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Pharmaceutical Technology

Erik Greb
Various groups have questioned the efficacy and safety of generics lately. That this topic is now being widely debated serves as a reminder that a drug is more than an active pharmaceutical ingredient, or API.

A prominent generic currently at the center of controversy is Teva's "Budeprion XL 300" (bupropion HCl), a generic version of GlaxoSmithKline's "Wellbutrin XL 300" antidepressant. Some patients who switched from Wellbutrin XL 300 to Budeprion XL 300 reported having panic attacks, anxiety, nausea, depression, and suicidal tendencies.

The reports spurred the independent to study Teva's drug. The study showed that after two hours, Budeprion released four times as much API as did Wellbutrin.

Although bupropion HCl is no longer patent-protected, the drug-delivery technology in Wellbutrin still is. This could explain the large disparity in dissolution between Teva's and GSK's products.

Drug companies, doctors, and patients mostly focus on APIs as the solutions to any disease. Though it's true the API is what relieves symptoms or cures a condition, it's not the end of the story.

We might think, as generics companies have argued, that generic treatments deserve less scrutiny because the drugs have already been tested and approved. But this argument does not take into account excipients, stability, formulation, or drug delivery mechanism. These elements influence a drug's safety and efficacy, and they could mean the difference between a beneficial treatment and a harmful substance.

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Erik Greb is an assistant editor of Pharmaceutical Technology,


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