Sarker Bakul, Fligge Mariele, Knaab Tanja, Breitkreutz Jörg
Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University, Universitätsstr. 1, 40225 Duesseldorf, Germany.
Pharmaceutics. 2022 Jul 29;14(8):1580. doi: 10.3390/pharmaceutics14081580.
An automated compounding device can be a useful tool for the rapid and accurate production of small batches for personalized medicine as well as for clinical batches. A novel electronic liquid dispensing system (ELDS) was investigated to produce hard capsules with individualized dose strengths. An ethanol-based solvent system containing the antihypertensive enalapril maleate was extruded through a cannula into prefilled capsules. The capsules were prefilled with a powder bed of mesoporous silica (Syloid 244 FP) or synthetic dibasic calcium phosphate anhydrous (Fujicalin). The dosing accuracy as well as content uniformity of ELDS was compared with manual preparation using a Hamilton syringe (HS). Both methods met the pharmacopeia criteria for all formulations with an acceptance value (AV) less than 15. Drug adherence to the capsule shells was also investigated. A recovery rate of 98% of enalapril maleate showed almost no drug loss, but the appropriateness of the new dispensing method.
自动配药装置对于快速准确地生产用于个性化药物的小批量产品以及临床批量产品而言可能是一种有用的工具。研究了一种新型电子液体分配系统（ELDS），以生产具有个体化剂量强度的硬胶囊。将含有抗高血压药马来酸依那普利的乙醇基溶剂系统通过套管挤出到预填充胶囊中。胶囊预先填充有介孔二氧化硅（Syloid 244 FP）或无水合成磷酸氢钙（Fujicalin）的粉末床。将ELDS的给药准确性以及含量均匀性与使用汉密尔顿注射器（HS）的手动制备方法进行了比较。两种方法对于所有制剂均符合药典标准，接受值（AV）小于15。还研究了药物在胶囊壳上的附着情况。马来酸依那普利98%的回收率表明几乎没有药物损失，证明了这种新分配方法的适用性。
