DrugPatentWatch Database Preview
Email this page to a colleague
« Back to Dashboard
Summary for Patent: 8,470,359
|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:||QLT USA, Inc. (Willmington, DE)|
1. A flowable composition for a controlled release formulation comprising an organic solvent, a medicament and a polymer of Formula HO--(P)--C(.dbd.O)O--R.sup.a--O(O.dbd.)C--(P)--OH
wherein: R.sup.a is an alkane diradical comprising about 4 to about 8 carbons and is a residue of an alkane diol, P is a polymeric segment of repeating units of lactide, lactic, co(lactide-glycolide) or co(lactic-glycolic) moieties, the polymer is
substantially insoluble in water and body fluid, the polymer has substantially no titratable carboxylic acid groups, and 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, the organic solvent is a polar, aprotic organic solvent having at least some water solubility.
2. The flowable composition of claim 1 wherein P comprises a lactide/glycolide copolymer segment with a lactide/glycolide ratio of about 45/55 to about 99/1.
3. The flowable composition of claim 1 wherein P comprises a lactide/glycolide copolymer segment with a lactide/glycolide ratio of about 70/30 to about 90/10.
4. The flowable composition of claim 1 wherein R.sup.a is a linear unsubstituted carbon chain.
5. The flowable composition of claim 1 wherein R.sup.a is a linear unsubstituted carbon chain of 6 carbon atoms.
6. The flowable composition of claim 1 wherein the polymer has a polydispersity of about 1.2 to about 2.0.
7. The flowable composition of claim 6 wherein the polymer has a polydispersity of about 1.4 to about 1.7.
8. The flowable composition of claim 1 wherein the polymer has an inherent viscosity of about 0.20 dL/gm to about 0.60 dL/gm.
9. The flowable composition of claim 1 wherein the polymer has an inherent viscosity of about 0.25 dL/gm to about 0.40 dL/gm.
10. A flowable composition of claim 1 comprising an organic solvent, a medicament and a polymer prepared by a method comprising contacting an alkanediol, and a polymerizable unit selected from the group consisting of glycolide, lactide, lactate, glycolate and a combination thereof, and a catalyst, the catalyst being adapted to catalyze ring-opening polymerization of polymerizable unit initiated by the alkanediol; wherein the alkanediol comprises an .alpha.,.omega.-diol of about 4 to about 8 carbon atoms.
11. The flowable composition of claim 1, wherein the organic solvent is N-methylpyrrolidone, N,N-dimethylformamide, N,N-dimethylacetamide, triacetin, propylene carbonate, or ethyl acetate.
12. The flowable composition of claim 1 wherein the medicament is leuprolide or a pharmaceutically acceptable salt thereof.
13. Method for use of the flowable composition of claim 1 for treatment of a malcondition in a patient in need thereof, comprising implantation of the flowable composition comprising an effective amount of a medicament, into body tissue of the patient.
14. The use of claim 13, wherein the malcondition is prostate cancer.
15. The use of claim 13, wherein the composition comprises leuprolide or a pharmaceutically acceptable salt thereof.
16. A flowable composition according to claim 1 wherein the weight percentage of alkane diol relative to the total weight of alkane diol and the starting materials forming the repeating units of the polymer P is from about 0.05 wt % to about 2 wt %.
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
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 verification 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.