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利用太赫兹脉冲成像技术评估包衣设备对片剂薄膜质量的影响。

Evaluating the effect of coating equipment on tablet film quality using terahertz pulsed imaging.

机构信息

School of Pharmacy, University of Otago, Dunedin, New Zealand; TeraView Ltd., St. John's Innovation Park, Cambridge, UK; Cavendish Laboratory, University of Cambridge, Cambridge, UK.

出版信息

Eur J Pharm Biopharm. 2013 Nov;85(3 Pt B):1095-102. doi: 10.1016/j.ejpb.2013.03.019. Epub 2013 Apr 4.

Abstract

In this study, terahertz pulsed imaging (TPI) was employed to investigate the effect of the coating equipment (fluid bed and drum coater) on the structure of the applied film coating and subsequent dissolution behaviour. Six tablets from every batch coated with the same delayed release coating formulation under recommended process conditions (provided by the coating polymer supplier) were mapped individually to evaluate the effect of coating device on critical coating characteristics (coating thickness, surface morphology and density). Although the traditional coating quality parameter (weight gain) indicated no differences between both batches, TPI analysis revealed a lower mean coating thickness (CT) for tablets coated in the drum coater compared to fluid bed coated tablets (p<0.05). Moreover, drum coated tablets showed a more pronounced CT variation between the two sides and the centre band of the biconvex tablets, with the CT around the centre band being 22.5% thinner than the top and bottom sides for the drum coated tablets and 12.5% thinner for fluid bed coated tablets. The TPI analysis suggested a denser coating for the drum coated tablets. Dissolution testing confirmed that the film coating density was the drug release governing factor, with faster drug release for tablets coated in the fluid bed coater (98 ± 4% after 6h) compared to drum coated tablets (72 ± 6% after 6h). Overall, TPI investigation revealed substantial differences in the applied film coating quality between tablets coated in the two coaters, which in turn correlated with the subsequent dissolution performance.

摘要

在这项研究中,太赫兹脉冲成像(TPI)被用于研究涂层设备(流化床和转鼓式涂层机)对应用薄膜涂层结构和随后溶解行为的影响。在推荐的工艺条件下(由涂层聚合物供应商提供),每个批次的六片片剂都被单独进行涂层,以评估涂层设备对关键涂层特性(涂层厚度、表面形态和密度)的影响。尽管传统的涂层质量参数(增重)表明两个批次之间没有差异,但 TPI 分析显示,转鼓式涂层机涂层的片剂平均涂层厚度(CT)低于流化床涂层的片剂(p<0.05)。此外,转鼓式涂层片剂在片剂的两侧和中央带之间表现出更明显的 CT 变化,中央带周围的 CT 比片剂的顶部和底部薄 22.5%,而流化床涂层片剂的 CT 比顶部和底部薄 12.5%。TPI 分析表明,转鼓式涂层片剂的涂层密度更高。溶解试验证实,涂层密度是控制药物释放的因素,流化床涂层片剂的药物释放更快(6 小时后 98 ± 4%),而转鼓式涂层片剂的药物释放更慢(6 小时后 72 ± 6%)。总体而言,TPI 研究揭示了两种涂层机涂层片剂之间应用薄膜涂层质量存在实质性差异,这与随后的溶解性能有关。

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