alexa Bioequivalence of a Fixed Dose Combination of Deslorata
ISSN: 0975-0851

Journal of Bioequivalence & Bioavailability
Open Access

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Research Article

Bioequivalence of a Fixed Dose Combination of Desloratadine/Betamethasone Tablets (Oradus Beta) in Healthy Human Volunteers

Bustami R1, Khasawneh S1, Absi W1, Feddah H1, Menassa M2, Daccache E2, Taha MS3 and Kyriacos S2*

1Pharmaceutical Research Unit, Clinical Evaluation Centre, Amman, Jordan

2Research and Development Department, Pharmaline, Jdeidet-El-Metn, Lebanon

3Pharmacy Practice Department, School of Pharmacy, Lebanese American University, Byblos, Lebanon

Corresponding Author:
Kyriacos S
R&D Manager, Pharmaline, Jdeidet-El-Metn, Lebanon
Tel: 961 9 440 901
Fax: 961 9 448 418
E-mail: [email protected]

Received Date: July 22, 2016; Accepted Date: August 19, 2016; Published Date: August 30, 2016

Citation: Bustami R, Khasawneh S, Absi W, Feddah H, Menassa M, et al. (2016) Bioequivalence of a Fixed Dose Combination of Desloratadine/Betamethasone Tablets (Oradus Beta) in Healthy Human Volunteers. J Bioequiv Availab 8:233-241. doi:10.4172/jbb.1000301

Copyright: © 2016 Bustami 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

A fixed dose combination of desloratadine, a long-acting tricyclic antihistamine with selective peripheral histamine H1 receptor antagonistic activity, and betamethasone, a glucocorticoid, can potentially provide synergistic effect in the treatment of severe allergic conditions and improve clinical outcomes. Co-administration of an anti-allergy medication and a corticosteroid is extensively used in clinical practice, either as single drug tablets or as a fixed dose combination tablet. The current study was conducted to compare the pharmacokinetics of fixed combination tablets of desloratadine and betamethasone in 40 healthy human volunteers after a single oral dose in a randomized two-period, two-treatment, and two-sequence cross-over study. The study protocol was prepared in accordance to the requirements set in the EMA guidance for conducting bioequivalence studies. Reference (Frenaler Cort 5 mg desloratadine/0.6 mg betamethasone film coated tablet, Roemmers S.A.I.C.F., Argentina) and test (Oradus β 5 mg desloratadine/0.6 mg betamethasone film coated tablet, Pharmaline, Lebanon) drugs were administered to fasted volunteers and blood samples were collected up to 72 h and assayed for desloratadine, hydroxydesloratadine metabolite and betamethasone using a validated LC-MS/MS method. The pharmacokinetic parameters AUC0-t, Cmax, Tmax, T1/2, Ke, in addition to (for betamethasone only) AUC0-∞, MRTinf, and residual area (%) were determined from plasma concentration-time profile by non-compartmental analysis method using thermos Scientific Kinetica (version 5.1). The analysis of variance did not show any significant difference between the two formulations and 90% confidence intervals fell within the acceptable range for bioequivalence (80-125%). The resulting data demonstrated that when administered as fixed dose combination, the pharmacokinetics of desloratadine and betamethasone were bioequivalent and were well-tolerated.

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