| 主权项 |
1. A method for treating nocturnal acid breakthrough in a subject in need thereof, the method comprising: administering to the subject a solid pharmaceutical composition comprising an acid labile proton pump inhibitor that is not enteric coated and a buffering agent, wherein:
(a) the proton pump inhibitor is present in the composition in an amount of about 5 mg to about 60 mg and is selected from the group of omeprazole, tenatoprazole, lansoprazole, rabeprazole, esomeprazole, pantoprazole, pariprazole, leminoprazole and nepaprazole or a free base, a free acid, or a salt, ester, amide, enantiomer, isomer, or tautomer of the proton pump inhibitor; (b) the buffering agent is present in the composition in an amount of about 300 mg to about 3000 mg and comprises a bicarbonate salt of a Group IA metal; (c) the administration step is performed prior to between about 8:00 pm and about 12:00 am and at such a time so as to result in a blood serum concentration of the proton pump inhibitor of at least about 0.1 micromolar at any time point from about 12:00 am to about 6:00 am following administration; and (d) upon administration of the composition to a subject, the subject exhibits a Cmax of the proton pump inhibitor of about 500 μg/ml to about 2000 μg/ml; a Tmax of the proton pump inhibitor of about 0.15 to about 2 hours; and/or an AUC(0-inf) of the proton pump inhibitor of about 1000 to about 3000 ng·hr/ml. |
