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Journal of Osteoporosis
Volume 2014 (2014), Article ID 420451, 6 pages
http://dx.doi.org/10.1155/2014/420451
Research Article

Differences in In Vitro Disintegration Time among Canadian Brand and Generic Bisphosphonates

1Saskatoon Osteoporosis Centre and Department of Medicine, University of Saskatchewan, Suite 103, 39-23rd Street East, Saskatoon, SK, Canada S7K 0H6
2Department of Medicine, St. Joseph’s Hospital, McMaster University, 501-25 Charlton Avenue E., Hamilton, ON, Canada L8N 1Y2
3University of Victoria, P.O. Box 1700 STN CSC, Victoria, BC, Canada V8W 2Y2

Received 28 July 2014; Accepted 22 September 2014; Published 2 October 2014

Academic Editor: Manuel Diaz Curiel

Copyright © 2014 Wojciech P. Olszynski et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

The objective of this study was to compare the disintegration times among Canadian-marketed brand (alendronate 70 mg, alendronate 70 mg plus vitamin D 5600 IU, and risedronate 35 mg) and generic (Novo-alendronate 70 mg and Apo-alendronate 70 mg) once-weekly dosed bisphosphonates. All disintegration tests were performed with a Vanderkamp Disintegration Tester. Disintegration was deemed to have occurred when no residue of the tablet, except fragments of insoluble coating or capsule shell, was visible. Eighteen to 20 samples were tested for each bisphosphonate group. The mean (±standard deviation) disintegration times were significantly faster for Apo-alendronate ( seconds) and Novo-alendronate ( seconds) as compared to brand alendronate ( seconds), brand alendronate plus vitamin D ( seconds), or brand risedronate ( seconds). The significantly faster disintegration of the generic tablets as compared to the brand bisphosphonates may have concerning safety and effectiveness implications for patients administering these therapies.