INJECTABLE PREPARATION

1 . An injectable preparation comprising a composition comprising a poorly soluble drug, a dispersion medium, and a suspending agent,

the suspending agent being at least one member selected from the group consisting of (i) and (ii):

(i) polyvinylpyrrolidone, and

(ii) polyethylene glycol and carboxymethyl cellulose or a salt thereof, the composition having a viscosity of 40 Pa·s or more in at least one point in the shear rate range of 0.01 to 0.02 s −1 and having a viscosity of 0.2 Pa·s or less in at least one point in the shear rate range of 900 to 1,000 s −1 , as measured by a rheometer.

2 . The injectable preparation according to claim 1 wherein

the composition has a viscosity of 40 Pa·s or more in at least one point in the shear rate range of 0.01 to 0.02 s −1 and having a viscosity of 0.2 Pa·s or less in at least one point in the shear rate range of 900 to 1,000 s −1 , as measured by a rheometer at 25° C.

3 . The injectable preparation according to claim 1 comprising a composition comprising at least water as a dispersion medium.

4 . The injectable preparation according to claim 1 wherein the poorly soluble drug is aripiprazole or a salt thereof, or 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one or a salt thereof.

5 . A gel composition comprising

a poorly soluble drug which is aripiprazole or a salt thereof, or 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one or a salt thereof,

water, and

at least one suspending agent selected from the group consisting of (i) and (ii):

(i) polyvinylpyrrolidone, and

(ii) polyethylene glycol and carboxymethyl cellulose or a salt thereof,

wherein the poorly soluble drug has a mean primary particle diameter of 0.5 to 30 □m and is contained in a concentration of 200 to 600 mg/mL.

6 . The composition according to claim 5 wherein (i) polyvinylpyrrolidone is contained as a suspending agent in a concentration of 0.1 to 100 mg/mL.

7 . The composition according to claim 5 wherein (ii) polyethylene glycol and carboxymethyl cellulose or a salt thereof are contained as suspending agents,

the concentration of polyethylene glycol being 0.05 to 2 mg/mL, and the concentration of carboxymethyl cellulose or a salt thereof being 0.5 to 50 mg/mL.

8 . The composition according to claim 5 wherein (i) polyvinylpyrrolidone and (ii) polyethylene glycol and carboxymethyl cellulose or a salt thereof are contained as suspending agents.

9 . The composition according to claim 5 wherein the poorly soluble drug has a mean secondary particle diameter that is up to but not exceeding three times the mean primary particle diameter thereof.

10 . (canceled)

11 . The composition according to claim 5 which has a viscosity of 40 Pa·s or more in at least one point in the shear rate range of 0.01 to 0.02 s −1 and which has a viscosity of 0.2 Pa·s or less in at least one point in the shear rate range of 900 to 1,000 s −1 , as measured by a rheometer at 25° C.

12 - 25 . (canceled)

26 . A sustained release injectable preparation comprising a composition comprising

a poorly soluble drug which is aripiprazole or a salt thereof, or 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one or a salt thereof,

water, and

at least one suspending agent selected from the group consisting of (i) and (ii):

(i) polyvinylpyrrolidone, and

(ii) polyethylene glycol and carboxymethyl cellulose or a salt thereof,

wherein the poorly soluble drug has a mean primary particle diameter of 1 to 10 □m and is contained in a concentration of 200 to 400 mg/mL,

the composition being in the form of a gel when allowed to stand, and changing to a sol when subjected to an impact, and

the preparation being administered once per month.

27 . The injectable preparation according to claim 26 wherein the poorly soluble drug has a mean primary particle diameter of 2 to 7 μm.

28 . A sustained release injectable preparation comprising a composition comprising

a poorly soluble drug which is aripiprazole or a salt thereof, or 7-[4-(4-benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one or a salt thereof,

water, and

at least one suspending agent selected from the group consisting of (i) and (ii):

(i) polyvinylpyrrolidone, and

(ii) polyethylene glycol and carboxymethyl cellulose or a salt thereof,

wherein the poorly soluble drug has a mean primary particle diameter of 4 to 30 μm and is contained in a concentration of 300 to 600 mg/mL,

the composition being in the form of a gel when allowed to stand, and changing to a sol when subjected to an impact, and

the preparation being administered once every two or three months.

29 . The injectable preparation according to claim 28 wherein the poorly soluble drug has a mean primary particle diameter of 5 to 20 μm.

30 . The injectable preparation according to claim 26 wherein (i) polyvinylpyrrolidone is contained as a suspending agent in a concentration of 0.1 to 100 mg/mL.

31 . The injectable preparation according to claim 26 wherein (ii) polyethylene glycol and carboxymethyl cellulose or a salt thereof are contained as suspending agents,

the concentration of polyethylene glycol being 0.05 to 2 mg/mL, and the concentration of carboxymethyl cellulose or a salt thereof being 0.5 to 50 mg/mL.

32 - 34 . (canceled)

35 . The injectable preparation according to claim 26 wherein the composition has a viscosity of 40 Pa·s or more in at least one point in the shear rate range of 0.01 to 0.02 s −1 and has a viscosity of 0.2 Pa·s or less in at least one point in the shear rate range of 900 to 1,000 s −1 , as measured by a rheometer at 25° C.

36 . A method for treating or preventing a recurrence of schizophrenia, bipolar disorder, or depression, the method comprising administering the injectable preparation according to claim 1 .

37 . The method according to claim 36 wherein the injectable preparation is administered intramuscularly or subcutaneously.