Journal of Bioequivalence & Bioavailability

Estela Dibildox

Publications

• Research Article
  Comparative Bioavailability of Two Extemporaneous Solid Formulations of Carbamazepine against the Innovator in Mexican Healthy Subjects
  Author(s): Aurigena Antunes de Araujo Ferreira, Gerlane Bernardo Coelho Guerra, Lílian Grace da Silva Solon, Estela Dibildox, Jose Perez-Urizar, Abraham Escobedo-Moratilla, Irma Torres-Roque, Maricela Martinez-Delgado, Juan Ramon Zapata-Morales, Luiz Alberto Lira Soares and Amador Covarrubias-PinedoAurigena Antunes de Araujo Ferreira, Gerlane Bernardo Coelho Guerra, Lílian Grace da Silva Solon, Estela Dibildox, Jose Perez-Urizar, Abraham Escobedo-Moratilla, Irma Torres-Roque, Maricela Martinez-Delgado, Juan Ramon Zapata-Morales, Luiz Alberto Lira Soares and Amador Covarrubias-Pinedo
  
  Extemporaneous or off-label prescribing is not illegal and may sometimes be clinically and economically appropriate. However it is associated with a number of clinical, safety and ethical issues. Bioequivalence of these products must be proven before they are used in place of patent medicines. In the present study, a single-center, open, randomized, single-dose, 2-period crossover, 2-sequences pilot assay (two subgroups with n=6) was carried out to evaluate the bioavailability of two extemporaneous capsule of carbamazepine (200 mg): A-Formula® (A); and Formule® (B) in comparison to a tablet of the innovator product Tegretol® (C). Twelve healthy volunteers were randomly assigned to one of two arms to receive one test/reference formulation and following a two week wash-out period they received the other compound. Blood sampling was performed over 72 hours after dosing and.. View More»
  DOI: 10.4172/jbb.1000177

  Abstract PDF