Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Patent
1993-12-14
1996-09-24
Weimar, Elizabeth C.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
514 2, 514 9, 514 11, A61K 3800, A61K 3114
Patent
active
055590969
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to pharmaceutical compositions of antimicrobial agents active against Helicobacter pylori and their use in the treatment of gastrointestinal disorders associated with Helicobacter pylori infection.
Helicobacter pylori (formerly known as Campylobacter pyloridis) is a spiral-shaped Gram-negative organism which appears to live beneath the mucus layer of the stomach. Many recent studies have shown an association between the presence of H. pylori in the gastric mucosa and histologically confirmed gastritis.
In the light of these results, it has been suggested that the organism may be a pathogen which causes, or at least exacerbates, gastritis, and may also be important in the aetiology of peptic triceration. Reviews on the state of the art include those by C.A.M. McNulty in J. Infection, 1986, 13, 107-113, and by C. S. Goodwin et al. in J. Clin. Pathol., 1986, 39, 353-365.
H.pylori is known to be susceptible to a large number of antimicrobial agents in vitro. Furthermore, several workers have shown that treatment of gastritis with antimicrobial agents, for example .beta.-lactam antibiotics such as amoxycillin, or bismuth salts, leads to eradication of the associated H.pylori organism in vivo.
Bacteriocins are peptide antimicrobial agents defined as proteinaceous substances produced by bacteria which have antimicrobial activity only against species closely related to the species of origin.
An example of a bacteriocin which has found commercial application is nisin. Nisin is a lanthocin comprising the atypical amino acid lanthionine. Nisin is a polypeptide having antibacterial properties which is produced naturally by various strains of the bacterium Streptococcus lactis. It is found at low concentration in milk and cheese. It is used as a food preservative to inhibit the outgrowth of spores of certain species of Gram positive bacteria. See U.S. Pat. Nos. 5,584,199 and 4,597,972 (Taylor). Nisin is recognised by the FDA as a direct food ingredient. It is considered non-toxic and non-allergenic to humans and, as a proteinaceous material, any residues in ingested foods are quickly degraded by digestive enzymes. A summary of nisin's properties is to be found in Advances in Applied Microbiology, 27, 85-123, (1981).
Recently, a purified form of nisin has been made available by Applied Microbiology Inc. under the trade name AMBICIN N. It has been suggested for use in a variety of applications, for example for use in oral care.
Nisin, in common with other bacteriocin antimicrobial agents, is generally regarded as ineffective against Gram negative bacteria, other than in the presence of non-bacterial enhancers such as chelating agents and surfactants. See PCT Publication No. WO 89/12399 (Blackburn).
Surprisingly, it has now been found that the group of bacteriocin peptide antimicrobial agents is efficacious in the in vitro eradication of the Gram negative organism Helicobacter pylori and therefore has potential utility in the treatment of H.pylori mediated gastric disorders in mammals.
Accordingly, the present invention provides the use of a bacteriocin antimicrobial agent for the manufacture of a medicament for the treatment of gastric disorders associated with H.pylori.
Suitable bacteriocin antimicrobial agents include nisin, gramicidin and tyrothricin including derivatives and purified forms of bacteriocins such as Ambicin N.
The invention also includes a method of treatment of gastric disorders associated with Helicobacter pylori in mammals which method comprises the administration to a mammal in need of treatment of an effective amount of a bacteriocin antimicrobial agent.
A pharmaceutical composition for use in the treatment of gastric disorders associated with Helicobacter pylori, comprising a bacteriocin antimicrobial agent and a pharmaceutically acceptable carrier also forms part of the present invention.
It has been found that treatment of H. pylori associated gastritis with antimicrobial agents given by a conventional oral dosing regimen may require a prolonged course of therapy to
REFERENCES:
patent: 4615697 (1986-10-01), Robinson
patent: 4980163 (1990-12-01), Blackburn et al.
patent: 5304540 (1994-04-01), Blackburn et al.
patent: 5334582 (1994-08-01), Blackburn et al.
Edwards Peter J.
Morwood Kim
Applied Microbiology, Inc.
Touzeau P. Lynn
Weimar Elizabeth C.
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