Pharmaceutical compositions for the treatment of <i>Helicobacter pylori</i>

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 capsule, comprising:
(1) an immediate release first dosage composition in the form of compressed minitablets, the immediate release first dosage composition comprising at least two antibiotics; and (2) a delayed release second dosage composition in the form of compressed minitablets, the delayed release second dosage composition comprising a proton pump inhibitor and a coating,
wherein, when tested in a basket apparatus, the delayed release second dosage composition meets the two stage test dissolution profile in a basket apparatus:
(a) release of not more than 10% by weight of the proton pump inhibitor in 120 min in an acid stage comprising 900 ml 0.1N HCl at 100 rpm; and(b) release of not less than 75% by weight of the proton pump inhibitor in 45 min in 900 ml phosphate buffer pH 6.8 at 100 rpm following the acid.