Aripiprazole complex formulation and method
AssigneeOtsuka Pharmaceutical Co., Ltd.
InventorsManoj Nerurkar, Vijay H. Naringrekar
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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.
Claims6
An aqueous injectable formulation having a pH of from about 3.5 to about 5, comprising:
- a) a complex comprising aripiprazole and sulfobutyl ether-β-cyclodextrin;
- b) tartaric acid;
- c) sodium hydroxide;
- and
- d) wafer for injection.
Dependencies are inferred from the claim text.