Methods of administering an aripiprazole injectable preparation

Abstract

The present disclosure is directed to the methods of treating a patient with schizophrenia or bipolar I disorder by administering to the patient an injectable preparation of aripiprazole, wherein the patient is administered the injectable preparation about once every two months.

1 .- 24 . (canceled) 
     
     
         25 . A method of treating a patient with schizophrenia or bipolar I disorder comprising:
 administering to the patient at a gluteal muscle an injectable preparation comprising aripiprazole or a salt thereof,   wherein the patient is administered the injectable preparation about once every 56 days, and the amount of aripiprazole in the injectable preparation is about 960 mg.   
     
     
         26 . The method according to  claim 25 , wherein the injectable preparation further comprises: water, and a suspending agent comprising polyvinylpyrrolidone, polyethylene glycol, and carboxymethylcellulose or a salt thereof, wherein aripiprazole or a salt thereof has a mean primary particle diameter ranging from about 0.5 μm to about 30 μm, and the concentration of aripiprazole in the injectable preparation is about 300 mg/mL. 
     
     
         27 . The method according to  claim 25 , wherein the injectable preparation further comprises: water for injection, and a suspending agent comprising polyvinylpyrrolidone, polyethylene glycol, and carboxymethylcellulose or a salt thereof, wherein the aripiprazole or a salt thereof is aripiprazole monohydrate, the aripiprazole monohydrate has a mean primary particle diameter ranging from about 2 μm to about 5 μm, and the concentration of aripiprazole in the injectable preparation is about 300 mg/mL, calculated based on an anhydrous form of aripiprazole. 
     
     
         27 . The method according to  claim 25 , wherein the injectable preparation is in a dosage form of a prefilled sol-gel formed injection. 
     
     
         28 . The method according to  claim 25 , wherein the injectable preparation has a thixotropic property. 
     
     
         29 . The method according to  claim 25 , further comprising administering a plurality of the injectable preparations to the patient, wherein the plurality of the injectable preparations results in an area under a concentration-time curve (AUC) of aripiprazole from time zero to 56 days postdose substantially equal to a twofold AUC of aripiprazole from time zero to 28 days postdose following a plurality of administration of an aripiprazole intramuscular (IM) depot formulation. 
     
     
         30 . The method of according to  claim 25 , further comprising administering aripiprazole or a salt thereof in a solid dosage form orally, and the solid dosage form is administered in an amount ranging from 10 mg to 20 mg per day consecutively for 5 days to 15 days with the administration of the injectable preparation. 
     
     
         31 . The method according to  claim 25 , further comprising administering from 10 mg to 20 mg of aripiprazole or a salt thereof in a solid dosage form orally per day consecutively for 7 days with the administration of the injectable preparation. 
     
     
         32 . The method according to  claim 30 , wherein the consecutive administrations allows for a mean plasma level of aripiprazole in the patient to maintain 90 ng/mL or more. 
     
     
         33 . The method according to  claim 32 , wherein the method does not comprise a further oral administration of aripiprazole or a salt thereof. 
     
     
         34 . A method of administering an injectable preparation comprising aripiprazole or a salt thereof to a patient with schizophrenia or bipolar I disorder comprising:
 administering orally to the patient from 10 mg/day to 20 mg/day of aripiprazole or a salt thereof consecutively for 5 days to 15 days from a first day;   administering intramuscularly to the patient the injectable preparation once every about 56 days,   wherein the injectable preparation comprises about 960 mg of aripiprazole or a salt thereof and is administered on the first day, and the consecutive administrations allows for a mean plasma level of aripiprazole in the patient to maintain 90 ng/mL or more.   
     
     
         35 . The method according to  claim 34 , wherein the method does not comprise a further oral administration of aripiprazole or a salt thereof. 
     
     
         36 . The method according to  claim 34 , wherein the injectable preparation further comprises: water, and a suspending agent comprising polyvinylpyrrolidone, polyethylene glycol, and carboxymethylcellulose or a salt thereof, wherein aripiprazole or a salt thereof has a mean primary particle diameter ranging from about 0.5 μm to about 30 μm, and the concentration of aripiprazole in the injectable preparation is about 300 mg/mL. 
     
     
         37 . The method according to  claim 34 , wherein the injectable preparation further comprises: water for injection, and a suspending agent comprising polyvinylpyrrolidone, polyethylene glycol, and carboxymethylcellulose or a salt thereof, wherein the aripiprazole or a salt thereof is aripiprazole monohydrate, the aripiprazole monohydrate has a mean primary particle diameter ranging from about 2 μm to about 5 μm, and the concentration of aripiprazole in the injectable preparation is about 300 mg/mL, calculated based on an anhydrous form of aripiprazole. 
     
     
         38 . The method according to  claim 34 , wherein the injectable preparation is in a dosage form of a prefilled sol-gel formed injection. 
     
     
         39 . The method according to  claim 34 , wherein the injectable preparation has a thixotropic property.