Claims for Patent: 9,526,726

Summary for Patent: 9,526,726

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:	15/164,473
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,526,726
Patent Claims:	1. A kit 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 continuous intramuscular injection within 10 seconds, wherein said pharmaceutical composition comprises: (a) 24-30 weight percent 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; wherein the pharmaceutical composition has a total injection volume of approximately 3.2 mL. 2. The kit according to claim 1, wherein the said pharmaceutical composition comprises: (a) about 26.6 weight percent Compound 1: ##STR00049## (b) about 0.37 weight percent sorbitan laurate; (c) about 0.15 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. 3. The kit according to claim 1, wherein the administration is instantaneous. 4. The kit according to claim 1, wherein the kit further comprises a 20 to 23 gauge needle. 5. The kit according to claim 4, wherein the needle is a 20 gauge needle. 6. The kit according to claim 1, wherein the injection is administered to the subject in the dorsal gluteal muscle. 7. The kit of claim 1, wherein the kit further comprises a container for containing the pharmaceutical composition. 8. The kit of claim 7, wherein the container is a prefilled syringe. 9. A kit 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 continuous intramuscular injection within 10 seconds, wherein said pharmaceutical composition comprises: (a) 24-30 weight percent Compound 1: ##STR00050## (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 of approximately 2.4 mL. 10. The kit of claim 9, wherein the said pharmaceutical composition comprises: (a) about 26.6 weight percent Compound 1: ##STR00051## (b) about 0.37 weight percent sorbitan laurate; (c) about 0.15 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. 11. The kit according to claim 9, wherein the administration is instantaneous. 12. The kit according to claim 9, wherein the kit further comprises a 20 to 23 gauge needle. 13. The kit according to claim 12, wherein the needle is a 20 gauge needle. 14. The kit according to claim 9, wherein the injection is administered to the subject in the dorsal gluteal muscle. 15. The kit of claim 9, wherein the kit further comprises a container for containing the pharmaceutical composition. 16. The kit of claim 15, wherein the container is a prefilled syringe.