US20050187213A1 - Meloxicam for the treatment of respiratory diseases in pigs - Google Patents

Meloxicam for the treatment of respiratory diseases in pigs Download PDF

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Publication number
US20050187213A1
US20050187213A1 US11/047,920 US4792005A US2005187213A1 US 20050187213 A1 US20050187213 A1 US 20050187213A1 US 4792005 A US4792005 A US 4792005A US 2005187213 A1 US2005187213 A1 US 2005187213A1
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meloxicam
pharmaceutically acceptable
acceptable salt
disease
administered
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US11/047,920
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Ingo Lang
Ioannis Papatsas
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Boehringer Ingelheim Vetmedica GmbH
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Boehringer Ingelheim Vetmedica GmbH
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Assigned to BOEHRINGER INGELHEIM VETMEDICA GMBH reassignment BOEHRINGER INGELHEIM VETMEDICA GMBH ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: LANG, INGO, PAPATSAS, IOANNIS
Publication of US20050187213A1 publication Critical patent/US20050187213A1/en
Priority to US12/114,509 priority Critical patent/US20080280840A1/en
Priority to US14/183,744 priority patent/US20140179639A1/en
Priority to US15/908,470 priority patent/US10548901B2/en
Priority to US16/719,681 priority patent/US11083731B2/en
Abandoned legal-status Critical Current

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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
    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/5415—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with carbocyclic ring systems, e.g. phenothiazine, chlorpromazine, piroxicam
    • 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
    • A61K31/65—Tetracyclines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory 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
    • 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
    • A61P31/10—Antimycotics
    • 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
    • A61P31/12—Antivirals
    • 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
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses

Definitions

  • the invention relates to the use of meloxicam or a pharmaceutically acceptable salt thereof for preparing a pharmaceutical composition for the treatment or prevention of respiratory diseases in pigs.
  • Respiratory disease in pigs belongs to the most important health problems in swine production. Porcine respiratory disease is primarily caused by infectious agents, but environmental factors have a strong influence.
  • the relevant pathogens include mycoplasmas, bacteria, and viruses (e.g., G. Christensen, V. Sorensen, and J. Mousing, Diseases of the Respiratory System, In: Diseases of Swine, B. E. Straw, S. D'Allaire, W. L. Mengeling, & D. J. Taylor (eds), Iowa State University Press, Ames, Iowa (1999) pp. 913-940).
  • porcine respiratory disease The most important measures for the control of porcine respiratory disease are to improve herd management and housing conditions and introduce a vaccination program. However, if pigs have developed respiratory disease, they have to be treated.
  • cyclooxygenase-2 plays a relevant role in the pathophysiology of porcine pleuropneumonia caused by Actinobacillus pleuropneumoniae.
  • Isolated porcine alveolar macrophages increase their COX-2 activity after exposure to Actinobacillus pleuropneumoniae (W. S. Cho & C. Chae, In vitro Effects of Actinobacillus pleuropneumoniae on Inducible Nitric Oxide Synthase and Cyclooxygenase- 2 in Porcine Alveolar Macrophages, Am J Vet Res 64, (2003) pp. 1514-1518).
  • in situ hybridization W. S. Cho & C.
  • acetylsalicylic acid can be used for the treatment of pigs with respiratory disease.
  • aspirin acetylsalicylic acid
  • Ketoprofen and, to a lesser extent, flunixin decrease fever induced by experimental infection with Actinobacillus pleuropneumoniae (J. M. Swinkels, A. Pijpers, J. C. Vernooy, A. Van Nes, & J. H.
  • Ketoprofen was further tested in a controlled, blinded clinical field study (M. F. De Jong, O. Sampimon, J. P. Arnaud, G. Theunissen, G. Groenland, & P. J. Werf, A Clinical Study with a Non Steroid Antiinflammatory Drug, 14, (1996) 659 IPVS). In this study, ketoprofen had no effect on clinical score, relapse, or cure rate.
  • Meloxicam is a non-steroidal anti-inflammatory compound that belongs to the oxicam class and exerts potent anti-inflammatory, anti-exudative, and anti-pyretic activity.
  • the efficacy of meloxicam as an adjunctive therapy in the treatment of respiratory infections in cattle has been widely proven.
  • Recently meloxicam was approved for the treatment of MMA (A. Hirsch et al., J Vet Pharmacol Therap 26 (2003) pp. 355-360) and locomotor disorders in pigs (G. Friton et al., Berl Münch Tiermaschinemaschineschztl Wschr 116 (2003) pp. 421-426).
  • the problem underlying the present invention was to provide a medication for the prevention or treatment of respiratory diseases in pigs, one of the most important health problems in swine production.
  • meloxicam can be used for the treatment or prevention of respiratory diseases in pigs.
  • the invention relates to the use of meloxicam or a pharmaceutically acceptable salt thereof for preparing a pharmaceutical composition for the treatment or prevention of respiratory diseases in pigs.
  • the invention relates to a method of treating or preventing respiratory diseases in pigs, which method comprises administering an effective amount of meloxicam to the pigs in need thereof.
  • the invention relates to veterinary preparation containing meloxicam as well as at least one antibiotic selected from the group consisting of ⁇ -lactams, quinolones, tetracyclines, sulfonamides, fenicoles, and macrolides.
  • Another aspect of the invention is a ready-to-use two-component system for the treatment of respiratory diseases in pigs, wherein:
  • Still another aspect of the invention is an article of manufacture comprising packaging material contained within which is a composition consisting of meloxicam and a pharmaceutically acceptable carrier, and a label which indicates that the composition can be used to treat or prevent respiratory diseases in pigs.
  • FIG. 1 shows the incidence of fever (rectal temperature ⁇ 40.56° C.) in percent following the first treatment in a group of pigs treated with oxytetracycline and meloxicam ( ⁇ ), in a group of pigs treated with oxytetracycline alone ( ⁇ ), and in the untreated control ( ⁇ ).
  • FIG. 2 shows the efficacy of meloxicam in drinking water in reducing lung lesions caused by experimental Swine Influenza Virus (SIV) infection on study days 7 and 14.
  • SIV Swine Influenza Virus
  • the invention relates to the use of meloxicam or a pharmaceutically acceptable salt thereof for preparing a pharmaceutical composition in a form suitable for systemic or oral administration for the treatment or prevention of respiratory diseases in pigs.
  • Meloxicam (4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H- 1,2-benzothiazine-3-carboxamide-1,1-dioxide) of formula is an active substance which belongs to the group of NSAIDs (non-steroidal-anti-inflammatory drugs).
  • NSAIDs non-steroidal-anti-inflammatory drugs.
  • Meloxicam and the sodium and meglumine salt thereof N-methyl-D-glucamine salt
  • EP-A-0 002 482 corresponding to U.S. Pat. No. 4,233,299
  • Meloxicam may be used according to the invention in the form of a physiologically acceptable acid addition salt.
  • physiologically acceptable acid addition salts are meant, according to the invention, the meglumine, sodium, potassium, or ammonium salt, preferably the meloxicam meglumine salt.
  • the pharmaceutical composition is administered corresponding to a daily dose of meloxicam ranging from 0.01 mg/kg to 5.0 mg/kg, preferably from 0.1 mg/kg to 3.5 mg/kg, in particular from 0.2 mg/kg to 2.0 mg/kg.
  • the pharmaceutical composition is preferably administered in a form suitable for injection, in particular for intramuscular injection, or in form of water soluble granules for administration via drinking water or as top dressing on feed.
  • a suitable injection formulation is disclosed, for example, in Example 25 of EP-A-0 002 482.
  • injection solutions may additionally contain excipients selected from among citric acid, lecithin, gluconic acid, tartaric acid, phosphoric acid and EDTA or the salts thereof as disclosed in the Examples 1 to 5 of the International Patent Application WO 01/97813 (corresponding to U.S. Patent App. Pub No. 2002/0035107), each of which is hereby incorporated by reference.
  • an injection solution of meloxicam for needleless injections is disclosed in the International Patent Application WO 03/049733 (corresponding to U.S. Patent App. Pub No. 2003/0119825), each of which is hereby incorporated by reference.
  • Suitable water soluble granules for administration via drinking water or as top dressing on feed are, for example, disclosed in the International Patent Application PCT/EP03/11802 (corresponding to U.S. Patent App. Pub No. 2004/0234596), each of which is hereby incorporated by reference.
  • the meloxicam granules contain a binder which may be selected from among hydroxypropylmethylcellulose, polyvinylpyrrolidone, gelatine, starch, and polyethylene glycol ether, preferably hydroxypropylmethylcellulose, polyvinylpyrrolidone, and polyethylene glycol ether, and most preferably hydroxypropylmethylcellulose and polyvinylpyrrolidone.
  • a binder which may be selected from among hydroxypropylmethylcellulose, polyvinylpyrrolidone, gelatine, starch, and polyethylene glycol ether, preferably hydroxypropylmethylcellulose, polyvinylpyrrolidone, and polyethylene glycol ether, and most preferably hydroxypropylmethylcellulose and polyvinylpyrrolidone.
  • meloxicam granules contain a sweetener, which may be selected from among sodium saccharine, aspartame, and SUNETT® (acesulfame K), preferably sodium saccharine or aspartame.
  • a sweetener which may be selected from among sodium saccharine, aspartame, and SUNETT® (acesulfame K), preferably sodium saccharine or aspartame.
  • meloxicam granules containing a flavoring agent which may be selected from among vanilla, honey flavoring, apple flavoring, and contramarum, preferably honey flavoring and apple flavoring.
  • meloxicam granules in which the carrier is selected from among lactose, glucose, mannitol, xylitol, sucrose, and sorbitol, preferably glucose, lactose, or sorbitol, more preferably glucose or lactose, and most preferably glucose.
  • the carrier is selected from among lactose, glucose, mannitol, xylitol, sucrose, and sorbitol, preferably glucose, lactose, or sorbitol, more preferably glucose or lactose, and most preferably glucose.
  • meloxicam granules in which the content of meloxicam is between 0.05% and 4%, preferably between 0.1% and 2%, preferably between 0.3% and 1.8%, more preferably between 0.4% and 1.5%, and most preferably 1.2%. Also particularly preferred are meloxicam granules which contain meglumine and meloxicam in a molar ratio of about 9:8 to 12:8, preferably 10:8.
  • Meloxicam can be used according to the invention to treat or prevent respiratory diseases in any breed of swines.
  • pigs selected from the swine breeds American Landrace, American Yorkshire, Angeln Saddleback, Arapawa Island, Ba Xuyen, Bantu, Bazna, Beijing Black, else Black Pied, Belgian Landrace, Bentheim Black Pied, Berkshire, Black Slavonian, British Landrace, British Lop, Bulgarian White, Cantonese, Chester White, Czech Improved White, Danish Landrace, Dermantsi Pied, Duroc, Dutch Landrace, Fengjing, Finnish Landrace, French Landrace, German Landrace, Gloucestershire Old Spots, Guinea Hog, Hampshire, Hereford, Hezuo, Iberian, Italian Landrace, Jinhua, Kele, Krskopolje, Kunekune, Lacombe, Large Black, Large Black-white, Large White, Lithuanian Native, Mangalitsa, Meishan, Middle White, Minzhu, Mong Cai, Mukota
  • meloxicam is in conjunction with an antibiotic, preferably selected from the group consisting of ⁇ -lactams, quinolones, tetracyclines, sulfonamides, fenicoles, and macrolides. Most preferred are amoxicillin, oxytetracycline, florfenicol, tylosin, tilmicosin, and sulfamethazine.
  • the dose of antibiotic is not critical per se and depends strongly on the different efficacies of the antibiotics used. As a rule up to 150.0 mg/kg, preferably from 0.1 mg/kg to 120 mg/kg, in particular from 10 mg/kg to 110 mg/kg of an antibiotic are co-administered together with meloxicam.
  • Amoxicillin 5 mg/kg to 30 mg/kg, in particular about 10 mg/kg
  • Oxytetracycline 20 mg/kg to 70 mg/kg, in particular about 30 mg/kg
  • Florfenicol 10 mg/kg to 20 mg/kg, in particular about 15 mg/kg
  • Tylosin 10 mg/kg to 25 mg/kg, in particular about 16 mg/kg
  • Tilmicosin 5 mg/kg to 30 mg/kg, in particular 10 mg/kg to 20 mg/kg
  • Sulfamethazine 80 mg/kg to 150 mg/kg, in particular about 100 mg/kg.
  • co-administration in defining use of meloxicam and an antibiotic, is intended to embrace administration of each agent in a sequential manner in a regimen that will provide beneficial effects, in particular, reduction of the symptoms of the respiratory disease in the affected pig of the drug combination.
  • the phrase also is intended to embrace co-administration of these agents in a substantially simultaneous manner, such as in a single capsule or injection solution having a fixed ratio of these active agents or in multiple, separate capsules for each agent.
  • meloxicam and the antibiotic may be co-administered in a combined form, or separately or separately and sequentially wherein the sequential administration is preferably close in time.
  • the medicament according to this invention is used for the prevention or treatment of Porcine Respiratory Disease Complex in growing or fattening pigs; or for the prevention or treatment of respiratory diseases in pigs caused by mycoplasmas, in particular Mycoplasma hyopneumoniae, Mycoplasma hyorhinis, for the prevention or treatment of respiratory diseases in pigs caused by bacteria in particular Actinobacillus spp., in particular Actinobacillus pleuropneumoniae, Bordetella bronchiseptica, Pasteurella multocida, Arcanobacterium pyogenes, Streptococcus spp., and Staphylococcus spp., or for the prevention or treatment of respiratory diseases in pigs caused by viruses, in particular Swine Influenza Virus, Aujetzky's Virus, Porcine Reproductive and Respiratory Syndrome Virus, Porcine Circovirus, and Transmissible Gastroenteritis and Porcine Respiratory Coronavirus.
  • the medicament according to this invention is used for the prevention or treatment of respiratory diseases in pigs caused by Mycoplasma hyopneumoniae, Actinobacillus pleuropneumoniae, Bordetella bronchiseptica, Pasteurella multocida, Streptococcus suis, Swine Influenza Virus, and Porcine Reproductive and Respiratory Syndrome Virus.
  • the study was a controlled, randomized, and blinded exploratory study under experimental conditions with a parallel group design.
  • Crossbred pigs of about 10 weeks of age were challenged with a single intranasal inoculation of Actinobacillus pleuropneumoniae. The next day, pigs were included in the study and treated if they fulfilled the following inclusion criteria: rectal temperature ⁇ 40° C. and clinical symptoms of acute or subacute infectious respiratory disease.
  • the treatment groups were: Group Treatment 1 untreated 2 oxytetracycline 3 oxytetracycline and meloxicam
  • Meloxicam was administered as 0.5% solution, at 0.5 mg/kg daily on three consecutive days, oxytetracycline as 20% long-acting solution (OXYTET® 200) at 20 mg/kg as single injection.
  • the aim of this study was to test the efficacy of meloxicam granules dissolved in drinking water in pigs experimentally infected with Swine Influenza Virus (SIV).
  • the study was an open, negative controlled randomized laboratory study carried out according to GCP at one site.
  • the study animals were clinically examined daily on study days 0 to 7 and 14. They were weighed on study days 7 and 14. All animals of group A and 5 animals of group C were euthanized and necropsied on study day 7; the remaining study animals, group B and 5 study animals of group C, on study day 14.
  • FIG. 2 shows the quantity of lung lesions by lung lobe on study days 7 and 14.
  • meloxicam-treated pigs reached significantly higher weight gains during the two weeks following infection than untreated controls.
  • Mean daily weight gain in the interval study day 0 to 7 was 557 g in meloxicam group A and 257 g in the control (5 study animals of group C).
  • mean daily weight gain was 629 g in meloxicam group B and 486 g in the control (5 study animals of group C).
  • Growth performance data for each group included the Average Daily Gain (ADG) for the following trial periods: d90 to d117, d117 to d170 (slaughtering), and d90 to d170 of age. Mortality was also calculated for these time periods. Slaughterhouse records per group, included the percentage of each lung surface (LS) affected by chronic and acute respiratory lesions.
  • ADG Average Daily Gain
  • RS and AIM in the meloxicam group were significantly lower (p ⁇ 0.05) compared to the control group. Same applies for LS affected by acute lesions (p ⁇ 0.01), while no differences were observed for LS in chronic cases (Table 1).

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US11/047,920 2004-02-23 2005-02-01 Meloxicam for the treatment of respiratory diseases in pigs Abandoned US20050187213A1 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
US12/114,509 US20080280840A1 (en) 2004-02-23 2008-05-02 Meloxicam for the treatment of respiratory diseases in pigs
US14/183,744 US20140179639A1 (en) 2004-02-23 2014-02-19 Meloxicam for the treatment of respiratory diseases in pigs
US15/908,470 US10548901B2 (en) 2004-02-23 2018-02-28 Meloxicam for the treatment of respiratory diseases in pigs
US16/719,681 US11083731B2 (en) 2004-02-23 2019-12-18 Meloxicam for the treatment of respiratory diseases in pigs

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP04004054.5 2004-02-23
EP04004054A EP1568369A1 (fr) 2004-02-23 2004-02-23 Utilisation du meloxicam pour le traitement de maladies respiratoires des porcs

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US11/047,920 Abandoned US20050187213A1 (en) 2004-02-23 2005-02-01 Meloxicam for the treatment of respiratory diseases in pigs
US12/114,509 Abandoned US20080280840A1 (en) 2004-02-23 2008-05-02 Meloxicam for the treatment of respiratory diseases in pigs
US14/183,744 Abandoned US20140179639A1 (en) 2004-02-23 2014-02-19 Meloxicam for the treatment of respiratory diseases in pigs
US15/908,470 Expired - Lifetime US10548901B2 (en) 2004-02-23 2018-02-28 Meloxicam for the treatment of respiratory diseases in pigs
US16/719,681 Expired - Fee Related US11083731B2 (en) 2004-02-23 2019-12-18 Meloxicam for the treatment of respiratory diseases in pigs

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US14/183,744 Abandoned US20140179639A1 (en) 2004-02-23 2014-02-19 Meloxicam for the treatment of respiratory diseases in pigs
US15/908,470 Expired - Lifetime US10548901B2 (en) 2004-02-23 2018-02-28 Meloxicam for the treatment of respiratory diseases in pigs
US16/719,681 Expired - Fee Related US11083731B2 (en) 2004-02-23 2019-12-18 Meloxicam for the treatment of respiratory diseases in pigs

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US (5) US20050187213A1 (fr)
EP (2) EP1568369A1 (fr)
JP (1) JP5009147B2 (fr)
KR (1) KR101233359B1 (fr)
CN (1) CN1921865B (fr)
AU (1) AU2005215122B2 (fr)
BR (1) BRPI0507966A (fr)
CA (1) CA2554040C (fr)
DK (1) DK1720554T3 (fr)
ES (1) ES2394038T3 (fr)
MX (1) MXPA06009575A (fr)
RU (1) RU2360680C2 (fr)
SG (1) SG150531A1 (fr)
TW (1) TW200533362A (fr)
UA (1) UA92584C2 (fr)
WO (1) WO2005079806A1 (fr)

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US20050288280A1 (en) * 2004-06-23 2005-12-29 Boehringer Ingelheim Vetmedica Gmbh Meloxicam in veterinary medicine
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US20080280840A1 (en) * 2004-02-23 2008-11-13 Boehringer Ingelheim Vetmedica, Gmbh Meloxicam for the treatment of respiratory diseases in pigs
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US20140179639A1 (en) 2014-06-26
US10548901B2 (en) 2020-02-04
UA92584C2 (ru) 2010-11-25
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US20180185380A1 (en) 2018-07-05
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CN1921865A (zh) 2007-02-28
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AU2005215122A1 (en) 2005-09-01
CA2554040A1 (fr) 2005-09-01
EP1720554B1 (fr) 2012-07-18
WO2005079806A1 (fr) 2005-09-01
US20200121692A1 (en) 2020-04-23
DK1720554T3 (da) 2012-10-15
JP2007523205A (ja) 2007-08-16
US20080280840A1 (en) 2008-11-13
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EP1568369A1 (fr) 2005-08-31
US11083731B2 (en) 2021-08-10

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