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Pharmaceutics 2018, 10(3), 139; https://doi.org/10.3390/pharmaceutics10030139

Lyophilization of Liposomal Formulations: Still Necessary, Still Challenging

Department of Pharmaceutical Sciences, Università degli Studi di Milano, via G. Colombo 71, Milano 20133, Italy
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Received: 15 July 2018 / Revised: 3 August 2018 / Accepted: 8 August 2018 / Published: 28 August 2018
(This article belongs to the Special Issue Micro and Nano Encapsulation Techniques)
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Abstract

Nowadays, the freeze-drying of liposome dispersions is still necessary to provide a solid dosage form intended for different routes of administration (i.e., parenteral, oral, nasal and/or pulmonary). However, after decades of studies the optimization of process conditions remains still challenging since the freezing and the dehydration destabilize the vesicle organization with the concomitant drug leakage. Starting from the thermal properties of phospholipids, this work reviews the main formulation and process parameters which can guarantee a product with suitable characteristics and increase the efficiency of the manufacturing process. In particular, an overview of the cryo- and/or lyo-protective mechanisms of several excipients and the possible use of co-solvent mixtures is provided. Attention is also focused on the imaging methods recently proposed to characterize the appearance of freeze-dried products and liposome dispersions upon reconstitution. The combination of such data would allow a better knowledge of the factors causing inter-vials variability in the attempt to improve the quality of the final medicinal product. View Full-Text
Keywords: cake appearance; cryoprotectant; freeze-drying; freezing rate; time and temperature; liposomes; lyoprotectant; QbD; solvent; stability; sublimation cake appearance; cryoprotectant; freeze-drying; freezing rate; time and temperature; liposomes; lyoprotectant; QbD; solvent; stability; sublimation
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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).
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Franzé, S.; Selmin, F.; Samaritani, E.; Minghetti, P.; Cilurzo, F. Lyophilization of Liposomal Formulations: Still Necessary, Still Challenging. Pharmaceutics 2018, 10, 139.

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