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通过压制包衣制备延迟释放片剂剂型:包衣材料对茶碱释放的影响。

Preparation of delayed release tablet dosage forms by compression coating: effect of coating material on theophylline release.

机构信息

Department of Basic Pharmaceutical Sciences, College of Pharmacy, University of Louisiana at Monroe, Monroe, Louisiana 71209-0497, USA.

出版信息

Pharm Dev Technol. 2010 Jun;15(3):305-10. doi: 10.3109/10837450903188519.

Abstract

In this study, compression-coated tablets were prepared and examined by real-time swelling/erosion analysis and dissolution studies. Of the coating materials, PVP showed no swelling behavior and had no impact on theophylline release. Polyox(®) exhibited swelling behavior of an entangled polymer, which was reflected in its > 14-hour delayed-release profile. Hydroxypropyl methylcellulose (HPMC), which revealed the characteristics of a disentangled polymer, caused a 2-h delay in theophylline release. Based on preliminary texture analysis data, Polyox(®)/PVP blends were used as coating materials to manipulate the onset of drug release from the compression-coated tablets. Of the blends, at a 1:1 ratio, for example, resulted in a burst release after 10 h, which demonstrated the feasibility of preparing delayed release dosage forms by compression coating. Furthermore, it was feasible to predict the dissolution behavior of polymers from their swelling/erosion data, which were generated from texture analysis.

摘要

在这项研究中,通过实时溶胀/侵蚀分析和溶解研究制备并考察了压缩包衣片剂。在这些包衣材料中,PVP 没有溶胀行为,对茶碱的释放没有影响。聚氧(®)表现出缠结聚合物的溶胀行为,这反映在其 14 小时以上的延迟释放特性中。羟丙基甲基纤维素(HPMC)表现出解缠聚合物的特性,导致茶碱释放延迟 2 小时。基于初步的质地分析数据,将聚氧(®)/PVP 混合物用作包衣材料来控制压缩包衣片剂中药物释放的开始时间。例如,以 1:1 的比例混合时,在 10 小时后会发生突释,这表明通过压缩包衣制备延迟释放剂型是可行的。此外,从质地分析产生的溶胀/侵蚀数据可以预测聚合物的溶解行为。

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