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Claims for Patent: 9,238,029

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Claims for Patent: 9,238,029

Title:Multiple PPI dosage form
Abstract: Herein provided are dosage forms (variously referred to as "formulations") comprising a PPI that is released from the dosage form as a first and a second dose. Each dose of PPI is present in an amount sufficient to raise the plasma levels of the PPI to at least 100 ng/ml.
Inventor(s): Taneja; Rajneesh (Libertyville, IL), Vakilynejad; Majid (Pleasant Prairie, WI)
Assignee: Takeda Pharmaceuticals U.S.A., Inc. (Deerfield, IL)
Application Number:13/874,219
Patent Claims: 1. A dosage form comprising a PPI wherein the PPI is released from the dosage form as a first and a second dose, wherein the first and second doses are released from the dosage form as discreet pulses of the PPI separated by a period of time, wherein the second dose contains at least 10% more of the PPI than the first dose, and wherein each of the first and second doses comprise a sufficient amount of the PPI to raise plasma levels of the PPI to a threshold concentration of at least 100 ng/ml, wherein the PPI is lansoprazole or any salts or enantiomers thereof.

2. The dosage form of claim 1, wherein the PPI is lansoprazole or enantiomers thereof.

3. The dosage form of claim 2, wherein the PPI is lansoprazole.

4. The dosage form of claim 2, wherein the second dose begins to be released between 2 and 20 hours after the first dose begins to be released.

5. The dosage form of claim 2, wherein the second dose begins to be released between 3 hours and 16 hours after the first dose begins to be released.

6. The dosage form of claim 2, wherein the second dose begins to be released between 4 hours and 12 hours after the first dose begins to be released.

7. The dosage form of claim 2, wherein each pulse of the PPI is sufficient to maintain plasma concentrations above the threshold concentration for at least 30 minutes.

8. The dosage form of claim 2, wherein the second dose contains at least 50% more than the first does.

9. The dosage form of claim 2, wherein the second dose contains at least 100% to 200% more than the first dose.

10. The dosage form of claim 2, wherein the second dose contains at least 200% to 900% more than the first dose.

11. The dosage form of claim 2, wherein the first and second doses independently comprise between 5 mg and 300 mg of the PPI.

12. The dosage form of claim 2, wherein the first and second doses independently comprise between 20 mg and 200 mg of the PPI.

13. The dosage form of claim 2, wherein each of the first and second doses comprise a sufficient amount of the PPI to raise plasma levels of the PPI to a threshold concentration of at least 200 ng/ml.

14. The dosage form of claim 2, wherein each of the first and second doses comprise a sufficient amount of the PPI to raise plasma levels of the PPI to a threshold concentration of at least 300 ng/ml.

15. The dosage form of claim 2, wherein each of the first and second doses comprise a sufficient amount of the PPI to raise plasma levels of the PPI to a threshold concentration of at least 400 ng/ml.

16. The dosage form of claim 2, wherein each of the first and second doses comprise a sufficient amount of the PPI to raise plasma levels of the PPI to a threshold concentration of at least 500 ng/ml.

17. The dosage form of claim 2, wherein the period of time is between 2 hours and 20 hours.

18. The dosage form of claim 2, wherein the period of time is between 3 hours and 16 hours.

19. The dosage form of claim 2, wherein the period of time is between 4 hours and 12 hours.

20. The dosage form of claim 2, wherein the dosage form is a matrix system.

21. The dosage form of claim 2, wherein the dosage form is a reservoir system.

22. The dosage form of claim 2, wherein each dose is in an amount sufficient to achieve a therapeutic effect and thereby alleviate nocturnal breakthrough phenomenon.
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