Claims for Patent: 8,975,243

Summary for Patent: 8,975,243

Title:	Viscous budesonide 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):	Ranjan Dohil, John Bastian, Seema S. Aceves
Assignee:	University of California San Diego UCSD
Application Number:	US13/690,807
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,975,243
Patent Claims:	1. A method of reducing or alleviating esophageal inflammation or symptoms associated therewith in an individual comprising orally administering a liquid composition as a topical esophageal therapy to said individual, the liquid composition comprising a corticosteroid and at least one excipient to increase the viscosity of the composition, and the liquid composition having at least a nectar-like viscosity. 2. The method of claim 1, wherein said corticosteroid is budesonide. 3. The method of claim 1, wherein said individual has eosinophilic esophagitis. 4. The method of claim 1, wherein said individual has been diagnosed with eosinophilic esophagitis. 5. The method of claim 1, wherein said individual is a child. 6. The method of claim 1, wherein said individual is a child less than 16 years old. 7. The method of claim 1, wherein said individual is a child less than 12 years old. 8. The method of claim 1, wherein said individual is a child less than 8 years old. 9. The method of claim 1, wherein said individual is a child less than 6 years old. 10. The method of claim 1, wherein said individual is a child less than 4 years old. 11. The method of claim 1, wherein said individual is a child less than 2 years old. 12. The method of claim 1, wherein 1-2 mg corticosteroid per day is administered to said individual. 13. The method of claim 1, wherein 2-3 mg corticosteroid per day is administered to said individual. 14. The method of claim 1, wherein a therapeutically effective amount of 6 mg/day or less of corticosteroid is administered. 15. The method of claim 1, wherein 0.5-6 mg corticosteroid per day is administered to said individual. 16. The method of claim 1, wherein 0.5-2 mg corticosteroid per day is administered to said individual. 17. The method of claim 1, wherein about 10-400 μg corticosteroid/kg of said individual per day is administered to said individual. 18. The method of claim 1, wherein the composition is a liquid suspension. 19. The method of claim 1, wherein said liquid composition comprises a liquid vehicle, wherein said liquid vehicle comprises water. 20. The method of claim 1, wherein the individual is a human. 21. The method of claim 1, wherein said excipient comprises lactose, sucrose, cellulose preparations, mannitol, sorbitol, honey, maize starch, wheat starch, rice starch, potato starch, gelatin, gum tragacanth, methyl cellulose, hydroxypropylmethyl-cellulose, sodium carboxymethyl-cellulose (CMC), polyvinylpyrrolidone (PVP: povidone), or a combination thereof. 22. The method of claim 1, wherein the liquid composition comprises a corticosteroid in the absence of another pharmaceutically active ingredient. 23. A method of reducing or eliminating esophageal eosinophils in an individual comprising administering to the esophagus of said individual a liquid composition, as a topical esophageal therapy to said individual, the liquid composition comprising a corticosteroid and at least one excipient that increases the viscosity of the composition, and the liquid composition having at least a nectar-like viscosity. 24. The method of claim 23, wherein the viscosity of the composition is nectar-like. 25. The method of claim 23, wherein said corticosteroid is budesonide. 26. The method of claim 23, wherein said individual has eosinophilic esophagitis. 27. The method of claim 23, wherein said individual has been diagnosed with eosinophilic esophagitis. 28. The method of claim 23, wherein a therapeutically effective amount of 6 mg/day or less of corticosteroid is administered. 29. The method of claim 23, wherein 0.5-6 mg corticosteroid per day is administered to said individual. 30. The method of claim 23, wherein 2-3 mg corticosteroid per day is administered to said individual. 31. The method of claim 23, wherein 1-2 mg corticosteroid per day is administered to said individual. 32. The method of claim 23, wherein 0.5-2 mg corticosteroid per day is administered to said individual. 33. The method of claim 23, wherein about 10-400 μg corticosteroid/kg of said individual per day is administered to said individual. 34. The method of claim 23, wherein the composition is a liquid suspension. 35. The method of claim 23, wherein said liquid composition comprises a liquid vehicle, wherein said liquid vehicle comprises water. 36. The method of claim 23, wherein the liquid composition comprises a corticosteroid in the absence of another pharmaceutically active ingredient. 37. A method of improving or resolving symptoms associated with eosinophilic infiltration of the esophagus in an individual comprising administering to the esophagus of said individual a liquid composition, as a topical esophageal therapy to said individual, the liquid composition comprising a corticosteroid and at least one excipient that increases the viscosity of the composition, and the liquid composition having at least a nectar-like viscosity. 38. The method of claim 37, wherein said corticosteroid is budesonide. 39. The method of claim 37, wherein said individual has eosinophilic esophagitis. 40. The method of claim 37, wherein said individual has been diagnosed with eosinophilic esophagitis. 41. The method of claim 37, wherein a therapeutically effective amount of 6 mg/day or less of corticosteroid is administered. 42. The method of claim 37, wherein 0.5-6 mg corticosteroid per day is administered to said individual. 43. The method of claim 37, wherein 2-3 mg corticosteroid per day is administered to said individual. 44. The method of claim 37, wherein 1-2 mg corticosteroid per day is administered to said individual. 45. The method of claim 37, wherein 0.5-2 mg corticosteroid per day is administered to said individual. 46. The method of claim 37, wherein about 10-400 μg corticosteroid/kg of said individual per day is administered to said individual. 47. The method of claim 37, wherein the composition is a liquid suspension. 48. The method of claim 37, wherein said liquid composition comprises a liquid vehicle, wherein said liquid vehicle comprises water. 49. The method of claim 37, wherein the liquid composition comprises a corticosteroid in the absence of another pharmaceutically active ingredient. 50. A method of reducing or alleviating esophageal inflammation or symptoms associated therewith in an individual comprising orally administering a liquid composition as a topical esophageal therapy to said individual for about 3 days to about 14 days for an acute condition and about 4 weeks to about 16 weeks for a chronic condition, the liquid composition comprising a corticosteroid and at least one excipient that increases the viscosity of the composition, and the liquid composition having a nectar-like to honey-like viscosity. 51. The method of claim 50, wherein said corticosteroid is budesonide. 52. The method of claim 50, wherein said individual has eosinophilic esophagitis. 53. The method of claim 50, wherein said individual has been diagnosed with eosinophilic esophagitis. 54. The method of claim 50, wherein a therapeutically effective amount of 6 mg/day or less of corticosteroid is administered. 55. The method of claim 50, wherein 0.5-6 mg corticosteroid per day is administered to said individual. 56. The method of claim 50, wherein about 10-400 μg corticosteroid/kg of said individual per day is administered to said individual. 57. The method of claim 50, wherein the composition is a liquid suspension. 58. The method of claim 50, wherein said liquid composition comprises a liquid vehicle, wherein said liquid vehicle comprises water. 59. The method of claim 50, wherein the liquid composition comprises a corticosteroid in the absence of another pharmaceutically active ingredient.