Aripiprazole injectable suspension formulation having prolonged shelf life
The present invention belongs to the field of pharmaceutical formulation, and particularly relates to an aripiprazole injectable suspension formulation having prolonged shelf life, and methods of using the formulation in treating schizophrenia and related diseases. In another aspect, the present invention also relates to a method of prolonging shelf life of an aripiprazole injectable suspension formulation.
1. An aripiprazole injectable suspension formulation having prolonged shelf life, comprising aripiprazole in an amount of 200 mg/mL;
sodium carboxymethyl cellulose in an amount selected from 4 mg/mL or 8 mg/mL;
mannitol in an amount of 40 mg/mL;
polyoxyethylene (20) sorbitan monooleate in an amount selected from 4 mg/mL, 8 mg/mL or 24 mg/mL; and
sodium dihydrogen phosphate in an amount of 0.6 mg/mL.
2. A method for treating schizophrenia, comprising:
administering the aripiprazole injectable suspension formulation according to claim 1 to a subject in need thereof.
3. The method of claim 2 , wherein the aripiprazole injectable suspension formulation is administered intramuscularly or subcutaneously.
4. A method of prolonging shelf life of an aripiprazole injectable suspension formulation, comprising
dispersing aripiprazole in a vehicle for injection,
wherein the aripiprazole is in an amount of 200 mg/mL, and the vehicle contains sodium carboxymethyl cellulose in an amount selected from 4 mg/mL or 8 mg/mL, mannitol in an amount of 40 mg/mL, polyoxyethylene (20) sorbitan monooleate in an amount selected from 4 mg/mL, 8 mg/mL or 24 mg/mL, and sodium dihydrogen phosphate in an amount of 0.6 mg/mL.