Claims for Patent: 8,461,187

Summary for Patent: 8,461,187

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 Prarie, WI)
Assignee:	Takeda Pharmaceuticals U.S.A., Inc. (Deerfield, IL)
Application Number:	11/629,016
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,461,187
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. 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.