
USP is working on revising procedures in USP–NF general chapters that allow for the use of enzymes in the dissolution testing of capsules in the presence of cross-linking. To gather input on possible changes, USP invites pharmaceutical and dietary supplement companies to participate in this interactive workshop. Discussion will focus on manufacturing, formulation, storage, and packaging conditions that could impact dissolution testing of any type of capsule containing any type of filling.
Topics Include
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Manufacture of hard and soft capsules, including nongelatin capsules and capsules containing lipophilic filling
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Causes of cross-linking in gelatin capsules (formulation, storage conditions, etc.)
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Modified-release capsules
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Use of enzymes in dissolution testing of cross-linked gelatin capsules
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Dissolution testing of dietary supplements
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Revisions to General Chapters <711> Dissolution, <1094> Capsules—Dissolution Testing and Related Quality Attributes, and <2040> Disintegration and Dissolution of Dietary Supplements
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Validation and verification of dissolution procedures using enzymes
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Case studies
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