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.

We claim: 
     
         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 .