Use of Enzymes in the Dissolution Testing of Gelatin Capsules

Use of Enzymes in the Dissolution Testing of Gelatin Capsules

Margareth R. C. Marques, M.Sc., Ph.D. Principal Scientific Liaison

Revisions to USP - NF

Pharmacopeial Forum (PF)

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Gelatin Capsule Working Group

Early 90s Study noncompliance of gelatin capsule products

during in vitro dissolution tests and potential changes in bioavailability CDER/FDA, pharmaceutical industry trade associations, gelatin capsule manufacturers, USP, and academia Protocol using differentially stressed hard and soft gelatin capsules

(Ref 4 and 11)

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 Dissolution (USP 38)

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 Dissolution

Chapter harmonized with the European and Japanese Pharmacopoeias

The blue highlighted text in the previous slide is not harmonized (USP national text).

Any revision will be done to this USP national text.

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