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Claims for Patent: 8,338,427

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Claims for Patent: 8,338,427

Title:Methods for administering aripiprazole
Abstract: The present invention relates, in part, to the discovery that a pharmaceutical composition comprising aripiprazole and a carrier administered in a bolus injection resulted in an extended release profile similar to that obtained by the injection of a poly lactide-co-glycolide microsphere formulation containing the active agent. This surprising result suggests that pharmacologically beneficial extended release formulations without the complexities and expense associated with the manufacture microspheres.
Inventor(s): Brown; Josiah (Seattle, WA)
Assignee: Alkermes, Inc. (Waltham, MA)
Application Number:12/251,656
Patent Claims: 1. An injectable composition that is free of sustained release materials for the extended release of aripiprazole comprising a suspension of at least about 10 mg/ml of aripiprazole in an injection vehicle optionally comprising a viscosity enhancing agent and wherein the aripiprazole release is for at least 7 days.

2. The composition of claim 1, wherein the viscosity enhancing agent comprises carboxymethyl cellulose.

3. The composition of claim 1, wherein said injection vehicle further comprises a wetting agent.

4. The composition of claim 3, wherein the wetting agent is selected from the group consisting of polysorbate 20, polysorbate 40, and polysorbate 80.

5. The composition of claim 1, wherein said injection vehicle comprises a density enhancing agent.

6. The composition of claim 5, wherein said density enhancing agent comprises sorbitol.

7. The composition of claim 1, wherein said injection vehicle comprises a tonicity adjusting agent.

8. The composition of claim 7, wherein said tonicity adjusting agent comprises sodium chloride.

9. A composition comprising a suspension of at least about 10 mg of aripiprazole and an aqueous injection vehicle comprising water, a viscosity enhancing agent, a wetting agent and a tonicity agent wherein upon administration of the composition the aripiprazole release is for at least 7 days.

10. A composition comprising a suspension of at least about 10 mg of aripiprazole and an aqueous injection vehicle comprising water, about 3% by volume carboxymethylcellulose, about 0.1% polysorbate 20 and about 0.9% by weight to about 1% by weight sodium chloride wherein upon administration of the composition the aripiprazole release is for at least 7 days.

11. A method for providing aripiprazole to an individual in an extended release injectable composition that is free of sustained release materials comprising administering a mixture of at least about 10 mg/ml of aripiprazole in an injection vehicle optionally comprising a viscosity enhancing agent and wherein a therapeutically effective amount of the aripiprazole is present in the plasma of the individual for at least about 7 days.

12. The method of claim 11, wherein the viscosity enhancing agent comprises carboxymethyl cellulose.

13. The method of claim 11, wherein the injection vehicle further comprises a wetting agent.

14. The method of claim 13, wherein the wetting agent is selected from the group consisting of polysorbate 20, polysorbate 40, and polysorbate 80.

15. The method of claim 11, wherein said injection vehicle comprises a density enhancing agent.

16. The method of claim 15, wherein said density enhancing agent comprises sorbitol.

17. The method of claim 11, wherein said injection vehicle comprises a tonicity adjusting agent.

18. The method of claim 17, wherein said tonicity adjusting agent comprises sodium chloride.

19. The method of claim 11, wherein the composition is administered by injection selected from the group consisting of: intramuscular injection or subcutaneous injection.

20. The method of claim 11 further comprising a second administration of the composition selected from the group consisting of: at least about 7 days after first administration and at least about 14 days after the first administration.

21. A method for providing aripiprazole to an individual in an extended release injectable composition comprising administering a composition of claim 10.
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