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Does anyone have any experience with dosing in a Phase I study using
multiple gelatin capsules? I'm wondering if giving 10 to 20 capsules
on a single occaision will alter drug absorption. Unfortunately, we
cannot give dose of current drug formulation in a smaller number of
capsules. I'm not sure of the capsule size being used.
--
Dan Combs
Combs Consulting Service
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Dan-
I am aware of a recent study where up to 16 capsules were
administered. There was no apparent evidence of giving the large
number of capsules, but I was definitely concerned. The drug was
quite well behaved pharmacokinetically and quite soluble (though not
particularly great bioavailability).
Hope this helps.
Tom
Thomas L. Tarnowski, Ph.D.
Bioanalytical Development
Elan Pharmaceuticals, Inc.
800 Gateway Boulevard
South San Francisco, CA 94080
thomas.tarnowski.aaa.elan.com
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The following message was posted to: PharmPK
Hi Dan,
I have used 8 capsules in a Phase 1 study and there was no apparent
loss or delay in absorption if memory serves me well. I imagine that
factors like greater surface area and delayed antral exit by the last
capsules tend to balance out.
There is the risk of forming a congealed mass that slows gastric
emptying and drug release but as far as I know that is a rarity and
would be countered by large enough group sizes.
Larger numbers of capsules are often used to maintain a blind and
that means that some doses will include placebos. I think it is
unlikely they would alter absorption, although someone else might
know of a case.
Good luck with the study
Andrew Sutton
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