Comparative Bioavailability of Two Extemporaneous Solid Formulations of Carbamazepine against the Innovator in Mexican Healthy Subjects

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dc.contributor.authorAraujo, Aurigena Antunes de
dc.contributor.authorGuerra, Gerlane Bernardo Coelho
dc.contributor.authorSolon, Lílian Grace da Silva
dc.contributor.authorDibildox, Estela
dc.contributor.authorPerez-Urizar, Jose
dc.contributor.authorEscobedo-Moratilla, Abraham
dc.contributor.authorTorres-Roque, Irma
dc.contributor.authorMartinez-Delgado, Maricela
dc.contributor.authorZapata-Morales, Juan Ramon
dc.contributor.authorSoares, Luiz Alberto Lira
dc.contributor.authorCovarrubias-Pinedo, Amador
dc.date.accessioned2018-06-16T11:51:25Z
dc.date.available2018-06-16T11:51:25Z
dc.date.issued2014-03-04
dc.description.resumoExtemporaneous 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 levels of carbamazepine were determined by HPLC. Main findings of the study include that peak of plasma carbamazepine was faster following the extemporaneous capsules as compared to reference (Tmax: A: 6.58 h; B: 4.83 h vs 8.25-10.00 h, respectively), although no changes was observed in Cmax (A: 3.32 μg/mL; B: 3.10 μg/mL vs C: 3.14-2.85 μg/mL) neither in AUC0-t (A: 116.34 μg*h/mL; B: 145.66 μg*h/mL vs C: 123.18-138.37 μg*h/mL). The elimination half-life that ranged between 38.64-61.29 h but not difference were observed between all formulations. By using bioequivalence statistics it appears that A-Formula® or Formule® is bioequivalent to Tegretol® in terms of AUC0-t but not regarding Cmax. In conclusion, we demonstrated that two extemporaneous capsules of carbamazepine, A-Formula® and Formule® show similar concentration-time profiles to the reference tablet of immediate Tegretol®, however further studies with longer sample size are needed to confirm its bioequivalence and interchangeability.pt_BR
dc.identifier.citationARAÚJO, Aurigena Antunes de et al. Comparative Bioavailability of Two Extemporaneous Solid Formulations of Carbamazepine against the Innovator in Mexican Healthy Subjects. Journal of Bioequivalence & Bioavailability, v. 6, p. 033-037, 2014. Disponível em: <https://www.omicsonline.org/open-access/comparative-bioavailability-of-two-extemporaneous-solid-formulations-of-carbamazepine-against-the-innovator-in-mexican-healthy-subjects-jbb.1000177.php?aid=25060>. Acesso em: 19 mar. 2018.pt_BR
dc.identifier.doihttp://dx.doi.org/10.4172/jbb.1000177
dc.identifier.issn0975-0851
dc.identifier.urihttps://repositorio.ufrn.br/jspui/handle/123456789/25422
dc.languageengpt_BR
dc.publisherOMICS Internationalpt_BR
dc.rightsAcesso Abertopt_BR
dc.subjectCarbamazepinept_BR
dc.subjectPharmacokineticspt_BR
dc.subjectAnti-epilepticspt_BR
dc.subjectHPLCpt_BR
dc.subjectBioavailabilitypt_BR
dc.subjectBioequivalencept_BR
dc.titleComparative Bioavailability of Two Extemporaneous Solid Formulations of Carbamazepine against the Innovator in Mexican Healthy Subjectspt_BR
dc.typearticlept_BR

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