Aripiprazole formulations having increased injection speeds
AssigneeAlkermes Pharma Ireland Limited
InventorsMagali B. Hickey, Jennifer Vandiver
Life of this patent
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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.
Claims36
A method of treating bipolar disorder, depression, or 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 injection rate, wherein said pharmaceutical composition comprises:
- (a) 24-30 weight percent of a compound of Formula (I):
- 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 of about 1.5 mL, about 2 mL, about 2.5 mL, about 3 mL, about 3.5 mL, or about 4 mL.
A method of treating schizophrenia in a subject in need thereof, comprising intramuscularly administering to said subject a therapeutically amount of a pharmaceutical composition at a rapid and continuous intramuscular injection rate, wherein said pharmaceutical composition comprises:
- (a) 24-30 weight percent of a compound of Formula (I):
- 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 of about 1.5 mL, about 2 mL, about 2.5 mL, about 3 mL, about 3.5 mL, or about 4 mL.
A kit useful for the treatment of bipolar disorder, depression, or 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:
- (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 about 1.5 mL, about 2 mL, about 2.5 mL, about 3 mL, about 3.5 mL, or about 4 mL.
A method of treating bipolar disorder in a subject in need thereof, comprising intramuscularly administering to said subject a therapeutically amount of a pharmaceutical composition at a rapid and continuous intramuscular injection rate, wherein said pharmaceutical composition comprises:
- 24-30 weight percent of a compound of Formula (I):
- wherein n is an integer between 4 and 14;
- (e) 0.3-0.4 weight percent sorbitan laurate;
- (f) 0.1-0.3 weight percent polysorbate 20;
- and
- (g) 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 about 1.5 mL, about 2 mL, about 2.5 mL, about 3 mL, about 3.5 mL, or about 4 mL.
Dependencies are inferred from the claim text.