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Claims for Patent: 4,049,809

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Claims for Patent: 4,049,809

Title: Solution of a oxazepine for oral or parenteral administration
Abstract:Stable, soluble solutions of 2-chloro-11-(4-methyl-1-piperazinyl)-dibenz[b,f][1,4]oxazepine are described, some of which are suitable for oral and others for parenteral administration.
Inventor(s): Haeger; Bruce Edwin (Highland Mills, NY), Krueger; James Elwood (New City, NY), Lowery; James Alfred (New City, NY), Ritter; Lawrence (Suffern, NY)
Assignee: American Cyanamid Company (Stamford, CT)
Application Number:05/734,682
Patent Claims: 1. A solubilized and stabilized solution comprising 2-chloro-11-(4-methyl-1-piperazinyl)-dibenz[b,f][1,4]oxazepine, or a pharmaceutically acceptable acid-addition salt thereof, in about 50% to about 80% v/v aqueous solution of propylene glycol having a pH of from about 5.0 to about 7.0.

2. A solution in accordance with claim 1, additionally containing from about 2% to about 10% polysorbate 80.

3. A solution in accordance with claim 1, for use as a oral concentrate.

4. A solution in accordance with claim 1, for use as a parenteral solution.

5. A solution in accordance with claim 2, for use as a parenteral solution.

6. A solution in accordance with claim 2, for use as a oral concentrate.

7. A method of preparing a solubilized and stabilized solution containing 2-chloro-11-(4-methyl-1-piperazinyl)-dibenz[b,f][1,4]oxazepine, or a pharmaceutically acceptable salt thereof, which comprises dissolving said oxazepine or salt thereof in about 50% to about 80% v/v aqueous solution of propylene glycol; adjusting the pH to about 5.0 to about 7.0 with a dilute mineral acid; and adding water to the desired volume.

8. A method according to claim 7, which involves the additional step of adding from about 2% to about 10% polysorbate 80.
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