Freeze-dried aripiprazole formulation
AssigneeOtsuka Pharmaceutical Co., Ltd.
InventorShogo HIRAOKA
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Abstract
An object of the present invention is to provide a freeze-dried aripiprazole powder formulation that exhibits good dispersibility and is easily dispersed into a homogenous suspension when reconstituted with water. The present invention provides a freeze-dried aripiprazole formulation obtained by a process comprising the steps of spraying for freezing an aripiprazole suspension containing (I) aripiprazole, (II) a vehicle for the aripiprazole, and (III) water for injection, and drying
Claims20
A freeze-dried aripiprazole formulation obtained by a process comprising the steps of spraying for freezing an aripiprazole suspension containing
- (I) aripiprazole,
- (II) a vehicle for the aripiprazole, and
- (III) water for injection;
- and
- drying.
A process for producing a freeze-dried aripiprazole formulation comprising the steps of
- (e′-1) spray-freezing an aripiprazole suspension having a mean particle size in the range of about 1 to about 10 microns to obtain spray-frozen particles;
- and
- (e′-2) drying the spray-frozen particles to obtain spray-freeze-dried particles.
Dependencies are inferred from the claim text.