Definition of Hard Gelatin Capsules:
Capsules are solid dosage forms in which the drug substance (active pharmaceutical ingredient, API) and excipients are enclosed in a soluble container or shell.
Hard gelatin capsules (HGCs) are two-piece shells consisting of a body and a cap.
Composition of Shell:
Typically composed of gelatin, water, and small quantities of opacifying agents (e.g., titanium dioxide), colorants, and/or dyes.
Advantages:
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).
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.