Details for Patent: 8,840,916
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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) |
Filing Date: | May 22, 2013 |
Application Number: | 13/900,338 |
Claims: | 1. A polymer of Formula (I/II): ##STR00010## wherein: wherein L/G signifies a PLG copolymer segment, the H atoms at both distal ends signify the hydrogen atoms borne by the terminal hydroxyl groups, and R.sup.a is an alkylene diradical; R.sup.b and R.sup.c are either hydrogen or methyl; the polymer is substantially insoluble in water and body fluid, the polymer has substantially no titratable carboxylic acid groups, the polymer has a weight average molecular weight from about 10 kD to about 50 kD, and the polymer in neat form is a solid at ambient temperature. 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 having a weight average molecular weight of about 8 kD to about 100 kD. 5. The polymer of claim 4 having a weight average molecular weight of about 10 kD to about 50 kD. 6. The polymer of claim 4 having a weight average molecular weight of about 15 kD to about 45 kD. 7. The polymer of claim 4 wherein R.sup.a is a linear unsubstituted carbon chain. 8. The polymer of claim 7 wherein R.sup.a is a linear unsubstituted carbon chain of 6 carbon atoms. 9. The polymer of claim 4 wherein a polydispersity of the polymer is about 1.2 to about 2.0. 10. The polymer of claim 4 wherein a polydispersity of the polymer is about 1.4 to about 1.7. 11. The polymer of claim 4 wherein an inherent viscosity of the polymer is about 0.20 dL/gm to about 0.60 dL/gm. 12. The polymer of claim 4 wherein an inherent viscosity of the polymer is about 0.25 dL/gm to about 0.40 dL/gm. |