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United States Patent (19) 11 Patent Number: 4,650,790 Simon Et Al

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United States Patent (19) 11 Patent Number: 4,650,790 Simon Et Al United States Patent (19) 11 Patent Number: 4,650,790 Simon et al. (45) Date of Patent: Mar. 17, 1987 54 DRUG COMBINATIONS HAVING 56) References Cited SYNERGISTICEFFECT U.S. PATENT DOCUMENTS 2,799,620 7/1957 Waksman et al. ................. 536/13.2 75) Inventors: Ferenc Simon; Attila Romváry; János 2,931,798 4/1960 Umezawa et al. ................. 536/13.7 Varga; László Bozzay, all of 3,915,955 10/1975 Copper et al. ..................... 536/13.6 Budapest; Edit Brickner née Gábor, Pápa, all of Hungary FOREIGN PATENT DOCUMENTS 2072012 9/1981 United Kingdom. 73). Assignee: Patentbureau Danubia, Hungary Primary Examiner-Johnnie R. Brown Assistant Examiner-Elli Peseler (21) Appl. No.: 717,157 Attorney, Agent, or Firm-Keil & Weinkauf 57 ABSTRACT 22 Filed: Mar. 28, 1985 The invention relates to a synergistic antibiotic compo sition useful for the treatment of respiratory, gastroin 30 Foreign Application Priority Data testinal or urinary infections and septicaemia of domes Mar. 28, 1984 HU) Hungary .............................. 1225/84 tic animals. The composition comprises tiamulin hydro Mar. 28, 1984 HU) Hungary .............................. 226/84 gen fumarate and an aminoglycoside antibiotic or a Apr. 20, 1984 HU Hungary .............................. 1527/84 pharmaceutically acceptable salt thereof in a weight ratio of 5:1 to 1:5. The active components are admixed 51) int. Cl.".............................................. A61K 31/71 or diluted with a carrier, used in veterinary therapy, in 52 U.S.C. ........................................ 514/39; 514/35; a weight ratio of 1:1 to 1:50 and formulated for oral or 514/36; 514/37; 514/38; 514/40, 514/41 parenteral application. 58) Field of Search ....................... 514/36, 37, 38, 39, 514/40, 41, 35 13 Claims, No Drawings 4,650,790 1. 2 The aminoglycoside antibiotics (streptomycin, neo DRUG COMBINATIONS HAVING SYNERGSTC mycin, kanamycin, gentamicin, tobramycin, spectino EFFECT mycin, apramycin etc.) are used in the treatment of acute and chronic infections of the respiratory organs, This invention relates to new drug combinations hav 5 gastro-intestinal and urogenital tract, caused by Gram ing synergistic effect which cure and prevent diseases of negative bacteria, Staphylococci and Corynebacterium protozoal and bacterial (Treponema hyodysenteriae, pyogenes. However, according to literary data the Escherichia coli, Pasteurella, Salmonella, Mycoplasma aminoglycoside antibiotics are effective against Gram spp.) origin of cattle, calves, sheep, goats, swine, rabbits positive germs, too (Staphylococcus aureus, Staphylococ and poultry. Furthermore the invention relates to a O cus albus, Corynebacterium strains, Aerobacter, Salmo process for the preparation of these drug combinations. nella, Proteus, Neiseria, Pasteurella spp.). It is known that the greatest economical losses in The single or combined use of streptomycin and neo swine and poultry flocks are due to diseases of the gas mycin is widespread in the veterinary therapy for treat trointestinal tract and of respiratory organs. Losses ing infections of various kinds. appear not only because of increased mortality and 15 Streptomycin alone or in combination with penicillin costs of treatment but adversely affected performance, (Stredipen inj) is primarily used for parenteral therapy tOO. of respiratory diseases. Mycoplasma strains play a great part in the back The combination of neomycin with oxytetracycline is ground of the disorders of the respiratory tract, but used in the treatment of mastitis, and enclosed in cap inflammatory signs due to secondary pathogens (e.g. sules it is available for intrauterin application. Streptococcus, Staphylococcus, Pasteurella, Bordetella Parenteral use of neomycin is limited because of its strains) are also important. nephrotoxic properties. It may cause azotaemia and Diseases of the digestive organs are usually caused by oliguria (Deutsche Med. Wsch. 104, the overgrowth of Gram negative pathogens in the 1783-1787/1979/). intestinal tract, among them the most important is the 25 Kanamycin alone or in combination with procaine invasion of Escherichia coli strains, which results in penicillin, dihydrostreptomycin, neomycin is applied diarrhoe and oedema disease in swine herds and in coli mainly parenterally (im., iv., sc., intrauterine or intra septicaemia in poultry flocks. cysternally). The number of gynecological diseases of dams on Tobramycin's and spectinomycin's main range of large scale units is continuously increasing and subclini 30 effectivity is against Gram negative pathogens (E. coli, cal disorders of the udder are more frequent. Mastitis is Proteus, Klebsiella, Pseudomonas). They may be ap caused mainly by Streptococcus, Staphylococcus, Esch plied both orally and parenterally. erichia coli and Corynebacterium strains. Apramycin's indications are coli-diarrhoea, oedema Infections of bacterial and protozoal origin have been disease, swine-dysentery (Antimicrob. Chemother. 3, most widely treated and prevented with antibiotics and 35 609-613/1977/), retention of fetal membrane, metritis, their combinations. pneumonia, fowl cholera, respiratory diseases and coli As the choice of antibiotics widened, marked de septicaemia of poultry. Apramycin acts favourably in crease of infectious diseases of bacterial and protozoal the treatment of mastitis of cows caused by Gram nega origin became possible. tive and Gram positive pathogens, and it may be used Widespread use of antibiotics resulted in the develop 40 for the treatment of MMA (metritis-mastitis-agalactia) ment of resistant strains, against which the single antibi syndrome of sows. It posseses particularly strong effect otics became ineffective. To avoid the development of against Pseudomonas strains of mastitic origin. resistance, antibiotics are generally used for short per Due to resistance patterns, combinations of apramy iod of time and this is the reason of the production of cin with other chemotherapeutics have been developed. newer and newer antibiotics for increasingly greater 45 Such a combination is described in the Belgian patent COStS. specification No. 886,765, in which aminoglycoside Tiamulin (14-desoxy-14-(2-diethyl-amino-ethyl)- antibiotics (apramycin, tobramycin, nebramycin) to mercapto-acetoxy-mutilin hydrogen fumarate is a rela gether with macrollides (tylosin, spiramycin, oleando tively new antibiotic in veterinary therapy. It has been mycin) are proposed against colibacillosis and Myco found effective against some Gram positive bacteria, 50 plasma infections. Mycoplasma and the most important Treponema. We carried out experiments to investigate the effect Orally applied tiamulin is extremely effective against of aminoglycoside antibiotics and tiamulin against Treponema hyodysenteriae (British patent specification pathogen strains cultured from diseased animals. The No. 2,072,012), which causes swine dysentery, and invention is based on the recognition that when tiamulin against Mycoplasma hyopneumoniae which causes enzo 55 hydrogen fumarate is applied in combination with an otic pneumonia (Taylor, D.J., IPVS Congress, Mexico, aminoglycoside antibiotic (streptomycin, neomycin, 1982). kanamycin, tobramycin, spectinomycin, apramycin, The application of tiamulin in combination with an gentamycin) beside the fact that the spectrum of activ tihelminthics (tetramisole, levamisole, fenbendasole, ity of the components is broadened, a more than addi parbendasole, piperazine and dichlorvos) has already tive, that is synergistic, interaction develops and this been studied. Toxicity and compatibility of the combi results in unexpectedly low antibacterial concentrations nations was investigated, too. There is no known combi of the components. nation of tiamulin with antibiotics until now. Accordingly, the invention relates to new synergistic It is the object of the present invention to produce antibiotic compositions useful for the treatment of respi drug combinations of known antibiotics which, beside 65 ratory or urinary infections and septicaemia of domestic considerable reduction of expenses, will include the animals, comprising the antibiotic tiamulin hydrogen individual effects of two or more components in a syn fumarate and an aminoglycoside antibiotic or a pharma ergistic way. ceutically acceptable salt thereof in a weight ratio of 5:1 4,650,790 3 4. to 1:5, admixed with inert, non toxic carriers used in The following Tables list the data of the microbiolog veterinary therapy. ical survey and prove synergism. The synergistic activity of the combinations of the As shown in the Tables, all the test organisms were invention can be demonstrated in microbiological as- controlled at highly reduced concentrations when any says. Forbetter understanding, the same field isolates of 5 of the tiamulin-aminoglycoside combinations was used. pathogens were used as test organisms. Minimal inhibit- The grade of intensification of the antimicrobial effect is ing concentrations (MIC) and minimal bactericide con- of 4 to 8 times and it can reach the 200 to 400 times centrations (MBC) of tiamulin and the aminoglycosides value in vitro. This means that the growth of the strains were determined. is inhibited even with considerably reduced doses. 10 The MIC and MBC values were measured in ug/ml units. TABLE I Intensification of the Antibacterial Activity of the l:l Ratio by Weight Combination of Tiamulin and Streptomycin Tiamulin Streptomycin Combination - Grade of Intensi Test Organism MIC MBC MC MBC MC MBC fication Staphylococcus
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