Claims for Patent: 11,406,632

Summary for Patent: 11,406,632

Title:	Aripiprazole formulations having increased injection speeds
Abstract:	The present invention relates to pharmaceutical compositions comprising a compound of Formula (I) that are useful for the intramuscular delivery of antipsychotic drugs using rapid injection rates.
Inventor(s):	Hickey; Magali B. (Westwood, MA), Vandiver; Jennifer (Arlington, MA)
Assignee:	ALKERMES PHARMA IRELAND LIMITED (Dublin, IE)
Application Number:	16/889,528
Patent Claims:	1. A method of treating schizophrenia in a subject in need thereof, comprising intramuscularly administering to said subject a therapeutically amount of the composition at a rapid and continuous intramuscular injection rate, wherein said pharmaceutical composition comprises: (a) 24-30 weight percent of compound 1: ##STR00048## (b) 0.3-0.4 weight percent sorbitan laurate; (c) 0.1-0.3 weight percent polysorbate 20; and (d) an aqueous vehicle wherein the percentages of (a), (b), and (c) are relative to the total weight of the composition; and wherein the pharmaceutical composition has a total injection volume from about 1.5 mL to 4.0 mL. 2. The method of claim 1, wherein the intramuscular injection rate is selected from the group consisting of 0.3 mL/s, 0.35 mL/s, 0.4 mL/s, 0.5 mL/s, 0.6 mL/s, 0.7 mL/s, 0.8 mL/s, and 0.9 mL/s. 3. The method of claim 1, wherein the total volume of the pharmaceutical composition is approximately 3.2 mL, 2.4 mL, or 1.6 mL. 4. The method of claim 3, wherein approximately 3.2 mL of the pharmaceutical composition is injected within 10 seconds. 5. The method of claim 3, approximately 2.4 mL of the pharmaceutical composition is injected within 8 seconds. 6. The method of claim 3, wherein approximately 1.6 mL of the pharmaceutical composition is injected within 5 seconds. 7. A kit useful for the treatment of schizophrenia, wherein the kit comprises a therapeutically effective amount of a pharmaceutical composition and further comprises instructions for intramuscular injection, wherein the instructions specify a rapid and continuous intramuscular injection rate, wherein said pharmaceutical composition comprises: (e) 24-30 weight percent Compound 1: ##STR00049## (f) 0.3-0.4 weight percent sorbitan laurate; (g) 0.1-0.3 weight percent polysorbate 20; and (h) an aqueous vehicle wherein the percentages of (a), (b), and (c) are relative to the total weight of the composition; and wherein the pharmaceutical composition has a total injection volume from about 1.5 mL to 4.0 mL. 8. The kit according to claim 7, wherein the kit is adapted to be associated with a treatment regimen. 9. The kit according to claim 7, wherein the intramuscular injection rate is selected from the group consisting of 0.3 mL/s, 0.35 mL/s, 0.4 mL/s, 0.5 mL/s, 0.6 mL/s, 0.7 mL/s, 0.8 mL/s, and 0.9 mL/s. 10. The kit of claim 7, wherein the total volume of the pharmaceutical composition is approximately 3.2 mL, 2.4 mL, or 1.6 mL. 11. The kit of claim 10, wherein approximately 3.2 mL of the pharmaceutical composition is injected within 10 seconds. 12. The kit of claim 10, wherein approximately 2.4 mL of the pharmaceutical composition is injected within 8 seconds. 13. The kit of claim 10, wherein approximately 1.6 mL of the pharmaceutical composition is injected within 5 seconds.