PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF HELICOBACTER PYLORI

摘要

Single oral solid dosage form comprising an immediate release first dosage composition having at least two antibiotic agents and a delayed release second dosage composition having a proton pump inhibitor are provided herein. The single oral solid dosage form according to some aspects of the invention can be used for the treatment of disorders associated with infection by H. pylori or the prevention of recurrence of disorders associated with infection by H. pylori.

主权项

1. A pharmaceutical composition, comprising:
(1) an immediate release first dosage composition comprising a first antibiotic and at least a second antibiotic, wherein the first antibiotic is rifabutin or derivatives thereof or pharmaceutically acceptable salts or solvates thereof, wherein the first dosage composition provides, when administered at a dose of 50 mg rifabutin three times a day to a human in a fasted state, an in vivo plasma profile having: (a) a mean Cmax ranging from about 60 ng/ml to about 113 ng/ml; (b) a Geometric LSMeans ranging from about 55 ng/ml to about 110 ng/ml; (c) a mean AUC0-24 ranging from about 800 ng.h/ml to about 1850 ng.h/ml; and (d) a mean Tmax ranging from about 14 h to about 19 h based on a three times a day dose administration; (2) a delayed release second dosage composition comprising a proton pump inhibitor and a coating; and (3) an outer layer encapsulating the first dosage composition and the second dosage composition.