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ISSN: 0975-0851

Journal of Bioequivalence & Bioavailability
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Research Article

Bioequivalency Study for Inhaled Drugs: A Pharmacodynamic Approach

Ricardo Zollner1*, Eduardo Abib Junior1,2*, Luciana Fernandes Duarte2, Maurício Wesley Perroud2 and Antonio Ricardo Amarante2

1Department of Clinical Medicine, Medical Sciences School, State University of Campinas (UNICAMP), 13083-970, Campinas, SP, Brazil

2Scentryphar Clinical Research, 13020-420, Campinas, SP, Brazil

*Corresponding Authors:
Eduardo Abib Junior
Scentryphar Clinical Research
885, Barão de Itapura Ave
Campinas, SP - Brazil. 13020-420
Tel: (19) 3232-6350
Fax: (19) 3231-6715
E-mail: [email protected]

Ricardo Zollner
Department of Clinical Medicine
Medical Sciences School
State University of Campinas (UNICAMP)
13083-970, Campinas, SP, Brazil
Tel: (19) 3521-7098
E-mail: [email protected]

Received Date: July 07, 2011; Accepted Date: October 01, 2011; Published Date: October 03,2011

Citation: Zollner R, Junior EA, Duarte LF, Perroud MW, Amarante AR (2011) Bioequivalency Study for Inhaled Drugs: A Pharmacodynamic Approach. J Bioequiv Availab S1: 004. doi: 10.4172/jbb.S1-004

Copyright: © 2011 Zollner R, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

The study was performed to evaluate the bioequivalence of two marketed dry powder inhaler products formoterol 6 mcg associated with and budesonide 200 mcg Alenia ® from Biosintética Farmacêutica Ltd. and Symbicort ®. AstraZeneca, Brazil) in 27 volunteers patients of both sexes. The study used an open, randomized, 2 period crossover balanced design, with a 36 days wash out period between the doses. The pharmacodynamic evaluation of formoterol and budesonide was performed by Spirometry, comparing the response of the two products to prevent wheezing illness (bronchial obstruction) induced by methacholine. The mean ratio of AUC 0-t parameters and 90% confidence intervals were calculated to determine the pharmacodynamic responses. Geometric mean for the test and reference formulation of formoterol with budesionide in the form of dry powder in capsule was AUC0-t ratio (test/ reference: 101.70% [98.53% - 104.98%]).

We concluded that the formulations Alenia® and Symbicort® are therapeutically equivalent, considering the confidence intervals (90%) of the ratios between the geometric means of the test and reference formulations, the AUC 0-t parameter, and taking into account this is a pharmacodynamic study, in which intervals to determine therapeutic equivalence have not been established yet. The limits of the confidence interval of the parameters studied are within the range established by RE 1170 (April 2006/ANVISA) for pharmacokinetic parameters.

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