This webinar discusses the procedure to be used in the dissolution testing of gelatin capsules when they fail the two-tier dissolution test. The webinar will include discussion of crosslinking in gelatin, its causes and prevention; quality requirements of the enzymes to be used and the procedure to determine their activity; and alternative procedures when the dissolution medium contains surfactants. A report on the activities related to the revision of this procedure in USP General Chapter <711> Dissolution will be presented.

Subject area:
Drug Products & APIs

Objectives (If applicable):
– Learn to identify the presence of crosslinking in gelatin capsules and possible ways of avoiding it
– Learn to run the dissolution test of gelatin capsules in the presence of crosslinking
– Understand the key elements:
– Determination of enzymatic activity for pepsin and pancreatin
– Procedure to be used when the dissolution medium contains surfactants

Target Audience (If applicable):
– Analysts who develop and/or execute dissolution testing of gelatin capsules.
– Formulators who are developing products in gelatin capsules.
– Materials managers who receive and store empty gelatin capsules.
– Stability studies managers who coordinate the studies of finished products filled into gelatin capsules.