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用新型水性聚醋酸乙烯酯分散体Kollicoat SR 30 D包衣的微丸的物理化学性质和释放特性,用于缓释。

Physicochemical and release properties of pellets coated with Kollicoat SR 30 D, a new aqueous polyvinyl acetate dispersion for extended release.

作者信息

Dashevsky A, Wagner K, Kolter K, Bodmeier R

机构信息

College of Pharmacy, Freie Universität Berlin, Kelchstr. 31, 12169 Berlin, Germany.

出版信息

Int J Pharm. 2005 Feb 16;290(1-2):15-23. doi: 10.1016/j.ijpharm.2004.10.024. Epub 2005 Jan 6.

Abstract

Kollicoat SR 30 D is a new aqueous colloidal polyvinyl acetate dispersion used for extended release coatings. Kollicoat SR 30 D is stable against sedimentation, has a low viscosity (54 mPas) and a negative zeta potential of -23.2 mV because of the presence of the anionic surfactant, sodium dodecyl sulfate. Because of its low minimum film formation temperature (MFT = 18 degrees C), plasticizer addition and a thermal after-treatment (curing) of coated pellets was not required. Coated pellets showed no aging or curing effect. The rate of release could be easily adjusted by varying the coating level. A subcoating layer of the hydrophilic polymer, polyvinyl alcohol, between an ibuprofen-containing core and the Kollicoat SR coating prevented the diffusion of the lipophilic, low melting ibuprofen into the polymer coating during storage. The drug release from Kollicoat SR 30 D coated pellets was almost independent of the pH and ionic strength of release medium.

摘要

Kollicoat SR 30 D是一种用于缓释包衣的新型水性胶体聚醋酸乙烯酯分散体。Kollicoat SR 30 D抗沉降稳定,具有低粘度(54毫帕斯卡),由于存在阴离子表面活性剂十二烷基硫酸钠,其ζ电位为 -23.2毫伏。由于其最低成膜温度低(MFT = 18摄氏度),无需添加增塑剂以及对包衣微丸进行热后处理(固化)。包衣微丸未显示出老化或固化效应。通过改变包衣量可轻松调节释放速率。在含布洛芬的丸芯与Kollicoat SR包衣之间的亲水性聚合物聚乙烯醇的底涂层可防止亲脂性、低熔点的布洛芬在储存期间扩散到聚合物包衣中。从Kollicoat SR 30 D包衣微丸中释放药物几乎与释放介质的pH值和离子强度无关。

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