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US 2016/0235681 A1Published application
Pharmaceutical compositions for the treatment of helicobacter pylori
AssigneeRedHill Biopharma Ltd.
InventorsReza Fathi, Gilead Raday, Guy Goldberg, Patrick Gosselin
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Abstract
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.
Claims20
A capsule comprising:
- (1) an immediate release first dosage composition in the form of compressed minitablets, the immediate release first dosage composition comprising an antibiotic;
- 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 stage.
1 more element
Dependencies are inferred from the claim text.