Flexible Subscriptions to Match your Budget and Timeline See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Baxter
Merck
Medtronic
Express Scripts
Harvard Business School

Last Updated: December 7, 2021

DrugPatentWatch Database Preview

Claims for Patent: 9,603,806


Email this page to a colleague

« Back to Dashboard

Summary for Patent: 9,603,806
Title:Pharmaceutical compositions for the treatment of Helicobacter pylori
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:15/135,309
Patent Claims: 1. 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.

2. The capsule of claim 1 wherein the coating in the second dosage composition delays the release of the proton pump inhibitor from 120 to at least 240 minutes following oral administration.

3. The capsule of claim 1 wherein the first dosage composition comprises amoxicillin.

4. The capsule of claim 1 wherein, in the second dosage composition, the proton pump inhibitor is one of omeprazole, pantoprazole, lansoprazole, ilaprazole, dexlansoprazole, esomeprazole or rabeprazole, pharmaceutically acceptable salt or solvates thereof or combinations thereof.

5. The capsule of claim 1 wherein the second dosage composition comprises a time delay agent.

6. The capsule of claim 5 wherein the time delay agent is one of sodium alginate, glyceryl monostearate, glyceryl distearate, acrylic acids, celluloses or combinations thereof.

7. The capsule of claim 1 wherein at least 70% by weight of the antibiotic is released between 5 and 120 minutes following oral administration; and at least 70% by weight of the proton pump inhibitor is released between 120 and 240 min following oral administration.

8. The capsule of claim 1 comprising amoxicillin and omeprazole.

9. The capsule of claim 8 wherein the amoxicillin to omeprazole ratio ranges from 20 to 40 by weight.

10. The capsule claim 1, wherein the first and second dosage compositions further comprise a filler, a disintegrant, a binder, a surfactant, an alkalizing agent, a lubricant or combinations thereof.

11. The capsule of claim 10 wherein the filler is one of lactose, cellulose, starch, calcium phosphates, calcium carbonate, sugar, or combinations thereof.

12. The capsule of claim 10 wherein the disintegrant is one of croscarmellose sodium, carboxymethyl cellulose, sodium starch glycolate, crospovidone or combinations thereof.

13. The capsule of claim 10 wherein the binder is one of starch, cellulose, polyvinylpyrrolidone, xanthan gum, alginic acid, agar or combinations thereof.

14. The capsule of claim 10 wherein the surfactant is one of sodium lauryl sulphate, polyoxyethylene polyoxypropylene glycol, polyethylene glycol, poplypropylene glycol, polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol, macrogolglycerol hydroxystearate or combinations thereof.

15. The capsule of claim 10 wherein the alkalizing agent is one of meglumine, calcium carbonate, sodium sulfate, sodium bicarbonate or combinations thereof.

16. The capsule of claim 10 wherein the lubricant is one of magnesium stearate, silicon dioxide, talc, stearic acid, sodium stearyl fumarate, glyceryl behenate or combinations thereof.

17. The capsule of claim 1 wherein the first dosage composition comprises 250 mg amoxicillin and wherein the second dosage composition comprises 10 mg omeprazole, derivatives thereof, or pharmaceutically acceptable salts or solvates thereof.

18. The capsule of claim 1, wherein the second dosage composition comprises an outer protective layer, an enteric coating and an inner protective layer.

19. A method for treating H. pylori in a host comprising administering to a host the capsule of claim 1 three times a day.

20. The method of claim 19 comprising treating a host for at least 14 days and wherein the treatment results in an eradication rate greater than 84%.

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Harvard Business School
Express Scripts
Mallinckrodt
Johnson and Johnson
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.