Soft chewable pharmaceutical products

Abstract

A soft chewable pharmaceutical product for delivery of a pharmaceutically acceptable active ingredient to an animal comprising pamoic acid or a pharmaceutically acceptable salt and a process for the manufacture of such soft chewable pharmaceutical product.

1 - 18 . (canceled) 
     
     
         19 . A soft chewable veterinary product for controlling a parasite of an animal comprising:
 an isoxazoline active ingredient or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable nonactive ingredients.   
     
     
         20 . The soft chewable veterinary product of  claim 19 , wherein the pharmaceutically acceptable nonactive ingredients comprise a filler, a flavoring, a forming agent, a solvent, a surfactant, a humectant, optionally an antioxidant, and optionally, a preservative. 
     
     
         21 . The soft chewable veterinary product of  claim 20 , wherein the filler comprises corn starch, the flavoring comprises beef, pork, liver or an edible artificial food-like flavoring, the forming agent comprises polyvinylpyrrolidone or polyethylene glycol, and the humectant comprises glycerol. 
     
     
         22 . The soft chewable veterinary product of  claim 19 , wherein the soft chewable veterinary composition further comprises pamoic acid or a pharmaceutically acceptable salt thereof. 
     
     
         23 . The soft chewable veterinary product of  claim 19 , wherein the isoxazoline active ingredient is present in an amount from 0.1% to 40%. 
     
     
         24 . The soft chewable veterinary product of  claim 23 , wherein the isoxazoline active ingredient is present in an amount between 5% and 20%. 
     
     
         25 . The soft chewable veterinary product of  claim 19 , wherein the isoxazoline active ingredient is 4-[5-(3,5-Dichlorophenyl)-5-trifluoromethyl-4,5-dihydroisoxazol-3-yl]-2-methyl-N-[(2,2,2-trifluoro-ethylcarbamoyl)-methyl]-benzamide. 
     
     
         26 . The soft chewable veterinary product of  claim 20 , wherein:
 a) the filler comprises corn starch and is present at a concentration of about 10% to about 20% w/w;   b) the forming agent is polyvinylpyrrolidone or polyethylene glycol and is present at a concentration of about 5% to about 30% w/w;   c) the humectant is glycerol or propylene glycol and is present at a concentration of 7.5% w/w;   d) the surfactant is sodium lauryl sulphate and is present at a concentration of 2% w/w;   e) the flavoring is pork, liver, beef, or an edible artificial food-like flavoring and is present at a concentration of 20% w/w.   
     
     
         27 . The soft chewable veterinary product of  claim 19 , further comprising at least a second active ingredient of another isoxazoline active ingredient, an avermectin or a milbemycin. 
     
     
         28 . The soft chewable veterinary product of  claim 27 , wherein the second active ingredient is eprinomectin, ivermectin, selamectin, milbemycin oxime, or moxidectin. 
     
     
         29 . The soft chewable veterinary product of  claim 19 , wherein the isoxazoline active ingredient is 4-[5-(3,5-Dichlorophenyl)-5-trifluoromethyl-4,5-dihydroisoxazol-3-yl]-2-methyl-N-[(2,2,2-trifluoro-ethylcarbamoyl)-methyl]-benzamide and the second active ingredient is milbemycin oxime or moxidectin. 
     
     
         30 . The soft chewable veterinary product of  claim 19 , wherein the parasite is a flea or tick. 
     
     
         31 . The soft chewable veterinary product of  claim 20 , wherein the solvent is a non-aqueous liquid solvent. 
     
     
         32 . The soft chewable veterinary product of  claim 19 , wherein the product further comprises one or more oils. 
     
     
         33 . The soft chewable veterinary product of  claim 19 , wherein the one or more oils is palm oil, corn oil, castor oil, canola oil, safflower oil, cotton-seed oil, soybean oil, olive oil, peanut oil or a mixture thereof. 
     
     
         34 . A method for controlling a parasite infestation of an animal comprising administering to the animal an effective amount of a soft chewable veterinary composition comprising:
 an isoxazoline active ingredient or a pharmaceutically acceptable salt thereof, and   one or more pharmaceutically acceptable nonactive ingredients.   
     
     
         35 . The method of  claim 34 , wherein the pharmaceutically acceptable nonactive ingredients comprise a filler, a flavoring, a forming agent, a solvent, a surfactant, a humectant, optionally an antioxidant, and optionally, a preservative. 
     
     
         36 . The method of  claim 35 , wherein the filler comprises corn starch, the flavoring comprises beef, pork, liver or an edible artificial food-like flavoring, the forming agent comprises polyvinylpyrrolidone or polyethylene glycol, and the humectant comprises glycerol. 
     
     
         37 . The method of  claim 34 , wherein the soft chewable veterinary composition further comprises at least a second active ingredient of another isoxazoline active ingredient, an avermectin or a milbemycin. 
     
     
         38 . The method of  claim 37 , wherein the second active ingredient is eprinomectin, ivermectin, selamectin, milbemycin oxime, or moxidectin. 
     
     
         39 . The method of  claim 35 , wherein the parasite is a flea or tick. 
     
     
         40 . The method of  claim 39 , wherein the animal receives a dosage of the soft chewable veterinary composition every 2 months, 3 months, 4 months, 5 months or 6 months. 
     
     
         41 . A method for controlling a flea or tick infestation of an animal comprising administering to the animal an effective amount of a soft chewable veterinary composition comprising:
 an isoxazoline active ingredient or a pharmaceutically acceptable salt thereof, and a filler comprising corn starch, a flavoring of beef, pork, liver or an edible artificial food-like flavoring, a forming agent comprising polyvinylpyrrolidone or a polyethylene glycol, and a humectant of glycerol.   
     
     
         42 . The method of  claim 41 , wherein soft chewable veterinary composition comprises a second active ingredient of milbemycin oxime or moxidectin. 
     
     
         43 . The method of  claim 41 , wherein the animal receives a dosage of the soft chewable veterinary product every 2 months, 3 months, 4 months, 5 months or 6 months. 
     
     
         44 . The method of  claim 42 , wherein the wherein the animal receives a dosage of the soft chewable veterinary product every 2 months, 3 months, 4 months, 5 months or 6 months.