Use of enzymes in the dissolution testing of gelatin capsules and gelatin-coated tablets— revisions to dissolution <711> and disintegration and dissolution of dietary supplements <2040>

Abstract

A revision to the general chapters Dissolution <711> and Disintegration and Dissolution of Dietary Supplements <2040> is being proposed to address the shortcomings of the current chapters regarding the use of enzymes in the dissolution test of gelatin capsules or gelatin-coated tablets. The recommendations are to use the enzymes pepsin (medium with pH equal to or below 4.0), papain or bromelain (medium with pH above 4.0 and below 6.8), and pancreatin (medium with pH equal to or above 6.8) if the dosage form does not comply to the appropriate Acceptance Table or, in the case of dietary supplements, appropriate Tolerances requirements due to the presence of cross-linking in the gelatin. Also, the revision clarifies how the enzyme activity should be determined, the amount of enzymes to be added to the medium, and a pre-treatment procedure to be used when the dissolution medium contains surfactant or any other ingredient known or suspect to inactivate the enzyme being used. This Stimuli article provides the rationale for these revisions and presents data to support the recommendations being made. Readers are encouraged to send any comments, questions, suggestions or data to the corresponding author. Also, see the section Other Related Revisions at the end of this article for information on other related general chapters and monographs.