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采用直接压片法对布洛芬片剂进行处方开发与优化。

Formulation development and optimization of Ibuprofen tablets by direct compression method.

作者信息

Bushra Rabia, Shoaib Muhammad Harris, Aslam Nousheen, Hashmat Durriya, Ur-Rehman Masud

机构信息

Department of Pharmaceutics, Faculty of Pharmacy, University of Karachi, Karachi-7520, Pakistan.

出版信息

Pak J Pharm Sci. 2008 Apr;21(2):113-20.

Abstract

Ibuprofen is widely used as a prescription and non-prescription medicine. The aim of study is to prepare Ibuprofen tablets (200mg) using direct compression technique which is now days considered a cost effective and simple method of manufacturing. It is considered as an appropriate method for hygroscopic and thermolabile substances. In order to obtain the best, optimized product, nine different formulations were developed. Diluent (X1), disintegrant (X2) and lubricant (X3) were taken as independent variables. Weight variation (Y1), thickness (Y2), length and width (Y3), hardness (Y4), friability (Y5), disintegration (Y6), dissolution (Y7) and pharmaceutical assay (Y8) were studied as response variables. The results of all nine formulations were found within the acceptable limits conforming to those given in official compendia. However, F-6 was selected as an optimized product on the basis of high dissolution (99.05%) and Assay (100.04%). The variation of weight among the tablets of F-6 was least which showed best ratio of excipients in the formulation. Optimization has proven as an effective tool in product development. This is because no clear relationship exists between the variables.

摘要

布洛芬作为处方药和非处方药被广泛使用。本研究的目的是采用直接压片技术制备布洛芬片(200毫克),如今直接压片技术被认为是一种经济高效且简单的生产方法。它被视为处理吸湿性和热敏性物质的合适方法。为了获得最佳的优化产品,研发了九种不同的配方。将稀释剂(X1)、崩解剂(X2)和润滑剂(X3)作为自变量。将重量差异(Y1)、厚度(Y2)、长度和宽度(Y3)、硬度(Y4)、脆碎度(Y5)、崩解(Y6)、溶出度(Y7)和药物含量测定(Y8)作为响应变量进行研究。发现所有九种配方的结果均在官方药典规定的可接受范围内。然而,基于高溶出度(99.05%)和含量测定(100.04%),F - 6被选为优化产品。F - 6片剂之间的重量差异最小,这表明该配方中辅料比例最佳。优化已被证明是产品开发中的有效工具。这是因为变量之间不存在明确的关系。

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