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Re: a1derfullife post# 25834

Sunday, 03/03/2013 4:32:09 PM

Sunday, March 03, 2013 4:32:09 PM

Post# of 402942
Since we don't really know where Dr Reddy is for manufacturing the first batch, what if they finished it last week? What does the schedule look like then? From the most recent PR (Feb 25) on Prurisol and Dr. Reddy:

"Dr. Reddy's has completed the process development of Prurisol and is now in the formulation stage for the manufacturing of Prurisol for the upcoming clinical trials in Europe planned for the second quarter of 2013."

The company also already has a great deal of experience with the drug base for Prurisol, so this is actually a reformulation and stability period. Formulation (reformulation?) and stability go hand in hand since formulation includes composition of any plasticizers, lubricants, pigments, or stabilizers. Each considers stability in the final composition, so I'm pretty sure Dr. Reddy's team already has a good idea of what they will include in the formulation, and whether capsule or tablet (I think I read tablet somewhere).

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