DISINTEGRANT-FREE DELAYED RELEASE DOXYLAMINE AND PYRIDOXINE FORMULATION AND PROCESS OF MANUFACTURING
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United States of America Patent
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Nov 13, 2014
app pub date -
Dec 7, 2012
filing date -
Dec 7, 2011
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Abstract
The present invention relates to a delayed release pharmaceutical composition containing doxylamine succinate and pyridoxine HCl for treatment of nausea and vomiting during pregnancy. More specifically, the present invention concerns a disintegrant-free delayed release pharmaceutical composition for oral administration comprising a core and an enteric coating, wherein said core comprising: a) at least one pharmaceutically active ingredient, and b) at least one pharmaceutically acceptable excipient, wherein said composition provides an in vitro drug release profile of about 80% of active ingredient dissolved within 20 minutes as measured by USP Type II apparatus and also a manufacturing process of said pharmaceutical composition.
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