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工业视角下的胃滞留型药物传递系统:物理化学、生物制药、技术和监管方面的考虑。

Industrial perspective of gastroretentive drug delivery systems: physicochemical, biopharmaceutical, technological and regulatory consideration.

机构信息

Pharmaceutics Division, CSIR-Central Drug Research Institute, Lucknow, UP 226001, India.

出版信息

Expert Opin Drug Deliv. 2012 May;9(5):551-65. doi: 10.1517/17425247.2012.677431.

DOI:10.1517/17425247.2012.677431
PMID:22512596
Abstract

INTRODUCTION

Gastroretentive drug delivery systems (GRDDS) can overcome drawbacks associated with oral drug delivery, by defeating natural physiological principles. Various gastroretentive technologies have been developed in the past, but few of them achieved success on the market.

AREAS COVERED

This review is focused on the key concepts required to make a high-quality drug product available in a timely and economical manner.

EXPERT OPINION

Pharmacotherapy of various disease states can be amended by drug repurposing through GRDDS. Assessment of the effect of the fed and fasted condition on product performance should be necessary during initial development phases. Dual working technology would be a possible way to overcome drawbacks associated with different GRDDS. Before development of a drug product, the principles of scale up and process validation must be considered to improve the quality and market availability of GRDDS. Knowledge of all regulatory aspects will help to deliver a product to the market within a reasonable timeframe and in a cost-effective manner.

摘要

简介

胃滞留药物输送系统(GRDDS)可以通过克服自然生理原理来克服与口服药物输送相关的缺点。过去已经开发出各种胃滞留技术,但其中很少有在市场上取得成功。

涵盖领域

本篇综述专注于以及时和经济的方式提供高质量药物产品所需的关键概念。

专家意见

通过 GRDDS 进行药物再利用可以修改各种疾病状态的药物疗法。在初始开发阶段,应该对进食和禁食条件对产品性能的影响进行评估。双重工作技术可能是克服不同 GRDDS 相关缺点的一种方法。在开发药物产品之前,必须考虑放大和工艺验证的原则,以提高 GRDDS 的质量和市场可用性。了解所有监管方面将有助于在合理的时间内以具有成本效益的方式将产品推向市场。

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