Abstract
Lyophilization is a promising approach to ensuring the long-term stability of liposomes. Decades of studies in this field have revealed various cryoprotective mechanisms such as water replacement and formation of a cryoprotector matrix. Much progress has been made in obtaining highly stable liposomes after lyophilization based on optimization of the formulation and process parameters. This paper reviews cryoprotective mechanisms, their parameters affecting the cryoprotective effect, and techniques used most often in the studies. The parameters are discussed with respect to two aspects, namely, formulation factors (choice of the lipid bilayer composition, vesicle size, selection of cryoprotectors, dry mass ratio of cryoprotector to lipid, distribution of cryoprotector on both sides of the lipid bilayer) and processing factors (freezing protocols, drying protocols, etc.).
Published Version
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