Journal of Bioequivalence & Bioavailability

Bioequivalency study for inhaled drugs: a pharmacodynamic approache

2^nd World Congress on Bioavailability & Bioequivalence: Pharmaceutical R & D Summit-2011 and International Conference on Pharmaceutics & Novel Drug Delivery Systems

06-08 June 2011, Las Vegas, USA

Luciana Fernandes Duarte, Eduardo Abib Junior

Scientific Tracks Abstracts: JBB

Abstract:

T he study was performed to evaluate the pharmacodynamics response of test formulation of formoterol 6 mcg associated with 200 mcg budesonide (Test formulation from Biosint�tica Farmac�utica Ltda and reference formulation from AstraZeneca, Brazil) in 27 volunteers of both sexes. Th e study was conducted open randomized 2 period crossover balanced design with a 36 days wash out period between the doses. Th e formoterol and budesonide were analyzed by evaluation of the pharmacodynamic test and reference formulations was performed by Spirometry comparing the process to prevent wheezing illness induced by methacholine. Th e mean ratio of parameters AUC 0-t and 90% confi dence intervals of correspondents were calculated to determine the pharmacodynamics response. Geometric mean for the test and reference formulation of formoterol with budesionida in the form of dry powder in capsule was AUC 0-t ratio (test/reference: 101.70% [98.53% - 104.98%]). Considering the confi dence intervals (90%) of the ratios between the geometric means for the test and reference formulation of formoterol with budesionida in the form of dry powder in capsule parameter AUC 0-t , which, being a pharmacodynamic study in which intervals for determination of therapeutic equivalence are not yet established and that the limits of the confi dence interval of the parameters studied are within the range established in 1170 by RE (ANVISA) for pharmacokinetic parameters, concluded that the formulation of formoterol with budesionida in the form of dry powder in a capsule being marketed by Biosint�tica Pharmaceuticals Ltd. is therapeutically equivalent to about pharmacodynamic evaluation to the formulation of Symbicort � produced by AstraZeneca Brazil

Biography :

Eduardo Abib Junior has completed his Ph.D studies from University of Campinas (UNICAMP). He is the director of Scentryphar, a Clinical Research service organization and President Brazilian Association of Bioavailability and Bioequivalence Centers. He has published more than 40 papers in reputed journals and serving as an editorial board member of repute. Participated in more than 08 Committees examinations theses, Invited Speaker and Instructor in the area of clinical research