The current requirement of the Mexican Authorities to demonstrate the interchangeability of ranitidine formulations is to establish that the dissolution profile of the drug shows similarity. In order to establish if this requirement is adequate, the bioavailability of two formulations that did not m
Comparative bioavailability of two oral formulations of ketorolac tromethamine: Dolac® and Exodol®
✍ Scribed by Francisco J. Flores-Murrieta; Vinicio Granados-Soto; Gilberto Castañeda-Hernández; Jorge E. Herrera; Enrique Hong
- Publisher
- John Wiley and Sons
- Year
- 1994
- Tongue
- English
- Weight
- 377 KB
- Volume
- 15
- Category
- Article
- ISSN
- 0142-2782
No coin nor oath required. For personal study only.
✦ Synopsis
Abstract
The bioavailability of ketorolac after administration of two oral formulations containing 10 mg of ketorolac tromethamine, Exodol^®^ and Dolac^®^, to 12 healthy Mexican volunteers was compared. Subjects received both formulations according to a randomized crossover design and blood samples were drawn at selected times during 24 h. Ketorolac plasma concentrations were determined by HPLC and individual plasma‐concentration‐against‐time curves were constructed. Maximal plasma concentration and AUC~0‐24~. values were compared by analysis of variance followed by Westlake's confidence interval test. 90% confidence limits ranged from 80 to 125% for C~max~ and from 85 to 118% for AUC~0‐24~. It is concluded that the two assayed formulations are bioequivalent.
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