Polymeric leuprolide acetate formulations

A pharmaceutical product comprising:

• a first syringe filled with a polymer solution of from 50% to 60% by weight of a poly(D,L-lactide-co-glycolide) (PLG) dissolved in N-methyl-2-pyrrolidone (NMP), wherein PLG has a molar ratio of lactide to glycolide monomers of 85:15, and wherein PLG has a weight average molecular weight of from 15 kDa to 35 kDa;
• and
• a second syringe filled with a drug solution of from 40 mg to 50 mg of leuprolide acetate dissolved in NMP at a concentration of from 20% to 45% (w/w) of leuprolide acetate,
• wherein the drug solution remains a solution over the entire shelf life of the pharmaceutical product, wherein the shelf life is at least 24 months of storage at from 2° C. to 8° C.;
• wherein the polymer and drug solutions of the first and second syringes are not mixed prior to use;
• and
• wherein when the polymer solution and the drug solution are mixed, the resulting composition is a homogenous extended-release composition for subcutaneous injection into a subject that upon injection into the subject, forms an in situ depot that releases leuprolide acetate over a time period of 6 months.