Pu Yu, Mazumder Malay, Cooney Charles
Department of Chemical Engineering, Massachusetts Institute of Technology, Cambridge, Massachusetts 02139, USA.
J Pharm Sci. 2009 Jul;98(7):2412-21. doi: 10.1002/jps.21595.
During the pharmaceutical powder blending process, electrostatic charges generate and accumulate unavoidably due to particle-particle and particle-wall collision. The effect of electrostatic charging on pharmaceutical powder blending homogeneity was investigated on two binary blending systems: (1) lactose as an excipient with caffeine as an Active Pharmaceutical Ingredient (API) and (2) Micro-crystalline Cellulose (MCC) with caffeine. Three different blending procedures were conducted: (1) conventional blending without any charge control, (2) blending with simultaneous charge neutralization, and (3) blending combined with a corona charging process. It was found that the average API concentration variation increases with the increase of charge-to-mass ratio of final blend samples. In other words, the presence of uncontrolled electrostatic charges has an adverse effect on powder blend uniformity. Elimination or minimization of electrostatic charges also appears to have a negative impact on powder blend uniformity. In contrast, blending of positively charged excipient material and negatively charged API material leads to a better blend uniformity. The controlled electrostatic charging opens an opportunity for improving uniformity of the pharmaceutical blending process.
在药物粉末混合过程中,由于颗粒与颗粒以及颗粒与器壁的碰撞,不可避免地会产生并积累静电荷。在两种二元混合体系中研究了静电荷对药物粉末混合均匀性的影响:(1)以乳糖作为辅料,咖啡因作为活性药物成分(API);(2)微晶纤维素(MCC)与咖啡因。进行了三种不同的混合程序:(1)无任何电荷控制的常规混合;(2)同时进行电荷中和的混合;(3)结合电晕充电过程的混合。结果发现,最终混合样品的电荷质量比增加时,平均API浓度变化也会增加。换句话说,不受控制的静电荷的存在对粉末混合均匀性有不利影响。消除或最小化静电荷似乎也会对粉末混合均匀性产生负面影响。相比之下,带正电的辅料材料与带负电的API材料混合会产生更好的混合均匀性。可控的静电荷充电为改善药物混合过程的均匀性提供了机会。