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Drug Res (Stuttg) 2013; 63(10): 545-549
DOI: 10.1055/s-0033-1348223
Original Article
© Georg Thieme Verlag KG Stuttgart · New York

Comparative Bioequivalence Study of Two Marketed Formulation of Betamethasone Injectable Suspensions

P. Zakeri-Milani
1   Liver and Gastrointestinal Diseases Research Center and Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran
,
S. Ghanbarzadeh
2   Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran
,
S. Basmenji
3   Dana Pharmaceutical Company, Tabriz, Iran
,
H. Valizadeh
4   Research Center for Pharmaceutical Nanotechnology and Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran
› Author Affiliations
Further Information

Publication History

received 21 April 2013

accepted 18 May 2013

Publication Date:
18 June 2013 (online)

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Abstract

Background:

The aim of this study was to determine the bioequivalence of generic (test) and branded (reference) formulations of betamethasone injectable suspension in healthy Iranian subjects for the purpose of meeting regulatory requirements for bioequivalence of the generic formulation in Iran.

Methods:

24 healthy Iranian male volunteers were participated for this single-dose, randomized, open label, 2 period crossover study separated by a 2-week washout period. For the assessment of betamethasone, blood samples were obtained before and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 h after drug administration. Plasma concentration of betamethasone was analyzed with a simple, rapid and validated high performance liquid chromatography method with ultraviolet detection. Pharmacokinetic parameters, representing the rate (Cmax, Tmax), and the extent (AUC0–t and AUC0–∞) of betamethasone absorption were calculated and analyzed for 2 formulations. The 2 formulations were to be considered bioequivalent if the 90% confidence intervals (CI)s for the logarithm-transformed values of Cmax, AUC0–t and AUC0–∞ fell within the predetermined range of 80–125%.

Results:

The 90% CIs of Cmax, AUC0–t and AUC0–∞ were 85.4–104.4%, 96.2–112.1% and 98.3–115.8%, respectively.

Conclusion:

Based on the 90% CIs of Cmax, AUC0–t and AUC0–∞ in these healthy Iranian male subjects, the test and reference formulations of betamethasone injectable suspension met the regulatory requirements for bioequivalence.

Key words

bioequivalence - betamethasone injectable suspension - pharmacokinetics - HPLC
 

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