AU590578B2 - Treatment of non-ulcer dyspepsia with bismuth salts - Google Patents

Treatment of non-ulcer dyspepsia with bismuth salts

Info

Publication number
AU590578B2
AU590578B2 AU59026/86A AU5902686A AU590578B2 AU 590578 B2 AU590578 B2 AU 590578B2 AU 59026/86 A AU59026/86 A AU 59026/86A AU 5902686 A AU5902686 A AU 5902686A AU 590578 B2 AU590578 B2 AU 590578B2
Authority
AU
Australia
Prior art keywords
ulcer dyspepsia
antibiotics
bismuth salt
antibiotic
amoxycillin
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
AU59026/86A
Other versions
AU5902686A (en
Inventor
Thomas Julius Borody
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Procter and Gamble Co
Original Assignee
Procter and Gamble Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=3771057&utm_source=***_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AU590578(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Procter and Gamble Co filed Critical Procter and Gamble Co
Publication of AU5902686A publication Critical patent/AU5902686A/en
Application granted granted Critical
Publication of AU590578B2 publication Critical patent/AU590578B2/en
Anticipated expiration legal-status Critical
Expired legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/28—Compounds containing heavy metals
    • A61K31/29—Antimony or bismuth compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • A61K31/429—Thiazoles condensed with heterocyclic ring systems
    • A61K31/43—Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula, e.g. penicillins, penems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Description

TREATMENT OF NON-ULCER DYSPEPSIA WITH BISMUTH SALTS BACKGROUND ART This invention relates to a method of treating non-ulcer dyspepsia . In the past bismuth compounds have been used in the treatment of dyspepsia arising from peptic ulcers. However, there has been previously no recognised therapy for the treatment of non-ulcer dyspepsia. Non-ulcer dyspepsia has not been widely recognised in the past as being a single disease process and has been considered as comprising various disorders with such names as "nervous dyspepsia", "irritable bowel syndrome", "gastritis", and also "post-cholecystectomy syndrome". Non-ulcer dyspepsia is characterised by epigastric discomfort, burning or pain, abdominal distention, bloating, belching or burping, nausea, and frequently it is said that the ingestion of food can precipitate such symptoms.
The treatment of this disorder has, until now, been non-specific, empirical and generally inadequate.
It has now been discovered that a new class of sp.iral bacteria reside in the stomach of humans. These bacteria have been found to be closely associated with the presence of gastritis. It has now also been found that the symptoms of non-ulcer dyspepsia are closely related to the presence of the newly discovered spiral bacteria. These bacteria are Campylobacter-like bacteria, currently called Campylobacter pyloridis.
While the use of bismuth salts to treat ulcers has been known, their utility in the treatment of non-ulcer dyspepsia has not been suspected previously. The symptoms of the two conditions are generally different, but may at times overlap. The diagnosis is made endoscopically.
DISCLOSURE OF THE INVENTION The present invention relates to a method of treating non-ulcer dyspepsia in patients suffering from the said non-ulcer dyspepsia, comprising administering to the said patients an effective amount of a pharmaceutically acceptable bismuth salt.
A preferred bismuth compound for the treatment of non-*αlcer dyspepsia is tripotassium dicitratobismuthate. This is also known as De-Nol (Registered Trade Mark). Other bismuth compounds known for the treatment of ulcer and other diseases may also be used in the present invention. Ideally, the bismuth salt is administered orally for a period of at least four (4) weeks and may be administered alone in an adequate dose or in combination with other antibiotics.
It has further been found that the treatment of non-ulcer dyspepsia with bismuth salt is enhanced by the concurrent administration of an antibiotic.
Particularly suitable antibiotics may be chosen from the classes consisting of β-lactams, such as penicillins; macrolide antibiotics; tetracycline antibiotics and nitro-imidazole sulfones. From within these classes Amoxycillin, Erythromycin, Tetracycline and Tinidazole have been found to be particularly efficacious.
Another aspect of the invention comprises a pharmaceutical composition comprising a pharmaceutically acceptable bismuth salt, an antibiotic and pharmaceutieally acceptable carrier or diluent.
Preferably the bismuth salt is tripotassium dicitrato-bismuthate.
The most preferable antibiotics are selected from the classes specified above. In particular, the β-lactam antibiotics. Most preferably, the antibiotic is Amoxycillin. The pharmaceutical composition is preferably presented in a form suitable for peroral administration, such as liquid, tablet or capsule form.
BEST MODE OF CARRYING OUT THE INVENTION The invention will now be further described with reference to the following examples. Example 1
27 Patients suffering from non-ulcer dyspepsia associated with C.pyloridis infection were treated with the bismuth salt, tripotassium dicitrato-bismuthate, known under the registered Trade Mark "De-Nol". All patients were administered 107.7mg De-Nol four times daily. Of the 27, 6 were treated with De-Nol alone. Of these it was found that 40% were completely clear of dyspepsia after 1 month and 60% after two months. The remaining patients were treated with combinations of De-Nol and the antibiotics Amoxycillin and Tinidazole. 250mg Amoxycillin was administered four times daily for four weeks and lgm Tinidazole was administered daily for 10 days. The results were 95% clear completely within 4 weeks. Rebiopsy of the completely clear patients, performed 2 weeks after the four week treatment ceased, showed that the patients remained completely clear.
Trials with Amoxycillin alone indicate that Amoxycillin has no appreciable effect in the treatment of dyspepsia. Example 2
The following pharmaceutical formulation is proposed for use in the performance of the present invention: Tablet formulation tripotassium dicitrato-bismuthate 107.7mg amoxycillin 250 mg magnesium.stearate 10 mg maize starch 20 mg
Flavouring substances may be added as required. It will be clear to those skilled in the art that other formulations falling within the scope of the present invention are possible, and that the invention is therefore not restricted to the above formulation.

Claims (12)

1. A method of treating non-ulcer dyspepsia in patients suffering from non-ulcer dyspepsia associated with Campylobacter pyloridis infection, comprising administering to said patients an effective amount of a pharmaceutically acceptable bismuth salt.
2. A method according to claim 1 wherein the bismuth salt is tripotassium dicitrato-bismuthate.
3. A method according to claim 1 wherein the bismuth salt is administered in conjunction with one or more antibiotics.
4. A method according to claim 3 wherein the antibiotics are selected from the β-lactam antibiotics, macrolide anitbiotics, tetracycline antibiotics and nitro-imidazole sul ones.
5. A method according to claim 4 wherein the antibiotics are selected from Amoxycillin, Tinidazole, Erythromycin and Tetracycline.
6. A method according to claim 5 wherein Amoxycillin and Tinidazole are administered in conjunction with the bismuth salt.
7. A method of treating non-ulcer dyspepsia in patients suffering from non-ulcer dyspepsia, substantially as hereinbefore described with reference to the examples.
8. A pharmaceutical composition comprising a pharmaceutically acceptable bismuth salt, an antibiotic and a pharmaceutically acceptable carrier or diluent.
9. A pharmaceutical composition according to claim 8 wherein the bismuth salt is tripotassium dicitrato-bismuthate.
10. A pharmaceutical composition according to either one of claims 8 or 9 wherein the antibiotic is a β-lactam antibiotic.
11. A pharmaceutical formulation according to claim 10 wherein the antibiotic is Amoxycillin.
12. A pharmaceutical formulation substantially as hereinbefore described with reference to the examples.
AU59026/86A 1985-04-18 1986-04-18 Treatment of non-ulcer dyspepsia with bismuth salts Expired AU590578B2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AUPH0198 1985-04-18
AUPH019885 1985-04-18

Publications (2)

Publication Number Publication Date
AU5902686A AU5902686A (en) 1986-11-05
AU590578B2 true AU590578B2 (en) 1989-11-09

Family

ID=3771057

Family Applications (1)

Application Number Title Priority Date Filing Date
AU59026/86A Expired AU590578B2 (en) 1985-04-18 1986-04-18 Treatment of non-ulcer dyspepsia with bismuth salts

Country Status (5)

Country Link
EP (1) EP0222834A4 (en)
JP (1) JPS62502967A (en)
AU (1) AU590578B2 (en)
SG (1) SG72632A1 (en)
WO (1) WO1986005981A1 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU621285B2 (en) * 1987-03-09 1992-03-12 Procter & Gamble Company, The Compositions and methods for treating gastrointestinal disorders

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE81010T1 (en) * 1985-06-13 1992-10-15 Barry James Marshall COMPOSITIONS FOR THE TREATMENT OF GASTROINTESTINAL DISORDERS.
DE3874917T2 (en) * 1987-03-09 1993-03-04 Procter & Gamble COMPOSITIONS AND THEIR USE FOR THE TREATMENT OF STOMACH.
AU623868B2 (en) * 1987-10-12 1992-05-28 Capability Services Pty. Limited Improved method for treatment of gastrointestinal disorders
EP0439453B1 (en) * 1987-10-12 1994-01-19 Exomed Australia Pty. Ltd. (ACN 051 976 446) Improved method for treatment of gastrointestinal disorders
US4935406A (en) * 1988-09-20 1990-06-19 Marion Laboratories, Inc. Use of bismuth (phosph/sulf)ated saccharides against Camplyobacter-associated gastrointestinal disorders
EP0375068A1 (en) * 1988-12-23 1990-06-27 Gist-Brocades N.V. Combining bismuth compounds and tetracyclines
EP0403048A3 (en) * 1989-06-14 1991-01-30 Warner-Lambert Company Medicated compositions containing sucralfate and processes for their production
FI910088A (en) * 1990-01-09 1991-07-10 Gist Brocades Nv ORAL PHARMACEUTICAL COMPOSITION.
YU45590A (en) * 1990-03-07 1992-07-20 PLIVA FARMACEVTSKA, KEMIJSKA, PREHRAMBENA I KOZMETIČKA INDUSTRIJA s.p.o. NEW COMPLEXES OR CHELATES OF ANTIBIOTICS WITH TWO-VALENT AND / OR TROVALENT METALS AND PROCEDURES FOR THEIR OBTAINING
GB9010039D0 (en) * 1990-05-03 1990-06-27 Reckitt & Colmann Prod Ltd Medicament preparation
US5192752A (en) * 1991-01-14 1993-03-09 The Procter & Gamble Company Swallowable pharmaceutical compositions containing colloidal bismuth subcitrate
GB9120131D0 (en) * 1991-09-20 1991-11-06 Glaxo Group Ltd Medicaments
EP0624373B1 (en) * 1993-05-11 1999-09-08 Spirig Ag Pharmazeutische Präparate Pharmaceutical preparation containing bismuth and amoxycillin and its use
US6426085B1 (en) 1994-05-02 2002-07-30 Josman Laboratories Inc. Use of bismuth-containing compounds in topical oral dosage forms for the treatment of halitosis
US6902738B2 (en) 1994-05-02 2005-06-07 Josman Laboratories, Inc. Topical oral dosage forms containing bismuth compounds
US5834002A (en) 1994-05-02 1998-11-10 Josman Laboratories, Inc. Chewing gum containing colloidal bismuth subcitrate
US6379651B1 (en) 1995-02-07 2002-04-30 Josman Laboratories Oral-topical dosage forms for delivering antibacterials/antibiotics to oral cavity to eradicate H. pylori as a concomitant treatment for peptic ulcers and other gastro-intestinal diseases
US6372784B1 (en) 1995-02-07 2002-04-16 Josman Laboratories, Inc. Bismuth-containing compounds in topical dosage forms for treatment of corneal and dermal wounds
CA2219758A1 (en) * 1995-05-09 1996-11-14 Jamesina Anne Fitzgerald Compositions comprising bismuth and one or more antimicrobials, for the treatment and prevention of gastrointestinal disorders
US5744168A (en) * 1995-12-07 1998-04-28 The Procter & Gamble Company Methods and compositions for the prevention and treatment of gastrointestinal disorders
US5702729A (en) * 1995-12-07 1997-12-30 The Procter & Gamble Company Methods for the prevention and treatment of gastrointestinal disorders caused or mediated by algae or cyanobacteria
US6051604A (en) * 1995-12-07 2000-04-18 The Proctor & Gamble Company Methods and compositions for the prevention and treatment of gastrointestinal disorders
AUPS088702A0 (en) 2002-03-04 2002-03-28 Borody, Thomas Julius Electrolyte purgative
MX355760B (en) 2010-12-13 2018-04-27 Salix Pharmaceuticals Inc Gastric and colonic formulations and methods for making and using them.
PT2877163T (en) 2012-07-27 2019-05-24 Redhill Biopharma Ltd Formulations and methods of manufacturing formulations for use in colonic evacuation

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FR2053002A1 (en) * 1969-06-21 1971-04-16 Clin Midy Bismuth slats of alpha methiminobenzyl - penicillin
AU440535B2 (en) * 1969-12-18 1973-09-17 Export Drugs Company Antacid compositions
AU563692B2 (en) * 1981-09-22 1987-07-16 Brocades Pharma B.V. Bismuth containing composition and method for the preparationthereof

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Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2053002A1 (en) * 1969-06-21 1971-04-16 Clin Midy Bismuth slats of alpha methiminobenzyl - penicillin
AU440535B2 (en) * 1969-12-18 1973-09-17 Export Drugs Company Antacid compositions
AU563692B2 (en) * 1981-09-22 1987-07-16 Brocades Pharma B.V. Bismuth containing composition and method for the preparationthereof

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU621285B2 (en) * 1987-03-09 1992-03-12 Procter & Gamble Company, The Compositions and methods for treating gastrointestinal disorders

Also Published As

Publication number Publication date
EP0222834A4 (en) 1989-10-04
JPS62502967A (en) 1987-11-26
AU5902686A (en) 1986-11-05
EP0222834A1 (en) 1987-05-27
SG72632A1 (en) 2000-05-23
WO1986005981A1 (en) 1986-10-23

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