Comparative bioavailability analysis of oral alendronate sodium formulations in Pakistan

Riaz, Humayun and Godman, Brian and Bashir, Sajid and Hussain, Shahzad and Mahmood, Sidra and Malik, Farnaz and Waseem, Durdana and Raza, Syed Atif and Mahmood, Wajahat and Alamgeer, (2016) Comparative bioavailability analysis of oral alendronate sodium formulations in Pakistan. Acta Poloniae Pharmaceutica, 73 (4). pp. 999-1007. ISSN 0001-6837

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    Abstract

    Alendronate sodium, a bisphosphonate drug, it is used to treat osteoporosis and other bone diseases. The present study was designed to conduct comparative bioavailability analysis of oral formulations of alendronate sodium through an open-label, randomized, 2-sequence, 2-period crossover study. Healthy adult male Pakistani volunteers received a single 70 mg dose of the test or reference formulation of alendronate sodium followed by a 7 day washout period. Plasma drug concentrations were determined using a validated HPLC post column fluorescence derivatization method. AUC0-t, AUC0-8, Cmax and Tmax were determined by non-compartmental analysis and were found within the permitted range of 80% to 125% set by the US Food and Drug Administration (FDA). Results show that both in vitro and in vivo assays of all test brands were within the specification of the US Pharmacopoeial limits and were statistically bioequivalent. No adverse events were reported in this study.