Aripiprazole formulations having increased injection speeds
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 method of treating bipolar disorder or depression 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:
(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. The method of claim 1 , wherein the method treats bipolar disorder.
8. The method of claim 1 , wherein the method treats depression.
9. A kit useful for the treatment of bipolar disorder or depression, 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:
(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.
10. The kit according to claim 9 , wherein the kit is adapted to be associated with a treatment regimen.
11. The kit according to claim 9 , 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.
12. The kit of claim 9 , wherein the total volume of the pharmaceutical composition is approximately 3.2 mL, 2.4 mL, or 1.6 mL.
13. The kit of claim 12 , wherein approximately 3.2 mL of the pharmaceutical composition is injected within 10 seconds.
14. The kit of claim 12 , wherein approximately 2.4 mL of the pharmaceutical composition is injected within 8 seconds.
15. The kit of claim 12 , wherein approximately 1.6 mL of the pharmaceutical composition is injected within 5 seconds.
16. The kit of claim 12 , wherein the kit is useful for the treatment of bipolar disorder.
17. The kit of claim 12 , wherein the kit is useful for the treatment of depression.