Claims for Patent: 11,197,822

Summary for Patent: 11,197,822

Title:	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.
Inventor(s):	Dohil Ranjan, Bastian John, Aceves Seema, Phillips Elaine, Hill Malcolm
Assignee:
Application Number:	US16299058
Patent Claims:	2. The oral dosage form of claim 1 , wherein the excipient that increases the viscosity of the composition is maltodextrin claim 1 , carboxymethyl cellulose claim 1 , microcrystalline cellulose claim 1 , or a combination of two or more thereof.3. The oral dosage form of claim 2 , wherein the oral dosage form is an aqueous suspension.4. The oral dosage form of claim 1 , wherein the solid form is a dissolving tablet or a dissolving wafer.5. The oral dosage form of claim 1 , wherein the oral dosage form is suitable for once a day administration.6. The oral dosage form of claim 1 , wherein the oral dosage form is administered no more than once a day.7. The oral dosage form of claim 1 , comprising about 0.01 mg to about 10 mg of the topically active corticosteroid.8. The oral dosage form of claim 7 , comprising about 0.25 mg to about 5 mg of the topically active corticosteroid.9. The oral dosage form of claim 1 , wherein the viscosity of the oral dosage form is nectar-like to honey-like.10. The oral dosage form of claim 1 , wherein the unit dose has a volume of about 5 mL to about 15 mL.11. The oral dosage form of claim 1 , wherein the excipient that improves the palatability of the composition comprises a sweetening agent.12. The oral dosage form of claim 11 , wherein the sweetening agent comprises glycerin claim 11 , sucrose claim 11 , lactose claim 11 , glucose claim 11 , fructose claim 11 , arabinose claim 11 , xylose claim 11 , ribose claim 11 , mannose claim 11 , galactose claim 11 , dextrose claim 11 , sorbose claim 11 , sorbitol claim 11 , mannitol claim 11 , maltose claim 11 , cellobiose claim 11 , xylitol lactose claim 11 , sucralose claim 11 , dextrose claim 11 , honey claim 11 , maize starch claim 11 , wheat starch claim 11 , rice starch claim 11 , potato starch claim 11 , gelatin claim 11 , gum tragacanth claim 11 , or a combination of two or more thereof.13. An oral dosage form comprising an active pharmaceutical ingredient consisting of a topically active corticosteroid claim 11 , wherein the topically active corticosteroid is budesonide or fluticasone claim 11 , a first excipient that improves the palatability of the composition claim 11 , and one or more of a second excipient in an amount that increases the viscosity of the composition to at least about 25 cP when measured at 25° C. and a shear rate of 13.2 s claim 11 , wherein the oral dosage form is an aqueous suspension formulated in a unit dose formulation for oral administration having a volume of about 5 mL to about 15 mL.14. The oral dosage form of claim 13 , wherein the excipient that increases the viscosity of the composition is maltodextrin claim 13 , carboxymethyl cellulose claim 13 , microcrystalline cellulose claim 13 , or a combination of two or more thereof.15. The oral dosage form of claim 13 , wherein the viscosity of the oral dosage form is nectar-like to honey-like.16. The oral dosage form of claim 13 , comprising about 0.01 mg to about 10 mg of the topically active corticosteroid.17. The oral dosage form of claim 16 , comprising about 0.25 mg to about 5 mg of the topically active corticosteroid.18. The oral dosage form of claim 1 , wherein the topically active corticosteroid is budesonide.19. The oral dosage form of claim 1 , wherein the topically active corticosteroid is fluticasone.20. The oral dosage form of claim 13 , wherein the topically active corticosteroid is budesonide.21. The oral dosage form of claim 13 , wherein the topically active corticosteroid is fluticasone.22. The oral dosage form of claim 16 , comprising about 0.5 mg to about 4 mg of the topically active corticosteroid.23. The oral dosage form of claim 16 , comprising about 1 mg to about 3 mg of the topically active corticosteroid.24. The oral dosage form of claim 1 , wherein the oral dosage form is a semi-solid form or a solid form that dissolves in the mouth.