Use of supercritical CO 2 for the sterilization of liposomes: Study of the influence of sterilization conditions on the chemical and physical stability of phospholipids and liposomes.

Autor: Delma KL; Laboratory of Pharmaceutical Technology and Biopharmacy, Nanomedicine Development, Center for Interdisciplinary Research on Medicines (CIRM), University of Liège, 4000 Liège, Belgium; Laboratory of Drug Development, Doctoral School of Sciences and Health, University Joseph KI-ZERBO, 03 BP 7021 Ouagadougou 03, Burkina Faso. Electronic address: delmakluc@yahoo.fr., Penoy N; Laboratory of Pharmaceutical Technology and Biopharmacy, Nanomedicine Development, Center for Interdisciplinary Research on Medicines (CIRM), University of Liège, 4000 Liège, Belgium., Sakira AK; Laboratoire de Toxicologie, Environnement et Santé (LATES), Ecole Doctorale Sciences et Santé (ED2S), Université Joseph KI-ZERBO, 03 BP 7021 03, Ouagadougou, Burkina Faso., Egrek S; Laboratory of Clinical Microbiology, Center for Interdisciplinary Research on Medicines (CIRM), University of Liège, 4000 Liège, Belgium., Sacheli R; Laboratory of Clinical Microbiology, Center for Interdisciplinary Research on Medicines (CIRM), University of Liège, 4000 Liège, Belgium., Grignard B; FRITCO(2)T Platform, CESAM Research Unit, University of Liege, Sart-Tilman B6a, 4000 Liege, Belgium., Hayette MP; Laboratory of Clinical Microbiology, Center for Interdisciplinary Research on Medicines (CIRM), University of Liège, 4000 Liège, Belgium., Issa Somé T; Laboratoire de Toxicologie, Environnement et Santé (LATES), Ecole Doctorale Sciences et Santé (ED2S), Université Joseph KI-ZERBO, 03 BP 7021 03, Ouagadougou, Burkina Faso., Evrard B; Laboratory of Pharmaceutical Technology and Biopharmacy, Nanomedicine Development, Center for Interdisciplinary Research on Medicines (CIRM), University of Liège, 4000 Liège, Belgium., Semdé R; Laboratory of Drug Development, Doctoral School of Sciences and Health, University Joseph KI-ZERBO, 03 BP 7021 Ouagadougou 03, Burkina Faso., Piel G; Laboratory of Pharmaceutical Technology and Biopharmacy, Nanomedicine Development, Center for Interdisciplinary Research on Medicines (CIRM), University of Liège, 4000 Liège, Belgium.
Jazyk: angličtina
Zdroj: European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V [Eur J Pharm Biopharm] 2023 Feb; Vol. 183, pp. 112-118. Date of Electronic Publication: 2023 Jan 11.
DOI: 10.1016/j.ejpb.2023.01.002
Abstrakt: The effects of four potential supercritical carbon dioxide (ScCO 2 ) sterilization conditions on the chemical stability of 9 phospholipids and on the physicochemical characteristics of liposomes consisting of stable phospholipids, as well as their sterilization efficiency were evaluated. These conditions were : C1 (ScCO 2 /70 °C/150 bar/240 min), C2 (ScCO 2 /0.25 % water/ 0.15% H 2 O 2 / 0.5% acetic anhydride/38° C/85 bar/45 min), C3 (ScCO 2 /0.08 % peracetic acid/35° C/104 bar/180 min) and C4 (ScCO 2 /200 ppm H 2 O 2 /40 °C/270 bar/90 min). The results showed for phospholipids, a significant increase in hydrolysis products of 3.77 to 14.50 % and an increase in oxidation index of 6.10 to 430.50 % with unsaturated phospholipids for all tested conditions while with saturated phospholipids, no significant degradation was observed. Concerning the liposome formulation, no change in dispersion color and no phospholipid degradation were observed. However, a decrease in liposome size from 126.90 nm to 111.80 nm, 96.27 nm, 99.60 nm and 109.13 nm and an increase in the PdI from 0.208 to 0.271, 0.233, 0.285, and 0.298 were found with conditions C1, C2, C3 and C4 respectively. For the sterilization efficiency, conditions C1, C2 and C3 achieved the required sterility assurance level (SAL) of 10 -6 for liposomes.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2023 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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