Novel sustained release polymer
AssigneeTolmar Therapeutics, Inc.
InventorRichard L. Dunn
Life of this patent
Estimating the term…
Abstract
A polymer and a method for its preparation are provided. The polymer comprises poly(lactide), poly(lactide/glycolide) or poly(lactic acid/glycolic acid) segments bonded by ester linkages to both ends of an alkanediol core unit. The polymer is for use in a controlled release formulation for a medicament, preferably leuprolide acetate. The controlled release formulation is administered to a patient as a subcutaneous depot of a flowable composition comprising the polymer, a biocompatible solvent, and the medicament. Controlled release formulations comprising the polymer release leuprolide for treatment of prostate cancer patients over periods of 3-6 months.
Claims21
(canceled)
A method of treatment of prostate cancer in a human male patient, comprising administering to the patient a flowable controlled release composition, wherein the flowable controlled release composition comprises:
- a. an organic solvent,
- b. a medicament selected from the group consisting of leuprolide and pharmaceutically acceptable salts thereof, and
- c. a biodegradable polymer comprising polymer segments selected from the group consisting of polylactide (PL) polymer segments, poly(lactic acid) (PLA) polymer segments, poly(lactide/glycolide) (PLG) copolymer segments, poly(lactic acid/glycolic acid) (PLGA) copolymer segments and combinations thereof, wherein the polymer has substantially no titratable carboxylic acid groups and is hydroxyl-terminated at the distal ends of the PL, PLA, PLG and/or PLGA segments;
- and
- wherein the serum testosterone level of the patient is reduced to 50 ng/dL or lower.
A method of preparing a controlled release formulation for the reduction of serum testosterone in a patient, comprising combining:
- a. an organic solvent,
- b. a medicament selected from the group consisting of leuprolide and pharmaceutically acceptable salts thereof, and
- c. a biodegradable polymer comprising polymer segments selected from the group consisting of polylactide (PL) polymer segments, poly(lactic acid) (PLA) polymer segments, poly(lactide/glycolide) (PLG) copolymer segments, poly(lactic acid/glycolic acid) (PLGA) copolymer segments and combinations thereof, wherein the polymer has substantially no titratable carboxylic acid groups and is hydroxyl-terminated at the distal ends of the PL, PLA, PLG and/or PLGA segments.
A method to reduce serum testosterone levels in a human patient, comprising administering a composition subcutaneously to the human patient, the composition comprising:
- a. a biodegradable polymer comprising polymer segments selected from the group consisting of polylactide (PL) polymer segments, poly(lactic acid) (PLA) polymer segments, poly(lactide/glycolide) (PLG) copolymer segments, poly(lactic acid/glycolic acid) (PLGA) copolymer segments and combinations thereof, wherein the polymer has substantially no titratable carboxylic acid groups and is hydroxyl-terminated at the distal ends of the PL, PLA, PLG and/or PLGA segments;
- b. an organic solvent;
- and
- c. a medicament selected from the group consisting of leuprolide and pharmaceutically acceptable salts thereof;
- and
- wherein the serum testosterone level of the patient is reduced to 50 ng/dL or lower.
A syringe comprising a flowable composition consisting essentially of:
- a. a biodegradable polymer comprising polymer segments selected from the group consisting of polylactide (PL) polymer segments, poly(lactic acid) (PLA) polymer segments, poly(lactide/glycolide) (PLG) copolymer segments, poly(lactic acid/glycolic acid) (PLGA) copolymer segments and combinations thereof and the polymer has substantially no titratable carboxylic acid groups and is hydroxyl-terminated at the distal ends of the PL, PLA, PLG and/or PLGA segments,
- b. an organic solvent, and
- c. leuprolide or a pharmaceutically acceptable salt thereof.
Dependencies are inferred from the claim text.