J Clin Pharmacol
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METHODS

In Vivo Disintegration Profiles of Encapsulated and Nonencapsulated Sumatriptan: Gamma Scintigraphy in Healthy Volunteers

Ian R. Wilding, PhD, Darren Clark, PhD, Heather Wray, MD, Jeff Alderman, PhD, Nancy Muirhead, MS and Carolyn R. Sikes, PhD

From Pharmaceutical Profiles, Ltd, Nottingham, United Kingdom (Dr Wilding, Dr Clark, Dr Wray) and Pfizer, Inc, New York (Dr Alderman, Ms Muirhead, Dr Sikes).

The goal of this exploratory pilot study was to use gamma scintigraphy to evaluate, under physiological conditions, disintegration profiles of encapsulated and nonencapsulated formulations of 100 mg sumatriptan. Using a crossover design, healthy volunteers (n = 10) ingested 100-mg doses of sumatriptan tablets radiolabeled with 111Indium, as well as encapsulated sumatriptan tablets that were prepared similarly, then placed within a gelatin capsule and backfilled with an excipient blend radiolabeled with 99mTechnetium. A gamma camera recorded scintigraphic images until 5 hours postdose. Initial disintegration of the gelatin capsule was observed at a mean (range) of 5 minutes (1-11 minutes); disintegration was complete within 14 minutes (5-24 minutes). For nonencapsulated versus encapsulated tablets, the mean (± standard deviation) time to initial disintegration (6 ± 5 minutes vs 8 ± 5 minutes) and time to complete disintegration (18 ± 14 minutes vs 16 ± 7 minutes) were comparable. Results of this study demonstrate that encapsulated and nonencapsulated sumatriptan have equivalent in vivo dissolution rates.

Key Words: Sumatriptan • encapsulation • disintegration • bioequivalence • gamma scintigraphy

Address for reprints: Carolyn R. Sikes, Pfizer, Inc, 235 E 42nd Street, New York, NY 10017.






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