Lyophilization of synthetic liposomal pulmonary surfactant

摘要

Lyophilized pulmonary surfactants having an increased specific surface area and porosity are described. A method of making lyophilized pulmonary surfactants is described.

主权项

1. A process of making a lyophilized synthetic pulmonary surfactant having a reduced or eliminated cake levitation during the process, the process comprising:
providing to a lyophilizing chamber a pre-lyophilization mixture comprising dipalmitoyl phosphatidylcholine (DPPC), palmitoyloleoyl phosphatidylglycerol (POPG), palmitic acid and a synthetic peptide with SEQ ID NO:1 (KL4 polypeptide) dispersed in a solvent having an organic solvent in a range of between 3% (v/v) and 20% (v/v) of the total volume of the pre-lyophilization mixture with a remainder being water and/or buffer, wherein the pre-lyophilization mixture is filled in a container; lowering a temperature inside the lyophilizing chamber to begin chilling and solidifying the pre-lyophilization mixture in a freezing phase; and conducting an annealing phase prior to a primary drying phase and thereby reducing or eliminating cake levitation in the lyophilized synthetic pulmonary surfactant wherein the lyophilized synthetic pulmonary surfactant has a specific surface area of at least 2.7 m2/g.