Abstract
ObjectiveCompare 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.ResultsMulticentre, 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.ConclusionNumerous 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.Electronic supplementary materialThe online version of this article (doi:10.1186/2193-1801-2-550) contains supplementary material, which is available to authorized users.
Highlights
Osteoporosis is a systemic disease typified by decreased bone strength and a consequent increased risk of fragility fracture (2000)
When a patient chooses generic alendronate, or has it chosen for them through mandatory substitution (Strom & Landfeldt 2012), there is an underlying assumption that the tolerability, safety and effectiveness of the generic version of alendronate are equal to that of brand alendronate
If differences in generic tablet composition exist, the tolerability, safety and efficacy of a brand therapy reported from clinical trials should not be automatically ascribed to the generic version of a drug until otherwise confirmed by assessing the generic in designed randomized control trials
Summary
Osteoporosis is a systemic disease typified by decreased bone strength and a consequent increased risk of fragility fracture (2000). As a result of these reports, the alendronate tablet was reformulated with a waxy coating to minimize contact with the esophagus and strict dosing instructions were added to the package insert to ensure that the risk of exposure of alendronate to the esophageal mucosa was minimized. These changes to formulation and dosing, as well as later availability of weekly dosing, all but eliminated GI AEs with alendronate usage
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