DEFINITION

Hard Gelatin Capsule Shells consist of two overlapping pieces (cap and body). One end of each piece is rounded, or other suitable shape, and closed, while the other is open. The cap overlaps the body and maintains a tight closure. Hard Gelatin Capsule Shells are composed of gelatin and water, and may also contain additives such as opacifiers, colorants, plasticizers, flavoring agents, antimicrobial agents, and sweeteners. They may contain processing aids such as surfactants, lubricants, and dispersing agents. They may be externally coated and imprinted.