Department of Chemical and Biochemical Engineering, University of Western Ontario, Ontario, London, Ont, Canada.
Eur J Pharm Biopharm. 2010 Oct;76(2):304-10. doi: 10.1016/j.ejpb.2010.06.009. Epub 2010 Jun 19.
An electrostatic dry powder coating process for pharmaceutical solid dosage forms was developed for the first time by electrostatic dry powder coating in a pan coater system. Two immediate release coating compositions with Opadry® AMB and Eudragit® EPO were successfully applied using this process. A liquid plasticizer was sprayed onto the surface of the tablet cores to increase the conductivity of tablet cores to enhance particle deposition, electrical resistivity reduced from greater than 1×10(13)Ωm to less than 1×10(9)Ωm, and to lower the glass transition temperature (T(g)) of the coating polymer for film forming in the pan coater. The application of liquid plasticizer was followed by spraying charged coating particles using an electrostatic charging gun to enhance the uniform deposition on tablet surface. The coating particles were coalesced into a thin film by curing at an acceptable processing temperature as formation was confirmed by SEM micrographs. The results also show that the optimized dry powder coating process produces tablets with smooth surface, good coating uniformity and release profile that are comparable to that of the tablet cores. The data also suggest that this novel electrostatic dry powder coating technique is an alternative to aqueous- or solvent-based coating process for pharmaceutical products.
首次在盘式包衣机系统中通过静电干粉包衣法开发了一种用于药物固体制剂的静电干粉包衣工艺。使用该工艺成功应用了两种含有 Opadry® AMB 和 Eudragit® EPO 的速释包衣组合物。将液体增塑剂喷涂到片剂芯的表面上,以增加片剂芯的导电性,从而增强颗粒沉积,将电阻率从大于 1×10(13)Ωm 降低到小于 1×10(9)Ωm,并降低包衣聚合物的玻璃化转变温度(T(g)),从而在盘式包衣机中形成薄膜。然后使用静电充电枪喷涂带电的包衣颗粒,以增强在片剂表面上的均匀沉积。通过在可接受的加工温度下固化使包衣颗粒聚结为薄膜,这从 SEM 显微照片得到证实。结果还表明,优化的干粉包衣工艺可生产出表面光滑、包衣均匀且释放特性与片剂芯相当的片剂。该数据还表明,这种新型静电干粉包衣技术可替代药物产品的水基或溶剂基包衣工艺。