AQUEOUS SYSTEMS FOR PREPARATION OF LIPID-BASED PHARMACEUTICAL COMPOUNDS; COMPOSITIONS, METHODS, AND USES THEREOF

摘要

PROBLEM TO BE SOLVED: To provide a method for the production of an aqueous suspension of an active compound lipid formulation produced by using a method which does not comprise the use of an organic solvent.SOLUTION: The invention relates to a method comprising a) adding a component consisting of 1) at least one solid lipid, and 2) at least one active compound which is a partially water-soluble or water-insoluble solid drug to a first aqueous medium to form a mixture, wherein the aqueous medium does not contain any surfactant, the weight ratio of the active compound and the lipid is between 1:10 and 1:60, and the active compound is added in the amount of 5 mg/mL or less to the aqueous medium; b) treating the mixture of the step a) to form a lipid-compound suspension with an average particle diameter of less than 0.5 micron; c) subjecting the lipid-compound suspension of the step b) to freeze-drying to form a freeze-dried substance; and d) reconstituting the freeze-dried substance of the step c) with a second aqueous medium to obtain the aqueous suspension with an average particle diameter of less than 0.5 micron.SELECTED DRAWING: None