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.
Claims30
A pharmaceutical composition, comprising:
- (1) an immediate release first dosage composition comprising at least two antibiotics;
- (2) a delayed release second dosage composition comprising a proton pump inhibitor and a coating,
- wherein the coating is sufficiently designed to meet the two stage test dissolution profile in a basket apparatus:
- (a) release of not more than 10% 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% of the proton pump inhibitor in 45 min in 900 ml phosphate buffer pH 6.8 at 100 rpm following the acid stage;
- and
- (3) an outer layer encapsulating the first and the second dosage compositions.
A method of treatment, the method comprising administering orally a dose of a pharmaceutical composition in a single solid dosage form, wherein the pharmaceutical composition comprises (1) an immediate release first dosage composition comprising at 12.5 mg rifabutin and 250 mg amoxicillin, derivatives thereof, or pharmaceutically acceptable salts and solvates thereof, (2) a delayed release second dosage composition comprising 10 mg omeprazole, derivatives thereof and pharmaceutically acceptable salts and solvates thereof and a coating, wherein the coating is sufficiently designed to meet the two stage test dissolution profile in a basket apparatus:
- (a) release of not more than 10% of omeprazole in 120 min in an acid stage comprising 900 ml 0.1N HCl at 100 rpm and (b) release of not less than 75% of omeprazole in 45 min in 900 ml phosphate buffer pH 6.8 at 100 rpm following the acid stage;
- and (3) an outer layer encapsulating the first and the second compositions,
- wherein in the step of administering, the dose comprises 50 mg rifabutin, 1000 mg amoxicillin, and 40 mg omeprazole and is administered three times per day.
Dependencies are inferred from the claim text.