Drug – bio-affecting and body treating compositions – Inorganic active ingredient containing – Heavy metal or compound thereof
Patent
1990-06-12
1993-03-23
Waddell, Frederick E.
Drug, bio-affecting and body treating compositions
Inorganic active ingredient containing
Heavy metal or compound thereof
514154, 514199, 514398, 514925, A01N 5916, A01N 3718, A01N 1350, A61K 3143
Patent
active
051962055
DESCRIPTION:
BRIEF SUMMARY
TECHNICAL FIELD
This invention relates to pharmaceutical compositions and therapeutic methods for eradication and/or prevention of recurrence of gastrointestinal disorders associated with infection by Campylobacter pylori
BACKGROUND ART
C. pylori is a recently described bacterium found to cause chronic histological gastritis. Its causal role in peptic ulceration is less clear and even less so in non-ulcer dyspepsia. Its role could be more effectively studied if effective therapy for its eradication were devised.
Until recent times, C. pylori has been found to be difficult to eradicate using known chemotherapeutic agents. Although many antibiotics can suppress C. pylori growth in vitro, in vivo the mucosal concentration appears to be inadequate and penetration of the usual gastric mucus layer poor. Hence, development of an adequate in vivo eradication method for chronic C. pylori infection has been difficult. Moreover, adequate prediction of in vivo results cannot be predicted from in vitro work.
European Patent Application No. 206,625 and Australian Patent Application No. 59026/86 describe the use of bismuth together with a single antibiotic for the treatment of C. pylori. However, bismuth alone achieves low (30 to 70%) initial clearance rates for C. pylori and recurrence of the infection approaches 100% by twelve months post therapy. Bismuth together with a single antibiotic, namely amoxicillin, appears to be relatively effective as a short term means of reducing the symptoms but it is now clear that the use of bismuth together with a single antibiotic frequently fails to eradicate the infection and has a high rate of infection recurrence (Rauws, Erik A. J. et al: Gastro-enterology, 1988; 94: 33-40).
DISCLOSURE OF THE INVENTION
The present inventor has now found that the use of a multi antibiotic therapy not only results in a high initial clearance rate of C. pylori, of the order of greater than 90%, but also leads to a high eradication rate where most patients remain free of infection for more than twelve to eighteen months. It now seems that therapeutic success measured at eight weeks biopsy (post treatment) should be termed as clearance only whilst the term "eradication" should be used in the context of patients who remain free of C. pylori infection for more than twelve months post treatment.
The present inventor has also found that C. pylori is not only associated with gastritis but is also casually associated with peptic ulcer including duodenal, pre-pyloric, gastric, oesophageal and marginal ulcer and consequently the novel therapy for eradication of C. pylori described in the present invention is useful in the treatment of peptic ulcer as well as non-ulcer dyspepsia. Moreover, the novel therapy of the present invention is useful in the treatment of oesophageal reflux, reflux oesophagitis as well as asymptomatic carrier states.
In one broad form the present invention provides a pharmaceutical composition for the treatment of gastro intestinal disorders associated with C. pylori infections comprising a pharmaceutically acceptable bismuth compound, a first antibiotic or antimicrobial agent and a second antibiotic or antimicrobial agent.
In a further form the invention provides a sequential pack comprising a first pharmaceutical composition in unit dosage form adapted and presented in said pack for a first administration period of 3 to 36 days, said first composition comprising a pharmaceutically acceptable bismuth compound and a first antibiotic or antimicrobial agent together with a second pharmaceutical composition comprising a second antibiotic or antimicrobial agent in unit dosage form adapted and presented in said pack for a second administration period different from said first administration period.
The invention also provides a sequential pack for the administration of at least two pharmaceutical compositions comprising a first composition which comprises a pharmaceutically acceptable bismuth compound, a first antibiotic or antimicrobial agent and a second antibiotic or antimicrobial a
REFERENCES:
patent: 4935406 (1990-06-01), Coleman
Lambert, J. R., et al., Colonization of Gnotobiotic Piglets with Gampylobacter Pyloridis, Gastroenterology 92, 1489 (May 1987).
Borsch, G., et al., Gastroenterology, vol. 94, No. 5, part 2, A44 (May 1988).
Borody, T., et al., Gastroenterology, vol. 94, No. 5, Part 2, A43 (May 1988).
Lambert, J. R., et al., Effect of Colloidal Bismuth (DE-Nol) on Healing and Relapse of Duodenal Ulcers--Role of Campylobacter Pyloridis, Gastroenterology 92, 1489 (May 1987).
Borody, T. J. et al., The Medical Journal of Australia, vol. 146, pp. 450-451 Apr. 20, 1987.
Blaser, M. J., et al., The New England Journal of Medicine, 1444-1452 Dec. 10, 1981.
Marshall, B. J., et al., The Medical Journal of Australia, vol. 142, 439-444 Apr. 15, 1985.
McNulty, C. A. M., et al., The Lancet, 1068 May 12, 1984.
Marhsall, B. J., et al., The Lancet 1311-1315 Jun. 16, 1984.
Marshall, B. J., et al., The Lancet, 281 Aug. 4, 1984.
Koo, J. Ho, et al., Gastroenterology, 864-870 May 1982.
Steinhoff, M. C., et al., Gastroenterology, 78(6), 1495-1499 Jun. 1980.
McNulty, C. A. M., et al, British Medical Journal, 293, 645-649 Sep. 13, 1986.
The Lancet, Jun. 7, 1986, pp. 1306-1307.
Hislop, I., et al, Gastroenterological Society of Australia, Dec. 1984, p. 907.
Walan, A., Non-Ulcer Dyspensia, Proceedings of a Symposium Held in Stockholm, Nov. 6/7, 1981, cover contents, preface pages.
Misiewicz, J. J., et al, Diseases of the Gut and Pancreas, 1987, Chapter by J. R. Bennet, p. 16.
Misiewicz, J. J., et al, Diseases of the Gut and Pancreas, 1987, chapter by La Brooy, S. J., p. 239.
Romaniuk, P. J., et al, Journal of Bacteriology, 169, No. 5, May, 1987, pp. 2137-2141.
Goodwin, S., et al., C. Pylori Symposium, Keystone, Colorado., Jul. 1987, Abstract page.
American Illustrated Medical Dictionary, W. B. Saunders Company, 1951, p. 501.
Gentleman, 1951, p. 83.
Clinics in Gastroenterology, vol. 13, No. 2, May 1984, pp. 437-446 (by Lagarde, S. P. et al.).
Marshall, B. The Lancet, Jun. 4, 1983, pp. 1273-1275.
Langenberg, M. L., et al, The Lancet, Jun. 16, 1984, pp. 1348-1349.
PDR, p. 646, undated; on Pepto-Bismol.RTM..
Specialties, p. 212 (undated).
Piper, D. W., "Bacteria, gastritis, acid hyposecretion and peptic ulcer," The Medical Journal of Australia, 142, No. 8, Apr. 15, 1985, 431.
Marshall, B. J., et al., "Attempt to fulfill Koch's postulates for pyloric campylobacter," The Medical Journal of Australia, 142, No. 8, Apr. 15, 1985, 436-439.
Jones, D. M., et al Campylobacter III, Proceedings of the Third International Workshop on Campylobacter Infection, Jul. 7-10, 1985, Abstract No. 097, pp. 161-162.
Langenberg, M. L., et al, Campylobacter III, Proceedings of the Third International Workshop on Campylobacter Infection, Jul. 7-10, 1985, Abstract No. 098, pp. 162, 163.
Bartlett, J. G., Gastroenterology, 94, 229-232 (1988).
Graham, J., The Medical Journal of Australia 148, 104 Jan. 1988.
Nyren, O., et al, The New England Journal of Medicine 314, No. 6 pp. 339-342 (Feb. 1986).
Talley, N. J., J. Clin. Gastroenterol 10(1), 10-12 (1988).
Marhsall, B. J., The Journal of Infectious Diseases, vol. 153, No. 4, pp. 650-657 (Apr. 1986).
Rathbone, B. J., et al, The Lancet, p. 398 (Aug. 15, 1987).
Michel, J., et al, Antimicrobial Agents and Cheotherapy, vol. 23, No. 5, pp. 796-797 (May 1983).
McNulty, C. A. M., Antimicrobial Agents and Chemotherapy, vol. 28, No. 6, pp. 837-838 (Dec. 1985).
Kasper, G., et al, Immunitat und Infektion, vol. 14, No. 2, pp. 58-62 (Apr. 1986).
Goodwin, C. S., J. Clin. Pathol. vol. 39, pp. 353-365 (1986).
McNulty, C. A. M., et al, Campylobacter III, Proceedings of the Third International Workshop of Campylobacter Infection, Jul. 7-10, 1985, Abstract No. 099, pp. 163-164.
Marshall, B. J., et al, Campylobacter III, Proceedings of the Third International Workshop on Campylobacter Infection, Jul. 7-10, 1985, Abstract No. 100, pp. 165-166.
Lambert, J. R. Gastroenterology, 88, No. 5, p. 1462 (1985).
Axon, A. R., BMJ, vol. 302, Apr. 20, 1991, 919-921.
Axon, A.
Hook Gregory
Kananen Ronald P.
Waddell Frederick E.
LandOfFree
Method for treatment of gastro intestinal disorders does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Method for treatment of gastro intestinal disorders, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Method for treatment of gastro intestinal disorders will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-1350349