Palatable ductile chewable veterinary composition

Abstract

The present invention is directed to palatable ductile chewable veterinary composition for oral administration. The composition is capable of killing endo-parasites and ecto-parasites and/or can be used for treating prophylactic or curative animal diseases, and it is useful for the treatment of any warm-blooded non-human animal, including herd animals, like horses, cattle, sheep or poultry and preferably pets like dogs and cats. It consists basically of (A) an effective amount of one or more ingredients that are active against animal pests, pathogens or animal diseases; (B) meat flavoring; (C) partially gelatinized starch; (D) a softener; and (E) up to 9% water.

What is claimed is: 
     
         1 . A highly palatable ductile chewable veterinary composition which is an extrudate, comprising:
 (a) An effective amount of one or more ingredients that are active against animal pests, pathogens or animal diseases;   (b) meat flavoring;   (c) about 25 to 70% (w/w) of partially gelatinized starch wherein said partially gelatinized starch comprises about 12 to about 17% (w/w) of gelatinized starch;   (d) a softener selected from the group consisting of glycerol, polyethylene glycol and polypropylene glycol; and   (e) up to 9% (w/w) of water.   
     
     
         2 . A chewable veterinary composition according to  claim 1  wherein the animal disease is selected from the group consisting of viral infections, bacterial infections, behavioral disorders, inflammatory diseases, and auto-immune diseases. 
     
     
         3 . A chewable veterinary composition according to  claim 1  wherein said meat flavoring is about 20 to about 30% (w/w) of a natural meat flavor. 
     
     
         4 . A chewable veterinary composition according to  claim 3  wherein the natural meat flavoring comprises about 20 to about 55% (w/w) fat. 
     
     
         5 . A chewable veterinary composition according to  claim 1  wherein said softener is about 10 to about 20% (w/w), based upon the weight of the partially gelatinized starch. 
     
     
         6 . A chewable veterinary composition according to  claim 1  wherein said water is about 4 to about 6% (w/w). 
     
     
         7 . A chewable veterinary composition according to  claim 1  wherein the animal pests are selected from the group consisting of external animal parasites, internal animal parasites and a combination of external and internal animal parasites. 
     
     
         8 . A chewable veterinary composition according to  claim 1  further comprising at least one of: about 1 to about 10% (w/w) of a sweetener, 0 to about 3.5% (w/w) of an antioxidant, 0 to about 5% (w/w) of a coloring agent, or 0 to about 4% (w/w) of sodium chloride 
     
     
         9 . A chewable veterinary composition according to  claim 1  wherein the ingredient is an effective amount of a parasiticide selected from the group consisting of an ecto-parasiticide, an endo-parasiticide, a combination of an ecto-parasiticide and an endo-parasiticide, a combination of an ectoparasite and an endectocide, a combination of an endo-parasiticide and an endectocide, and a combination of an ecto-parasiticide, an endo-parasiticide and an endectocide. 
     
     
         10 . A chewable veterinary composition according to  claim 9  wherein the ecto-parasiticide is active against insects, members of the order Acarina or insects and members of the order Acarina. 
     
     
         11 . A chewable veterinary composition according to  claim 10  wherein the ecto-parasiticide is an insecticide which is either an insect adulticides or insect growth regulators. 
     
     
         12 . A chewable veterinary composition according to  claim 9  wherein said parasiticide is selected from the group consisting of macrocyclic lactones, benzimidazoles, pro-benzimidazoles, imidazothiazoles, tetrahydropyrimidines, organophosphates and piperazines. 
     
     
         13 . A chewable veterinary composition according to  claim 12  wherein said parasiticide is an effective amount of a natural or chemically modified macrocyclic lactone of formula (I) 
       
         
           
           
               
               
           
         
       
       wherein X is —C(H)(OH)—; —C(O)—; or —C(═N—OH)—; Y is —C(H 2 )—; ═C(H)—; —C(H)(OH)—; or —C(═N—OCH 3 )—; R 1  is hydrogen or one of radicals 
       
         
           
           
               
               
           
         
       
       R 4  is hydroxyl, —NH—CH 3  or —NH—OCH 3 ; R 2  is hydrogen, —CH 3 , —C 2 H 5 , —CH(CH 3 )—CH 3 , —CH(CH 3 )—C 2 H 5 , —C(CH 3 )═CH—CH(CH 3 ) 2  or cyclohexyl; and if the bond between atoms 22 and 23 represents a double bond the carbon atom in 23-position is unsubstituted so that Y is ═C(H)—, or if is the bond between atoms 22 and 23 is a single bond the carbon atom in 23-position is unsubstituted or substituted by hydroxy or by the group ═N—O—CH 3  so that Y is —C(H 2 )—; —C(H)(OH)—; or —C(═N—OCH 3 )—; in free form or in the form of a physiologically acceptable salt. 
     
     
         14 . A chewable veterinary composition according to  claim 13  wherein the macrocyclic lactone is a compound of the formula (I) wherein X is —C(H)(OH)—; Y is —C(H 2 )—; R 1  is the radical 
       
         
           
           
               
               
           
         
       
       R 2  is —CH 3  or C 2 H 5 , and the bond between atoms 22 and 23 represents a single bond. 
     
     
         15 . A chewable veterinary composition according to  claim 12  wherein the macrocyclic lactone is selected from the group consisting of avermectins, milbemycins and derivatives thereof, in free form or in the form of a physiologically acceptable salt. 
     
     
         16 . A chewable veterinary composition according to  claim 15  wherein the macrocyclic lactone is selected from the group consisting of Ivermectin, Doramectin, Moxidectin, Selamectin, Emamectin, Eprinomectin, Milbemectin, Abamectin, Milbemycin oxime, Nemadectin, and a derivative thereof, in free form or in the form of a physiologically acceptable salt. 
     
     
         17 . A chewable veterinary composition according to  claim 15  comprising an effective amount of a macrocyclic lactone in combination with an effective amount of an anthelmintic selected from the group consisting of Albendazole, Clorsulon, Cydectin, Diethylcarbamazine, Febantel, Fenbendazole, Haloxon, Levamisole, Mebendazole, Morantel, Oxyclozanide, Oxibendazole, Oxfendazole, Oxfendazole, Oxamniquine, Pyrantel, piperazine, Praziquantel, Thiabendazole, Tetramisole, Trichlorfon, Thiabendazole, and a derivative thereof. 
     
     
         18 . A chewable veterinary composition according to  claim 15  comprising additionally an effective amount of an insecticide, acaricide or an insecticide and an acaricide. 
     
     
         19 . A chewable veterinary composition according to  claim 1  wherein said one or more ingredients are an effective amount of milbemycin oxime and praziquantel. 
     
     
         20 . A chewable veterinary composition according to  claim 1  wherein said one or more ingredients are an effective amount of lufenuron, praziquantel and milbemycin oxime. 
     
     
         21 . A chewable veterinary composition according to  claim 1  wherein said ingredient is an effective amount of cyclosporin. 
     
     
         22 . A chewable veterinary composition according to  claim 1  wherein said ingredient is an effective amount of an antimicrobial selected from the group consisting of a penicillin, tetracycline, sulfonamide, cephalosporin, cephamycin, aminoglucosid, trimethoprim, dimetridazole, erythromycin, framycetin, fruazolidone, pleuromutilin, streptomycin and a compound that is active against protozoa. 
     
     
         23 . A chewable veterinary composition according to  claim 1  wherein said ingredient is an effective amount of compound that is active against one or more behavioral disorders including separation worry or travel sickness of dogs and cats. 
     
     
         24 . A method for the production of a highly palatable ductile chewable veterinary composition of  claim 1 , comprising (i) feeding the hopper of an extruder with an effective amount of one or more ingredients that are active against animal pests, pathogens or animal diseases; meat flavoring; partially gelatinized starch; a softener; and up to about 9% (w/w) of water, (ii) cooling constantly down the mixture of active ingredients and carriers so that the temperature of the extrudate that leaves the tip of the extruder does during the whole extrusion process at no time exceed 40° C., (iii) pressing the extrudate through a die that is decisive for the shape of the chewable product, and (iv) cutting the extrudate that leaves the extruder into equal pieces. 
     
     
         25 . The method according to  claim 24  wherein the hopper of the extruder is fed continuously and simultaneously with pre-mixture (1) and pre-mixture (2), wherein pre-mixture (1) comprises a homogenized mixture of one or more active ingredients and partially gelatinized starch, and pre-mixture (2) comprises a homogenized mixture of meat flavoring, a softener and optionally of a carrier selected from the group consisting of a sweetener, softener, an antioxidant, a coloring agent and sodium chloride.