A novel powder coating process for attaining taste masking and moisture protective films applied to tablets.

A novel powder coating process for attaining taste masking and moisture protective films applied to tablets.
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DOI:
10.1016/j.ijpharm.2004.04.015
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发表时间:
2004-07
影响因子:
5.8
通讯作者:
M. Cerea;Weijia Zheng;C. R. Young;J. Mcginity
M. Cerea;Weijia Zheng;C. R. Young;J. Mcginity
中科院分区:
医学2区
文献类型:
--
作者:
M. Cerea;Weijia Zheng;C. R. Young;J. Mcginity

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开发了一种新型粉末包衣工艺,用于在片剂上施加掩味和防潮膜,同时避免使用溶剂或水。通过研究微粉化丙烯酸聚合物(E PO)的干粉层积以产生游离膜,研究了颗粒聚结以形成聚合物膜。使用粉末包衣技术,在实验室规模的滚圆机中用相同的丙烯酸聚合物对含有茶碱的片剂进行包衣。在pH 6.8介质中,干粉层延迟了药物释放的开始,这取决于包衣水平,而在pH 1.0介质中没有观察到延迟。在pH 6.8介质中,亲水性聚合物在丙烯酸涂层中的存在减少了药物释放的滞后时间,而在酸性介质中,只有HPMC在膜中的存在减缓了药物释放速率。经证明,干包衣工艺是溶剂或水性薄膜包衣技术的可靠替代方法,可用于将掩味和防潮薄膜包衣应用于压片。在pH6.8介质中实现了药物的控释特性。
A novel powder coating process was developed for the application of taste masking and moisture protective films on tablets while avoiding the use of solvents or water. The coalescence of particles to form a polymeric film was investigated through studies of dry powder layering of micronized acrylic polymer (E PO) to produce free films. Theophylline containing tablets were coated with the same acrylic polymer in a laboratory scale spheronizer using a powder coating technique. The dry powder layer delayed the onset of drug release in pH 6.8 medium, depending on the coating level, while no delay was observed in pH 1.0 medium. The presence of hydrophilic polymers in the acrylic coating layer decreased the lag time for drug release in pH 6.8 medium, while only the presence of HPMC in the film slowed the drug release rate in acidic medium. The dry coating process was demonstrated to be a reliable alternative to solvent or aqueous film coating technologies for applying taste masking and moisture protective film coats onto compressed tablets. A controlled drug release profile was achieved in pH 6.8 media.