Claims for Patent: 10,813,928
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Summary for Patent: 10,813,928
| 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: | 16/271,248 |
| Patent Claims: |
1. A method of treating schizophrenia in a subject in need thereof, comprising intramuscularly administering to said subject a therapeutically effective amount of a
pharmaceutical composition at a rapid and continuous rate, wherein said pharmaceutical composition comprises: (a) 24-30 weight percent of a compound of Formula (I): ##STR00048## wherein n is an integer between 4 and 14; (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 1.0 mL to 10 mL.
2. The method of 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 method of claim 1, wherein the pharmaceutical composition has a total injection volume 3.2 mL, 2.4 mL, or 1.6 mL. 4. The method of claim 1, wherein approximately 3.2 mL of the pharmaceutical composition is injected within 10 seconds, or wherein approximately 2.4 mL of the pharmaceutical composition is injected within 8 seconds, or wherein approximately 1.6 mL of the pharmaceutical composition is injected within 5 seconds. 5. The method of claim 1, wherein the intramuscular injection rate is selected from the group consisting of: 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. 6. A method of treating bipolar disorder in a subject in need thereof, comprising intramuscularly administering to said subject a therapeutically effective amount of a pharmaceutical composition at a rapid and continuous rate, wherein said pharmaceutical composition comprises: (a) 24-30 weight percent of a compound of Formula (I): ##STR00050## wherein n is an integer between 4 and 14; (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 1.0 mL to 10 mL. 7. The method of claim 6, 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. 8. The method of claim 6, wherein the pharmaceutical composition has a total injection volume 3.2 mL, 2.4 mL, or 1.6 mL. 9. The method of claim 6, wherein approximately 3.2 mL of the pharmaceutical composition is injected within 10 seconds, or wherein approximately 2.4 mL of the pharmaceutical composition is injected within 8 seconds, or wherein approximately 1.6 mL of the pharmaceutical composition is injected within 5 seconds. 10. The method of claim 6, wherein the intramuscular injection rate is selected from the group consisting of: 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. 11. A method of treating depression in a subject in need thereof, comprising intramuscularly administering to said subject a therapeutically effective amount of a pharmaceutical composition at a rapid and continuous rate, wherein said pharmaceutical composition comprises: (a) 24-30 weight percent of a compound of Formula (I): ##STR00052## wherein n is an integer between 4 and 14; (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 1.0 mL to 10 mL. 12. The method of claim 11, wherein the said pharmaceutical composition comprises: (a) about 26.6 weight percent Compound 1: ##STR00053## (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. 13. The method of claim 11, wherein the pharmaceutical composition has a total injection volume 3.2 mL, 2.4 mL, or 1.6 mL. 14. The method of claim 11, wherein approximately 3.2 mL of the pharmaceutical composition is injected within 10 seconds, or wherein approximately 2.4 mL of the pharmaceutical composition is injected within 8 seconds, or wherein approximately 1.6 mL of the pharmaceutical composition is injected within 5 seconds. 15. The method of claim 11, wherein the intramuscular injection rate is selected from the group consisting of: 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. |
