公开(公告)号：WO2020064985A1

公开(公告)日：2020-04-02

申请号：PCT/EP2019/076140

申请日：2019-09-27

Applicant: INIBSA GINECOLOGÍA, S.A.

Inventor： SAURA I VALLS, Marc ,  NEBOT TROYANO, Joaquín ,  ROCA I JUANES, Ramon M.

IPC: A61K9/48 ,  A61K9/50 ,  A61K31/4402 ,  A61K31/4415

Abstract: The present invention relates to a process for the preparation of a modified release multiple unit oral dosage form comprising a plurality of modified release pellets of doxylamine or salt thereof and a modified release pellets of pyridoxine or a salt thereof; wherein the process comprises coating the pellets of doxylamine having the inner active coating layer and the intermediate enteric coating layer; and the pellets of pyridoxine having the inner active coating layer, wherein the coating step comprising simultaneous spraying of a mixture comprising the enteric and modified release coating agents and an adding pore-forming agents in powder form.

公开(公告)号：WO2021191268A1

公开(公告)日：2021-09-30

申请号：PCT/EP2021/057555

申请日：2021-03-24

Applicant: INIBSA GINECOLOGÍA, S.A.

Inventor： SAURA I VALLS, Marc ,  NEBOT TROYANO, Joaquín ,  ROCA I JUANES, Ramon M. ,  MALDONADO VILLEGAS, Adrià ,  COLOMBO, Giuseppe

IPC: A61K9/50 ,  A61K31/4402 ,  A61K31/4415 ,  A61K9/48 ,  A61K9/5026 ,  A61K9/5063 ,  A61K9/5078 ,  A61K9/5084 ,  A61K9/5089

Abstract: A modified release multiple unit oral dosage form of doxylamine succinate and pyridoxine hydrochloride and a process for its preparation 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 nuclei have a particle size from 300 µm to 1700 µm and a particle size variability of not more than200 µm measured by analytical sieving. It also relates to a process for its preparation and its use in therapy.