18-09-2014 дата публикации
Номер: US20140271853A1
The present invention relates to combinations of a proton pump inhibiting agent and at least one buffering agent that have been found to possess improved bioavailability, chemical stability, physical stability, dissolution profiles, disintegration times, 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 including nocturnal acid breakthrough, or the symptoms associated therewith 1. A pharmaceutical composition in a solid dosage form comprising:(a) about 10 mgs to about 100 mgs of at least one acid labile bicyclic-aryl-imidazole proton pump inhibiting agent;{'sub': '3', '(b) at least one antacid in an amount sufficient to increase gastric fluid pH to a pH that prevents acid degradation of at least some of the proton pump inhibitor in the gastric fluid; wherein the antacid comprises at least about 400 mgs of NaHCO; and'}(c) about 0.5 wt-% to about 3 wt-% of a hydrophilic lubricant;wherein the composition achieves an in vitro initial rise in pH within about 4 minutes.2. The pharmaceutical composition of claim 1 , wherein the composition achieves an in vitro initial pH of at least about 4 within about 2 minutes.3. The pharmaceutical composition of claim 1 , wherein the hydrophilic lubricant is sodium stearyl fumarate.4. The pharmaceutical formulation according to claim 1 , wherein the proton pump inhibitor is omeprazole claim 1 , esomeprazole or lansoprazole claim 1 , or a pharmaceutically acceptable salt thereof.5. The pharmaceutical formulation according to claim 1 , wherein the solid dosage form further comprising an antacid selected from potassium bicarbonate claim 1 , sodium carbonate claim 1 , calcium carbonate claim 1 , magnesium oxide claim 1 , magnesium hydroxide claim 1 , magnesium carbonate claim 1 , aluminum hydroxide claim 1 , and ...
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