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Claims for Patent: 5,362,737

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Claims for Patent: 5,362,737

Title: Methods of treating aphthous ulcers and other mucocutaneous disorders with amlexanox
Abstract:A method of treating aphthous ulcers and other mucocutaneous disorders is disclosed. The method comprises contacting the mucocutaneous disorder with a composition in the form of a paste, solution, gel, quick-disintegrating tablet, mouthwash, ointment, cream, powder, adhesive patch, aerosolized spray, lozenge, troche, dentifrice, or dental floss that contains an effective amount of an active compound of the formula: ##STR1## wherein R.sub.1 is hydrogen, alkyl, phenyl, carboxyl, hydroxyl, alkoxy, carboxyalkyl (i.e. esters), cyano, acylamino, or amino group which may be unsubstituted or substituted by up to two alkyl groups; m is 0, 1 or 2 and R.sub.2 is alkyl, alkenyl, alkoxy, halgoen, nitro, hydroxy, carboxyl, butadienylene (--CH.dbd.CH--CH.dbd.CH--) which forms a benzene ring with any adjacent carbon atoms, cyano, carboxyalkyl, trifluoromethyl, or amino group which may be unsubstituted or substituted by at least one alkyl; and R.sub.3 is carboxyl, cyano, arylalkoxycarbonyl, alkoxycarbonyl, or carboxamide which may be unsubstituted or substituted by at least one alkyl, and the salts thereof.
Inventor(s): Vora; Kakubhai R. (Littleton, CO), Khandwala; Atul (Aurora, CO), Smith; Charles G. (Sante Fe, CA)
Assignee: Chemex Pharmaceuticals, Inc. (Fort Lee, NJ)
Application Number:08/006,670
Patent Claims: 1. A method for speeding the healing of aphthous ulcers as determined by the reduction of the size of the ulcers which method consists essentially of reducing the size of the ulcers by administering topically to the oral mucosal membrane a composition which comprises a compound of the formula: 2-amino-7-(1-methylethyl)-5-oxo-5H-[1]benzopyrano(2,3-b) pyridine-3-carboxylic acid or a pharmaceutically acceptable salt thereof in an effective concentration and a pharmaceutically acceptable vehicle.

2. The method of claim 1 wherein the concentration of the compound in the composition is from about 1 to about 5%.

3. The method of claim 2 wherein the concentration of the compound in the composition is about 1%.

4. The method of claim 2 wherein the concentration of the compound in the composition is about 5%.

5. The method of claim 1 wherein the compound is administered for three days.

6. The method of claim 1 wherein the vehicle is selected from the group consisting of an oral paste, a masticatable gum, a solution, a gel, a disintegrating tablet, a mouthwash, an ointment, a cream, a powder, an aerosolized spray, a lozenge, a troche, a dentifrice and dental floss.

7. The method of claim 1 wherein the composition is administered on the buccal mucosa, oral labial mucosa, floor of the mouth or distal half of the tongue.

8. The method of claim 1 wherein the reduction of ulcers' size is statistically significant.

9. The method of claim 1 wherein the reduction of ulcers' size is a clinically significant improvement.

10. The method of claim 1 wherein the speeding of healing as determined by reduction of the ulcers' size is observable separately from reduction of erythema.
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