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Last Updated: May 16, 2024

Claims for Patent: 11,097,006

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Summary for Patent: 11,097,006

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 (Waltham, MA)
Application Number:	16/834,565
Patent Claims:	1. A pharmaceutical composition comprising: (a) Compound 1 ##STR00030## (b) a non-ionic water insoluble and/or immiscible ester co-surfactant that is a sorbitan ester of a carboxylic acid, wherein the carboxylic acid comprises 4-20 carbon atoms; (c) a water miscible and/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 Compound 1. 2. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition comprises less than 30 parts per million of the hydrolysis product of Compound 1 after standing for at least 24 months. 3. The pharmaceutical composition of claim 1, wherein the water miscible and/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. 4. The pharmaceutical composition of claim 1, wherein the sorbitan ester is sorbitan laurate. 5. The pharmaceutical composition of claim 3, wherein the polyoxyethylene derivative of a sorbitan ester is polysorbate 20. 6. A pharmaceutical composition comprising: (a) 20-30 weight percent compound I: ##STR00031## (b) about 0.2-1 weight percent sorbitan laurate; (c) about 0.1-0.3 weight percent polysorbate 20; and (d) an aqueous vehicle; wherein the pharmaceutical composition comprises less than 50 parts per million of the hydrolysis product of Compound 1. 7. A method of treating schizophrenia in a subject in need thereof comprising administering to the subject the composition of claim 1. 8. A method of treating schizophrenia in a subject in need thereof comprising administering to the subject the composition of claim 6. 9. A method of treating bipolar disorder in a subject in need thereof comprising administering to the subject the composition of claim 6. 10. A method of treating anxiety in a subject in need thereof comprising administering to the subject the composition of claim 6. 11. A method of treating depression in a subject in need thereof comprising administering to the subject the composition of claim 6. 12. A method of treating autism-related irritability in a subject in need thereof comprising administering to the subject the composition of claim 6. 13. A method of treating acute mania in a subject in need thereof comprising administering to the subject the composition of claim 6. 14. The pharmaceutical composition of claim 1, wherein the hydrolysis product of Compound 1 is: ##STR00032## 15. The pharmaceutical composition of claim 6, wherein the hydrolysis product of Compound 1 is: ##STR00033##

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