Claims for Patent: 11,135,172

Summary for Patent: 11,135,172

Title:	Rifabutin-based compositions and methods for treating Helicobacter pylori infection
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.
Inventor(s):	Fathi; Reza (Oradell, NJ), Raday; Gilead (Palo Alto, CA), Goldberg; Guy (Tel Aviv, IL), Gosselin; Patrick (Laval, CA)
Assignee:	RedHill Biopharma Ltd. (Tel-Aviv, IL)
Application Number:	16/515,621
Patent Claims:	1. A capsule comprising a mixture of: immediate release dosage compositions having a size ranging from about 100 .mu.m to about 2 mm, wherein each immediate release dosage composition comprises rifabutin and amoxicillin; and extended release dosage compositions having a size ranging from about 100 .mu.m to about 2 mm, wherein each extended release dosage composition comprises a proton pump inhibitor, and wherein the capsule provides, when multiple capsules are administered daily to a patient for a total daily dose of about 150 mg rifabutin, multiple peak plasma concentrations (C.sub.max) of rifabutin with a mean rifabutin C.sub.max ranging from about 60 ng/mL to about 113 ng/mL. 2. The capsule of claim 1, wherein the amoxicillin is amoxicillin trihydrate. 3. The capsule of claim 1, wherein the proton pump inhibitor is one of omeprazole, pantoprazole, lansoprazole, ilaprazole, dexlansoprazole, esomeprazole and rabeprazole, pharmaceutically acceptable salt and solvates thereof or combinations thereof. 4. The capsule of claim 3, wherein the omeprazole is magnesium omeprazole. 5. The capsule of claim 1, wherein the extended release dosage compositions are enteric-coated. 6. The capsule of claim 1, wherein the immediate release dosage compositions comprise both rifabutin and amoxicillin trihydrate, and wherein the extended release dosage compositions comprise magnesium omeprazole. 7. The capsule of claim 1 wherein the immediate release dosage compositions and the extended release dosage compositions are selected from the group consisting of pellets, microgranules, granulates, minitablets, and drug crystals. 8. The capsule of claim 7 wherein the immediate release dosage compositions and the extended release dosage compositions are selected from one of pellets and minitablets. 9. The capsule of claim 1 wherein the immediate release dosage compositions and the extended release dosage compositions are in the form of minitablets. 10. The capsule of claim 1 comprising: 12.5 mg rifabutin; 250 mg amoxicillin; and 10 mg omeprazole or an equivalent amount of omeprazole magnesium. 11. A method of treating H. pylori infection comprising orally administering capsules of claim 1 for an effective period of time, wherein the effective period of time is a time sufficient so as to result in an eradication rate of at least 80%. 12. A packaged pharmaceutical preparation comprising a plurality of the capsules of claim 1 in a sealed container and instructions for administering the capsules orally to treat a patient infected with H. pylori. 13. A packaged pharmaceutical preparation comprising a plurality of the capsules of claim 1 each in a discrete sealed housing, and instructions for administering the capsules orally to treat a patient infected with H. pylori infection.