Claims for Patent: 9,119,863

Summary for Patent: 9,119,863

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):	Dohil Ranjan, Bastian John, Aceves Seema S., Phillips Elaine, Hill Malcolm
Assignee:	The Regents of the University of California
Application Number:	US13936773
Patent Claims:	1. A method of alleviating esophageal inflammation in an individual comprising orally administering to said individual a corticosteroid in association with at least one excipient , wherein upon oral administration , the corticosteroid is present in a medium with a viscosity of at least 2 cP at 25° C. and a shear rate of about 13.2 sec.2. The method of claim 1 , wherein the corticosteroid is administered in a pharmaceutical composition comprising the corticosteroid and the at least one excipient.3. The method of claim 2 , wherein the pharmaceutical composition further comprises a liquid vehicle.4. The method of claim 3 , wherein the pharmaceutical composition is a suspension comprising corticosteroid microparticles.5. The method of claim 3 , wherein the viscosity of the pharmaceutical composition is at least 10 cP at 25° C. and a shear rate of about 13.2 sec.6. The method of claim 2 , wherein the pharmaceutical composition is in the form of a dissolvable tablet claim 2 , a dissolvable wafer claim 2 , or a dissolvable capsule.7. The method of claim 2 , wherein the pharmaceutical composition is administered once a day claim 2 , twice a day claim 2 , or three times a day.8. The method of claim 2 , wherein the pharmaceutical composition is administered no more than once a day.9. The method of claim 1 , wherein said corticosteroid is a topical corticosteroid.10. The method of claim 1 , wherein said corticosteroid is Budesonide.11. The method of claim 1 , wherein the excipient is a viscosity enhancing excipient selected from the group consisting of: lactose claim 1 , sucrose claim 1 , sucralose claim 1 , maltodextrin claim 1 , dextrose claim 1 , mannitol claim 1 , sorbitol claim 1 , honey claim 1 , maize starch claim 1 , wheat starch claim 1 , rice starch claim 1 , potato starch claim 1 , gelatin claim 1 , gum tragacanth claim 1 , methyl cellulose claim 1 , hydroxypropylmethyl-cellulose claim 1 , a carboxymethyl cellulose (CMC) claim 1 , sodium carboxymethyl-cellulose (NaCMC) claim 1 , polyvinylpyrrolidone (PVP: povidone) claim 1 , and combinations thereof.12. The method of claim 1 , wherein the esophageal inflammation is eosinophilic esophagitis.13. The method of claim 1 , wherein said individual has been diagnosed with a disease or condition selected from the group consisting of eosinophilic esophagitis claim 1 , inflammatory bowel diseases involving the esophagus claim 1 , Crohn's disease claim 1 , esophageal inflammation secondary to caustic/irritant ingestion claim 1 , persistent/recurrent esophageal strictures of any cause and including caustic/irritant ingestion claim 1 , pill-induced esophagitis claim 1 , systemic diseases claim 1 , congenital diseases claim 1 , and post-surgery inflammation.14. The method of claim 1 , wherein 0.5-10 mg corticosteroid per day is administered to said individual.15. The method of claim 2 , wherein oral administration of the pharmaceutical composition provides a decreased systemic load of corticosteroid claim 2 , as measured by plasma AUC claim 2 , when compared to inhaled administration delivering an identical amount of corticosteroid.16. The method of claim 2 , wherein the pharmaceutical composition comprises corticosteroid microparticles claim 2 , wherein at least 95% of the corticosteroid microparticles have a diameter of less than 10 microns.17. The method of claim 1 , wherein the corticosteroid is present in a medium with a viscosity of at least 10 cP at 25° C. and a shear rate of about 13.2 sec.18. The method of claim 1 , wherein the corticosteroid is present in a medium with a viscosity of at least 50 cP at 25° C. and a shear rate of about 13.2 sec.19. The method of claim 1 , wherein the corticosteroid is present in a medium with a viscosity of at least 200 cP at 25° C. and a shear rate of about 13.2 sec.20. The method of claim 1 , wherein the corticosteroid is present in a medium with a viscosity of at least 10 cP at 37° C. and a shear rate of about 13.2 sec.21. The method of claim 1 , wherein the corticosteroid is present in a medium with a viscosity of at least 50 cP at 37° C. and a shear rate of about 13.2 sec.22. The method of claim 1 , wherein the corticosteroid is present in a medium with a viscosity of at least 200 cP at 37° C. and a shear rate of about 13.2 sec.