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AssigneeIronwood Pharmaceuticals, Inc.
InventorsVasu Sethuraman, David Bruce HEDDEN, Kristen Marie LESKOW
Estimating the term…
Disclosed herein are novel compositions and methods for controlling the release of bile acid sequestrant to the stomach in order to treat or prevent upper GI tract disorders or disorders of the throat. The methods generally include administering to a patient in need thereof a therapeutically effective amount of a pharmaceutical composition comprising at least one bile acid sequestrant dispersed in a polymeric matrix. The bile acid sequestrant composition may be administered alone or in combination with at least one proton pump inhibitor, and optionally one or more agents chosen from antacids, histamine H2-receptor antagonists, y-aminobutyric acid-I3 (GABA-B) agonists, prodrugs of GABA-B agonists, acid pump antagonists, protease inhibitors and GC-C agonists.
1-88. (canceled)
A method for treating gastroesophageal reflux disease (GERD), said method comprising administering a therapeutically effective amount of a gastro-retentive oral dosage form to a subject in need thereof, said gastro-retentive oral dosage form comprising:
The method of claim 1, wherein between 75% and 100% percent of the bile acid sequestrant is released from the gastro-retentive oral dosage form after 16 hours, as measured in vitro, in acetate buffer at pH 4.5, using a USP Type II (paddle) apparatus with the gastro-retentive oral dosage form placed in a sinker.
The method of claim 1, wherein the gastro-retentive oral dosage form comprises between 100 mg and 750 mg of the bile acid sequestrant.
The method of clam 97, wherein the gastro-retentive oral dosage form is a tablet.
The method of clam 97, said tablet further comprising a coating, wherein the coating has a level of coating between 5% and 7.5% (weight:weight) of the total tablet weight.
Dependencies are inferred from the claim text.