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Predicting the API partitioning between lipid-based drug delivery systems and water

pmid: 33486017
Partitioning tests in water are early-stage standard experiments during the development of pharmaceutical formulations, e.g. of lipid-based drug delivery system (LBDDS). The partitioning behavior of the active pharmaceutical ingredient (API) between the fatty phase and the aqueous phase is a key property, which is supposed to be determined by those tests. In this work, we investigated the API partitioning between LBDDS and water by in-silico predictions applying the Perturbed-Chain Statistical Associating Fluid Theory (PC-SAFT) and validated these predictions experimentally. The API partitioning was investigated for LBDDS comprising up to four components (cinnarizine or ibuprofen with tricaprylin, caprylic acid, and ethanol). The influence of LBDDS/water mixing ratios from 1/1 up to 1/200 (w/w) as well as the influence of excipients on the API partitioning was studied. Moreover, possible API crystallization upon mixing the LBDDS with water was predicted. This work showed that PC-SAFT is a strong tool for predicting the API partitioning behavior during in-vitro tests. Thus, it allows rapidly assessing whether or not a specific LBDDS might be a promising candidate for further in-vitro tests and identifying the API load up to which API crystallization can be avoided.
- TU Dortmund University Germany
Ethanol, Chemistry, Pharmaceutical, Drug Compounding, Water, Ibuprofen, Lipids, Cinnarizine, Excipients, Drug Delivery Systems, Pharmaceutical Preparations, Solubility, Thermodynamics, Caprylates, Crystallization, Triglycerides
Ethanol, Chemistry, Pharmaceutical, Drug Compounding, Water, Ibuprofen, Lipids, Cinnarizine, Excipients, Drug Delivery Systems, Pharmaceutical Preparations, Solubility, Thermodynamics, Caprylates, Crystallization, Triglycerides
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