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 solid soft chewable veterinary composition effective for treating and/or controlling flea or tick infestation in an animal comprising:
 a) an isoxazoline active ingredient of 4-[5-(3,5-Dichlorophenyl)-5-trifluoromethyl-4,5-dihydroisoxazol-3-yl]-2-methyl-N-[(2,2,2-trifluoro-ethylcarbamoyl)-methyl]-benzamide or a pharmaceutically acceptable salt thereof at a concentration between 5% and 20% by weight;   b) a forming agent, a surfactant, a filler and a humectant, wherein the forming agent is PEG 3350; the surfactant is sodium lauryl sulfate at a concentration of 2% (w/w); the filler is corn starch and the humectant is glycerol;   c) wherein the effect is achieved at a dosage based upon the weight and type of animal; and   d) wherein the composition is effective for fleas or ticks by administration to the animal every 2 or 3 months.   
     
     
         20 . The solid soft chewable veterinary composition of  claim 19 , wherein the composition further comprises soybean oil. 
     
     
         21 . The solid soft chewable veterinary composition of  claim 19 , wherein the carrier further comprises a lubricant agent which is magnesium stearate. 
     
     
         22 . The solid soft chewable veterinary composition of  claim 19 , wherein the composition further comprises a flavoring which is pork or liver. 
     
     
         23 . The solid soft chewable veterinary composition of  claim 22 , wherein the flavoring is present in a concentration of about 10% to about 20% (w/w). 
     
     
         24 . The solid soft chewable veterinary composition of  claim 19 , wherein the filler is present in a concentration of about 10% to about 20% (w/w). 
     
     
         25 . The solid soft chewable veterinary composition of  claim 19 , wherein the humectant is present in a concentration of about 5% to 50% (w/w). 
     
     
         26 . The solid soft chewable veterinary composition of  claim 19 , wherein the humectant is present in a concentration of about 2.9% to 4% (w/w). 
     
     
         27 . The solid soft chewable veterinary composition of  claim 19 , wherein the forming agent is present at a concentration of about 1% to 40% (w/w). 
     
     
         28 . The solid soft chewable veterinary composition of  claim 19 , wherein the composition comprises a pharmaceutically acceptable salt of the isoxazoline active ingredient. 
     
     
         29 . A solid soft chewable veterinary composition effective for treating and/or controlling flea or tick infestation in an animal comprising:
 a) an isoxazoline active ingredient of 4-[5-(3,5-Dichlorophenyl)-5-trifluoromethyl-4,5-dihydroisoxazol-3-yl]-2-methyl-N-[(2,2,2-trifluoro-ethylcarbamoyl)-methyl]-benzamide or a pharmaceutically acceptable salt thereof at a concentration of about 9% to about 14% by weight;   b) a forming agent, a surfactant, a filler and a humectant, wherein the forming agent is PEG 3350; the surfactant is sodium lauryl sulfate at a concentration of 2% (w/w); the filler is corn starch and the humectant is glycerol;   c) wherein the effect is achieved at a dosage based upon the weight and type of animal; and   
       d) wherein the composition is effective for fleas or ticks by administration to the animal every 2 or 3 months. 
     
     
         30 . A solid soft chewable veterinary composition effective for treating and/or controlling flea or tick infestation in an animal comprising:
 a) an isoxazoline active ingredient of 4-[5-(3,5-Dichlorophenyl)-5-trifluoromethyl-4,5-dihydroisoxazol-3-yl]-2-methyl-N-[(2,2,2-trifluoro-ethylcarbamoyl)-methyl]-benzamide or a pharmaceutically acceptable salt thereof at a concentration from about 0.1% to 40% by weight;   b) a forming agent, a surfactant, a filler and a humectant, wherein the forming agent is PEG 3350; the surfactant is sodium lauryl sulfate at a concentration of 2% (w/w); the filler is corn starch and the humectant is glycerol;   c) wherein the effect is achieved at a dosage dependent upon the weight and type of animal; and   d) wherein the composition is effective for fleas or ticks by administration to the animal every 3 months.   
     
     
         31 . The solid soft chewable veterinary composition of  claim 19 , wherein the effect is about 100% against ticks about 48 hours after administration to the animal. 
     
     
         32 . The solid soft chewable veterinary composition of  claim 29 , wherein the effect is about 100% against ticks about 48 hours after administration to the animal. 
     
     
         33 . The solid soft chewable veterinary composition of  claim 30 , wherein the effect is about 100% against ticks about 48 hours after administration to the animal. 
     
     
         34 . The solid soft chewable veterinary composition of  claim 19 , wherein the effect is achieved at a dosage of about 8 mg/kg-20 mg/kg of isoxazoline active ingredient. 
     
     
         35 . The solid soft chewable veterinary composition of  claim 29 , wherein the effect is achieved at a dosage of about 8 mg/kg-20 mg/kg of isoxazoline active ingredient. 
     
     
         36 . The solid soft chewable veterinary composition of  claim 30 , wherein the effect is achieved at a dosage of about 8 mg/kg-20 mg/kg of isoxazoline active ingredient. 
     
     
         37 . The solid soft chewable veterinary composition of  claim 19 , wherein the composition is effective against ticks for at least 58 days after administration to the animal. 
     
     
         38 . The solid soft chewable veterinary composition of  claim 29 , wherein the composition is effective against ticks for at least 58 days after administration to the animal. 
     
     
         39 . The solid soft chewable veterinary composition of  claim 30 , wherein the composition is effective against ticks for at least 58 days after administration to the animal.