Details for Patent: 8,999,952
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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 (Bangalore, IN), Naringrekar; Vijay H. (Princeton, NJ) |
Assignee: | Otsuka Pharmaceutical Co., Ltd. (Tokyo, JP) |
Filing Date: | Apr 29, 2013 |
Application Number: | 13/872,517 |
Claims: | 1. An aqueous injectable formulation having a pH of from about 3.5 to about 5, comprising: a) a complex comprising aripiprazole and sulfobutyl ether-.beta.-cyclodextrin; b) tartaric acid; c) sodium hydroxide; and d) wafer 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 comprising from about 0.1 to about 2.5% by weight aripiprazole. 4. The formulation as defined in claim 1 comprising from about 0.2 to about 1.5% by weight aripiprazole. 5. 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/m of solution. 6. The formulation as defined in claim 1 wherein the tartaric acid is present in an amount from about 7 to about 9 mg/mi. |