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Details for Patent: 8,840,916

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Details for Patent: 8,840,916

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.
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