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Claims for Patent: 9,193,685

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Claims for Patent: 9,193,685

Title:Pharmaceutical compositions having improved storage stability
Abstract: The present invention relates to a pharmaceutical composition that provides long-term stability of a hydrolytically labile antipsychotic agent
Inventor(s): Perry; Jason M. (Cambridge, MA), Deaver; Daniel R. (Franklin, MA), Hickey; Magali B. (Westwood, MA), Remenar; Julius F. (Framingham, MA), Vandiver; Jennifer (Arlington, MA), Palmieri, Jr.; Michael J. (Hopkington, MA), Pan; Zhengzheng (Arlington, MA)
Assignee: ALKERMES PHARMA IRELAND LIMITED (Dublin, IE)
Application Number:14/031,842
Patent Claims: 1. A pharmaceutical composition comprising: (a) a hydrolytically labile antipsychotic agent; (b) a non-ionic water insoluble or immiscible ester co-surfactant; (c) a water miscible or soluble non-ionic surfactant; and (d) an aqueous vehicle; wherein the pharmaceutical composition comprises less than 50 parts per million of the hydrolysis product of the antipsychotic agent.

2. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition comprises less than 30 parts per million of the hydrolyzed antipsychotic agent.

3. The pharmaceutical composition of claim 1, wherein the non-ionic water insoluble or immiscible ester co-surfactant is a sorbitan ester of a carboxylic acid, wherein the carboxylic acid comprises 4-20 carbon atoms.

4. The pharmaceutical composition of claim 1, wherein the water miscible or soluble non-ionic surfactant is a polyoxyethylene derivative of a sorbitan ester of a carboxylic acid, wherein the carboxylic acid comprises 8-14 carbon atoms.

5. The pharmaceutical composition of claim 1, wherein the antipsychotic agent is Compound 1 ##STR00030##

6. The pharmaceutical composition of claim 5, wherein the hydrolysis product is of one or more of the following formulas: ##STR00031##

7. The pharmaceutical composition of claim 1, wherein the water miscible or soluble non-ionic surfactant is a polyoxyethylene derivative of a sorbitan ester of a carboxylic acid, wherein the carboxylic acid comprises 8-14 carbon atoms.

8. The pharmaceutical composition of claim 7, wherein the sorbitan ester is sorbitan laurate.

9. A pharmaceutical composition comprising: (a) 24-30 weight percent Compound 1: ##STR00032## (b) 0.3-0.4 weight percent sorbitan laurate; (c) 0.1-0.3 weight percent polysorbate 20; and (d) an aqueous vehicle.

10. A pharmaceutical composition comprising: (a) about 26.6 weight percent Compound 1: ##STR00033## (b) about 0.37 weight percent sorbitan laurate; (c) about 0.15 weight percent polysorbate 20; and (d) an aqueous vehicle.

11. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition comprises less than 50 parts per million of the hydrolysis product of the antipsychotic agent after standing for at least 12 months.

12. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition comprises less than 50 parts per million of the hydrolysis product of the antipsychotic agent after standing for at least 24 months.

13. The pharmaceutical composition of claim 1, wherein the non-ionic water insoluble or immiscible ester co-surfactant is sorbitan laurate, and wherein the water miscible or soluble non-ionic surfactant is polysorbate 20.

14. A method for treating a disorder of the central nervous system, comprising administering an effective amount of the composition of claim 1 to an individual in need of such treatment, wherein the disorder of the central nervous system is schizophrenia or bipolar disorder.
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