Orally administered corticosteroid compositions
Inventors
Perrett, Stephen • Cohen, Fredric Jay • Venkatesh, Gopi M.
Assignees
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Publication Number
US-11246828-B2
Publication Date
2022-02-15
Expiration Date
Abstract
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.
Core Innovation
The invention relates to an orally dispersing tablet comprising budesonide for topical deposition in the upper gastrointestinal tract. The tablet includes an amount of budesonide and at least one pharmaceutically acceptable ingredient that facilitates dispersal of the tablet in the oral cavity.
The tablet disintegrates within 60 seconds in simulated saliva when tested using the USP <701> Disintegration Test. Upon administration, a therapeutically effective amount of budesonide is deposited topically in the upper gastrointestinal tract.
The disclosed approach is directed to minimizing systemic glucocorticoid and mineralocorticoid activity while enabling topical anti-inflammatory treatment in the gastrointestinal tract, including upper gastrointestinal treatment such as eosinophilic esophagitis.
Claims Coverage
The partial content identifies one independent claim and describes dependent claims. The independent claim requires three core inventive features: a budesonide-containing orally dispersing tablet with a dispersal-facilitating ingredient set, a topically deposited upper gastrointestinal therapeutic effect, and a specific disintegration performance criterion in simulated saliva.
Orally dispersing tablet with budesonide for topical deposition
An orally dispersing tablet comprising about 0.5 mg to about 1 mg of budesonide, and 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 budesonide is deposited topically in the upper gastrointestinal tract.
Simulated saliva disintegration performance by USP <701>
The orally dispersing tablet disintegrates within 60 seconds in simulated saliva when tested using the USP <701> Disintegration Test.
Specified dispersal-facilitating ingredients
The orally dispersing tablet further comprises sucralose, mannitol, magnesium stearate, polyvinyl pyrrolidone, polyethylene glycol, or combinations thereof, as part of the pharmaceutically acceptable ingredients that facilitate dispersal in the oral cavity.
Overall, the claim coverage centers on an orally dispersing tablet formulation that meets a defined disintegration criterion in simulated saliva and that, upon administration, deposits a therapeutically effective amount of budesonide topically in the upper gastrointestinal tract, using specified dispersal-facilitating ingredients.
Stated Advantages
Reduced or no significant systemic glucocorticoid activity.
Reduced or no significant mineralocorticoid activity.
Topical anti-inflammatory treatment in the gastrointestinal tract, including upper gastrointestinal tract treatment.
Documented Applications
Treating eosinophilic esophagitis by orally administering an orally dispersing tablet to an individual in need thereof.
Topical deposition of budesonide for therapeutically effective treatment in the upper gastrointestinal tract.
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