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Journal of Osteoporosis
Volume 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.

Linked References

  1. D. M. Black, S. R. Cummings, D. B. Karpf et al., “Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures,” The Lancet, vol. 348, no. 9041, pp. 1535–1541, 1996. View at Publisher · View at Google Scholar · View at Scopus
  2. S. R. Cummings, D. M. Black, D. E. Thompson et al., “Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the fracture intervention trial,” Journal of the American Medical Association, vol. 280, no. 24, pp. 2077–2082, 1998. View at Publisher · View at Google Scholar · View at Scopus
  3. S. T. Harris, N. B. Watts, H. K. Genant et al., “Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: a randomized controlled trial,” Journal of the American Medical Association, vol. 282, no. 14, pp. 1344–1352, 1999. View at Publisher · View at Google Scholar · View at Scopus
  4. M. R. McClung, P. Geusens, P. D. Miller et al., “Effect of risedronate on the risk of hip fracture in elderly women,” The New England Journal of Medicine, vol. 344, no. 5, pp. 333–340, 2001. View at Publisher · View at Google Scholar · View at Scopus
  5. D. M. Black, P. D. Delmas, R. Eastell et al., “Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis,” New England Journal of Medicine, vol. 356, no. 18, pp. 1809–1822, 2007. View at Publisher · View at Google Scholar · View at Scopus
  6. K. W. Lyles, C. S. Colón-Emeric, J. S. Magaziner et al., “Zoledronic acid and clinical fractures and mortality after hip fracture,” The New England Journal of Medicine, vol. 357, no. 18, pp. 1799–1809, 2007. View at Publisher · View at Google Scholar · View at Scopus
  7. A. Papaioannou, S. Morin, A. M. Cheung et al., “2010 clinical practice guidelines for the diagnosis and management of osteoporosis in Canada: summary,” CMAJ, vol. 182, no. 17, pp. 1864–1873, 2010. View at Publisher · View at Google Scholar · View at Scopus
  8. Health Canada, Comparative Bioavailability Standards: Formulations Used for Systemic Effects, http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodpharma/applic-demande/guide-ld/bio/gd_standards_ld_normes-eng.pdf.
  9. “Canadian Food and Drug Regulations, CRC, c 870,” Tech. Rep. C.08.001.1, 2011.
  10. Health Canada, Guidance for Industry: Conduct and Analysis of Bioavailability and Bioequivalence Studies—Part A: Oral Dosage Formulations Used for Systemic Effects, 2012, http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodpharma/applic-demande/guide-ld/bio/gd_cbs_ebc_ld-eng.pdf.
  11. R. J. Dansereau, D. J. Crail, and A. C. Perkins, “In vitro disintegration and dissolution studies of once-weekly copies of alendronate sodium tablets (70 mg) and in vivo implications,” Current Medical Research and Opinion, vol. 24, no. 4, pp. 1137–1145, 2008. View at Publisher · View at Google Scholar · View at Scopus
  12. S. Epstein, B. Cryer, S. Ragi et al., “Disintegration/dissolution profiles of copies of Fosamax (alendronate),” Current Medical Research and Opinion, vol. 19, no. 8, pp. 781–789, 2003. View at Publisher · View at Google Scholar · View at Scopus
  13. R. J. Dansereau, D. J. Crail, and A. C. Perkins, “In vitro disintegration studies of weekly generic alendronate sodium tablets (70 mg) available in the US,” Current Medical Research and Opinion, vol. 25, no. 2, pp. 449–452, 2009. View at Publisher · View at Google Scholar · View at Scopus
  14. A. C. Perkins, P. E. Blackshaw, P. D. Hay et al., “Esophageal transit and in vivo disintegration of branded risedronate sodium tablets and two generic formulations of alendronic acid tablets: a single-center, single-blind, six-period crossover study in healthy female subjects,” Clinical Therapeutics, vol. 30, no. 5, pp. 834–844, 2008. View at Publisher · View at Google Scholar · View at Scopus
  15. B. J. Gertz, S. D. Holland, W. F. Kline et al., “Studies of the oral bioavailability of alendronate,” Clinical Pharmacology and Therapeutics, vol. 58, no. 3, pp. 288–298, 1995. View at Publisher · View at Google Scholar · View at Scopus
  16. A. B. Thomson, J. K. Marshall, R. H. Hunt et al., “14 Day endoscopy study comparing risedronate and alendronate in postmenopausal women stratified by Helicobacter pylori status,” The Journal of Rheumatology, vol. 29, no. 9, pp. 1965–1974, 2002. View at Google Scholar · View at Scopus
  17. F. L. Lanza, R. H. Hunt, A. B. R. Thomson, J. M. Provenza, and M. A. Blank, “Endoscopic comparison of esophageal and gastroduodenal effects of risedronate and alendronate in postmenopausal women,” Gastroenterology, vol. 119, no. 3, pp. 631–638, 2000. View at Google Scholar · View at Scopus
  18. M. A. Blank, B. L. Ems, G. W. Gibson et al., “Nonclinical model for assessing gastric effects of bisphosphonates,” Digestive Diseases and Sciences, vol. 42, no. 2, pp. 281–288, 1997. View at Publisher · View at Google Scholar · View at Scopus
  19. United States Pharmacopenia National Formulary, United States Pharmacopeial Convention, Rockville, Md, USA, 33rd edition, 2010.
  20. M. Pazianas, C. Cooper, F. H. Ebetino, and R. G. Russell, “Long-term treatment with bisphosphonates and their safety in postmenopausal osteoporosis,” Therapeutics and Clinical Risk Management, vol. 6, pp. 325–343, 2010. View at Google Scholar
  21. M. Shakweh, I. Bravo-Osuna, and G. Ponchel, “Comparative in vitro study of oesophageal adhesiveness of different commercial formulations containing alendronate,” European Journal of Pharmaceutical Sciences, vol. 31, no. 5, pp. 262–270, 2007. View at Publisher · View at Google Scholar · View at Scopus
  22. A. D. Walker and J. D. Adachi, “In vitro disintegration studies of weekly generic and branded risedronate sodium formulations available in Canada,” Current Medical Research and Opinion, vol. 27, no. 9, pp. 1749–1754, 2011. View at Publisher · View at Google Scholar · View at Scopus
  23. E. S. Siris, S. T. Harris, C. J. Rosen et al., “Adherence to bisphosphonate therapy and fracture rates in osteoporotic women: relationship to vertebral and nonvertebral fractures from 2 US claims databases,” Mayo Clinic Proceedings, vol. 81, no. 8, pp. 1013–1022, 2006. View at Publisher · View at Google Scholar · View at Scopus
  24. V. Rabenda, R. Mertens, V. Fabri et al., “Adherence to bisphosphonates therapy and hip fracture risk in osteoporotic women,” Osteoporosis International, vol. 19, no. 6, pp. 811–818, 2008. View at Publisher · View at Google Scholar · View at Scopus
  25. O. Sheehy, C. Kindundu, M. Barbeau, and J. LeLorier, “Adherence to weekly oral bisphosphonate therapy: cost of wasted drugs and fractures,” Osteoporosis International, vol. 20, no. 9, pp. 1583–1594, 2009. View at Publisher · View at Google Scholar · View at Scopus
  26. O. Sheehy, C. M. Kindundu, M. Barbeau, and J. Lelorier, “Differences in persistence among different weekly oral bisphosphonate medications,” Osteoporosis International, vol. 20, no. 8, pp. 1369–1376, 2009. View at Publisher · View at Google Scholar · View at Scopus
  27. D. T. Grima, A. Papaioannou, P. Airia, G. Ioannidis, and J. D. Adachi, “Adverse events, bone mineral density and discontinuation associated with generic alendronate among postmenopausal women previously tolerant of brand alendronate: a retrospective cohort study,” BMC Musculoskeletal Disorders, vol. 11, article 68, 2010. View at Publisher · View at Google Scholar · View at Scopus
  28. J. D. Ringe, P. Fardellone, H.-P. Kruse, M. Amling, S. A. P. van der Geest, and G. Mller, “Value of a new fixed-combination pack of bisphosphonate, calcium and vitamin d in the therapy of osteoporosis: results of two quantitative patient research studies,” Drugs and Aging, vol. 26, no. 3, pp. 241–253, 2009. View at Publisher · View at Google Scholar · View at Scopus