A novel electrostatic dry powder coating process for pharmaceutical dosage forms: immediate release coatings for tablets.
A novel electrostatic dry powder coating process for pharmaceutical dosage forms: immediate release coatings for tablets.
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DOI：
10.1016/j.ejpb.2010.06.009
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发表时间：
2010-10
期刊：
影响因子：
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通讯作者：
Mingxi Qiao;Liqiang Zhang;Yingliang Ma;Jesse Zhu;Kwok Chow
中科院分区：
文献类型：
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作者：
Mingxi Qiao;Liqiang Zhang;Yingliang Ma;Jesse Zhu;Kwok Chow
首次在盘式包衣机系统中采用静电干粉包衣技术，开发了药物固体剂型的静电干粉包衣工艺。使用该方法成功地施加了具有Opadry® AMB和Eudragit® EPO的两种立即释放包衣组合物。将液体增塑剂喷雾到片芯表面上以增加片芯的电导率，从而增强颗粒沉积，电阻率从大于1×1013Ωm降低至小于1×109Ωm，并降低包衣聚合物的玻璃化转变温度（Tg），以用于在盘式包衣机中成膜。施用液体增塑剂后，使用静电充电枪喷涂带电包衣颗粒，以增强片剂表面上的均匀沉积。通过在可接受的加工温度下固化，将涂层颗粒聚结成薄膜，通过SEM显微照片确认形成。结果还表明，优化的干粉包衣工艺生产的片剂具有光滑的表面、良好的包衣均匀性和与片芯相当的释放曲线。数据还表明，这种新型的静电干粉包衣技术是一种替代水性或溶剂型包衣工艺的药物产品。
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 1×1013Ωm to less than 1×109Ωm, and to lower the glass transition temperature (Tg) 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.