Aripiprazole complex formulation and method
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Abstract
An aripiprazole formulation is provided which includes the antipsychotic agent aripiprazole in the form of an inclusion complex in a β-cyclodextrin, preferably, sulfobutyl ether β-cyclodextrin (SBECD), which in the form of an injectable produces reversible generally minimal to mild irritation at the intramuscular injection site. A method for minimizing or reducing irritation caused by aripiprazole at an intramuscular injection site and a method for treating schizophrenia employing the above formulation are also provided.
19 Citations
32 Claims
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1-24. -24. (canceled)
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25. An aqueous injectable formulation comprising
a) a complex comprising aripiprazole and sulfobutyl ether-β - -cyclodextrin;
b) tartaric acid;
c) sodium hydroxide; and
d) water for injection. - View Dependent Claims (26, 27, 28, 29, 30, 31, 32)
- -cyclodextrin;
Specification