Course Description:
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.
Upon completion of this course, you will be able to:
- 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
Who Should Participate:
- 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.
The live version of this recording took place on April 4, 2024.
Access Duration:
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
USP Approved Instructor
Dr. Margareth R. C. Marques
Principal Scientific Liaison, USP
Ph.D., Analytical Chemistry, State University of Campinas