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Executive Summary

GELATIN CAPSULE PELLICLE FORMATION DOES NOT AFFECT IN VIVO RELEASE FDA and industry have tentatively concluded. The conclusion that currently marketed gelcap drug products do not pose immediate concern with regard to dissolution failures resulted from a March 1 meeting between industry and FDA on in vitro dissolution testing of soft and hard gelatin capsules. FDA's Office of Generic Drugs called the meeting "to discuss recent findings in the field concerning multiple hard and soft gelatin capsuled products failing dissolution testing due to pellicle formation." While most of the meeting participants concluded that the formation of a skin-like film on the gelatin capsules of certain drug products does not reflect a serious in vivo problem at the current time, FDA said it plans to form a working group "to address science and regulatory issues associated with these dosage forms." FDA added that "further effort on the topic will occur at [the Center for Drug Evaluation and Research] under the direction of the newly formed Chemistry, Manufacturing and Controls Coordination Committee (CMCCC)." FDA said a joint agency and industry open workshop on gelcaps may be held in the future. FDA's field findings had received a preliminary evaluation by a task force convened by the CMCCC headed by OGD Director Roger Williams and Office of Drug Evaluation I Assistant Director for Chemistry Charles Kumkumian. The task force had recommended further evaluation of the problem to determine whether the in vitro dissolution data is an indicator of in vivo bioavailability for the gelatin capsule products. FDA and industry plan to continue to look at the available data to determine whether pellicle formation has any affect on the in vivo performance of drugs. They also will study whether an in vitro dissolution test may be developed to better indicate how the gelap products dissolve in patients' stomachs. Meeting attendees included representatives from the U.S. Pharmacopoeia, the Generic Pharmaceutical Industry Association, the National Association of Pharmaceutical Manufacturers, the National Pharmaceutical Alliance and the Pharmaceutical Manufacturers Association. Representatives from gelatin capsule manufacturers Warner-Lambert, Lilly and R.P. Scherer participated in the meeting.

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