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Claims for Patent: 8,173,158

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Claims for Patent: 8,173,158

Title:Methods of treating gastrointestinal disorders independent of the intake of food
Abstract: The present invention relates to a method of treating a gastrointestinal disorder by administering to a patient in need of treatment thereof a pharmaceutical composition, wherein said pharmaceutical composition can be administered to the patient independent of the intake of food.
Inventor(s): Lee; Ronald D. (Round Lake Beach, IL), Vakily; Majid (Gurnee, IL), Mulford; Darcy (Grayslake, IL), Wu; Jing-Tao (Mundelein, IL), Atkinson; Stuart (Lake Forest, IL)
Assignee: Takeda Pharmaceuticals U.S.A., Inc. (Deerfield, IL)
Application Number:12/249,258
Patent Claims: 1. A method of treating heartburn, acid reflux or gastroesophageal reflux disease in a patient in need of treatment thereof, the method comprising the steps of: a) obtaining a pharmaceutical composition comprising dexlansoprazole from a group of pharmaceutical compositions comprising proton pump inhibitors; and b) administering to a patient suffering from heartburn, acid reflux or gastroesophageal reflux, regardless of whether the patient is under fasted or fed conditions, a therapeutically effective amount of the pharmaceutical composition obtained in step a), wherein the pharmaceutical composition comprises: (i) a first solid particle, wherein said first solid particle comprises dexlansoprazole and a first enteric coating, wherein the first enteric coating releases the proton pump inhibitor from the solid particle at a pH of about 5.0 to about 5.5; and (ii) a second solid particle, wherein said second solid particle comprises dexlansoprazole and a second enteric coating, wherein the second enteric coating releases the proton pump inhibitor from the solid particle at a pH of about 6.2 to about 6.8; wherein the first solid particle comprises from about 15% to about 50% by weight of the pharmaceutical composition and the second solid particle comprises from about 50% to about 85% by weight of the pharmaceutical composition.

2. The method of claim 1, wherein the first enteric coating has a pH of about 5.5.

3. The method of claim 1, wherein the second enteric coating has a pH of about 6.75.

4. The method of claim 1, wherein the changes in pharmacokinetics after administration to the patient of a single dose of a therapeutically effective amount of the pharmaceutical composition comprising dexlansoprazole under fasting or fed conditions does not produce statistically significant changes in intragastric pH.

5. The method of claim 1, wherein the patient is suffering from heart burn.

6. The method of claim 1, wherein the patient is suffering from acid reflux.

7. The method of claim 1, wherein the patient is suffering from gastroesophageal reflux.

8. The method of claim 1, wherein the pharmaceutical composition comprising dexlansoprazole is in the form of a tablet or a capsule.

9. The method of claim 1, wherein the administration of the composition to a human subject in a fed state is bioequivalent to administration of the composition to a human subject in a fasted state.

10. The method of claim 9, wherein bioequivalency of the composition is established by a 90% Confidence Interval for AUC which is between 0.80 and 1.25.

11. The method of claim 9, wherein bioequivalency of the composition is established by a 90% Confidence Interval for C.sub.max, which is between 0.80 and 1.25.

12. The method of claim 1, wherein the pharmaceutical composition comprising dexlansoprazole administration provides a mean intragastric pH of between about 4.2 and about 4.5 on day 3 following administration regardless of whether the dexlansoprazole was administered in a fed or fasted state.
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