Claims for Patent: 9,539,333

Summary for Patent: 9,539,333

Title:	Sustained release polymer
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.
Inventor(s):	Dunn; Richard L. (Fort Collins, CO)
Assignee:	Tolmar Therapeutics, Inc. (Fort Collins, CO)
Application Number:	15/014,810
Patent Claims:	1. A polymer for use in manufacture of a controlled release formulation for a drug, comprising a structure of Formula I: ##STR00010## wherein: R.sup.a is an alkane diradical comprising about 4 to about 8 carbon atoms; R.sup.b is hydrogen or methyl with the proviso that both R.sup.b groups are identical; R.sup.c is independently hydrogen or methyl with the proviso that both R.sup.c groups are identical; each L/G independently comprises a lactide/glycolide copolymer segment; the polymer has substantially no titratable carboxylic acid groups, and the polymer has a weight average molecular weight of from about 6 kD to about 200 kD. 2. The polymer of claim 1 wherein L/G comprises a lactide/glycolide copolymer segment with a lactide/glycolide ratio of about 45/55 to about 99/1. 3. The polymer of claim 1 wherein L/G comprises a lactide/glycolide copolymer segment with a lactide/glycolide ratio of about 70/30 to about 90/10. 4. The polymer of claim 1 wherein L/G comprises a lactide/glycolide copolymer segment with a lactide/glycolide ratio of about 85/15. 5. The polymer of claim 1 wherein the weight average molecular weight is about 9 kD to about 100 kD. 6. The polymer of claim 1 wherein the weight average molecular weight is about 25 kD to about 45 kD. 7. The polymer of claim 1 in combination with a drug wherein the combination is a controlled release formulation. 8. The polymer combination of claim 7 wherein the drug is leuprolide. 9. A method of treatment of prostate cancer in a human male patient comprising treating the patient with an effective dose of the polymer combination of claim 8. 10. A method of treatment of claim 9 wherein the treatment s accomplished once every 3 months, 4 months or 6 months. 11. The polymer combination of claim 8 further including an organic solvent which is N-methyl pyrrolidone, N,N-dimethyl formamide or N,N-dimethyl acetamide. 12. The polymer combination of claim 11 wherein the organic solvent is N-methyl pyrrolidone. 13. A method of treatment of prostate cancer in a human male patient comprising administration to the patient an effective dose of a polymer combination of claim 12. 14. A method of treatment of claim 13 wherein the administration is accomplished once every 3 months, 4 months or 6 months.