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 . (canceled) 
     
     
         2 . A pharmaceutical formulation comprising about 20 mg of omeprazole or a salt thereof, an antacid consisting of about 1100 mg of sodium bicarbonate, a disintegrant consisting of croscarmellose sodium, and a lubricant consisting of magnesium stearate, wherein the pharmaceutical formulation does not comprise a binder. 
     
     
         3 . The pharmaceutical formulation of  claim 2 , wherein upon oral administration of the capsule to a fasted human subject, a T max  of the omeprazole or salt thereof is obtained within 60 minutes after administration on day 1. 
     
     
         4 . The pharmaceutical formulation of  claim 2 , wherein an initial serum concentration of the omeprazole or salt thereof is greater than 300 ng/ml within 45 minutes after administration. 
     
     
         5 . The pharmaceutical formulation of  claim 2 , further comprising polysorbate-80. 
     
     
         6 . The pharmaceutical formulation of  claim 2 , wherein the croscarmellose sodium is provided in an amount of about 2 wt-% to about 8 wt-%. 
     
     
         7 . The pharmaceutical formulation of  claim 2 , wherein the magnesium stearate is provided in an amount of about 0.5 wt-% to about 3 wt-%. 
     
     
         8 . A capsule comprising the pharmaceutical formulation of  claim 2 . 
     
     
         9 . The capsule of  claim 8 , wherein the capsule comprises gelatin.