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.

1 .- 23 . (canceled) 
     
     
         24 . An injectable composition comprising a suspension of at least about 10 mg/ml of aripiprazole in an injection vehicle comprising water, carboxymethyl cellulose or sodium carboxy methylcellulose, wherein the injectable composition is free of sustained release materials for the extended release of aripiprazole, and the aripiprazole release is for at least 7 days. 
     
     
         25 . The composition of  claim 24 , wherein said injection vehicle further comprises a wetting agent. 
     
     
         26 . The composition of  claim 25 , wherein said wetting agent is chosen from polysorbate 20, polysorbate 40, and polysorbate 80. 
     
     
         27 . The composition of  claim 24 , wherein said injection vehicle further comprises a density enhancing agent. 
     
     
         28 . The composition of  claim 27 , wherein said density enhancing agent comprises sorbitol. 
     
     
         29 . The composition of  claim 24 , wherein said injection vehicle further comprises a tonicity adjusting agent. 
     
     
         30 . The composition of  claim 29 , wherein said tonicity adjusting agent comprises sodium chloride. 
     
     
         31 . A method for providing aripiprazole to an individual in an injectable composition comprising a suspension of at least about 10 mg/ml of aripiprazole in an injection vehicle comprising water, carboxymethyl cellulose or sodium carboxy methylcellulose, wherein the injectable composition is free of sustained release materials for the extended release of aripiprazole, and the aripiprazole release is for at least 7 days. 
     
     
         32 . The method of  claim 31 , wherein said injection vehicle further comprises a wetting agent. 
     
     
         33 . The method of  claim 32 , wherein said wetting agent is chosen from polysorbate 20, polysorbate 40, and polysorbate 80. 
     
     
         34 . The method of  claim 31 , wherein said injection vehicle further comprises a density enhancing agent. 
     
     
         35 . The method of  claim 34 , wherein said density enhancing agent comprises sorbitol. 
     
     
         36 . The method of  claim 31 , wherein said injection vehicle further comprises a tonicity adjusting agent. 
     
     
         37 . The method of  claim 36 , wherein said tonicity adjusting agent comprises sodium chloride. 
     
     
         38 . The method of  claim 31 , wherein the composition is administered by injection chosen from intramuscular injection and subcutaneous injection. 
     
     
         39 . The method of  claim 31 , further comprising a second administration of the composition chosen from at least about 7 days after first administration and at least about 14 days after the first administration. 
     
     
         40 . A composition comprising a suspension of at least 50 mg of aripiprazole and an aqueous injection vehicle comprising water; carboxymethylcellulose or sodium carboxy methylcellulose; a wetting agent; and a tonicity agent; wherein the composition is free of sustained release materials; wherein the concentration of aripiprazole in the composition is at least 20 mg/ml; and wherein upon injection of the composition into an individual, the aripiprazole is present in the plasma of the individual for about 7 days or more.