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羟乙基纤维素/羟丙基甲基纤维素聚合物体系薄膜包衣性能的评估

Evaluation of the film-coating properties of a hydroxyethyl cellulose/hydroxypropyl methylcellulose polymer system.

作者信息

Li Shun Por, Martellucci Stephen A, Bruce Richard D, Kinyon Adam C, Hay Michael B, Higgins John D

机构信息

R&D, McNeil Consumer Healthcare, Fort Washington, Pennsylvania 19477, USA.

出版信息

Drug Dev Ind Pharm. 2002 Apr;28(4):389-401. doi: 10.1081/ddc-120003000.

Abstract

The effect of different grades of hydroxyethyl cellulose (HEC) and hydroxypropyl methllcellulose (HPMC) on the film-formation and taste-masking ability for ibuprofen granules was evaluated. Three batches of coated ibuprofen granules were prepared using a roto-granulator, each with a different coating composition. Two grades of HEC [MW300,000 (H) and MW90,000 (L)] were combined with three different grades of HPMC [MW 11,000 (L), MW 25,000 (M) and MW 35,000 (H)] to prepare the coating solutions. Mechanical strength and physical properties of the polymer films were evaluated. Films made from HPMC (L)/HEC (H), HPMC (M)/HEC (H), and HPMC (H)/HEC (H) were stronger and more flexible than the HPMC (L) HEC (L) films. The assay, dissolution, particle size distribution, and environmental scanning electron microscopy (ESEM) data of the three batches of the coated ibuprofen granules were similar.

摘要

评估了不同等级的羟乙基纤维素(HEC)和羟丙基甲基纤维素(HPMC)对布洛芬颗粒成膜和掩味能力的影响。使用旋转制粒机制备了三批包衣布洛芬颗粒,每批具有不同的包衣组成。将两种等级的HEC [分子量300,000(H)和分子量90,000(L)]与三种不同等级的HPMC [分子量11,000(L)、分子量25,000(M)和分子量35,000(H)]混合以制备包衣溶液。对聚合物薄膜的机械强度和物理性质进行了评估。由HPMC(L)/ HEC(H)、HPMC(M)/ HEC(H)和HPMC(H)/ HEC(H)制成的薄膜比HPMC(L)HEC(L)薄膜更强且更具柔韧性。三批包衣布洛芬颗粒的含量测定、溶出度、粒度分布和环境扫描电子显微镜(ESEM)数据相似。

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