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See detailSterilization methods of liposomes: drawbacks of conventional methods and perspectives
Delma, Kouka Luc ULiege; Lechanteur, Anna ULiege; Semde, Rasmané et al

in International Journal of Pharmaceutics (2021)

Liposomes are targeted drug delivery systems that are of great pharmaceutical and therapeutic interest. Parenteral route is the main way used for liposome administration. In this case, their sterility is ... [more ▼]

Liposomes are targeted drug delivery systems that are of great pharmaceutical and therapeutic interest. Parenteral route is the main way used for liposome administration. In this case, their sterility is a requirement. However, due to the particular sensitivity of liposomes and their tendency to physicochemical alterations, their sterilization remains a real challenge. Conventional sterilization methods such as heat, ethylene oxide, ultraviolet and gamma irradiations are considered as unsuitable for liposome sterilization and the recommended methods for obtaining sterility of liposomes are filtration and aseptic manufacturing. Unfortunately, these recommended methods are not without limitations. This review outlines the difficulties associated with the use of these different classical methods for obtaining liposome sterility. The effects on liposome physicochemical and biopharmaceutical characteristics as well as efficacy, toxicity and practical problems of these sterilization techniques have been discussed. The search for an alternative method being therefore necessary, the applicability of supercritical carbon dioxide (ScCO2) technology, which is nowadays a promising strategy for the sterilization of sensitive products such as liposomes, is also examined. It appears from this analysis that ScCO2 could effectively be an interesting alternative to achieve sterility of liposomes, but for this, sterilization assays including challenge tests and optimization studies are needed. [less ▲]

Detailed reference viewed: 47 (8 ULiège)
See detailStérilisation des liposomes par le dioxyde de carbone en phase supercritique : effets des conditions sur leurs caractéristiques physicochimiques
Delma, Kouka Luc ULiege; Evrard, Brigitte ULiege; Piel, Géraldine ULiege et al

Conference (2020, December)

Introduction : Les liposomes sont des vecteurs de médicaments généralement administrés par voie parentérale. Cependant, les techniques actuellement utilisées pour obtenir leur stérilité présentent des ... [more ▼]

Introduction : Les liposomes sont des vecteurs de médicaments généralement administrés par voie parentérale. Cependant, les techniques actuellement utilisées pour obtenir leur stérilité présentent des limites. Le dioxyde de carbone supercritique (CO2Sc) représente une stratégie prometteuse pour la stérilisation des produits sensibles comme les liposomes. Le but de ce travail est d’étudier l’applicabilité de la technologie du CO2Sc à la stérilisation des liposomes. Méthodologie : Les liposomes ont été préparés par la méthode d’hydratation du film lipidique puis leurs caractéristiques physico-chimiques ont été déterminées avant et après soumission à 4 conditions de stérilisation par le CO2Sc choisies : C1 (70°C, 150 bar, 240 min), C2 (38° C, 85 bar, 45 min, 0.25 % H2O /0.15 % H2O2) / 0.5% anhydride acétique), C3 (35° C, 104 bar, 180 min, 0.08 % acide peracétique ) et C4 (40° C, 270 bar, 90 min, 200 ppm H2O2). Résultats et discussion : Des modifications de caractéristiques physicochimiques ont été observés après soumission des liposomes aux conditions C1, C2 et C3. Par contre, aucune variation majeure de caractéristiques n’a été mise en évidence après traitement des liposomes par la condition C4. L’absence de variation avec la condition C4 pourrait s'expliquer par les paramètres (température, pression, temps de traitement) assez souples de cette condition, la faible quantité et la décomposition rapide de l’additif utilisée. Conclusion : La condition C4 semble être la meilleure en termes de maintien des caractéristiques physicochimiques des liposomes et pourrait donc constituer une condition de stérilisation des liposomes par le CO2Sc. [less ▲]

Detailed reference viewed: 94 (1 ULiège)
See detailEffects of supercritical carbon dioxide sterilization conditions on physicochemical characteristics of liposomes
Delma, Kouka Luc ULiege; Semdé, Rasmané; Evrard, Brigitte ULiege et al

Poster (2019, December 11)

Sterility is a requirement for parenteral administration of liposomes. However, conventional sterilization methods of liposomes have limitations. Supercritical Carbon Dioxide (ScCO2) is a promising ... [more ▼]

Sterility is a requirement for parenteral administration of liposomes. However, conventional sterilization methods of liposomes have limitations. Supercritical Carbon Dioxide (ScCO2) is a promising strategy for the sterilization of sensitive products. In this work, the effects of ScCO2 sterilization conditions on physicochemical characteristics of liposomes were investigated using a liposome formulation previously validated in the LPTB. This model formulation contains cholesterol, dimethylaminoethane-carbamoyl hydrochloride (DC-cholesterol), egg phosphatidylcholine (EPC) and distearoylphosphatidylethanolamine (DSPE) PEG2000, and as active drug, apigenin. Liposomes were prepared by thin-film hydration method and the physicochemical characteristics such as pH, particle size, polydispersity index (PDI), zeta potential, amount of encapsulated apigenin and phospholipids concentration were determined before and after submission to the selected ScCO2 sterilization conditions: 70 ° C, 150 bar for 4h (Karajanagi and al, 2011). The results showed a decrease of the pH of the dispersion, the size, the zeta potential of the vesicles and of the amount of encapsulated apigenin. On the contrary, an increase in PDI after treatment with ScCO2 was observed. In spite of changes observed with this liposome formulation under sterilization conditions used in this work, others conditions should be tested in order to maintain the characteristics of the formulations before and after the sterilization process. [less ▲]

Detailed reference viewed: 77 (2 ULiège)
See detailEtude de l’influence des conditions de stérilisation par le dioxyde de carbone en phase supercritique (CO2Sc) sur les caractéristiques physicochimiques de liposomes
Delma, Kouka Luc ULiege; Semdé, Rasmané; Evrard, Brigitte ULiege et al

Conference (2019, November 27)

Sterility is a requirement for parenteral administration of liposomes. However, conventional sterilization methods of liposomes have limitations. Supercritical Carbon Dioxide (ScCO2) is a promising ... [more ▼]

Sterility is a requirement for parenteral administration of liposomes. However, conventional sterilization methods of liposomes have limitations. Supercritical Carbon Dioxide (ScCO2) is a promising strategy for the sterilization of sensitive products. In this work, the effects of ScCO2 sterilization conditions on physicochemical characteristics of liposomes were investigated using a liposome formulation previously validated in the LPTB. This model formulation contains cholesterol, dimethylaminoethane-carbamoyl hydrochloride (DC-cholesterol), egg phosphatidylcholine (EPC) and distearoylphosphatidylethanolamine (DSPE) PEG2000, and as active drug, apigenin. Liposomes were prepared by thin-film hydration method and the physicochemical characteristics such as pH, particle size, polydispersity index (PDI), zeta potential, amount of encapsulated apigenin and phospholipids concentration were determined before and after submission to the selected ScCO2 sterilization conditions: 70 ° C, 150 bar for 4h (Karajanagi and al, 2011). The results showed a decrease of the pH of the dispersion, the size, the zeta potential of the vesicles and of the amount of encapsulated apigenin. On the contrary, an increase in PDI after treatment with ScCO2 was observed. In spite of changes observed with this liposome formulation under sterilization conditions used in this work, others conditions should be tested in order to maintain the characteristics of the formulations before and after the sterilization process. [less ▲]

Detailed reference viewed: 78 (2 ULiège)
See detailEtude de l’influence des conditions de stérilisation par le dioxyde de carbone en phase supercritique (CO2Sc) sur les caractéristiques physicochimiques de liposomes
Delma, Kouka Luc ULiege; Semdé, Rasmané; Evrard, Brigitte ULiege et al

Poster (2019, November)

Sterility is a requirement for parenteral administration of liposomes. However, conventional sterilization methods of liposomes have limitations. Supercritical Carbon Dioxide (ScCO2) is a promising ... [more ▼]

Sterility is a requirement for parenteral administration of liposomes. However, conventional sterilization methods of liposomes have limitations. Supercritical Carbon Dioxide (ScCO2) is a promising strategy for the sterilization of sensitive products. In this work, the effects of ScCO2 sterilization conditions on physicochemical characteristics of liposomes were investigated using a liposome formulation previously validated in the LPTB. This model formulation contains cholesterol, dimethylaminoethane-carbamoyl hydrochloride (DC-cholesterol), egg phosphatidylcholine (EPC) and distearoylphosphatidylethanolamine (DSPE) PEG2000, and as active drug, apigenin. Liposomes were prepared by thin-film hydration method and the physicochemical characteristics such as pH, particle size, polydispersity index (PDI), zeta potential, amount of encapsulated apigenin and phospholipids concentration were determined before and after submission to the selected ScCO2 sterilization conditions: 70 ° C, 150 bar for 4h (Karajanagi and al, 2011). The results showed a decrease of the pH of the dispersion, the size, the zeta potential of the vesicles and of the amount of encapsulated apigenin. On the contrary, an increase in PDI after treatment with ScCO2 was observed. In spite of changes observed with this liposome formulation under sterilization conditions used in this work, others conditions should be tested in order to maintain the characteristics of the formulations before and after the sterilization process. [less ▲]

Detailed reference viewed: 65 (1 ULiège)