Method for manufacturing uniform size polymeric nanoparticles containing poorly soluble drugs

A method for manufacturing uniform size polymeric nanoparticles containing poorly soluble drugs, consisting essentially of:

• a first step of forming a solution of a biodegradable polymer by dissolving a biodegradable polymer in a non-volatile polar organic solvent;
• a second step of forming a drug dispersion by adding poorly soluble drugs in water and to the biodegradable polymer solution obtained from the first step to produce a dispersion;
• a third step of forming polymeric nanoparticles dispersed aqueous solution by adding the dispersion obtained from the second step to an aqueous solution of an emulsifier in a batch with a single stirring at 100-1,000 rpm;
• and
• a fourth step of removing the organic solvent and water from the nanoparticles dispersed aqueous solution obtained from the third step by using a separation membrane filtration device,
• wherein
• the average size of the polymeric nanoparticles is 200 nm or less;
• the non-volatile polar organic solvent in the first step is selected from the group consisting of dimethyl sulfoxide (DMSO), dimethyl formamide (DMF), Dimethyl acetamide (DMAc), N-methyl-2-pyrrolidone (NMP), pyrrolidone, 1,3-Dimethyl-3,4,5,6-tetrahydro-2(1H)-pyrimidinone (DMPU), hexamethylphosphoramide (HMPA), and a mixture thereof;
• and
• the emulsifier in the third step is selected from the group consisting of propylene glycol (1,2-dihydroxypropane), polyethylene glycol with a molecular weight of 200 to 600, propylene carbonate (4-methyl-2-oxo-1,3-dioxolane), polyvinyl alcohol (PVA), polyvinyl pyrrolidone (PVP) and mixtures thereof.