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Last Updated: November 28, 2020

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Claims for Patent: 10,058,554

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Summary for Patent: 10,058,554
Title:Sustained release small molecule drug formulation
Abstract: An injectable depot formulation includes a biocompatible polymer, an organic solvent combined with the biocompatible polymer to form a viscous gel, and a small molecule drug incorporated in the viscous gel such that the formulation exhibits an in vivo release profile having C.sub.max to C.sub.min ratio less than 200 and lag time less than 0.2.
Inventor(s): Luk; Andrew S. (Castro Valley, CA), Junnarkar; Gunjan H. (Palo Alto, CA), Chen; Guohua (Sunnyvale, CA)
Assignee: Indivior UK Limited (Slough, Berkshire, GB)
Application Number:15/422,626
Patent Claims: 1. A method of administering risperidone base to a subject, comprising: implanting in the subject a formulation comprising: a copolymer of lactic acid and glycolic acid having a number average molecular weight ranging from 1000 Daltons to 30,000 Daltons; an organic solvent combined with the copolymer to form a viscous gel, the organic solvent comprising N-methyl-2-pyrrolidone; and risperidone base in particle form incorporated in the viscous gel, wherein the copolymer and the N-methyl-pyrrolidone comprise a vehicle, the copolymer is present in the vehicle in an amount ranging from 40% to 55% by weight, and the organic solvent is present in the vehicle in an amount ranging from 45% to 60% by weight.

2. The method of claim 1, wherein the copolymer of lactic acid and glycolic acid has a monomer ratio of lactic acid to glycolic acid ranging from about 100:0 to 60:40.

3. The method of claim 1, wherein the copolymer of lactic acid and glycolic acid has a monomer ratio of lactic acid to glycolic acid ranging from 100:0 to 75:25.

4. The method of claim 1, wherein the copolymer has a number average molecular weight ranging from 5000 Daltons to 30,000 Daltons.

5. The method of claim 1, wherein the organic solvent consists of N-methyl-2-pyrrolidone.

6. The method of claim 1, wherein the risperidone base is present in the formulation in an amount ranging from 5 wt % to 40 wt %.

7. The method of claim 1, wherein the risperidone base is present in the formulation in an amount ranging from 10 wt % to 30 wt %.

8. The method of claim 1, wherein the copolymer of lactic acid and glycolic acid has a monomer ratio of lactic acid to glycolic acid ranging from about 100:0 to 60:40, and the copolymer has a number average molecular weight ranging from 5000 Daltons to 30,000 Daltons.

9. The method of claim 1, wherein the copolymer of lactic acid and glycolic acid has a monomer ratio of lactic acid to glycolic acid ranging from 100:0 to 75:25, and the copolymer has a number average molecular weight ranging from 5000 Daltons to 30,000 Daltons.

10. The method of claim 1, wherein the copolymer of lactic acid and glycolic acid has a monomer ratio of lactic acid to glycolic acid ranging from about 100:0 to 60:40, and the organic solvent consists of N-methyl-2-pyrrolidone.

11. The method of claim 1, wherein the copolymer of lactic acid and glycolic acid has a monomer ratio of lactic acid to glycolic acid ranging from 100:0 to 75:25, the copolymer has a number average molecular weight ranging from 5000 Daltons to 30,000 Daltons, and the organic solvent consists of N-methyl-2-pyrrolidone.

12. The method of claim 1, wherein the organic solvent consists of N-methyl-2-pyrrolidone, and the risperidone base is present in the formulation in an amount ranging from 10 wt % to 30 wt %.

13. The method of claim 1, wherein the copolymer of lactic acid and glycolic acid has a monomer ratio of lactic acid to glycolic acid ranging from about 100:0 to 60:40, the organic solvent consists of N-methyl-2-pyrrolidone, and the risperidone base is present in the formulation in an amount ranging from 10 wt % to 30 wt %.

14. The method of claim 1, wherein the copolymer of lactic acid and glycolic acid has a monomer ratio of lactic acid to glycolic acid ranging from 100:0 to 75:25, the copolymer has a number average molecular weight ranging from 5000 Daltons to 30,000 Daltons, the organic solvent consists of N-methyl-2-pyrrolidone, and the risperidone base is present in the formulation in an amount ranging from 10 wt % to 30 wt %.

15. The method of claim 1, wherein the copolymer of lactic acid and glycolic acid has a monomer ratio of lactic acid to glycolic acid ranging from 100:0 to 75:25, the organic solvent consists of N-methyl-2-pyrrolidone, and the risperidone base is present in the formulation in an amount ranging from 10 wt % to 30 wt %.

16. The method of claim 1, wherein the formulation exhibits a lag time less than 0.2.

17. The method of claim 1, wherein the risperidone base in particle form comprises particles having an average particle size ranging from 0.1 .mu.m to 125 .mu.m.

18. The method of claim 1, wherein the risperidone base is released from the formulation for one week.

19. The method of claim 1, wherein the risperidone base is released from the formulation for one month.

20. The method of claim 1, wherein the risperidone base in particle form comprises particles having a particle size less than 38 .mu.m.

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