# US 2014/0154317 A1 · Pharmaceutical Composition for Treatment of Helicobacter Pylori Associated Diseases

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- Number: US 2014/0154317 A1
- Document ID: US20140154317A1
- Status: Published application
- Kind: A1
- Application number: 14/094,912
- Filed: 2013-12-03
- Published: 2014-06-05
- Earliest claimed: 2012-12-04
- Inventors: Abo Bakr Mohammed Ali Al-Mehdar
- Web page: https://patentgrep.com/patent/US20140154317A1

## CPC

- A61K 9/28: Dragees; Coated pills or tablets {, e.g. with film or compression coating (A61K9/2072 takes precedence, e.g. partially coated tablets A61K9/2072, coated multilayer tablets A61K9/2086, tablets with drug-coated core A61K9/209)}
- A61K 9/1652: {Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin (homeopathic globules A61K9/1623)}
- A61K 9/2054: {Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose}
- A61K 9/209: {containing drug in at least two layers or in the core and in at least one outer layer}
- A61K 31/133: having hydroxy groups, e.g. sphingosine
- A61K 31/315: Zinc compounds
- A61K 31/341: not condensed with another ring, e.g. ranitidine, furosemide, bufetolol, muscarine
- A61K 31/4164: 1,3-Diazoles
- A61K 31/4188: condensed with other heterocyclic ring systems, e.g. biotin, sorbinil
- A61K 31/43: Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula [IMAGE cpc-sch-A61K-0952.gif], e.g. penicillins, penems
- A61K 31/4439: containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole (nicotine A61K31/465)
- A61K 31/549: having two or more nitrogen atoms in the same ring, e.g. hydrochlorothiazide
- A61K 31/7048: having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin {, digitoxin or digoxin}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 31/04: Antibacterial agents
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

An oral pharmaceutical composition for the treatment of helicobacter pylori associated diseases is disclosed comprising a proton pump inhibitor, an antibiotic or a combination of antibiotics, and additionally at least one agent selected from the group consisting of a) taurolidine or taurultam or a combination thereof, b) a zinc amino acid chelate, c) tromethamole, within a fixed-dose combination for oral administration in the form of either an instant release formulation, for example a compressed tablet, granules or the like, or in the form of a biphasic release form, for example a tablet with a slow release core and a compressed outer fast release layer, wherein the tromethamole is always present in instant release formulations.

## Claims

### Claim 1

An oral pharmaceutical composition for treatment of helicobacter pylori associated diseases comprising
a proton pump inhibitor,
an antibiotic or a combination of antibiotics,
additionally at least one agent selected from the group consisting of taurolidine or taurultam or a combination thereof, a zinc amino acid chelate, tromethamole,
within a fixed-dose combination for oral administration in the form of either an instant release formulation or a biphasic release form, wherein the tromethamole is always present in the instant release formulations.

### Claim 2 (depends on 1)

A pharmaceutical composition according to claim 1, wherein the antibiotic is amoxicillin or a combination of tinidazole and clarithromycin.

### Claim 3 (depends on 1)

A pharmaceutical composition according to claim 1, wherein the proton pump inhibitor is omeprazole.

### Claim 4 (depends on 1)

A pharmaceutical composition according to claim 1, wherein it is formulated as capsules, effervescent granules or powder, effervescent tablets, liquids, dispersible and/or soluble tablets, dispersible powder, suspensions, sachets, premix syrups, jellies, glycerites or tablets.

### Claim 5 (depends on 4)

A pharmaceutical composition according to claim 4, wherein the tablets are compressed tablets or biphasic tablets with an inner slow release layer and an outer fast release layer, preferably wherein the outer layer is formulated in a compressed form.

### Claim 6 (depends on 1)

A pharmaceutical composition according to claim 1 in a biphasic release form, wherein the inner layer or slow release phase composition is enteric coated and comprises the proton pump inhibitor.

### Claim 7 (depends on 6)

A pharmaceutical composition according to claim 6, wherein the outer layer or immediate release phase composition comprises the antibiotic or mixture of antibiotics.

### Claim 8 (depends on 7)

A pharmaceutical composition according to claim 7, wherein the antibiotic or the combination of antibiotics is comprised in both of the phases, in particular both of the layers.

### Claim 9 (depends on 6)

A pharmaceutical composition according to claim 6, wherein the substance or substances selected from taurolidine or taurultam or a combination thereof, the zinc amino acid chelate, the tromethamole is/are comprised in the outer layer of fast release phase.

### Claim 10 (depends on 6)

A pharmaceutical composition according to claim 6, wherein the biphasic release form is a biphasic compressed tablet with an enteric coating on the core phase comprising a pharmaceutically suitable plasticizer.

### Claim 11

A method for treatment of helicobacter pylori associated diseases comprising administering orally to a patient in need thereof.
a proton pump inhibitor,
an antibiotic or a combination of antibiotics,
additionally at least one agent selected from the group consisting of taurolidine or taurultam or a combination thereof, a zinc amino acid chelate, tromethamole,
where said components are arranged within one or more pharmaceutical compositions administered concomitantly or sequentially over a time period from minutes to hours.
