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Claims for Patent: 7,550,445

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Claims for Patent: 7,550,445

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)
Application Number:11/452,782
Patent Claims: 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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