J Pharm Sci. 2009 Oct;98(10):3575-81.

In vitro determination of the release of alendronic acid from alendronate tablets of different brands during deglutition.

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Institute of Analytical Chemistry and Food Chemistry, University of Vienna, Waehringerstrasse 38, A-1090 Vienna, Austria. guenther.lamprecht@univie.ac.at

Abstract

Alendronic acid, a frequently applied compound for the treatment of different forms of diseases of bone metabolism, is a strong acid with a high solubility in water. In connection with the oral administration this exhibits a potential health risk for the upper gastrointestinal tract. The in vitro release of tablets containing alendronic acid of different brands (Stada, ratiopharm, interpharm, Fosamax) was determined by dissolution tests for the time period required for oral intake. The effect of rotation speed, temperature, and solvent volume on the release rate of alendronic acid was determined for the used dissolution apparatus. Analysis of alendronic acid was performed by a validated HPLC method. The highest rate of release was found for the original brand. The dissolution rate of the generic formulations was significantly lower in the early stage of dissolution. Over the complete range of dissolution, more than 85% of the claimed amount was dissolved within 4 min. Dissolution profiles were compared by calculation of the similarity factor f(2) showing equal products with the exception of one generic product, whose dissolution rate was lower.

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Chemical compound information

pamidronate

MW: 235.06 g/mol

MF: C₃H₁₁NO₇P₂

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In vitro determination of the release of alendronic acid from alendronate tablets of different brands during deglutition.

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