Topical corticosteroids for the treatment of inflammatory diseases of the gastrointestinal tract

Abstract

Provided herein are methods for preventing or alleviating the symptoms of and inflammation associated with inflammatory diseases and conditions of the gastrointestinal tract, for example, those involving the esophagus. Also provided herein are pharmaceutical compositions useful for the methods of the present invention.

1 . (canceled) 
     
     
         2 . A method for treating an esophageal inflammatory disease in a subject in need thereof, the method comprising orally administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising a topically active corticosteroid selected from budesonide and fluticasone, a first excipient that improves the palatability of the composition, and a second excipient that increases the viscosity of the composition. 
     
     
         3 . The method of  claim 2 , wherein the composition is formulated in a unit dose formulation for oral administration. 
     
     
         4 . The method of  claim 2 , wherein the composition is formulated as a dosage form selected from the group consisting of an aqueous suspension, a semi-solid form, and a solid form that dissolves in the mouth. 
     
     
         5 . The method of  claim 2 , wherein the excipient that increases the viscosity of the composition is maltodextrin, carboxymethyl cellulose, microcrystalline cellulose, or a combination of two or more thereof 
     
     
         6 . The method of  claim 2 , wherein the composition is administered once daily. 
     
     
         7 . The method of  claim 2 , wherein the composition is administered no more than once a day. 
     
     
         8 . The method of  claim 2 , wherein the composition comprises about 0.01 mg to about 10 mg of the topically active corticosteroid. 
     
     
         9 . The method of  claim 2 , wherein the composition comprises about 0.25 mg to about 5 mg of the topically active corticosteroid. 
     
     
         10 . The method of  claim 2 , wherein the viscosity of the composition is nectar-like to honey-like. 
     
     
         11 . The method of  claim 3 , wherein the administered unit dose has a volume of about 5 mL to about 15 mL. 
     
     
         12 . The method of  claim 2 , wherein the excipient that improves the palatability of the composition comprises a sweetening agent. 
     
     
         13 . The method of  claim 12 , wherein the sweetening agent comprises glycerin, sucrose, lactose, glucose, fructose, arabinose, xylose, ribose, mannose, galactose, dextrose, sorbose, sorbitol, mannitol, maltose, cellobiose, xylitol lactose, sucralose, dextrose, honey, maize starch, wheat starch, rice starch, potato starch, gelatin, gum tragacanth, or a combination of two or more thereof. 
     
     
         14 . The method of  claim 2 , wherein the esophageal inflammatory disease is eosinophilic esophagitis. 
     
     
         15 . The method of  claim 2 , wherein the method for treating the esophageal inflammatory disease is a method for treating a symptom of the esophageal inflammatory disease; a method for treating inflammation associated with the esophageal inflammatory disease; or a combination thereof 
     
     
         16 . The method of  claim 2 , wherein the subject is less than 16 years old. 
     
     
         17 . The method of  claim 2 , wherein the subject is less than 12 years old. 
     
     
         18 . The method of  claim 2 , wherein the subject is less than 8 years old. 
     
     
         19 . The method of  claim 2 , wherein the subject is less than 6 years old. 
     
     
         20 . The method of  claim 2 , wherein the subject is less than 4 years old. 
     
     
         21 . The method of  claim 2 , wherein the subject is less than 2 years old.