Encapsulation; Green process; Liposome; One-step process; Production; Quality by design; Sterility assurance level; Sterilization; Supercritical carbon dioxide; Liposomes; Carbon Dioxide; Carbon Dioxide/chemistry; Drug Delivery Systems; Liposomes/chemistry
Abstract :
[en] Liposomes are very interesting drug delivery systems for pharmaceutical and therapeutic purposes. However, liposome sterilization as well as their industrial manufacturing remain challenging. Supercritical carbon dioxide is an innovative technology that can potentially overcome these limitations. The aim of this study was to optimize a one-step process for producing and sterilizing liposomes using supercritical CO2. For this purpose, a design of experiment was conducted. The analysis of the experimental design showed that the temperature is the most influential parameter to achieve the sterility assurance level (SAL) required for liposomes (≤10-6). Optimal conditions (80 °C, 240 bar, 30 min) were identified to obtain the fixed critical quality attributes of liposomes. The conditions for preparing and sterilizing empty liposomes of various compositions, as well as liposomes containing the poorly water-soluble drug budesonide, were validated. The results indicate that the liposomes have appropriate physicochemical characteristics for drug delivery, with a size of 200 nm or less and a PdI of 0.35 or less. Additionally, all liposome formulations demonstrated the required SAL and sterility at concentrations of 5 and 45 mM, with high encapsulation efficiency.
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Penoy, Noémie ✱; Université de Liège - ULiège > Unités de recherche interfacultaires > Centre Interdisciplinaire de Recherche sur le Médicament (CIRM)
Delma, Kouka Luc ✱; Université de Liège - ULiège > Unités de recherche interfacultaires > Centre Interdisciplinaire de Recherche sur le Médicament (CIRM)
Homkar, Nirmayi; Laboratory of Pharmaceutical Technology and Biopharmacy, Development of Nanomedicine, Center for Interdisciplinary Research on Medicines (CIRM), University of Liege, Avenue Hippocrate 15, 4000 Liege, Belgium
Karim Sakira, Abdoul; Laboratoire de Toxicologie, Environnement et Santé (LATES), Ecole Doctorale des Sciences de La 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 ; Université de Liège - ULiège > Département des sciences biomédicales et précliniques > Bactériologie, mycologie, parasitologie, virologie et microbiologie
Sacre, Pierre-Yves ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Grignard, Bruno ; Université de Liège - ULiège > Département de chimie (sciences) > Centre d'études et de recherches sur les macromolécules (CERM)
Hayette, Marie-Pierre ; Université de Liège - ULiège > Département des sciences biomédicales et précliniques > Bactériologie, mycologie, parasitologie, virologie et microbiologie
Somé, Touridomon Issa; Laboratoire de Toxicologie, Environnement et Santé (LATES), Ecole Doctorale des Sciences de La Santé (ED2S), Université Joseph KI-ZERBO, 03 BP 7021 03 Ouagadougou, Burkina Faso
Semdé, Rasmané ; Laboratory of Drug Development, Doctoral School of Sciences and Health, University Joseph KI-ZERBO, 03 BP 7021 Ouagadougou 03, Burkina Faso
Evrard, Brigitte ; Université de Liège - ULiège > Département de pharmacie > Pharmacie galénique
Piel, Géraldine ; Université de Liège - ULiège > Unités de recherche interfacultaires > Centre Interdisciplinaire de Recherche sur le Médicament (CIRM)
The authors would like to acknowledge the Professors Michel Frederich and Joëlle Leclercq for their precious material and technical support, the laboratory of Microbiology for the material and technical support and the FEDER funds (PHARE project) as well as the Academy of Research and Higher Education – Committee for Development Cooperation (ARES-CCD) for their financial assistance.
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