Capsule Flashcards
(15 cards)
Capsule
Capsules are defined as solid preparation with hard or soft shells of various shapes and capacities, usually contain a single dose of active ingredients and are intended for oral administration.
The word capsule is derived from the Latin capsula, meaning a small box.
Components
shell, contents
Shell
Shell is the the outer covering or reservoir in which the active ingredient is encapsulated.
Hard gelatin capsule shell:
The hard capsule shell consists of two pieces in the form of cylinders closed at one end. The shorter piece is called the ‘cap’, fits over the open end of the longer piece, called the ‘body’.
Soft gelatin capsule shell:
The shell of a soft gelatin capsule is a single, flexible piece.
Content
The content of a capsule is the material which is encapsulated inside the shell, which contain the active pharmaceutical ingredient and excipients. It can be solid, semi-solid, or liquid.
classification
formulation, route of administration, size
Formulation
. Formulation:
Depending on formulation capsules are classified as:
i. Hard gelatin capsule:
Hard gelatin capsules are clear, colorless and essentially taste less two-piece capsules which are prepared from a mixture of gelatin, sugar and water and the drug substances are enclosed inside the shells.
E.g. Antibiotic capsule.
ii. Soft gelatin capsules:
Soft gelatin capsules are soft, globular, one piece, gelatin shelled capsules which are somewhat thicker than the hard gelatin capsules
E.g. vitamin E capsules.
Route of administration
Depending on routes of administration capsules are classified as:
i. Oral capsules:
Capsules which are administered through oral route are called oral capsules.
E.g. Antibiotic capsule.
ii. Vaginal capsules:
Capsules which are administered through vaginal root are called vaginal capsules.
E.g. AVC suppositories, which are soft gelatin capsules.
iii. Rectal capsules:
Capsules which are administered through rectal road are called rectal capsules.
E.g. Emesert inserts, which are soft gelatin capsules.
Size
Depending on size capsules are classified as:
i. 000 size capsule:
is a Capsule with an approximate volume capacity of 1.37 mL and a fill weight capacity of 1gm. It is the largest size hard gelatin capsule.
ii. 00 size capsule:
is a Capsule with an approximate volume capacity of 0.95 mL and a fill weight capacity of 0.65 gm.
iii. 0 size capsule:
is a Capsule with an approximate volume capacity of 0.68 mL and a fill weight capacity of 0.50 gm.
iv. 1 size capsule:
is a Capsule with an approximate volume capacity of 0.50 mL and a fill weight capacity of 0.32gm.
v. 2 size capsule:
is a Capsule with an approximate volume capacity of 0.37 mL and a fill weight capacity of 0.25gm.
vi. 3 size capsule:
is a Capsule with an approximate volume capacity of 0.30 mL and a fill weight capacity of 0.20gm.
vii. 4 size capsule:
is a Capsule with an approximate volume capacity of 0.21 mL and a fill weight capacity of 0.15gm.
viii. 5 size capsule:
is a Capsule with an approximate volume capacity of 0.13 mL and a fill weight capacity of 0.10gm. It is the smallest size hard gelatin capsule.
Preparation of hard gelatin capsules
Selection of Capsule Size:
Choose the appropriate capsule size based on the volume and weight of the fill material.
Preparation of Fill Material:
If the active material is solid, blend it to powder form to reduce particle size. Ensure the material is homogenous and free-flowing, often requiring blending with excipients like diluents, glidants, and lubricants.
Filling Process:
Filling can be:
Manual Filling: Suitable for small-scale operations; the fill material is manually placed into the capsule body.
Automated Filling: For large-scale production, automated machines orient, separate, fill, and rejoin the capsules.
Sealing:
Techniques like banding or liquid sealing are used to secure the capsule cap and body together, preventing tampering and ensuring integrity.
Polishing:
Polishing removes any powder residues and enhances the appearance, done using a polishing cloth or machine.
Storage and Packaging:
Store in a cool, dry place, and use appropriate packaging to protect against moisture, light, and mechanical damage.
Preparation of soft gelatin capsules
plate process, rotatory process,reciprocating process, accogel process
Plate process
. Plate Process:
Gelatin Preparation:
Gelatin, plasticizers, and other ingredients are mixed to form a viscous solution.
Plate Molding:
The gelatin solution is spread over a flat plate with multiple cavities (molds) of the desired capsule shape and size.
Filling:
The fill material, usually in liquid form, is injected into the gelatin-filled cavities.
Sealing:
A second layer of gelatin is applied over the cavities to seal the fill material inside.
Drying:
The capsules are dried to remove excess moisture, solidifying the gelatin shells and ensuring stability.
Rotatory process
. Rotary Die Process:
The Rotary Die Process is a highly automated method used for the mass production of soft gelatin capsules.
Spreading of gelatin solution:
The gelatin solution is first spread on two rotated drums that form a pair of sheet of gelatin.
Feeding of a sheet of gelatin:
The sheet pairs of gelatin are fed between two matching rotatory dies, which have cavities with the help of injection wedge.
Filling:
The fill material, typically in liquid form, is injected into the space between the two gelatin ribbons.
Sealing:
The ribbons are pressed together and cut into capsule lengths, simultaneously sealing the fill material inside each capsule.
Drying:
The capsules are dried in controlled conditions to remove excess moisture, ensuring the gelatin shells solidify and stabilize.
Trimming and Polishing:
Capsules may undergo trimming to remove any excess gelatin and polishing to improve their appearance.
Reciprocating dye process
The Reciprocating Die Process is a method used in the production of soft gelatin capsules.
Gelatin Preparation:
Gelatin, plasticizers, and other additives are mixed and heated to form a gelatin solution or mass.
Die System:
The gelatin mass is fed into a reciprocating mold or die system, which consists of individual cavities or molds of the desired capsule size and shape.
Filling:
The fill material, usually in liquid form, is injected into the gelatin-filled cavities using precise metering systems.
Sealing:
The filled cavities are sealed using a heated platen or die that presses against the gelatin, ensuring a secure closure and encapsulation of the fill material.
Drying:
The sealed capsules undergo drying in controlled conditions to remove excess moisture, solidifying the gelatin shells and ensuring stability.
Trimming and Inspection:
After drying, capsules may be trimmed to remove any excess gelatin and undergo visual inspection to ensure quality and uniformity.
Accogel process
Gelatin Solution Preparation:
Gelatin, plasticizers (like glycerin or sorbitol), and other additives are mixed and heated to form a homogeneous gelatin solution.
Molding:
The gelatin solution is metered into a mold that forms individual capsule cavities of the desired size and shape.
Filling:
The fill material, often in liquid or semi-solid form, is injected into each gelatin cavity.
Sealing:
Another layer of gelatin is applied over the filled cavities, sealing the fill material inside each capsule.
Cooling:
The capsules are cooled in a controlled environment to solidify the gelatin shells and stabilize the fill material.
Drying:
Capsules undergo drying to remove excess moisture, ensuring the gelatin shells achieve the desired hardness and stability.
Trimming and Polishing:
Capsules may be trimmed to remove any excess gelatin and polished to enhance their appearance.
Application
Pharmaceutical Applications:
Oral Drug Delivery: Ideal for delivering liquid or semi-solid medications that are poorly soluble or require controlled release.
Encapsulation of Volatile or Sensitive Ingredients: Protects active pharmaceutical ingredients (APIs) from degradation due to oxygen or moisture.
Ease of Swallowing: Soft gelatin capsules are easier to swallow compared to tablets, making them suitable for pediatric and geriatric patients.
Taste and Odor Masking: Helps mask unpleasant tastes or odors of medications, enhancing patient compliance.
Nutraceutical Applications:
Dietary Supplements: Encapsulate vitamins, minerals, and herbal extracts.
Omega-3 Fatty Acids: Deliver fish oil and other essential fatty acids.
Sports Nutrition: Provide convenient and precise doses of amino acids, creatine, and other sports supplements.Cosmetics and Personal Care:
Skincare Products: Encapsulate active ingredients for enhanced skin penetration and efficacy.
Hair Care: Deliver vitamins, oils, and nutrients for hair health.
Veterinary Use:
Animal Health Products: Deliver medications and supplements to pets and livestock in a palatable form.
Specialty Applications:
Diagnostic Agents: Encapsulate contrast agents for imaging studies.
Industrial Applications: Encapsulate dyes, lubricants, and other chemicals for controlled release.
