Claims for Patent: 10,226,458

Summary for Patent: 10,226,458

Title:	Pharmaceutical compositions comprising sorbitan esters
Abstract:	The present invention relates to a pharmaceutical composition comprising sorbitan esters of carboxylic acids that are useful for the delivery of anti-psychotic drugs.
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)
Assignee:	ALKERMES PHARMA IRELAND LIMITED (Dublin, IE)
Application Number:	15/388,554
Patent Claims:	1. A method for treating schizophrenia, bipolar disorder, or depression in a subject in need thereof comprising administering to the subject an effective amount of a pharmaceutical composition comprising: (a) compound A-7: ##STR00017## (b) sorbitan laurate; (c) polysorbate 20; and (d) an aqueous vehicle, wherein the composition forms an aqueous, flocculated, injectable suspension. 2. The method of claim 1, wherein depression is treated. 3. The method of claim 1, wherein bipolar disorder is treated. 4. The method of claim 1, wherein schizophrenia is treated. 5. The method of claim 1, wherein the ratio of components (b) to (c) is approximately 5 to 2, by weight. 6. The method of claim 1, comprising about 0.2- 1 weight percent sorbitan laurate. 7. The method of claim 1, comprising about 0.4- 0.7 weight percent sorbitan laurate. 8. The method of claim 1, comprising about 0.5 weight percent sorbitan laurate. 9. The method of claim 1, comprising about 0.05- 0.8 weight percent polysorbate 20. 10. The method of claim 1, comprising about 0.1- 0.3 weight percent polysorbate 20. 11. The method of claim 1, comprising about 0.2 weight percent polysorbate 20. 12. The method of claim 1, comprising approximately 15- 35 weight percent compound A-7. 13. The method of claim 1, comprising approximately 20- 30 weight percent compound A-7. 14. A method for treating schizophrenia, bipolar disorder, or depression in a subject in need thereof comprising administering to the subject an injectable pharmaceutical composition comprising: (a) 15-35 weight percent compound A-7: ##STR00018## (b) approximately 0.2-1 weight percent sorbitan laurate; (c) approximately 0.05-0.8 weight percent polysorbate 20; and (d) an aqueous carrier. 15. The method of claim 14, wherein schizophrenia is treated. 16. A method for treating schizophrenia, bipolar disorder, or depression in a subject in need thereof comprising administering to the subject an injectable composition comprising: (a) compound A-7: ##STR00019## (b) sorbitan laurate; (c) polysorbate 20; and (d) an aqueous vehicle. 17. The method of claim 16, wherein the composition further comprises a buffer. 18. The method of claim 17, wherein the buffer is a phosphate, citrate, tartrate or acetate buffer. 19. The method of claim 16, wherein schizophrenia is treated. 20. A method for treating schizophrenia, bipolar disorder, or depression in a subject in need thereof comprising administering to the subject a pharmaceutical composition comprising: (a) 24-30 weight percent compound A-7: ##STR00020## (b) 0.2-1 weight percent sorbitan laurate; (c) 0.1-0.3 weight percent polysorbate 20; and (d) an aqueous vehicle. 21. The method of claim 20, wherein schizophrenia is treated.