Claims for Patent: 10,293,052

Summary for Patent: 10,293,052

Title:	Compositions for the treatment of gastrointestinal inflammation
Abstract:	Provided herein are methods for treating, 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):	Phillips Elaine, Hill Malcolm
Assignee:	MERITAGE PHARMA, INC.
Application Number:	US14485017
Patent Claims:	2. The stable oral pharmaceutical composition of claim 1 , wherein the corticosteroid is budesonide.3. The stable oral pharmaceutical composition of claim 1 , wherein the corticosteroid is fluticasone propionate.4. The stable oral pharmaceutical composition of claim 1 , wherein at least 10% of the corticosteroid adheres to the esophagus for at least 15 seconds after oral administration of the stable oral pharmaceutical composition.5. The stable oral pharmaceutical composition of claim 1 , wherein at least 10% of the corticosteroid adheres to or is absorbed by the esophagus at least 15 seconds after oral administration of the stable oral pharmaceutical composition.6. The stable oral pharmaceutical composition of claim 1 , wherein the weight percent of oral pharmaceutical composition that adheres to the esophagus 15 seconds after oral administration of the stable oral pharmaceutical composition is greater than the weight percent of a control composition that adheres to the esophagus 15 seconds after oral administration of the control composition claim 1 , wherein the control composition comprises the same corticosteroid in the same amount as present in the stable oral pharmaceutical composition claim 1 , and wherein the control composition further comprising about 4 mL of aqueous formulation and 10 packs of a mixture comprising dextrose claim 1 , maltodextrin and sucralose for every 0.5 mg of corticosteroid.7. The stable oral pharmaceutical composition of claim 1 , wherein the amount of corticosteroid that adheres to the esophagus 15 seconds after oral administration of the stable oral pharmaceutical composition is greater than the amount of corticosteroid that adheres to or is absorbed by the esophagus 15 seconds after oral administration of a control composition claim 1 , wherein the control composition comprises the same corticosteroid in the same amount as present in the stable oral pharmaceutical composition claim 1 , and wherein the control composition further comprising about 4 mL of aqueous formulation and 10 packs of a mixture comprising dextrose claim 1 , maltodextrin and sucralose for every 0.5 mg of corticosteroid.8. The stable oral pharmaceutical composition of claim 1 , wherein the amount of corticosteroid that adheres to or is absorbed by the esophagus 15 seconds after oral administration of the stable oral pharmaceutical composition is greater than the amount of corticosteroid that adheres to or is absorbed by the esophagus 15 seconds after oral administration of a control composition claim 1 , wherein the control composition comprises the same volume and the same corticosteroid in the same amount as present in the stable oral pharmaceutical composition claim 1 , and wherein the control composition has a viscosity of about 1 cP at 25° C. and a shear rate of about 13.2 sec.9. The stable oral pharmaceutical composition of claim 1 , wherein the stable oral pharmaceutical composition comprises a second maltodextrin that increases the viscosity of the stable oral pharmaceutical composition.10. The stable oral pharmaceutical composition of claim 9 , wherein the second maltodextrin does not substantially affect the mucoadhesive characteristic of the pharmaceutical composition.11. The stable oral pharmaceutical composition of claim 1 , further comprising a mucoadhesive agent.12. The stable oral pharmaceutical composition of claim 1 , further comprising a viscosity enhancing agent.