Topical corticosteroids for the treatment of inflammatory diseases of the gastrointestinal tract
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. An oral dosage form comprising a topically active corticosteroid, a first excipient that improves the palatability of the composition, and about 25% w/v to about 60% w/v of one or more of a second excipient that increases the viscosity of the composition, wherein the oral dosage form is formulated in a unit dose formulation for oral administration, wherein the topically active corticosteroid is selected from budesonide and fluticasone, and wherein the oral dosage form is selected from the group consisting of an aqueous suspension, a semi-solid form, and a solid form that dissolves in the mouth.
2. The oral dosage form of claim 1 , wherein the excipient that increases the viscosity of the composition is maltodextrin, carboxymethyl cellulose, microcrystalline cellulose, 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, 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.
13. An oral dosage form comprising an active pharmaceutical ingredient consisting of a topically active corticosteroid, wherein the topically active corticosteroid is budesonide or fluticasone, a first excipient that improves the palatability of the composition, 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 −1 , 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, carboxymethyl cellulose, microcrystalline cellulose, 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.