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WO2012010701A1 - Composition for the treatment of botulism - Google Patents

Composition for the treatment of botulism Download PDF

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Publication number
WO2012010701A1
WO2012010701A1 PCT/EP2011/062667 EP2011062667W WO2012010701A1 WO 2012010701 A1 WO2012010701 A1 WO 2012010701A1 EP 2011062667 W EP2011062667 W EP 2011062667W WO 2012010701 A1 WO2012010701 A1 WO 2012010701A1
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Prior art keywords
composition
animal
copper sulphate
antibiotic
botulism
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PCT/EP2011/062667
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French (fr)
Inventor
William Taylor
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    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/34—Copper; Compounds thereof
    • 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

Definitions

  • composition for the treatment of botulism Composition for the treatment of botulism
  • This invention relates to a composition comprising copper sulphate for use in the treatment of botulism. Also disclosed are methods of treating an animal, optionally a bovine animal, suffering from botulism.
  • Copper sulphate has previously been used by agricultural farmers as a treatment to kill lice and put a shine on the coat of bovine animals. Copper sulphate is also thought to have an effect in the treatment of ringworm.
  • composition comprising copper sulphate for use in the treatment of botulism.
  • the use comprises the administration of a pharmacologically effective amount of copper sulphate to an animal, optionally a bovine animal, suffering from botulism.
  • a method of treating botulism comprising the step of administering a pharmacologically effective amount of a composition comprising copper sulphate to an animal, optionally a bovine animal, suffering from botulism.
  • the copper sulphate is used in combination with one or more antibiotics.
  • the copper sulphate is administered orally.
  • the composition comprises copper sulphate and at least one antibiotic.
  • the at least one antibiotic is an antibiotic comprising a beta-lactam ring.
  • the at least one antibiotic is selected from penicillin, streptomycin, and amoxicillin, although combinations of the same may be preferred.
  • the antibiotic is administered by injection into the muscle, although the skilled person may select the most appropriate route of administration, depending on the at least one antibiotic selected.
  • penicillin functions as an antibiotic by interfering with the cell wall synthesis of bacteria, leading to rupture of the cell. Although it may be effective in the destruction of Clostridium botulinum cells, it is not thought to react in any way with the neurotoxins produced by this organism, and should have no discernable effects on the development of botulism in cattle.
  • the amount of the at least one antibiotic administered may be selected by one skilled in the art.
  • the at least one antibiotic optionally penicillin
  • penicillin is administered in an amount of 7.5 - 12.5 milligrams (mg) per kilogramme body weight of the animal, optionally daily.
  • penicillin is administered in an amount of 7.5 - 12.5 mg per kilogramme body weight of the animal, optionally daily.
  • amoxicillin is administered in an amount of 7.5 - 12.5 mg per kilogramme body weight of the animal, optionally daily.
  • penicillin and streptomycin are administered in a total amount 7.5 - 12.5 mg per kilogramme body weight of the animal and amoxicillin is administered in an amount of 7.5 - 12.5 mg per kilogramme body weight of the animal, optionally daily.
  • the amount of the copper sulphate administered may range from 0.5 to 15g depending on the weight of the animal; optionally, with an amount of about 5g being appropriate for a 400-400Kg animal.
  • the copper sulphate is administered in an amount of 1 .25 microgrammes ⁇ g) - 37.5 ⁇ g per kilogramme body weight of the animal. Further optionally, the copper sulphate is administered in an amount ranging from 12.5 ⁇ g - 25.0 ⁇ g per kilogramme body weight of the animal.
  • the animals treated are bovine, more preferable, cattle such as bulls and cows.
  • the animals are humans.
  • the copper sulphate may be administered separately, sequentially or simultaneously with one or more antibiotics.
  • the use comprises the simultaneous administration of copper sulphate and the at least one antibiotic.
  • the copper sulphate may be formulated with the antibiotics to form a medicament comprising copper sulphate, one or more antibiotics and optionally one or more pharmaceutically acceptable excipients, such as filler or diluents.
  • a third aspect of the present invention there is provided use of copper sulphate in the manufacture of a medicament for the treatment of botulism.
  • the medicament further comprises at least one antibiotic, optionally selected from penicillin, streptomycin, and amoxicillin.
  • the composition may be formulated in solid or liquid dosage form.
  • a liquid dosage form for injection may be optional, although solid dosage forms for oral administration are also desirable.
  • composition comprising copper sulphate for use in the treatment of Escherichia coli infection.
  • the use comprises the administration of a pharmacologically effective amount of copper sulphate to an animal, optionally a bovine animal, suffering from Escherichia coli infection. Accordingly to a fifth aspect of the present invention there is provided a method of treating
  • Escherichia coli infection the method comprising the step of administering a pharmacologically effective amount of a composition comprising copper sulphate to an animal, optionally a bovine animal, suffering from Escherichia coli infection.
  • Comparative Example 1 [0014] During the summer of 2004, the Taylor's had rented a near neighbouring farm to graze their cattle. A group of 8 animals were diagnosed by a veterinary professional as suffering from botulism. The animals were Holstein Heifers of about 18 months of age, which were grazing in an area adjacent an area, wherein poultry litter, a known source of Clostridium botulinum, was spread as a fertilizer. The group were administered an antibiotic (penicillin) on a regular basis, in a dose as determined by the veterinary professional. In all, a total of seven animals died within a very short period of time, reflecting the vicious course of the disease. One animal survived. These results suggest that treatment of penicillin alone is not sufficient to treat botulism in cattle.
  • Example 1 In the winter of 2009, one of the hardest winters of recent records, an animal from the same herd of cattle as described in Comparative Example 1 (a young Charolais bull) that had not been outside since the previous summer went off his feet. The animal had been on a diet of a
  • the second animal went down with the same symptoms.
  • the second animal was a Holstein Bull from the same herd of cattle as described in Comparative Example 1 , and was separated from the herd of cattle and put along with the first animal. Botulism was suspected by the agricultural farmer and the veterinary professional called.
  • the veterinary professional examined the first animal externally and internally, revealing that the gut of the animal was ceasing to function properly, and determined that the improper function was a consequence of suspected botulism. The veterinary professional called for a second opinion and botulism was confirmed.
  • Amoxicillin (20ml at 150 mg/ml) was administered to both animals (together with something to kick start the stomach of the first animal) - a pale yellow to brown sterile solution for injection containing four members of the B-complex vitamins together with vitamin C.
  • Both animals were also administered an additional dose (20ml) of penicillin/streptomycin (250 mg/ml), which equated to approximately 5g of penicillin/streptomycin, and an additional dose (20ml) of amoxicillin (150 mg/ml), which equated to 3g, was given together daily.
  • penicillin/streptomycin 250 mg/ml
  • amoxicillin 150 mg/ml
  • Penstrep is a combination antibiotic of penicillin and streptomycin.
  • Penicillin:streptomycin pen:strep
  • pen:strep is a composition comprising penicillin and streptomycin for use in treating a wide variety of Gram-positive and Gram-negative bacterial infections. It has no activity against fungi. This product is useful both as a preventive agent and as a treatment for bacterially contaminated cultures.
  • Clamoxil is amoxicillin (a member of the penicillin family) - a broad-spectrum semi-synthetic antibiotic having resistance to gastric acid, thereby permitting higher serum levels with oral administration.

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

Abstract

This invention relates to a composition comprising copper sulphate for use in the treatment of botulism. Also disclosed are methods of treating an animal, optionally a bovine animal, suffering from botulism, the method comprising the step of administering a pharmacologically effective amount of a composition comprising copper sulphate to an animal suffering from botulism.

Description

Composition for the treatment of botulism
[0001 ] This invention relates to a composition comprising copper sulphate for use in the treatment of botulism. Also disclosed are methods of treating an animal, optionally a bovine animal, suffering from botulism.
Background
[0002] The prior art teaches that there are no specific treatments for botulism, only supportive treatments. These supportive treatments typically comprise a medical professional, for example a veterinary professional, administering an antibiotic, for example penicillin, to an animal suffering from botulism.
[0003] Copper sulphate has previously been used by agricultural farmers as a treatment to kill lice and put a shine on the coat of bovine animals. Copper sulphate is also thought to have an effect in the treatment of ringworm.
Brief Summary of the Disclosure [0004] In accordance with a first aspect of the present invention, there is provided a composition comprising copper sulphate for use in the treatment of botulism.
Optionally, the use comprises the administration of a pharmacologically effective amount of copper sulphate to an animal, optionally a bovine animal, suffering from botulism.
Accordingly to a second aspect of the present invention there is provided a method of treating botulism, the method comprising the step of administering a pharmacologically effective amount of a composition comprising copper sulphate to an animal, optionally a bovine animal, suffering from botulism.
[0005] Preferably, the copper sulphate is used in combination with one or more antibiotics.
Preferably the copper sulphate is administered orally. Optionally, the composition comprises copper sulphate and at least one antibiotic. Preferably, the at least one antibiotic is an antibiotic comprising a beta-lactam ring.
[0006] Preferably the at least one antibiotic is selected from penicillin, streptomycin, and amoxicillin, although combinations of the same may be preferred. Preferably the antibiotic is administered by injection into the muscle, although the skilled person may select the most appropriate route of administration, depending on the at least one antibiotic selected. Without being bound by theory, it is thought that penicillin functions as an antibiotic by interfering with the cell wall synthesis of bacteria, leading to rupture of the cell. Although it may be effective in the destruction of Clostridium botulinum cells, it is not thought to react in any way with the neurotoxins produced by this organism, and should have no discernable effects on the development of botulism in cattle.
[0007] Doses of the antibiotics will be those prescribed routinely. The amount of the at least one antibiotic administered may be selected by one skilled in the art. Optionally, the at least one antibiotic, optionally penicillin, is administered in an amount of 7.5 - 12.5 milligrams (mg) per kilogramme body weight of the animal, optionally daily. Further optionally, penicillin is administered in an amount of 7.5 - 12.5 mg per kilogramme body weight of the animal, optionally daily. Still further optionally, amoxicillin is administered in an amount of 7.5 - 12.5 mg per kilogramme body weight of the animal, optionally daily. Alternatively, penicillin and streptomycin are administered in a total amount 7.5 - 12.5 mg per kilogramme body weight of the animal and amoxicillin is administered in an amount of 7.5 - 12.5 mg per kilogramme body weight of the animal, optionally daily.
The amount of the copper sulphate administered may range from 0.5 to 15g depending on the weight of the animal; optionally, with an amount of about 5g being appropriate for a 400-400Kg animal. Optionally, the copper sulphate is administered in an amount of 1 .25 microgrammes ^g) - 37.5 μg per kilogramme body weight of the animal. Further optionally, the copper sulphate is administered in an amount ranging from 12.5 μg - 25.0 μg per kilogramme body weight of the animal.
[0008] Preferably, the animals treated are bovine, more preferable, cattle such as bulls and cows. Alternatively, the animals are humans.
[0009] In one embodiment the copper sulphate may be administered separately, sequentially or simultaneously with one or more antibiotics. Optionally, the use comprises the simultaneous administration of copper sulphate and the at least one antibiotic.
[0010] In another embodiment the copper sulphate may be formulated with the antibiotics to form a medicament comprising copper sulphate, one or more antibiotics and optionally one or more pharmaceutically acceptable excipients, such as filler or diluents. According to a third aspect of the present invention there is provided use of copper sulphate in the manufacture of a medicament for the treatment of botulism.
Optionally, the medicament further comprises at least one antibiotic, optionally selected from penicillin, streptomycin, and amoxicillin. [001 1 ] The composition may be formulated in solid or liquid dosage form. A liquid dosage form for injection may be optional, although solid dosage forms for oral administration are also desirable.
In accordance with a fourth aspect of the present invention, there is provided a composition comprising copper sulphate for use in the treatment of Escherichia coli infection.
Optionally, the use comprises the administration of a pharmacologically effective amount of copper sulphate to an animal, optionally a bovine animal, suffering from Escherichia coli infection. Accordingly to a fifth aspect of the present invention there is provided a method of treating
Escherichia coli infection, the method comprising the step of administering a pharmacologically effective amount of a composition comprising copper sulphate to an animal, optionally a bovine animal, suffering from Escherichia coli infection. [0012] An embodiment of the invention is further described hereinafter with reference to the accompanying Example and Comparative Examples.
Detailed Description [0013] The role that copper sulphate alone, or in combination with one or more antibiotics, plays in the treatment of botulism in cattle is supported by the following Example and Comparative Examples:
Comparative Example 1 [0014] During the summer of 2004, the Taylor's had rented a near neighbouring farm to graze their cattle. A group of 8 animals were diagnosed by a veterinary professional as suffering from botulism. The animals were Holstein Heifers of about 18 months of age, which were grazing in an area adjacent an area, wherein poultry litter, a known source of Clostridium botulinum, was spread as a fertilizer. The group were administered an antibiotic (penicillin) on a regular basis, in a dose as determined by the veterinary professional. In all, a total of seven animals died within a very short period of time, reflecting the vicious course of the disease. One animal survived. These results suggest that treatment of penicillin alone is not sufficient to treat botulism in cattle.
Comparative Example 2
[0015] In the summer of 2005, seventy Holstein dairy cows went down with Botulism. The veterinary professional administered penicillin, but despite this, all of the animals died. Again, these results suggest that treatment of penicillin alone is not sufficient to treat botulism in cattle.
Example 1 [0016] In the winter of 2009, one of the hardest winters of recent records, an animal from the same herd of cattle as described in Comparative Example 1 (a young Charolais bull) that had not been outside since the previous summer went off his feet. The animal had been on a diet of a
commercially available compound mix of high protein concentrates, with ad libitum straw to provide fibre.
[0017] It was not initially considered by the agricultural farmer whether that the animal may have contracted botulism and the animal was separated from the herd of cattle and housed on a straw bed where it lay off its feet. Penicillin was administered daily for 48 hours.
Subsequently, a second animal went down with the same symptoms. The second animal was a Holstein Bull from the same herd of cattle as described in Comparative Example 1 , and was separated from the herd of cattle and put along with the first animal. Botulism was suspected by the agricultural farmer and the veterinary professional called.
[0018] The veterinary professional examined the first animal externally and internally, revealing that the gut of the animal was ceasing to function properly, and determined that the improper function was a consequence of suspected botulism. The veterinary professional called for a second opinion and botulism was confirmed. Amoxicillin (20ml at 150 mg/ml) was administered to both animals (together with something to kick start the stomach of the first animal) - a pale yellow to brown sterile solution for injection containing four members of the B-complex vitamins together with vitamin C.
[0019] Both animals were also administered an additional dose (20ml) of penicillin/streptomycin (250 mg/ml), which equated to approximately 5g of penicillin/streptomycin, and an additional dose (20ml) of amoxicillin (150 mg/ml), which equated to 3g, was given together daily.
Both animals were also administered 5.0 - 7.5g of copper sulphate (Blue Stone) crystals.
[0020] Subsequently, a daily dose of 20ml of penicillin was given, and 10 days later the second animal returned to his feet. 30 days later, the first animal eventually returned to his feet.
[0021 ] The fact that both animals recovered was surprising. That the first animal took longer to recover than the second may be due to:
1 . The delay (2 days) in the administration of the copper sulphate; and
2. His condition - he had a 'hole in his hip' caused by a difficult birth. This made it more difficult for him to get to his feet to regain his strength after lying for so long.
[0022] The results of the respective incidence of botulism, the treatment and the outcomes of the Example and Comparative Examples are set out in Table 1 below:
[0023] Table 1
Figure imgf000006_0001
[0024] Penstrep is a combination antibiotic of penicillin and streptomycin. Penicillin:streptomycin (pen:strep) is a composition comprising penicillin and streptomycin for use in treating a wide variety of Gram-positive and Gram-negative bacterial infections. It has no activity against fungi. This product is useful both as a preventive agent and as a treatment for bacterially contaminated cultures.
Clamoxil is amoxicillin (a member of the penicillin family) - a broad-spectrum semi-synthetic antibiotic having resistance to gastric acid, thereby permitting higher serum levels with oral administration. Conclusions
[0025] Whilst the supporting data is circumstantial, it is considered credible that the copper sulphate (either alone or in combination with the antibiotics) has contributed to the survival of the animals, against all expectation. Normally a survival rate of about 1 in 10 may be expected.

Claims

Claims
A composition comprising copper sulphate for use in the treatment of botulism.
A composition for use according to Claim 1 , wherein the use comprises the administration of a pharmacologically effective amount of copper sulphate to an animal suffering from botulism.
A method of treating botulism, the method comprising the step of administering a pharmacologically effective amount of a composition comprising copper sulphate to an animal suffering from botulism.
A composition for use according to Claim 1 or 2, or a method according to Claim 3, wherein the composition comprises copper sulphate and at least one antibiotic.
A composition for use according to Claim 4, or a method according to Claim 4, wherein the at least one antibiotic is an antibiotic comprising a beta-lactam ring.
A composition for use according to Claim 4, or a method according to Claim 4, wherein the at least one antibiotic is selected from penicillin, streptomycin, amoxicillin, and a combination thereof.
A composition for use according to any one of Claims 4-6, or a method according to any one of Claims 4-6, wherein the at least one antibiotic is administered in an amount of 7.5 - 12.5 mg per kilogramme body weight of the animal, optionally daily.
A composition for use according to Claim 7, or a method according to Claim 7, wherein the at least one antibiotic is penicillin and is administered in an amount of 7.5 - 12.5 mg per kilogramme body weight of the animal, optionally daily.
A composition for use according to Claim 7, or a method according to Claim 7, wherein the at least one antibiotic is amoxicillin and is administered in an amount of 7.5 - 12.5 mg per kilogramme body weight of the animal, optionally daily.
10. A composition for use according to Claim 8 or 9, or a method according to Claim 8 or 9, wherein the at least one antibiotic further comprises penicillin and streptomycin, administered in a total amount of 7.5 - 12.5 mg per kilogramme body weight of the animal, optionally daily.
1 1 . A composition for use according to any one of Claims 1 , 2, and 4-10, or a method according to any one of Claims 3-10, wherein the copper sulphate is administered in an amount ranging from 2.5 μg - 37.5 μg per kilogramme body weight of the animal.
12. A composition for use according to Claim 1 1 , or a method according to Claim 1 1 , wherein the copper sulphate is administered in an amount ranging from 12.5 μg - 25.0 μg per kilogramme body weight of the animal.
13. A composition for use according to any one of Claims 1 , 2, and 4-12, or a method according to any one of Claims 3-12, wherein the animal is a bovine animal.
14. A composition for use according to any one of Claims 1 , 2, and 4-12, or a method according to any one of Claims 3-12, wherein the animal is a human.
15. A composition for use according to any one of Claims 4-12, or a method according to any one of Claims 4-12, wherein the copper sulphate is administered separately, sequentially, or simultaneously with the at least one antibiotic.
16. Use of copper sulphate in the manufacture of a medicament for the treatment of botulism.
17. Use according to Claim 16, wherein the medicament further comprises at least one
antibiotic, optionally selected from penicillin, streptomycin, and amoxicillin.
18. A composition comprising copper sulphate for use in the treatment of Escherichia coli
infection.
19. A composition according to Claim 18, wherein the use comprises the administration of a pharmacologically effective amount of copper sulphate to an animal suffering from
Escherichia coli infection.
20. A method of treating Escherichia coli infection, the method comprising the step of
administering a pharmacologically effective amount of a composition comprising copper sulphate to an animal suffering from Escherichia coli infection.
PCT/EP2011/062667 2010-07-22 2011-07-22 Composition for the treatment of botulism Ceased WO2012010701A1 (en)

Applications Claiming Priority (2)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002102352A1 (en) * 2001-06-15 2002-12-27 Forty Eight Shelf (80) Limited Composition for the treatment of diseases which affect animals' hooves
WO2008068533A2 (en) * 2006-12-06 2008-06-12 Nature Therapeutics Limited Antimicrobial composition

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002102352A1 (en) * 2001-06-15 2002-12-27 Forty Eight Shelf (80) Limited Composition for the treatment of diseases which affect animals' hooves
WO2008068533A2 (en) * 2006-12-06 2008-06-12 Nature Therapeutics Limited Antimicrobial composition

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
XIA M S ET AL: "Effects of copper bearing montmorillonite on the growth performance, intestinal microflora and morphology of weanling pigs", ANIMAL FEED SCIENCE AND TECHNOLOGY, ELSEVIER, vol. 118, no. 3-4, 4 February 2005 (2005-02-04), pages 307 - 317, XP004917684, ISSN: 0377-8401, DOI: 10.1016/J.ANIFEEDSCI.2004.11.008 *

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