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WO1995031180A1 - Composition a usage veterinaire - Google Patents

Composition a usage veterinaire Download PDF

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Publication number
WO1995031180A1
WO1995031180A1 PCT/IE1994/000029 IE9400029W WO9531180A1 WO 1995031180 A1 WO1995031180 A1 WO 1995031180A1 IE 9400029 W IE9400029 W IE 9400029W WO 9531180 A1 WO9531180 A1 WO 9531180A1
Authority
WO
WIPO (PCT)
Prior art keywords
veterinary composition
antibiotic
gel
seal
formulation
Prior art date
Application number
PCT/IE1994/000029
Other languages
English (en)
Inventor
Owen Corrigan
James Patrick Morgan
Paul Logue
John O'leary
Original Assignee
Bimeda Research And Development Limited
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
Priority to GB9325186A priority Critical patent/GB2273443B/en
Priority to GB9325161A priority patent/GB2273441B/en
Priority to GB9325184A priority patent/GB2273655B/en
Application filed by Bimeda Research And Development Limited filed Critical Bimeda Research And Development Limited
Priority to PCT/IE1994/000029 priority patent/WO1995031180A1/fr
Priority to AU66879/94A priority patent/AU6687994A/en
Publication of WO1995031180A1 publication Critical patent/WO1995031180A1/fr

Links

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
    • A61K31/33—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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0041—Mammary glands, e.g. breasts, udder; Intramammary administration

Definitions

  • the invention relates to a veterinary composition, particularly for the prophylaxis and treatment of mastitis in cows .
  • Bacterial infection via the teats of a cow is the most common cause of mastitis.
  • One commercially available barrier system comprises a twin injector pack, one injector containing an antibiotic formulation and a second injector containing a barrier or seal formulation.
  • the antibiotic formulation comprises penicillin salts and dihydrostreptomycin which is infused into the udder following the last lactation and before the cow is dried off.
  • the seal formulation comprises a gel of aluminium stearate and liquid paraffin containing approximately 35% by weight of bismuth subnitrate. This is infused into the udder after the antibiotic formulation to seal the teat canal. This invention is therefore directed towards providing an improved veterinary composition for the prophylaxis and treatment of mastitis in dry cows.
  • a veterinary composition comprising an antibacterial formulation, and a seal formulation, the seal formulation comprising a polyethylene gel.
  • the gel is based on low density polyethylene.
  • the gel is based on high density polyethylene.
  • the gel typically includes a vehicle such as liquid paraffin.
  • a non-toxic heavy metal salt is present in the gel base.
  • the heavy metal salt is present in an amount of at least 40% by weight of the base, most preferably between 50% and 75%, especially 65% by weight.
  • the heavy metal salt is bismuth subnitrate.
  • the antibacterial agent comprises an antibiotic in the form of a substantially insoluble salt in an aqueous suspension.
  • the antibiotic agent is a substantially insoluble salt of a synthetic penicillin such as cloxacillin benzathine.
  • the antibiotic comprises cloxacillin ben ⁇ athine.
  • the antibiotic is in a micronised form having an average dimension of less than 25 ⁇ .
  • a substantial proportion of the antibiotic has an average dimension of less than lO ⁇ .
  • the composition is a unit dose.
  • the composition contain 600 mg of cloxacillin as cloxacillin benzathine.
  • the antibacterial agent is present in the gel base.
  • the antibacterial formulation and the seal formulation are separate.
  • the invention also provides a veterinary composition for use in the prophylaxis or treatment of mammary disorders in non-human animals during an animals' dry period.
  • a veterinary composition comprising a first antibiotic - containing injector (1A) and a second seal-containing injector (2A) were prepared as follows: INJECTOR 1A
  • the cloxacillin benzathine was in a micronised form having an average dimension less than 25 ⁇ with approximately 75% less than 15 ⁇ and 50% less than lO ⁇ and 85% was greater than 2 ⁇ .
  • This formulation is stable when subjected to extended storage periods in its proposed marketing container.
  • Study 2 Residues of cloxacillin in bovine colostrum following intramammary infusion of the first Injector 1A.
  • Fig. 1 is a graphic representation of the results of this study.
  • Fig. 2 is a log transformation of the results of Fig. 1.
  • Study 2 was conducted to specifically determine the end point for milk withholding. Animals were infused in each of four quarters with Injector 1A. Samples were taken every 24 hours and analysed for cloxacillin levels. Eight days after administration of the first Injector the levels of drug were below the acceptable maximum residue level for cloxacillin.
  • a veterinary composition comprising a first antibiotic-containing injector having the same formulation as Injector 1A described above and a second seal injector 2B as described below.
  • LDPE low density
  • HDPE high density
  • YV Yield value - (A measure of the relative fluidity of the gel. Low yield values indicate a more liquid gel) .
  • Irritancy of the seals was the first characteristic to be assessed as any product which was irritant would have to be rejected irrespective of its performance against the other criteria. Irritancy was measured by conducting somatic cell counts in treated and untreated quarters of lactating cows and comparing these results by measuring area under the curve ratios using the following formula:
  • AUC Ratio AUC of treated quarter AUC of untreated quarter
  • PE-LP gels have high tensile strengths for relatively low yield values.
  • the merits of these two properties were studied by X-ray analysis of various PE-LP formulations in dry cows.
  • 2B3 1 Formulation is identical to 2B3. Gel was formed using different temperature profile, leading to different yield values.
  • test formulations were infused into quarters of dry cows.
  • the effectiveness of sealing was measured by X- ray analysis.
  • % BSN recovered and the effective seal duration [ESD] were estimated.
  • a combination of seal and a non aqueous based antibiotic offers a superior combination to seal and an oily based antibiotic. This can be deduced from the fact that the ESD's for the seal/aqueous combinations were significantly better than those for oily combinations. This is further evidenced by the high BSN recoveries (>75%) for the aqueous products, indicating retention of seal in situ. In contrast the amount of bismuth found in the fluid portion at parturition was far lower for the aqueous than the oily combination. This shows that there was a larger degree of dispersal of the seal into the udder with the oily combinations.
  • polyethylene as a gelling agent in combination with heavy metal salts in a teat seal product in combination with an aqueous based antibiotic system provides a product with the desired properties as earlier outlined which should be efficacious in the treatment and prophylaxis of dry cow mastitis.
  • Bismuth subnitrate (6Bi 2 0 3 .5N 2 05.9H 2 0) is a white, slightly hydroscopic powder
  • injector type 2C may be prepared as follows:
  • polyethylene which is a pharmaceutically acceptable excipient is capable of being infused by an intramammary injector and has the described rheological properties allowing it to form a seal in situ in the teat canal, particularly in combination with heavy metal salts .

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

Produit à usage vétérinaire destiné au traitement de la mammite chez les vaches taries. Ce produit comporte, dans des injecteurs permettant l'administration par voie intramammaire, une première composition renfermant un antibiotique, et une seconde composition d'obturation. La composition renfermant un antibiotique comporte de la benzathine de cloxacilline sous forme micronisée dans une base aqueuse. La composition d'obturation comprend un sel de métal lourd, par exemple le sous-nitrate de bismuth, de préférence à raison de plus de 40 % en poids, et notamment à raison de 65 % en poids. Un gel à base de polyéthylène de basse densité ou de haute densité est utilisé dans la composition d'obturation.
PCT/IE1994/000029 1992-12-08 1994-05-16 Composition a usage veterinaire WO1995031180A1 (fr)

Priority Applications (5)

Application Number Priority Date Filing Date Title
GB9325186A GB2273443B (en) 1992-12-08 1993-12-08 Veterinary composition for the treatment of mastitis
GB9325161A GB2273441B (en) 1992-12-08 1993-12-08 Veterinary compositions for treating mastitis
GB9325184A GB2273655B (en) 1992-12-08 1993-12-08 Veterinary compositions for the treatment of mastitis
PCT/IE1994/000029 WO1995031180A1 (fr) 1992-12-08 1994-05-16 Composition a usage veterinaire
AU66879/94A AU6687994A (en) 1992-12-08 1994-05-16 A veterinary composition

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IE922872 1992-12-08
PCT/IE1994/000029 WO1995031180A1 (fr) 1992-12-08 1994-05-16 Composition a usage veterinaire

Publications (1)

Publication Number Publication Date
WO1995031180A1 true WO1995031180A1 (fr) 1995-11-23

Family

ID=26319533

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IE1994/000029 WO1995031180A1 (fr) 1992-12-08 1994-05-16 Composition a usage veterinaire

Country Status (1)

Country Link
WO (1) WO1995031180A1 (fr)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005072644A1 (fr) 2004-02-02 2005-08-11 Bimeda Research & Development Limited Procede et dispositif de traitement du canal du trayon d'un animal
US7842791B2 (en) 2002-12-19 2010-11-30 Nancy Jean Britten Dispersible pharmaceutical compositions
CN102058612A (zh) * 2011-01-06 2011-05-18 河南亚卫动物药业有限公司 一种兽用复方乳浊液及其制备方法
EP2344168A1 (fr) 2008-09-17 2011-07-20 Mastitis Research Centre Limited Formulation anti-infection et procédés d'utilisation correspondants
US8758831B2 (en) 1996-12-18 2014-06-24 Bimeda Research & Development Limited Antiinfective free intramammary veterinary composition
US9180249B2 (en) 2004-02-02 2015-11-10 Bimeda Research & Development Limited Method and device
US9694134B2 (en) 2013-09-16 2017-07-04 Zoetis Services Llc Assembly for sequentially delivering substances, and associated methods
RU2698820C1 (ru) * 2019-04-29 2019-08-30 Общество с ограниченной ответственностью научно-производственное предприятие "Агрофарм" (ООО НПП "Агрофарм") Препарат для лечения мастита у коров в период лактации

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2273441A (en) * 1992-12-08 1994-06-22 Bimeda Res Dev Ltd Veterinary composition for treating mastitis

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2273441A (en) * 1992-12-08 1994-06-22 Bimeda Res Dev Ltd Veterinary composition for treating mastitis

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8758831B2 (en) 1996-12-18 2014-06-24 Bimeda Research & Development Limited Antiinfective free intramammary veterinary composition
US7842791B2 (en) 2002-12-19 2010-11-30 Nancy Jean Britten Dispersible pharmaceutical compositions
EP2962660A1 (fr) 2004-02-02 2016-01-06 Bimeda Research & Development Limited Dispositif de traitement d'un canal du trayon d'un animal
US8353877B2 (en) 2004-02-02 2013-01-15 Bimeda Research & Development Limited Method for administering two components into the teat canal of a non-human animal
US7828765B2 (en) 2004-02-02 2010-11-09 Bimeda Research & Development Ltd Method and device for administering two components into the teat canal of a non-human animal
US9180249B2 (en) 2004-02-02 2015-11-10 Bimeda Research & Development Limited Method and device
WO2005072644A1 (fr) 2004-02-02 2005-08-11 Bimeda Research & Development Limited Procede et dispositif de traitement du canal du trayon d'un animal
EP2344168A1 (fr) 2008-09-17 2011-07-20 Mastitis Research Centre Limited Formulation anti-infection et procédés d'utilisation correspondants
AU2009304000B2 (en) * 2008-09-17 2015-08-06 Elanco New Zealand Anti-infective formulation and methods of use
AU2009304000C1 (en) * 2008-09-17 2022-04-28 Elanco New Zealand Anti-infective formulation and methods of use
CN102058612A (zh) * 2011-01-06 2011-05-18 河南亚卫动物药业有限公司 一种兽用复方乳浊液及其制备方法
US9694134B2 (en) 2013-09-16 2017-07-04 Zoetis Services Llc Assembly for sequentially delivering substances, and associated methods
RU2698820C1 (ru) * 2019-04-29 2019-08-30 Общество с ограниченной ответственностью научно-производственное предприятие "Агрофарм" (ООО НПП "Агрофарм") Препарат для лечения мастита у коров в период лактации

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