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Details for Patent: 8,497,304

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Details for Patent: 8,497,304

Title:Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
Abstract: An aqueous liquid preparation of the present invention containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid or its pharmacologically acceptable salt or a hydrate thereof, an alkyl aryl polyether alcohol type polymer such as tyloxapol, or a polyethylene glycol fatty acid ester such as polyethylene glycol monostearate is stable. Since even in the case where a preservative is incorporated into said aqueous liquid preparation, the preservative exhibits a sufficient preservative effect for a long time, said aqueous liquid preparation in the form of an eye drop is useful for the treatment of blepharitis, conjunctivitis, scleritis, and postoperative inflammation. Also, the aqueous liquid preparation of the present invention in the form of a nasal drop is useful for the treatment of allergic rhinitis and inflammatory rhinitis (e.g. chronic rhinitis, hypertrophic rhinitis, nasal polyp, etc.).
Inventor(s): Sawa; Shirou (Kobe, JP), Fujita; Shuhei (Kakogawa, JP)
Assignee: Senju Pharmaceutical Co., Ltd. (Osaka, JP)
Filing Date:Jan 19, 2012
Application Number:13/353,653
Claims:1. An aqueous liquid preparation comprising 2-amino-3-(4-bromobenzoyl)phenylacetic acid or a sodium salt or a hydrate thereof, and polyoxyl 40 stearate, wherein the concentration of the polyoxyl 40 stearate is selected from a range of a minimum concentration of 0.02 w/v % to a maximum concentration of 0.1 w/v %.

2. The aqueous liquid preparation according to claim 1, wherein the concentration of the 2-amino-3-(4-bromobenzoyl)phenylacetic acid sodium salt or the hydrate thereof is 0.01 to 0.5 w/v %.

3. The aqueous liquid preparation according to claim 1, wherein benzalkonium chloride is contained as a preservative.

4. The aqueous liquid preparation according to claim 1, wherein the pH of the aqueous liquid preparation is within a range of 7 to 9.

5. The aqueous liquid preparation according to claim 4, wherein the pH of the aqueous liquid preparation is within a range of 7.5 to 8.5.

6. The aqueous liquid preparation according to claim 1, wherein the aqueous liquid preparation is an eye drop.

7. The aqueous liquid preparation according to claim 1, wherein the aqueous liquid preparation is a nasal drop.

8. An eye drop comprising sodium 2-amino-3-(4-bromobenzoyl)phenylacetate hydrate and 0.02 to 0.1 w/v % of polyoxyl 40 stearate.

9. A method for stabilizing 2-amino-3-(4-bromobenzoyl)phenylacetic acid sodium salt or a hydrate thereof in an aqueous liquid preparation, which comprises incorporating polyoxyl 40 stearate into an aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid sodium salt or a hydrate thereof.

10. A method for inhibiting decrease in preservative effect of a preservative in an aqueous liquid preparation of 2-amino-3-(4-bromobenzoyl)phenylacetic acid sodium salt or a hydrate thereof, which comprises incorporating polyoxyl 40 stearate into an aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid sodium salt or a hydrate thereof and a preservative.

11. The aqueous liquid preparation according to claim 1, which consists essentially of the following two components, wherein the first component is the 2-amino-3-(4-bromobenzoyl)phenylacetic acid sodium salt or the hydrate thereof, and the second component is polyoxyl 40 stearate.

12. The aqueous liquid preparation according to claim 1, which is formulated for ophthalmic administration.

13. The aqueous liquid preparation according to claim 1, wherein when a quaternary ammonium compound is included in said liquid preparation, the quaternary ammonium compound is benzalkonium chloride.

14. The aqueous liquid preparation according to claim 1, which further includes one or more additives selected from the group consisting of a preservative, buffer, thickener, stabilizer, chelating agent, and pH controlling agent.

15. The aqueous liquid preparation according to claim 14, wherein said preservative is benzalkonium chloride; wherein said buffer is boric acid and/or sodium borate; wherein said thickener is polyvinylpyrrolidone; wherein said stabilizer is sodium sulfite; wherein said chelating agent is sodium edetate; and wherein said pH controlling agent is sodium hydroxide.

16. The aqueous liquid preparation according to claim 1, wherein the concentration of the 2-amino-3-(4-bromobenzoyl)phenylacetic acid sodium salt is about 0.2 w/v %.

17. The aqueous liquid preparation according to claim 1, wherein the hydrate is at least one selected from a 1/2 hydrate, 1 hydrate and 3/2 hydrate.
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