Special Use: Capsule Key Facts

Pharmacopoeia Standards	Comply with U.S., European and Japanese Pharmacopoeias
Dissolution Time	Within 30 minutes (BP 1980 and USP XX test methods: 37°C water and specified apparatus).
Gelatin Properties	Gelatin is a macromolecular protein and is physiologically inert. Gelatin is considered pharmacologically relatively inert with the exception of: aldehydes, strong acids or bases and materials with significant free moisture.
Capsule Sizes & Colors	Available clear (without color) in 7 sizes ranging from 3ml to 26ml. Special colors, custom size, wall thickness and dissolution time made to order.
Fill Materials	Capsules may be filled with dry materials in any form, and non-aqueous liquids or pastes, parts or even foam sponges. Aldehydes, strong acids or bases may react with the gelatin shell.
Filling	Filling machinery for capsules is available from Torpac. Capsules can also be filled using powder filling machinery suitable for filling vials.
Packaging	Air tight containers are recommended: »Plastic bag in a cardboard box or jar. »Blister or strip packing.
Dissolution	Gelatin dissolves in aqueous (water) solutions above 37C. At temperatures between 30-37C dissolution may occur due to presence of enzymes, bacteria or acids. Special capsules with thin walls or holes may dissolve faster.