Aripiprazole formulations having increased injection speeds
View Patent ↗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.
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:
(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:
(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:
(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:
(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.