ABSTRACT

Liposome preparation, as well as production, consists of various steps. One should distinguish between "liposome preparation" which refers to a laboratory-scale for which many methods are available to meet very varied needs, and "liposome production," namely, large-scale preparation of liposomes for industrial and pharmaceutical needs. The reason for the slow development of large-scale production is related to the time it took to resolve technological and quality control issues, including: availability of high-quality lipid raw materials; validated quality control assays; fool-proof methods for obtaining sterile liposomal products; and long-term chemical and physical stability. Liposome characterization and quality control was, and to some extent is, the Achilles' tendon of liposome production. Aqueous loading is controlled by physical and structural parameters, such as size, shape, and number of lamellae, which control the aqueous trapped volume. The exact composition and pH of the hydration medium, downsizing medium and storage medium should be well controlled and defined in order to optimize liposome loading.