DISINTEGRANT-FREE DELAYED RELEASE DOXYLAMINE AND PYRIDOXINE FORMULATION AND PROCESS OF MANUFACTURING

摘要

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.

主权项

1. A disintegrant-free delayed release pharmaceutical composition for oral administration comprising:
a core; an enteric coating; wherein said core comprises: at least one pharmaceutically active ingredient, and at least one pharmaceutically acceptable excipient,wherein said composition provides an in vitro drug release profile of about 95% of active ingredient dissolved within 20 minutes as measured by USP Type II apparatus at 100 rpm in 900 ml at pH 6.5 phosphate buffer.