Method for stabilizing amphiphilic block copolymer micelle composition containing poorly water-soluble drug

A method for stabilizing a poorly water-soluble drug-containing amphiphilic block copolymer micelle composition, comprising the steps of:

• dissolving poorly water-soluble drug and an amphiphilic block copolymer into an organic solvent to provide a polymer solution;
• adding an aqueous solution containing an ionizable salt to the polymer solution to form polymeric micelles;
• adding a lyophilization aid to the polymeric micelles;
• and
• carrying out lyophilization,
• wherein the steps are carried out in sequence, and
• wherein the poorly water-soluble drug-containing amphiphilic block copolymer micelle composition consists of 0.1-30 wt % of poorly water-soluble drug, 20-98 wt % of the amphiphilic block copolymer containing a hydrophilic block (A) and a hydrophobic block (B), 0.1-50 wt % of the ionizable salt, and 1-60 wt % of lyophilization aid, based on the total dry weight of the composition, and
• wherein the hydrophilic block (A) is polyethylene glycol or monomethoxypolyethylene glycol, and the hydrophobic block (B) is polylactic acid (PLA) or a copolymer of polylactic acid and glycolic acid (PLGA).