Implementation of a New Electronic Liquid Dispensing System for Individualized Compounding of Hard Capsules

新型电子液体分配系统在硬胶囊个性化配制中的应用

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Abstract

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.

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