USP Excipients Workshop: Introduction to Pharmaceutical Excipients (On-Demand)

Curriculum

Course Description:

  • Excipients are a very diverse group of materials. They are not active pharmaceutical ingredients (APIs), pharmaceutical finished products or simply “inert carriers.”
  • We must understand the properties and limitations of excipients. Excipient variability must be recognized and built into formulation and process design and development.
  • The transition to continuous manufacturing will require some new understanding of excipients.
  • Excipients are used in regulated products.
    • Excipients listed in the FDA Center for Drug Evaluation and Research Inactive Ingredient Database (IID) are part of an approved drug product. IID does not include excipients for products marketed on the basis of Biologics License Applications.
    • Excipients may also appear in the National Institutes of Health DailyMed list. USP communicates with FDA on a case-by-case basis about whether there is a need for development of a compendial standard.

Featuring Chris Moreton, Ph.D., Vice Chair, USP Excipient Monographs 1 Expert Committee (EC)

Access Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.

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