Granted Patent B2

US 10,632,069 · App. 15/816,154 · Granted Apr 28, 2020

Inventors: Stephen Perrett (Princeton, NJ); Fredric Jay Cohen (Washington Crossing, PA); Gopi Venkatesh (Vandalia, OH)

Assignee: Adare Pharmaceuticals US, L.P.

A61K9/0065A61K9/006A61K9/0053A61K9/0056A61K9/08A61K31/56A61K31/569A61K31/58A61K45/06A61K47/38A61K9/06

Abstract

Claims (19)

1. An orally dispersing tablet comprising (i) 0.5 mg to 5 mg of budesonide and (ii) at least one pharmaceutically acceptable ingredient which facilitates the dispersal of the tablet in the oral cavity,

wherein upon administration a therapeutically effective amount of the corticosteroid is deposited topically in the upper gastrointestinal tract, and

wherein the orally dispersing tablet disintegrates within 60 seconds in simulated saliva when tested using the USP <701> Disintegration Test.

2. The orally dispersing tablet of claim 1 , wherein the at least one pharmaceutically acceptable ingredient is at least one disintegrant.

3. The orally dispersing tablet of claim 2 , wherein the at least one disintegrant is selected from the group consisting of crospovidone, sodium starch glycolate, crosslinked carboxymethyl cellulose, low-substituted hydroxylpropylcellulose, mannitol, xylitol, sorbitol, maltol, maltitol, lactose, sucrose, maltose, and combinations thereof.

4. The orally dispersing tablet of claim 1 , further comprising an excipient selected from the group consisting of mannitol, xylitol, sorbitol, maltol, maltitol, lactose, sucrose, sucralose, maltose, cyclodextrin, polyvinyl pyrrolidone, magnesium stearate, and combinations thereof.

5. The orally dispersing tablet of claim 4 , wherein the excipient is selected from the group consisting of mannitol, sucralose, magnesium stearate, and combinations thereof.

6. The orally dispersing tablet of claim 5 , wherein the excipient is mannitol.

7. The orally dispersing tablet of claim 5 , wherein the excipient is sucralose.

8. The orally dispersing tablet of claim 5 , wherein the excipient is magnesium stearate.

9. The orally dispersing tablet of claim 1 , comprising from about 1 mg to about 3 mg of budesonide.

10. The orally dispersing tablet of claim 1 , comprising about 1 mg of budesonide.

11. The orally dispersing tablet of claim 5 , comprising about 1 mg of budesonide.

12. The orally dispersing tablet of claim 6 , comprising about 1 mg of budesonide.

13. The orally dispersing tablet of claim 7 , comprising about 1 mg of budesonide.

14. The orally dispersing tablet of claim 8 , comprising about 1 mg of budesonide.

15. A method for treating an inflammatory condition of the gastrointestinal tract comprising administering to an individual in need thereof an orally dispersing tablet according to claim 1 .

16. The method of claim 15 , wherein said inflammatory condition of the gastrointestinal tract comprises inflammation of the esophagus.

17. The method of claim 15 , wherein said inflammatory condition of the gastrointestinal tract is eosinophilic esophagitis.

Assignments (8)