Pharmaceutical formulations useful for inhibiting acid secretion and methods for making and using them

Abstract

The present invention relates to pharmaceutical formulations comprising at least one acid-labile proton pump inhibiting agent and at least one antacid, which have improved bioavailability, chemical stability, physical stability, dissolution profiles, disintegration times, safety, as well as other improved pharmacokinetic, pharmacodynamic, chemical and/or physical properties. The present invention is directed to methods, kits, combinations, and compositions for treating, preventing or reducing the risk of developing a gastrointestinal disorder or disease, or the symptoms associated with, or related to, a gastrointestinal disorder or disease in a subject in need thereof.

1 - 34 . (canceled) 
     
     
         35 . A pharmaceutical formulation in a capsule dosage form, comprising:
 a. about 20 mg of omeprazole or a salt thereof;   b. about 1100 mg of sodium bicarbonate;   c. croscarmellose sodium; and   d. magnesium stearate.   
     
     
         36 . The pharmaceutical formulation of  claim 35 , further comprising polysorbate-80. 
     
     
         37 . The pharmaceutical formulation of  claim 35 , wherein the croscarmellose sodium is provided in an amount of about 2 wt-% to about 8 wt-%. 
     
     
         38 . The pharmaceutical formulation of  claim 35 , wherein the magnesium stearate is provided in an amount of about 0.5 wt-% to about 3 wt-%. 
     
     
         39 . The pharmaceutical formulation of  claim 35 , further comprising gelatin. 
     
     
         40 . The pharmaceutical formulation of  claim 35 , wherein the omeprazole is micronized omeprazole.