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

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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Chemicals and Reagents

Enalapril maleate was purchased from Zhejiang Huahai Pharmaceutical Company (Taizhou, China). The chemical reference substance enalaprilat was bought from EDQM. Hard gelatin capsules (Coni Snap), size 0, were donated by Lonza-Capsugel (Bornem, Belgium). Silicon dioxide (Syloid 244 FP) was purchased from Grace GmbH & KG (Worms, Germany). Dibasic calcium phosphate, anhydrous (Fujicalin), was bought from Fuji Chemical (Toyama, Japan). Ethanol was purchased from in house chemical supply. Acetonitrile (HPLC grade) and sodium dihydrogen phosphate dihydrate (for analysis) were obtained from Honeywell Research Chemicals (Schwerte, Germany) and Merck (Darmstadt, Germany), respectively, for the HPLC analysis of capsules. Distilled water was obtained by in-lab distillation of demineralized water. The disposable syringe filter (Chromafil Xtra PA- 45/25) was purchased from Macherey-Nagel (Dueren, Germany).

Sarker, B.; Fligge, M.; Knaab, T.; Breitkreutz, J. Implementation of a New Electronic Liquid Dispensing System for Individualized Compounding of Hard Capsules. Pharmaceutics 2022, 14, 1580. https://doi.org/10.3390/pharmaceutics14081580