|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|
|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.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.