Dried reconstituted vesicle formation for pharmaceutical application

摘要

The present invention relates to dried reconstituted vesicle (DRV) compositions and water based formulations thereof, which contain one or more therapeutic agents (e.g. hydrophilic protein). More particularly, it relates to DRVs comprising at least one lipid and a fusion promoting agent which after reconstitution form large multilamellar liposomes encapsulating an active agent in an aqueous phase.

主权项

1. A dried pharmaceutical composition comprising freeze dried active agent comprising vesicles comprising
a) at least one lipid, wherein the lipid comprises phosphatidylcholine b) at least one active agent, and c) a fusion promoting agent, wherein the fusion promoting agent is an alkaline amino acid selected from arginine, histidine, lysine or citrulline
wherein rehydration of the dried pharmaceutical composition with an aqueous solution results in the formation of multilamellar liposomes having an average liposomal diameter of more than 1 μm, which liposomes encapsulate the active agent,wherein no protective sugar, sugar alcohol or glycoside is present,wherein the at least one active agent is a protein, wherein the protein comprises the mature sequence of CD-RAP (SEQ ID NO:1) and functional fragments or variants thereof.