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Editors Selection IGR 10-3

Medical Treatment: Are generic formulations up to quality standards?

Comment by Louis Cantor on:

48653 A comparison of active ingredients and preservatives between brand name and generic topical glaucoma medications using liquid chromatography-tandem mass spectrometry, Kahook MY; Fechtner RD; Katz LJ et al., Current Eye Research, 2012; 37: 101-108

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Ophthalmic generic formulations are an important part of our medical treatment options for glaucoma medical therapy. However, concerns regarding generic medications exist due to the lower regulatory standards required by the FDA for ophthalmic formulations in the United States. Specifically, ophthalmic generic formulations are required to meet formulary equivalency standards and good manufacturing practices, but are not held to therapeutic or bio-equivalence testing standards.

Ophthalmic generic formulations are not held to therapeutic or bio-equivalence testing standards

Kahook and colleagues provide valuable information comparing the active ingredients and preservatives in commonly used brand and generic glaucoma medications using liquid chromatography-mass spectrometry at baseline and after exposure to different temperatures that may reflect what patients do with their medications. In addition, micro flow imaging was used to quantify particulate material greater than one micron in diameter. Higher temperatures resulted in a decrease in the concentration of the active ingredients and BAK in generic formulations. Higher levels of particular matter were also noted in generic formulations compared to their brand name counterparts. While no data is presented on the therapeutic effect of their findings, the authors' urge clinicians to reassess efficacy and tolerability of generic formulations. This would apply when either switching patients from a brand name to a generic formulation, or in patients on one generic who be switched to a different generic formulation, as is commonly the case. Kahook and colleagues are to be congratulated for bringing this important and unique information to light regarding our different formulations for the medical management of glaucoma.

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