Details for Patent: 9,889,152
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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) |
Filing Date: | Nov 11, 2015 |
Application Number: | 14/938,670 |
Claims: | 1. A dosage form comprising one or more pellets 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 discrete 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, wherein each of the first and second dose comprise a sufficient amount of the PPI to raise plasma levels of the PPI to a threshold concentration of at least 100 ng/ml, and wherein the PPI is lansoprazole or any salts or enantiomers thereof. 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. The dosage form of claim 1, wherein the second dose contains at least 50% more than the first does. 7. The dosage form of claim 1, wherein the second dose contains at least 100% to 200% more than the first dose. 8. The dosage form of claim 1, wherein the second dose contains at least 200% to 900% more than the first dose. 9. The dosage form of claim 1, wherein the first and second doses independently comprise between 5 mg and 300 mg of the PPI. 10. The dosage form of claim 1, wherein the first and second doses independently comprise between 20 mg and 200 mg of the PPI. 11. 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. 12. 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 300 ng/ml. 13. 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 400 ng/ml. 14. 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 500 ng/ml. 15. The dosage form of claim 1, wherein the period of time is between 2 hours and 20 hours. 16. The dosage form of claim 1, wherein the period of time is between 3 hours and 16 hours. 17. The dosage form of claim 1, wherein the period of time is between 4 hours and 12 hours. 18. The dosage form of claim 1, wherein the dosage form is a matrix system. 19. The dosage form of claim 1, wherein each dose is in an amount sufficient to achieve a therapeutic effect and thereby alleviate nocturnal breakthrough phenomenon. 20. The dosage form of claim 1, wherein the dosage form is a tablet, pill, or granulate filled into capsules. 21. The dosage form of claim 20, wherein the dosage form is a capsule. 22. The dosage form of claim 1, wherein the pellets are coated with a pharmaceutically acceptable polymer. 23. The dosage form of claim 22, wherein the pharmaceutically acceptable polymer is selected from the group consisting of: ethylcellulose, cellulose acetate, cellulose propionate (lower, medium or higher molecular weight), cellulose acetate propionate, cellulose acetate butyrate, cellulose acetate phthalate, cellulose triacetate, poly(methyl methacrylate), poly(ethyl methacrylate), poly(butyl methacrylate), poly(isobutyl methacrylate), poly(hexyl methacrylate), poly(isodecyl methacrylate), poly(lauryl methacrylate), poly(phenyl methacrylate), poly(methyl acrylate), poly(isopropyl acrylate), poly(isobutyl acrylate), poly(octadecyl acrylate), poly(ethylene), poly(ethylene) low density, poly(ethylene) high density, poly(propylene), poly(ethylene oxide), poly(ethylene terephthalate), poly(vinyl isobutyl ether), poly(vinyl acetate), poly(vinyl chloride) or polyurethane and mixtures thereof. |