Use of supercritical CO2 for the sterilization of liposomes: Study of the influence of sterilization conditions on the chemical and physical stability of phospholipids and liposomes.
[en] The effects of four potential supercritical carbon dioxide (ScCO2) 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 (ScCO2/70 °C/150 bar/240 min), C2 (ScCO2/0.25 % water/ 0.15% H2O2/ 0.5% acetic anhydride/38° C/85 bar/45 min), C3 (ScCO2/0.08 % peracetic acid/35° C/104 bar/180 min) and C4 (ScCO2/200 ppm H2O2/40 °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.
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Delma, Kouka Luc ; Université de Liège - ULiège > Unités de recherche interfacultaires > Centre Interdisciplinaire de Recherche sur le Médicament (CIRM)
Penoy, Noémie ; Université de Liège - ULiège > Unités de recherche interfacultaires > Centre Interdisciplinaire de Recherche sur le Médicament (CIRM)
Sakira, Abdoul Karim; 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, Sabrina ; Centre Hospitalier Universitaire de Liège - CHU > > Service de microbiologie clinique
Sacheli, Rosalie ; Centre Hospitalier Universitaire de Liège - CHU > > Service de microbiologie clinique
Grignard, Bruno ; Université de Liège - ULiège > Département de chimie (sciences) > Centre d'études et de recherches sur les macromolécules (CERM)
Hayette, Marie-Pierre ; Centre Hospitalier Universitaire de Liège - CHU > > Service de microbiologie clinique
Issa Somé, Touridomon; 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, Brigitte ; Université de Liège - ULiège > Département de pharmacie > Pharmacie galénique
Semdé, Rasmané; Laboratory of Drug Development, Doctoral School of Sciences and Health, University Joseph KI-ZERBO, 03 BP 7021 Ouagadougou 03, Burkina Faso
Piel, Géraldine ; Université de Liège - ULiège > Unités de recherche interfacultaires > Centre Interdisciplinaire de Recherche sur le Médicament (CIRM)
Language :
English
Title :
Use of supercritical CO2 for the sterilization of liposomes: Study of the influence of sterilization conditions on the chemical and physical stability of phospholipids and liposomes.
Publication date :
11 January 2023
Journal title :
European Journal of Pharmaceutics and Biopharmaceutics
Authors would like to acknowledge the Academy for research and Higher Education- Development Cooperation Committee (ARES-CCD) for the financial support as well as the Professors Michel Frederich and Joëlle Leclercq for their invaluable material and technical assistance in the realization of this work.
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