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可挤出核心系统:单层渗透控释片的研发

Extrudable core system: development of a single-layer osmotic controlled-release tablet.

作者信息

Waterman Kenneth C, MacDonald Bruce C, Roy Michael C

机构信息

Pfizer Global Research and Development, Eastern Point Road, Groton, CT 06340, USA.

出版信息

J Control Release. 2009 Mar 19;134(3):201-6. doi: 10.1016/j.jconrel.2008.11.017. Epub 2008 Dec 3.

DOI:10.1016/j.jconrel.2008.11.017
PMID:19100796
Abstract

A new controlled-release, extrudable core system (ECS) tablet has been developed which osmotically delivers high doses of low solubility active pharmaceutical ingredients (API's). The tablet has a single core formed in a modified oval shape with a semi-permeable coating. The core contains hydroxyethylcellulose, which serves to entrain the API particles as they are extruded out a hole in the coating at one end of the tablet, and a sugar, which provides the osmotic driving force for water imbibing. The dosage form has been successfully shown to control delivery of API over a range of delivery rates even with 50% of the tablet being API (up to about 500 mg).

摘要

一种新型控释、可挤出核心系统(ECS)片剂已被研发出来,它能以渗透方式递送高剂量低溶解度的活性药物成分(API)。该片剂有一个呈改良椭圆形的单核,并带有半透膜包衣。核心包含羟乙基纤维素,其作用是在API颗粒从片剂一端包衣上的一个孔挤出时夹带这些颗粒,还有一种糖,它为水的吸收提供渗透驱动力。该剂型已成功证明,即使片剂的50%为API(高达约500毫克),也能在一系列释放速率范围内控制API的释放。

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