Introduction to Hard Gelatin Capsules:
Definition:
- Capsules are solid dosage forms in which the drug substance (active pharmaceutical ingredient, API) and excipients are enclosed in a soluble container or shell.
- These capsules are cylindrical shells made from gelatin, designed to hold solid or semi-solid drugs. They consist of a cap and body that lock together to enclose the medication.
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Composition of Shell:
- Typically composed of gelatin, water, and small quantities of opacifying agents (e.g., titanium dioxide), colorants, and/or dyes.
Advantages of Hard gelatin capsules:
- Ideal for delivering powdered, granular, or pelletized formulations.
- Mask unpleasant tastes and odors.
- Offer versatility in drug formulation (can accommodate multiple APIs or modified-release beads).
- Generally, have a faster disintegration time than tablets (leading to quicker onset of action).
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Disadvantages:
- More expensive manufacturing process than simple tableting.
- Potential for capsule tampering (though modern banding and sealing can mitigate this).
- Sensitivity to moisture and humidity.
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