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Claims for Patent: 9,034,867

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Claims for Patent: 9,034,867

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; Magall B. (Medford, MA), Remenar; Julius F. (Waltham, MA), Vandiver; Jennifer (Arlington, MA)
Assignee: ALKERMES PHARMA IRELAND LIMITED (Dublin, IE)
Application Number:13/423,606
Patent Claims: 1. 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 composition of claim 1, wherein the composition comprises components (b) and (c) at a ratio that results in flocs comprising component (a), wherein the flocs settle to greater than a predetermined sediment bed height, such that components (a), (b) and (c) can be resuspended for injection.

3. The composition of claim 2, wherein the bed height is comprised of at least a 20 to 80% increase in sediment height compared to a non flocculated composition after 24 hours of undisturbed sitting.

4. The composition of claim 2, wherein components (a), (b) and (c) can be resuspended for injection within 1-60 seconds of handshaking.

5. The composition of claim 1, wherein the ratio of components (b) to (c) is such that the composition can be injected using a 20 to 25 gauge needle.

6. The composition of claim 2, wherein (a), (b), and (c) form flocs having the following sizes: Dv[10]: 2-10 .mu.m, Dv[50]: 10-30 .mu.m, and Dv[90]: less than 65 .mu.mM.

7. The composition of claim 1, wherein the ratio of components (b) to (c) is approximately 5 to 2, by weight.

8. The composition of claim 1, comprising about 0.2-1 weight percent sorbitan laurate.

9. The composition of claim 1, comprising about 0.4-0.7 weight percent sorbitan laurate.

10. The composition of claim 1, comprising about 0.5 weight percent sorbitan laurate.

11. The composition of claim 1, comprising about 0.05-0.8 weight percent polysorbate 20.

12. The composition of claim 1, comprising about 0.1-0.3 weight percent polysorbate 20.

13. The composition of claim 1, comprising about 0.2 weight percent polysorbate 20.

14. The composition of claim 1, comprising approximately 15-35 weight percent compound A-7.

15. The composition of claim 1, comprising approximately 20-30 weight percent compound A-7.

16. An injectable pharmaceutical composition comprising: (a) compound A-7: ##STR00018## wherein component (a) is in a weight ratio of approximately 15-35%; (b) sorbitan laurate in a weight ratio of approximately 0.2-1% (c) polysorbate 20 in a weight ratio of approximately 0.05-0.8%; and (d) an aqueous carrier.

17. An injectable composition comprising: (a) compound A-7: ##STR00019## (b) sorbitan laurate; (c) polysorbate 20; and (d) an aqueous vehicle.

18. The composition of claim 17, wherein the composition is formulated for modulating tissue reaction associated with the delivery of a water-insoluble antipsychotic agent.

19. The composition of claim 18, wherein the modulation of the tissue reaction is a reduction in the irritation at the site of injection.

20. The composition of claim 17, wherein the composition further comprises a buffer.

21. The composition of claim 20, wherein the buffer is a phosphate, citrate, tartrate or acetate buffer.

22. A method for treating disorders of the central nervous system, comprising administering an effective amount of the composition of claim 1 to an individual in need of such treatment.

23. The method of claim 22, wherein the disorder is anxiety or depression.

24. The method of claim 22, wherein the disorder is bipolar disorder.

25. The method of claim 22, wherein the disorder is autism-related irritability.

26. The method of claim 22, wherein the disorder is a psychotic condition.

27. The method of claim 26, wherein the psychotic condition is schizophrenia or schizophreniform diseases.

28. The method of claim 26, wherein the psychotic condition is acute mania.

29. 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.
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