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Brown JP, Davison KS, Olszynski WP, et al. A critical review of brand and generic alendronate for the treatment of osteoporosis. Springerplus. 2013;2:550doi: 10.1186/2193-1801-2-550.
Brown, J. P., Davison, K. S., Olszynski, W. P., Beattie, K. A., & Adachi, J. D. (2013). A critical review of brand and generic alendronate for the treatment of osteoporosis. SpringerPlus, 2550. https://doi.org/10.1186/2193-1801-2-550
Brown, Jacques P, et al. "A critical review of brand and generic alendronate for the treatment of osteoporosis." SpringerPlus vol. 2 (2013): 550. doi: https://doi.org/10.1186/2193-1801-2-550
Brown JP, Davison KS, Olszynski WP, Beattie KA, Adachi JD. A critical review of brand and generic alendronate for the treatment of osteoporosis. Springerplus. 2013 Oct 21;2:550. doi: 10.1186/2193-1801-2-550. eCollection 2013. PMID: 25674402; PMCID: PMC4320211.
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Springerplus. 2013 Oct 21;2:550. doi: 10.1186/2193-1801-2-550. eCollection 2013.

A critical review of brand and generic alendronate for the treatment of osteoporosis.

SpringerPlus

Jacques P Brown, Kenneth S Davison, Wojciech P Olszynski, Karen A Beattie, Jonathan D Adachi

Affiliations

  1. Department of Medicine, Laval University, and CHU de Québec Research Centre, Quebec City, QC Canada.
  2. University of Victoria, Victoria, BC Canada.
  3. Department of Medicine, University of Saskatchewan and Saskatoon Osteoporosis Centre, Saskatoon, SK Canada.
  4. Department of Medicine, McMaster University, 501-25 Charlton Ave. East, Hamilton, ON L8N 1Y2 Canada.

PMID: 25674402 PMCID: PMC4320211 DOI: 10.1186/2193-1801-2-550

Abstract

OBJECTIVE: Compare in vitro and in vivo characteristics and clinical outcomes of brand and generic alendronate.

RESEARCH DESIGN AND METHODS: Relevant search terms were input into Medline ("alendronate" AND "generic" up to August 5, 2013) and any abstracts deemed possibly relevant selected for full paper review and abstraction.

RESULTS: Multicentre, randomized, placebo-controlled Phase III clinical trials of substantial size and duration have established the anti-fracture efficacy and safety of brand amino-bisphosphonates. For regulatory approval, generic versions of brand drugs need to demonstrate bioequivalence in young, healthy volunteers and have similar dissolution times. While the potency and amount of active drug within generic formulations must be identical to the brand, differences are permitted in the excipients. Significant differences in tablet disintegration time among different versions of generic and brand alendronate have been reported. Rapidly disintegrating alendronate pills may increase oesophageal bioadhesion and adverse event risk. Oesophageal-bound alendronate or slow disintegrating alendronate tablets may be made inert and ineffective by subsequently ingested food or drink. Investigations have reported a lower persistence to therapy with generic brands of alendronate as compared to brand bisphosphonates and patients switched from brand to generic alendronate have increased adverse event rates and losses in bone mineral density.

CONCLUSION: Numerous differences exist between brand and generic alendronate including: disintegration time, bioadhesion to the oesophagus, patient persistence to therapy, adverse event incidence, and maintenance of bone mineral density. Generic forms of alendronate warrant closer clinical study before they are ascribed the clinical effectiveness and tolerability of brand alendronate.

Keywords: Adverse event; Alendronate; Disintegration; Generic; Osteoporosis

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