20.500.12556/RUL-168758 The advancement of in vitro lipolysis two-step flow-through method for the evaluation of lipid-based drug delivery systems Objectives: A novel two-step flow-through in vitro lipolysis model was developed for the evaluation of drug release from a self-microemulsifying drug delivery system (SMEDDS). Methods: Firstly, the SMEDDS was dispersed in an acidic medium. Subsequently, the pH was increased, and a lipolytic reaction was immediately initiated, accompanied by medium flow onset. The latter enabled increase of the initial low pH of the medium, improving the physiological relevance of the method by simulating dosage form retainment in the stomach and transfer to the duodenum, which is very important for a weakly basic active pharmaceutical ingredient (API) incorporated in an SMEDDS. Results: Conversely to the traditional pH-stat in vitro lipolysis, the developed method is not established on titration, as the reaction vessel pH is regulated by a medium flow and buffer capacity. Individual parameters, such as pancreatin activity, buffer capacity, and medium shift, were researched using traditional pH-stat in vitro lipolysis prior to their implementation in the flow-through setup. Conclusions: The concentration of the solubilized model API, carvedilol, was increased as pancreatin activity decreased and as buffer capacity increased. The ratios between release profiles obtained under different conditions utilizing the pH-stat and novel two-step flow-through in vitro lipolysis were comparable; however, the differences were more pronounced in the flow-through method. in vitro lipolysis flow-through dissolution system drug release self-microemulsifying drug delivery systems in vitro lipoliza pretočni sistem raztapljanja sproščanje zdravila samomikroemulgirajoči sistemi za dostavo zdravil dostavni sistemi topnost true false true Angleški jezik Slovenski jezik Članek v reviji 2025-04-23 13:13:18 2025-04-23 13:13:23 2025-04-24 04:03:33 0000-00-00 00:00:00 2025 0 0 21 str. iss. 5, art. 545 Vol. 17 2025 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 615.015.14+544.351.3 1999-4923 10.3390/pharmaceutics17050545 234023939 pharmaceutics-17-00545.pdf pharmaceutics-17-00545.pdf 1 CD7FB05FDDA89CCB0C85A8AFA156A393 1c9966563bb2e86c6f533699f9c5f943b5c9c901e86fedd910557e2ac5982bfb 55a7a3e1-2033-11f0-b232-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=209679 https://www.mdpi.com/1999-4923/17/5/545 1 d4f6ddf3-2032-11f0-b232-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=209677 Fakulteta za farmacijo 0 0 0