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|Title:||Aripiprazole complex formulation and method|
|Abstract:||An aripiprazole formulation is provided which includes the antipsychotic agent aripiprazole in the form of an inclusion complex in a .beta.-cyclodextrin, preferably, sulfobutyl ether .beta.-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.|
|Inventor(s):||Nerurkar; Manoj (Monmouth Junction, NJ), Naringrekar; Vijay (Princeton, NJ)|
|Assignee:||Bristol-Myers Squibb Company (Princeton, NJ)|
1. An aqueous injectable formulation comprising a) a complex comprising aripiprazole and sulfobutyl ether-.beta.-cyclodextrin; b) tartaric acid; c) sodium hydroxide; and
d) water for injection.
2. The formulation as defined in claim 1 which contains 2 mg aripiprazole/ml, 5 mg aripiprazole/ml or 7.5 mg aripiprazole/ml.
3. The formulation as defined in claim 1 having a pH of about 4.3.
4. The formulation as defined in claim 1 comprising from about 0.1 to about 2.5% by weight aripiprazole.
5. The formulation as defined in claim 1 comprising from about 0.2 to about 1.5% by weight aripiprazole.
6. The formulation as defined in claim 1 wherein the sulfobutyl ether-.beta.-cyclodextrin is present in an amount from about 100 to about 700 mg/ml of solution.
7. The formulation as defined in claim 1 wherein the tartaric acid is present in an amount from about 7 to about 9 mg/ml.
8. The formulation as defined in claim 1 wherein the tartaric acid and the sodium hydroxide are present in amounts to impart a pH of about 4.3 to the formulation.
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