FIELD: medicine.
SUBSTANCE: group of inventions relates to a method of producing an injection composition comprising: purifying a lactate-based polymer selected from a group consisting of poly (D,L-lactide-co-glycolide) or poly (D,L-lactide), having weight-average molecular weight from 5000 to 50000 daltons, acid value of less than 3 mgKON/g, and content of residual lactide monomers in said lactate-based polymer, less than about 0.3 % by weight, and combining said lactate-based purified polymer with a pharmaceutically acceptable organic solvent and leuprolide or an acetate or mesylate thereof, capable of reacting with a monomer of lactide to form a conjugate, provided that when preparing said composition, no acid additive and also relates to a controlled release drug delivery composition comprising: a lactate-based polymer selected from a group, consisting of poly (D,L-lactide-co-glycolide) or poly (D,L-lactide), having weight-average molecular weight from 5000 to 50000 daltons, acid value of less than 3 mgKON/g, and content of residual lactide monomers in the lactate-based polymer of less than about 0.3 % by weight; pharmaceutically acceptable organic solvent; as well as leuprolide or its acetate or mesylate, capable of reacting with a lactide monomer with formation of a conjugate, provided that during production of said composition no acid additive is added.
EFFECT: group of inventions provides minimization or prevention of formation of impurities, related to biologically active substances, and undesired premature decomposition of biologically degradable polymer.
14 cl, 23 tbl, 12 ex, 25 dwg
