelatin or other substance, the consistency of which may be adjusted by the addition of substances such as glycerol or sorbitol. Excipients such as surface-active agents, opaque fillers, antimicrobial preservatives, sweeteners, colouring matter authorised by the competent authority and flavouring substances may be added. The capsules may bear surface markings.The contents of capsules may be solid, liquid or of a paste-like consistency. They consist of one or more active ingredients with or without excipients such as solvents, diluents, lubricants and disintegrating agents. The contents do not cause deterioration of the shell. The shell, however, is attacked by the digestive fluids and the contents are release
Several categories of capsules may be distinguished
PRODUCTION
In the manufacture, packaging, storage and distribution of capsules, suitable means are taken to ensure their microbial quality; recommendations on this aspect are provided in the text on Microbial Quality of Pharmaceutical Preparation (In the Pharmacopoeia).
Hard Capsules
Hard capsules have shells consisting of two prefabricated cylindrical sections.
PRODUCTION
The active ingredient(s) usually in solid form (powder or granules) are filled into one of the sections which is then closed by slipping the other section over it. The security of the closure may be strengthened by suitable means.
Soft Capsules
Soft capsules have thicker shells than those of hard capsules. The shells consist of one part and are of various shapes (usually oval).
PRODUCTION
Soft capsules are usually formed, filled and sealed in one operation but may be prefabricated. The shell material may contain an active ingredient.
Liquids may be enclosed directly; solids are usually dissolved or dispersed in a suitable vehicle to give a solution or dispersion of a somewhat paste-like consistency. There may be partial migration of the constituents from the capsule contents into the shell and vice versa because of the nature of the materials and the surfaces in contact.
Gastro-Resistant Capsules
Gastro-resistant capsules are modified release capsules that are intended to resist the gastric fluid and to release their active ingredient or ingredients in the intestinal fluid. They are prepared by providing hard or soft capsules with a gastro-resistant shell (enteric capsules) or by filling capsules with granules or with particles covered with a gastro-resistant coating.
PRODUCTION
For capsules filled with granules or filled with particles covered with a gastro-resistant coating, a suitable test is carried out to demonstrate the appropriate release of the active ingredient(s).
Modified-Release Capsules
Modified-release capsules are hard or soft capsules in which the contents or the shell or both contain special excipients or are prepared by a special process designed to modify the rate or the place at which the active ingredient(s) are released.
A suitable test is carried out to demonstrate the appropriate release of the active ingredient(s).
TESTS
The tests to be conducted on Capsules can include the following depending on the capsule type.
Content of Active Ingredient
Labeling
The label states
Some of the materials used in the production of a Capsule include,
Capsules are solid medication forms in which the drug is contained in an outer coating. Both the active and inactive ingredients are held together by the coating.
The most common type of coating is a gelatine shell. The gelatine shells are made of protein from animals. The smooth surface of the gelatine shells allow for easier swallowing. Gelatine shells are classified into two types: hard a soft. Soft gelatine shells have had ingredients added to the shell to give it a soft, elastic consistency. This allows the capsule to be flexible during administration. The two halves of the soft capsules are sealed together and cannot be broken apart. The shape of soft capsules can vary from round to oblong. They are filled with powdered, pasty, or liquid medications. The soft gelatine capsule is broken apart in the body during absorption to allow the medication to
Be distributed to the body. Hard gelatine capsules are characterized by two oblong halves joined together. These capsules are filled with a powdered substance and often intended for oral administration. They are to be swallowed whole. One advantage of a hard gelatine capsule is that it can be broken open and its contents sprinkled over a food substance or into water before administration. This is helpful for patients who are not able to swallow a whole capsule. The ingredients will be dissolved more quickly outside the gelatine shell
Capsules are solid preparations with hard or soft shells of various shapes and capacities, usually containing a single dose of active ingredient. They are intended for oral administration.The capsule shells are made of gelatin or other substance, the consistency of which may be adjusted by the addition of substances such as glycerol or sorbitol. Excipients such as surface-active agents, opaque fillers, antimicrobial preservatives, sweeteners, colouring matter authorised by the competent authority and flavouring substances may be added. The capsules may bear surface markings.The contents of capsules may be solid, liquid or of a paste-like consistency. They consist of one or more active ingredients with or without excipients such as solvents, diluents, lubricants and disintegrating agents. The contents do not cause deterioration of the shell. The shell, however, is attacked by the digestive fluids and the contents are release
Several categories of capsules may be distinguished
- hard capsules
- soft capsules
- gastro-resistant capsules
- modified-release capsules.
PRODUCTION
In the manufacture, packaging, storage and distribution of capsules, suitable means are taken to ensure their microbial quality; recommendations on this aspect are provided in the text on Microbial Quality of Pharmaceutical Preparation (In the Pharmacopoeia).
Hard Capsules
Hard capsules have shells consisting of two prefabricated cylindrical sections.
PRODUCTION
The active ingredient(s) usually in solid form (powder or granules) are filled into one of the sections which is then closed by slipping the other section over it. The security of the closure may be strengthened by suitable means.
Soft Capsules
Soft capsules have thicker shells than those of hard capsules. The shells consist of one part and are of various shapes (usually oval).
PRODUCTION
Soft capsules are usually formed, filled and sealed in one operation but may be prefabricated. The shell material may contain an active ingredient.
Liquids may be enclosed directly; solids are usually dissolved or dispersed in a suitable vehicle to give a solution or dispersion of a somewhat paste-like consistency. There may be partial migration of the constituents from the capsule contents into the shell and vice versa because of the nature of the materials and the surfaces in contact.
Gastro-Resistant Capsules
Gastro-resistant capsules are modified release capsules that are intended to resist the gastric fluid and to release their active ingredient or ingredients in the intestinal fluid. They are prepared by providing hard or soft capsules with a gastro-resistant shell (enteric capsules) or by filling capsules with granules or with particles covered with a gastro-resistant coating.
PRODUCTION
For capsules filled with granules or filled with particles covered with a gastro-resistant coating, a suitable test is carried out to demonstrate the appropriate release of the active ingredient(s).
Modified-Release Capsules
Modified-release capsules are hard or soft capsules in which the contents or the shell or both contain special excipients or are prepared by a special process designed to modify the rate or the place at which the active ingredient(s) are released.
A suitable test is carried out to demonstrate the appropriate release of the active ingredient(s).
TESTS
The tests to be conducted on Capsules can include the following depending on the capsule type.
Content of Active Ingredient
- Uniformity of content
- Uniformity of mass
- Dissolution/Disintegration
Labeling
The label states
- the quantity of the active ingredient contained in each Capsule
- the date after which the Capsules are not intended to be used
- the conditions under which the Capsules should be stored.
Some of the materials used in the production of a Capsule include,
- Modified Maize starch,
- Glycerol,
- Gelling agent