Methods for Administering Aripiprazole
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.
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.
2 . The composition of claim 1 , wherein the aripiprazole release is for at least 7 days.
3 . The composition of claim 1 , wherein the viscosity enhancing agent comprises carboxymethyl cellulose.
4 . The composition of claim 1 , wherein said injection vehicle further comprises a wetting agent.
5 . The composition of claim 4 , wherein the wetting agent is selected from the group consisting of polysorbate 20, polysorbate 40, and polysorbate 80.
6 . The composition of claim 1 , wherein said injection vehicle comprises a density enhancing agent.
7 . The composition of claim 6 , wherein said density enhancing agent comprises sorbitol.
8 . The composition of claim 1 , wherein said injection vehicle comprises a tonicity adjusting agent.
9 . The composition of claim 8 , wherein said tonicity adjusting agent comprises sodium chloride.
10 . 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.
11 . 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.
12 . 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.
13 . The method of claim 12 , wherein a therapeutically effective amount of the aripiprazole is present in the plasma of the individual for at least about 7 days.
14 . The method of claim 12 , wherein the viscosity enhancing agent comprises carboxymethyl cellulose.
15 . The method of claim 12 , wherein the injection vehicle further comprises a wetting agent.
16 . The method of claim 15 , wherein the wetting agent is selected from the group consisting of polysorbate 20, polysorbate 40, and polysorbate 80.
17 . The method of claim 12 , wherein said injection vehicle comprises a density enhancing agent.
18 . The method of claim 17 , wherein said density enhancing agent comprises sorbitol.
19 . The method of claim 12 , wherein said injection vehicle comprises a tonicity adjusting agent.
20 . The method of claim 19 , wherein said tonicity adjusting agent comprises sodium chloride.
21 . The method of claim 12 , wherein the composition is administered by injection selected from the group consisting of: intramuscular injection or subcutaneous injection.
22 . The method of claim 12 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.
23 . A method for providing aripiprazole to an individual in an extended release injectable composition comprising administering a composition of claim 11 .