ORALLY ADMINISTERED CORTICOSTEROID COMPOSITIONS
The present invention is directed to orally administered corticosteroid compositions. The present invention also provides a method for treating a condition associated with inflammation of the gastrointestinal tract in an individual. The method comprises administering to an individual in need thereof a pharmaceutical composition of the present invention.
1 . An orally dispersing tablet comprising:
(i) about 0.5 mg to about 1.5 mg of budesonide; and
(ii) at least one pharmaceutically acceptable ingredient which facilitates the dispersal of the tablet in the oral cavity; and
(iii) sucralose, mannitol, magnesium stearate, polyvinyl pyrrolidone, polyethylene glycol, or combinations thereof;
wherein upon administration a therapeutically effective amount of budesonide is deposited topically in the esophagus,
wherein the orally dispersing tablet disintegrates within 60 seconds when tested using the USP <701> Disintegration Test; and
wherein the orally dispersing tablet has a hardness of 8-48 N or a friability of not more than 1%.
2 . The orally dispersing tablet of claim 1 , comprising about 0.5 mg to about 1 mg of budesonide.
3 . The orally dispersing tablet of claim 1 , comprising about 0.5 mg of budesonide.
4 . The orally dispersing tablet of claim 1 , comprising about 1 mg of budesonide.
5 . The orally dispersing tablet of claim 1 , wherein the at least one pharmaceutically acceptable ingredient which facilitates the dispersal of the tablet in the oral cavity is at least one disintegrant.
6 . The orally dispersing tablet of claim 1 , comprising sucralose.
7 . The orally dispersing tablet of claim 1 , comprising sucralose and mannitol.
8 . The orally dispersing tablet of claim 1 , comprising sucralose, mannitol, and magnesium stearate.
9 . The orally dispersing tablet of claim 1 , comprising sucralose, mannitol, magnesium stearate, and polyvinyl pyrrolidone.
10 . The orally dispersing tablet of claim 1 , comprising sucralose and magnesium stearate.
11 . The orally dispersing tablet of claim 1 , comprising sucralose and polyvinyl pyrrolidone.
12 . The orally dispersing tablet of claim 1 , comprising two or more of sucralose, mannitol, magnesium stearate, or polyvinyl pyrrolidone.
13 . The orally dispersing tablet of claim 1 , comprising three or more of sucralose, mannitol, magnesium stearate, or polyvinyl pyrrolidone.
14 . The orally dispersing tablet of claim 1 , wherein the orally dispersing tablet disintegrates within 60 seconds when tested in simulated saliva fluid using the USP <701> Disintegration Test.
15 . The orally dispersing tablet of claim 1 , wherein the orally disintegrating tablet has a friability of not more than 1%.
16 . The orally dispersing tablet of claim 9 , wherein the orally disintegrating has a hardness of 8-48 N and a friability of not more than 1%.
17 . The orally dispersing tablet of claim 1 , wherein the orally disintegrating tablet has a friability of not more than 0.6%.
18 . The orally dispersing tablet of claim 16 wherein the orally disintegrating tablet has a friability of not more than 0.6%.
19 . The orally dispersing tablet of claim 1 , wherein the orally disintegrating tablet has a thickness of 2-2.8 mm.
20 . The orally dispersing tablet of claim 16 , wherein the orally disintegrating tablet has a thickness of 2-2.8 mm.
21 . A method for treating eosinophilic esophagitis comprising administering to patient in need thereof the orally dispersing tablet according to claim 1 .