Posted by Tomatheus on March 11, 2013, at 22:02:15
In reply to Re: Nardil question for you Nardil vets » Tomatheus, posted by joe schmoe on March 11, 2013, at 21:39:47
Well, the stated purpose of the formulation change was to improve upon the "poor disintegration and dissolution properties" of the "old" Nardil and to address the medication's shelf-life issues (U.S. Food and Drug Administration, 2002, 2005). So, apparently, it was Pfizer's goal to allow Nardil to undergo dissolution in the body more rapidly, and one of the ways that they tried to achieve this goal was to remove the enteric coating. But I agree with you that the enteric coating of the "old" Nardil was probably put there for a reason. I don't think that such a coating would have been used on Nardil originally if the medication didn't need it in some way.
Tomatheus
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REFERENCES
U.S. Food and Drug Administration. (2002). Office of Clinical Pharmacology and Biopharmaceutics review (NDA 11-909/SCM-032). City of publication not available: Author.
U.S. Food and Drug Administration. (2005). Office of Clinical Pharmacology and Biopharmaceutics addendium [sic] to review (NDA 11-909/SCF-032). City of publication not available: Author.
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