Cross-Linking of Gelatin Capsule Shells - Agilent
Cross-Linking of Gelatin Capsule Shells
Ken Boda Applications Engineer Agilent
Agenda
? Gelatin and Cross-Linking ? USP Procedure pre-40(6) ? 40(6) Revisions to USP and
? Failures ? Prevention of Cross-Linking
What is Gelatin?
? Hydrolyzed form of collagen ? Collagen is obtained from various
animal by-products ? Used as a gelling agents in a
variety of applications:
? Food ? Cosmetics ? Photography ? Pharmaceuticals
What is Cross-Linking?
Cross-linking is the "formation of strong chemical linkages beyond simple hydrogen and ionic bonding between gelatin chains." ? Reaction is generally irreversible ? Renders gelatin insoluble ? Reaction catalyzed by a number of chemical and
environmental factors
*From USP Stimuli to the Revision Process, Use of Enzymes in the Dissolution Testing of Gelatin Capsules and Gelatin-Coated Tablets ? Revisions. USP-PF 40(6)
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