公开(公告)号：WO2011000518A1

公开(公告)日：2011-01-06

申请号：PCT/EP2010/003857

申请日：2010-06-30

Applicant: ALFRED E. TIEFENBACHER (GMBH & CO. KG) ,  YOGANANDA, Chaitanya, Gujjar ,  BODDU, Srinath ,  RALLABANDI, BaIa, Ramesha, Chary ,  PASAHN, Manohar, LaI ,  FITZNER, Ansgar

Inventor： YOGANANDA, Chaitanya, Gujjar ,  BODDU, Srinath ,  RALLABANDI, BaIa, Ramesha, Chary ,  PASAHN, Manohar, LaI ,  FITZNER, Ansgar

IPC: A61K9/20 ,  A61K9/28

CPC classification number: A61K9/2018 ,  A61K9/2866 ,  A61K31/4545

Abstract: The present invention relates to a production process of a solid pharmaceutical composition in dosage form of a tablet comprising desloratadine or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients and/or adjuvants including lactose, characterized in that a) desloratadine or the pharmaceutically acceptable salt thereof is present in a therapeutically effective amount and that b) the lactose is present as anhydrous lactose in an amount of 22 to 78 wt.-% based on the total weight of the solid pharmaceutical composition, the solid pharmaceutical composition in dosage form of a tablet obtainable by the inventive production process as well as uses thereof.

Abstract translation: 本发明涉及包含地氯雷他定或其药学上可接受的盐和一种或多种药学上可接受的赋形剂和/或佐剂（包括乳糖）的片剂剂型的固体药物组合物的制备方法，其特征在于a）地氯雷他定或药学上可接受的盐 其可接受的盐以治疗有效量存在，并且b）乳糖以固体药物组合物的总重量为基准，为22至78重量％的无水乳糖，固体药物组合物为剂型 的片剂，其可通过本发明的制备方法获得，以及其用途。