Claims for Patent: 4,910,225

Summary for Patent: 4,910,225

Title:	Locally administrable therapeutic composition for inflammatory disease
Abstract:	This invention relates to a locally administrable therapeutic composition for inflammatory disease which is characterized by comprising benzoylphenylacetic acid of the formula ##STR1## (wherein R is a hydrogen or halogen atom), or a salt thereof, or the hydrate of said acid or salt, as active ingredient. An ophthalmic composition according to the invention can treat effectively inflammatory eye disease by topical application, is not an irritant to the eye, and has a superior effect to conventional drugs of the same or similar type. The aqueous composition prepared in accordance with this invention has excellent stability and can be used advantageously as a nasal or otic composition as well as an ophthalmic one in the treatment of inflammatory otic or nasal disease.
Inventor(s):	Ogawa; Takahiro (Nishinomiya, JP), Kuribayashi; Yoshikazu (Kobe, JP), Ushio; Kazumichi (Nishinomiya, JP), Ohtori; Akira (Nara, JP)
Assignee:	Senju Pharmaceutical Co., Ltd. (Osaka, JP) A. H. Robins Company, Incorporated (Richmond, VA)
Application Number:	07/301,033
Patent Claims:	1. A locally administrable opthalmic, otic or nasal therapeutic composition for the treatment of inflammatory disease of the eye, ear or nasal passage which comprises an anti-inflammatory effective amount of a benzoylphenylacetic acid of the formula ##STR3## wherein R is hydrogen or a halogen atom or a pharmaceutically acceptable salt thereof or a hydrate of said acid or salt in admixture with (a) an isotonizing agent, and (b) at least one member of the group consisting of a microbial agent and a preservative. 2. The locally administrable therapeutic composition for inflammatory disease according to claim 1, wherein the water-soluble polymer is polyvinyl pyrrolidone, polyvinyl alcohol, carboxypropylcellulose, hydroxyethylcellulose, hydroxypropylcellulose or sodium salt of polyacrylic acid. 3. The locally administrable therapeutic composition for inflammatory disease according to claim 1, wherein the concentration of the water-soluble polymer is in the range of about 0.1-10 W/W %. 4. The locally administrable therapeutic composition for inflammatory disease according to claim 1, wherein the sulfite is in the form of sodium, potassium, calcium or magnesium salt. 5. The locally administrable therapeutic composition for inflammatory disease according to claim 1, wherein the concentration of the sulfite is in the range of about 0.1-1 W/W %. 6. A composition according to claim 1 in the form of an aqueous solution. 7. A method of treating animals or humans to alleviate inflammation of the eye, nasal passage or ear canal which comprises applying to the eye, nasal passage or ear canal an anti-inflammatory effective amount of a compound of the formula: ##STR4## wherein R is hydrogen or a halogen atom or a pharmaceutically acceptable salt thereof, or a hydrate of said acid or salt, as active ingredient. 8. In a locally administrable stable aqueous therapeutic composition for use in the treatment of inflammatory disease comprising an anti-inflammatory effective amount of a benzoylphenylacetic acid of the formula ##STR5## wherein R is hydrogen or a halogen atom, or a pharmaceutically acceptable salt thereof, or a hydrate of said acid or salt, the improvement wherein said composition contains a stabilizing amount of a water-soluble polymer and a sulfite, the pH of said composition being in the range of about 6-9. 9. A locally administrable opthalmic ointment for the treatment of inflammatory disease of the eye which comprises an anti-inflammatory effective amount of a benzoylphenylacetic acid of the formula ##STR6## wherein R is hydrogen or a halogen atom or a pharmaceutically acceptable salt thereof or a hydrate of said acid or salt in admixture with an eye ointment base.