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US 12,758,609 B2Granted
Leuprolide acetate compositions and methods of using the same to treat breast cancer
AssigneeTolmar International Limited
InventorsJohn Middleton, Avinash Nangia, John Arthur McLane, Terri L. Morton
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Abstract
Compositions and methods for suppressing ovarian function in subjects with hormone receptor-positive breast cancer.
Claims24
An extended release composition for use in suppressing ovarian function during treatment of hormone receptor-positive breast cancer in pre- or peri-menopausal women, comprising
- a biodegradable polymer comprising co-polymer segments of poly(lactide-co-glycolide) (PLG) having a lactide to glycolide molar ratio of 70:30 to 80:20, no titratable carboxylic acid groups, and at least one distal end that is hydroxyl-terminated;
- N-methyl-2-pyrrolidone (NMP);
- and
- leuprolide or a pharmaceutically acceptable salt thereof, present in an amount to provide 26 mg to 30 mg of a free base equivalent of leuprolide;
- wherein the extended release composition has an injection volume of less than 0.5mL;
- wherein the extended release composition comprises 35-60% by weight of the biodegradable polymer and 50-60% by weight of NMP;
- and
- wherein the extended release composition is a 3-monthly formulation formulated to release up to 10 mg/mL leuprolide per month when administered subcutaneously every three months to pre-or peri-menopausal women with hormone receptor-positive breast cancer.
5 more elements
A dual syringe system for use in suppressing ovarian function during treatment of hormone receptor-positive breast cancer in pre-or peri-menopausal women, comprising an extended release composition comprising
- a biodegradable polymer comprising co-polymer segments of poly(lactide-co-glycolide) (PLG) having a lactide to glycolide molar ratio of 70:30 to 80:20, no titratable carboxylic acid groups, and at least one distal end that is hydroxyl-terminated;
- N-methyl-2-pyrrolidone (NMP);
- and
- leuprolide or a pharmaceutically acceptable salt thereof, present in an amount to provide 26 mg to 30 mg of a free base equivalent of leuprolide;
- wherein a first syringe comprises the biodegradable polymer and NMP, and a second syringe comprises leuprolide or the pharmaceutically acceptable salt thereof;
- wherein the extended release composition in the dual syringe system has an injection volume of less than 0.5 mL;
- wherein the extended release composition comprises 35-60% by weight of the biodegradable polymer and 50-60% by weight of NMP;
- and
- wherein the extended release composition is a 3-monthly formulation formulated to release up to 10 mg/mL leuprolide per month when administered subcutaneously every three months to pre-or peri-menopausal women with hormone receptor-positive breast cancer.
6 more elements
Dependencies are inferred from the claim text.