In vitro disintegration studies of weekly generic alendronate sodium tablets (70 mg) available in the US

ABSTRACT Background: Bisphosphonates as a class have the potential to cause upper gastrointestinal irritation. Although the generic alendronate sodium tablets are bioequivalent to the branded product, a potential concern is that the pharmaceutical attributes of the various generic formulations my af...

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Bibliographic Details
Published in:Current medical research and opinion 2009-02, Vol.25 (2), p.449-452
Main Authors: Dansereau, Richard J., Crail, Debbie J., Perkins, Alan C.
Format: Article
Language:English
Subjects:
Alendronate - chemistry
Drugs, Generic - chemistry
Tablets - chemistry
United States
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Summary:ABSTRACT Background: Bisphosphonates as a class have the potential to cause upper gastrointestinal irritation. Although the generic alendronate sodium tablets are bioequivalent to the branded product, a potential concern is that the pharmaceutical attributes of the various generic formulations my affect the potential for local irritation and tolerability. Scope: The in vitro disintegration times were determined using the method described in the US Pharmacopeia 30 (USP 30). The disintegration of three generic alendronate sodium tablets 70 mg available in the United States was compared to that of the branded product. Findings: The mean disintegration times of the generic alendronate sodium tablets ranged from 9 to 10 s for the Barr lots to 108 s for the Watson lot. The disintegration time of the branded product (Fosamax®) was 53 s. The three Barr lots and one Teva lot had rapid disintegration times which were similar to the disintegration standards (
ISSN:0300-7995
1473-4877
DOI:10.1185/03007990802648903