N&P Posted February 10, 2009 Share Posted February 10, 2009 http://www.icis.com/Articles/2008/03/10/91...in-effects.html Both drugs contained the same amount of active ingredient. However, when they were subjected to the dissolution testing methods described in the FDA's approval letters for Wellbutrin XL 300 and Budeprion XL 300, ConsumerLab discovered that the release rates for the two products were quite different. Whereas GSK's Wellbutrin XL 300 had released 8% of its bupropion HCl after two hours, Teva's Budeprion XL 300 had released 34%. After four hours, a similar disparity was observed: Well-butrin XL 300 had rel-eased 25% of the active ingredient, while Budeprion XL 300 had released 49%. It was only after eight hours that results for the two drugs became comparable, says Cooperman. "The more rapid release means that more active drug was getting into the blood stream faster with the generic than the originator compound, and [it] could easily explain why hundreds of people have reported on our website side effects [such as nausea and anxiety] typical of too much bupropion when they took the generic," says Joe Graedon. However, a generic can be considered bioequivalent even when there is a significant difference in release rates, notes Cooperman. For example, a twice-a-day (SR) version of bupropion HCl is permitted to release anywhere from 60-85% of its ingredient after four hours into a dissolution test, and anywhere from 80-100% or more by the end of the eight-hour test. I thought I felt a bigger surge of side effects (nausea and anxiety) in the first few hours after taking Budeprion than I did with Wellbutrin. Anyone else notice a difference? Link to comment Share on other sites More sharing options...
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