首页> 外国专利> PHARMACEUTICAL COMPOSITION FOR PREVENTING OR TREATING DEMENTIA AND COGNITIVE DYSFUNCTION, CONTAINING DONEPEZIL OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND MEMANTINE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND PREPARATION METHOD THEREFOR

PHARMACEUTICAL COMPOSITION FOR PREVENTING OR TREATING DEMENTIA AND COGNITIVE DYSFUNCTION, CONTAINING DONEPEZIL OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND MEMANTINE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND PREPARATION METHOD THEREFOR

机译:预防或治疗痴呆和认知功能障碍的药物组合物,包含多奈哌齐或药学上可接受的盐和肉毒碱或药学上可接受的盐,其制备方法

摘要

An immediate-release type pharmaceutical composition for preventing or treating dementia and cognitive dysfunction, including donepezil or a pharmaceutically acceptable salt thereof and memantine or a pharmaceutically acceptable salt thereof, and a method of preparing the pharmaceutical composition are disclosed. The method includes: granulating donepezil or a pharmaceutically acceptable salt thereof by a wet process; and adding memantine or a pharmaceutically acceptable salt thereof to the granulated donepezil or a pharmaceutically acceptable salt thereof and directly compressing and homogenizing the resulting mixture, thereby addressing problems such as reduced efficacy due to a decrease in elution of a donepezil active ingredient upon co-administration of Aricept® (donepezil hydrochloride) and Ebixa® (memantine hydrochloride), which are commercially available, and content uniformity is secured by selecting an excipient having a particle size similar to that of particles of the active ingredients. In addition, the pharmaceutical composition of the present invention is very stable without related substances.
机译:公开了一种用于预防或治疗痴呆和认知功能障碍的速释型药物组合物,包括多奈哌齐或其药学上可接受的盐和美金刚或其药学上可接受的盐,以及制备该药物组合物的方法。该方法包括:通过湿法将多奈哌齐或其药学上可接受的盐制粒;将多奈哌齐或其药学上可接受的盐制粒。将美金刚或其药学上可接受的盐添加到颗粒状多奈哌齐或其药学上可接受的盐中,并直接压制和均化所得混合物,从而解决诸如因共同给药时多奈哌齐活性成分洗脱减少而导致功效降低的问题(盐酸多奈哌齐)和Ebixa(美金刚盐酸盐)的产品可通过选择粒度与活性成分颗粒大小相似的赋形剂来确保含量均匀性。另外,本发明的药物组合物在没有相关物质的情况下非常稳定。

著录项

  • 公开/公告号EP3520792A1

    专利类型

  • 公开/公告日2019-08-07

    原文格式PDF

  • 申请/专利权人 BIO PHARMARTIS CO. LTD.;

    申请/专利号EP20170856827

  • 发明设计人 KOO HYOUNG MO;KO CHAN YOUNG;LEE MASE;

    申请日2017-09-29

  • 分类号A61K31/445;A61K31/13;

  • 国家 EP

  • 入库时间 2022-08-21 12:26:52

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