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.

Introduction: Transdermal patches and medicated plasters (patch) represent well-established prolonged release dosage forms. Even if satisfactory adhesion to the skin is strictly linked to the efficacy and safety of the therapeutic treatment, nowadays numerous reports of in vivo ‘adhesion lacking’ are still addressed to regulatory agencies. The adhesive properties of a patch should be characterized considering i) the ability to form a bond with the surface of another material on brief contact and under light pressure (tack); ii) the resistance of the adhesive to flow (shear adhesion); and iii) the force required to peel away a patch from a surface (peel adhesion). Areas covered: In this manuscript, the most widely used methods to measure adhesive properties during development studies are described, along with the quality control of patches. The influence of formulative variables on patch adhesive properties, and their possible relationship with the in vivo adhesion performances, is also discussed. Expert o...