Multiple PPI dosage form

• US 8,461,187 B2
• Filed: 06/01/2005
• Issued: 06/11/2013
• Est. Priority Date: 06/16/2004
• Status: Active Grant

• Current Assignee: Takeda Pharmaceuticals USA Incorporated (Takeda Pharmaceutical Company Limited)
• Original Assignee: Takeda Pharmaceuticals USA Incorporated (Takeda Pharmaceutical Company Limited)
• Inventors: Taneja, Rajneesh, Vakilynejad, Majid
• Primary Examiner(s): McCormick, Melenie
• Assistant Examiner(s): Betton, Timothy E
• Application Number:
  US11/629,016
• Publication Number:
  US 20090215830A1
• Time in Patent Office: 2,932 Days
• Field of Search: 514/338
• US Class Current: 514/338
• CPC Class Codes: A61K 31/4439 containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole nicotine A61K31/465
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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.

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.

2. The dosage form of claim 1 wherein the second dose begins to be released between 2 and 20 hours after the first dose begins to be released.

3. The dosage form of claim 1 wherein the second dose begins to be released between 3 hours and 16 hours after the first dose begins to be released.

4. The dosage form of claim 1 wherein the second dose begins to be released between 4 hours and 12 hours after the first dose begins to be released.

5. The dosage form of claim 1 wherein each pulse of the PPI is sufficient to maintain plasma concentrations above the threshold concentration for at least 30 minutes.

6. A method of treating a gastrointestinal disorder comprising administering to a patient in need of such therapy the dosage form of claim 1.

7. The method of claim 6 wherein the first and second dose are released from the dosage form as discreet pulses of the PPI and the second dose begins to be released between 2 and 20 hours after the first dose begins to be released.

8. The method of claim 7 wherein the second dose contains at least 10% more of the PPI than the first dose.

9. The method of claim 6 wherein the first dose of the PPI and the second dose of the PPI are released continuously such that there is a extended release of the PPI for a period between 2 and 20 hours and the plasma level concentration of the PPI is maintained above 100 ng/ml for at least 4 hours.

10. The dosage form of claim 1 wherein the second dose contains at least 50% more than the first does.

11. The dosage form of claim 1 wherein the second dose contains at least 100% to 200% more than the first dose.

12. The dosage farm of claim 1 wherein the second dose contains at least 200% to 900% more than the first dose.

13. The dosage form of claim 1 wherein the first and second doses independently comprise between 5 mg and 300 mg of the PPI.

14. The dosage form of claim 1 wherein the first and second doses independently comprise between 20 mg and 200 mg of the PPI.

15. The dosage form of claim 1 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.

16. The dosage form of claim 1 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 450 ng/ml.

17. The dosage form of claim 1, wherein the period of time is between 2 hours and 20 hours.

18. The dosage form of claim 1, wherein the period of time is between 3 hours and 16 hours.

19. The dosage form of claim 1, wherein the period of time is between 4 hours and 12 hours.