Pharmaceutical compositions comprising sorbitan esters

• US 10,226,458 B2
• Filed: 12/22/2016
• Issued: 03/12/2019
• Est. Priority Date: 03/18/2011
• Status: Active Grant

• Current Assignee: Alkermes Pharma Ireland Limited (Alkermes plc)
• Original Assignee: Alkermes Pharma Ireland Limited (Alkermes plc)
• Inventors: Perry, Jason M., Deaver, Daniel R., Hickey, Magali B., Remenar, Julius F., Vandiver, Jennifer
• Primary Examiner(s): Richter, Johann R
• Assistant Examiner(s): Alley, Genevieve S
• Application Number:
  US15/388,554
• Publication Number:
  US 20170196856A1
• Time in Patent Office: 810 Days
• CPC Class Codes: A61K 31/496 Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
• CPC Class Codes: A61K 31/4965 Non-condensed pyrazines
• CPC Class Codes: A61K 31/497 containing further heterocyclic rings
• CPC Class Codes: A61K 31/551 having two nitrogen atoms, e.g. dilazep
• CPC Class Codes: A61K 31/5513 1,4-Benzodiazepines, e.g. diazepam or clozapine
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/10 Dispersions; Emulsions A61K9/06 takes precedence; composition of dispersions, emulsions A61K47/00
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/18 Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
• CPC Class Codes: A61P 25/24 Antidepressants

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.

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;

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;

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;

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;

21. The method of claim 20, wherein schizophrenia is treated.