Bioavailability of immediate- and extended-release formulations of glipizide in healthy male volunteers

Clinical Pharmacokinetics
Sanju DhawanVivek Ranjan Sinha

Abstract

An extended-release glipizide formulation using a hydrophilic matrix system containing hydrophilic polymers has been developed for use in diabetes mellitus. This study compared the pharmacokinetic parameters of immediate- and extended-release formulations of glipizide 5mg in healthy male volunteers. In a single-dose, four-period, four-treatment, Latin-square crossover study, the bioavailability of immediate-release glipizide 5mg (Glynase) [GL], extended-release glipizide 5mg (Glynase) XL [GLXL], Glucotrol XL [GTXL], and the new formulation developed in our laboratory [GLPF]) was compared. Plasma glipizide levels of the four formulations were determined at different time intervals, and pharmacokinetic parameters were analysed using a two-compartment body model. The mean peak plasma concentration (C(max)) of the immediate-release formulation (523+/-60 ng/mL) was significantly higher (p<0.05) than those of the three extended-release formulations (403+/-24, 349+/-37 and 426+/-55 ng/mL for GLXL, GTXL and GLPF, respectively). Mean time to reach C(max) was 1.83+/-0.3 hours for GL, 4.41+/-1.2 hours for GLXL, 3.21+/-0.8 hours for GTXL and 3.24+/-0.4 hours for GLPF. The order of magnitude of area under the plasma concentration-time curve...Continue Reading

References

Feb 1, 1978·Journal of Pharmacokinetics and Biopharmaceutics·K C Yeh, K C Kwan
Jan 1, 1988·Acta Medica Scandinavica·P ReichardU Rosenqvist

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Citations

May 20, 2008·BJU International·François Giuliano, Wayne J G Hellstrom
Oct 2, 2008·Biological & Pharmaceutical Bulletin·Animesh GhoshTapan Kumar Pal

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