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Comparative bioavailability of two oral formulations of ranitidine
Author(s) -
FloresMurrieta Francisco J.,
Toledo Alejandra,
CarrascoPortugal Miriam del Carmen,
ReyesGarcía Gerardo,
RodríguezSilverio Juan,
MedinaSantillán Roberto,
Herrera Jorge E.
Publication year - 2006
Publication title -
biopharmaceutics and drug disposition
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.419
H-Index - 58
eISSN - 1099-081X
pISSN - 0142-2782
DOI - 10.1002/bdd.477
Subject(s) - bioequivalence , bioavailability , cmax , ranitidine , interchangeability , pharmacokinetics , mathematics , chromatography , dissolution testing , pharmacology , chemistry , medicine , biopharmaceutics classification system , computer science , programming language
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 meet this similarity were compared. Twenty‐five female volunteers received 150 mg ranitidine (Azantac ® or Midaven ® ) under fasting conditions in two separate sessions using a cross‐over design. Plasma samples were obtained at selected times for a period of 12 h and stored frozen at −80°C until analysed. Ranitidine plasma levels were determined and pharmacokinetic parameters were obtained. Values (mean ± SEM) were: C max 528.85 ± 25.34 and 563.03 ± 33.25 ng/ml, t max 2.76 ± 0.19 and 2.79 ± 0.18 h, and AUC 12 h 2694.94 ± 99.50 and 2648.51 ± 133.38 ng.h/ml, for Azantac ® or Midaven ® , respectively. No statistically significant difference was obtained in the parameters evaluated. Moreover, 90% confidence limits were 96.6%–116.2% and 90.7%–105.1% for C max and AUC 12 h ratios, respectively, indicating that the formulations tested are bioequivalent, despite the dissimilarity in the dissolution profile of the formulations. These results suggest that the comparative dissolution profile is not an adequate test to demonstrate the interchangeability of ranitidine formulations. Copyright © 2005 John Wiley & Sons, Ltd.