A modified release multiple unit oral dosage form of doxylamine succinate and pyridoxine hydrochloride and a process for its preparation

Abstract

The present invention relates to modified release multiple unit oral dosage form comprising: a first plurality of modified release pellets of doxylamine comprising: a pharmaceutically acceptable inert nucleus; an inner active coating layer comprising a doxylamine; optionally an intermediate enteric release coating layer; and an external modified release coating layer; and a second plurality of modified release pellets of pyridoxine or a pharmaceutically acceptable salt thereof comprising: a pharmaceutically acceptable inert nucleus; an inner active coating layer comprising pyridoxine or a pharmaceutically acceptable salt thereof; and an external modified release coating layer; wherein the particle size of the pharmaceutically acceptable inert nucleus of the first and the second plurality of pellets is such that at least 90% of the inert nucleus have a particle size from 300 μm to 1700 μm and a particle size variability of not more than 200 μm measured by analytical sieving. It also relates to a process for its preparation and its use in therapy.