Proton pump inhibitor formulations, and methods of preparing and using such formulations
AssigneeAGI Therapeutics Ltd.
InventorsJohn DEVANE, David YOUNG
Life of this patent
Estimating the term…
Abstract
Pharmaceutical formulation comprising at least one proton pump inhibitor structured and arranged to provide an initial pH-dependent delayed release, and a pH-dependent extended release of the at least one proton pump inhibitor.
Claims33
A method of controlling nocturnal acid breakthrough in a patient undergoing proton pump inhibitor therapy, the method comprising:
- identifying a patient undergoing proton pump inhibitor therapy and exhibiting symptoms of nocturnal acid breakthrough;
- and
- switching said patient from his or her current proton pump inhibitor therapy to a proton pump inhibitor therapy that comprises ingesting, once daily, in the evening, an extended-release proton pump inhibitor formulation comprising a core comprising at least one proton pump inhibitor, which is coated with a pH-dependent coating, which is further coated with a pH-dependent extended release coating,
- wherein ingesting the extended-release proton pump inhibitor formulation results in a maximum plasma concentration of the proton pump inhibitor at least two hours after administration.
A method of controlling stomach acid secretion in a mammal comprising orally administering a pharmaceutical formulation to the mammal, wherein said pharmaceutical formulation comprises at least one proton pump inhibitor structured and arranged to provide a pH-dependent extended-release of a proton pump inhibitor.
A pharmaceutical formulation for treatment of nocturnal acid breakthrough, the formulation comprising:
- an extended component comprising from about 10 to about 60 mg omeprazole, an isomer of omeprazole, or a salt of either of the foregoing, in a core,
- the core coated with a coating composition comprising at least one polymer that exhibits a pH-dependent dissolution profile, wherein the polymer exhibits a dissolution that begins at a pH of greater than about 5, to form a coated core, and
- the coated core being further coated with an outer coating composition comprising at least one polymer that exhibits a pH-dependent dissolution profile, wherein the polymer exhibits a dissolution that begins at a pH of greater than about 6.5, the outer coating composition further comprising talc.
Dependencies are inferred from the claim text.