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 composition for controlling a 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; and   b) a forming agent and a humectant, wherein the forming agent is PEG 3350 and the humectant is glycerol.   
     
     
         20 . The soft chewable veterinary composition of  claim 19 , wherein the composition further comprises a filler, a surfactant, a lubricating agent and a flavoring. 
     
     
         21 . The soft chewable veterinary composition of  claim 19 , wherein the composition further comprises soybean oil. 
     
     
         22 . The soft chewable veterinary composition of  claim 19 , wherein the composition further comprises pamoic acid or a pharmaceutically acceptable salt thereof. 
     
     
         23 . The soft chewable veterinary composition of  claim 20 , wherein the filler comprises corn starch, the surfactant is sodium lauryl sulfate, the lubricating agent is magnesium stearate, and the flavoring is liver, pork, beef or an edible artificial food-like flavoring. 
     
     
         24 . The soft chewable veterinary composition of  claim 19 , wherein the isoxazoline active ingredient is present in a concentration between 0.1% and 40% w/w. 
     
     
         25 . The soft chewable veterinary composition of  claim 24 , wherein the isoxazoline active ingredient is present in a concentration between 5% and 20% w/w. 
     
     
         26 . The soft chewable veterinary composition of  claim 20 , wherein the forming agent is present in a concentration of about 10% to about 20% w/w,
 the humectant is present in a concentration of about 4% to about 7.5% w/w,   the filler is present in a concentration of about 10% to about 20% w/w,   the surfactant is present in a concentration of about 2% w/w,   the lubricating agent is present in a concentration of about 0.75% w/w, and   the flavoring is present in a concentration of about 20% w/w.   
     
     
         27 . A soft chewable veterinary composition for controlling a 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; and
 i) corn starch or pre-gelatinized corn starch; 
 ii) a flavoring agent of pork, liver, beef or an artificial food-like flavoring; 
 iii) a forming agent which is polyethylene glycol; 
 iv) a solvent; 
 v) a surfactant which is sodium lauryl sulfate; 
 vi) a humectant which is glycerol; 
 vii) optionally an antioxidant; and 
 viii) optionally a preservative. 
   
     
     
         28 . A solid soft chewable veterinary product effective for 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; and   b) a forming agent, a surfactant, a filler and a humectant.   
     
     
         29 . The solid soft chewable veterinary product of  claim 28 , wherein the forming agent is PEG 3350, the surfactant is sodium lauryl sulfate, the filler comprises corn starch, and the humectant is glycerol. 
     
     
         30 . A method for controlling a flea or tick infestation in an animal comprising administering to the animal an effective amount of a soft chewable veterinary composition 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; and   b) a forming agent and a humectant, wherein the forming agent is PEG 3350 and the humectant is glycerol.   
     
     
         31 . The method of  claim 30 , wherein the composition further comprises a filler, a surfactant, a lubricating agent and a flavoring. 
     
     
         32 . The method of  claim 30 , wherein the composition further comprises soybean oil. 
     
     
         33 . The method of  claim 30 , wherein the composition further comprises pamoic acid or a pharmaceutically acceptable salt thereof. 
     
     
         34 . The method of  claim 31 , wherein the filler comprises corn starch, the surfactant is sodium lauryl sulfate, the lubricating agent is magnesium stearate, and the flavoring is liver, pork, beef or an edible artificial food-like flavoring. 
     
     
         35 . The method of  claim 30 , wherein the isoxazoline active ingredient is present in a concentration between 0.1% and 40% w/w. 
     
     
         36 . The method of  claim 35 , wherein the isoxazoline active ingredient is present in a concentration between 5% and 20% w/w. 
     
     
         37 . The method of  claim 31 , wherein the a forming agent is present in a concentration of about 10% to about 20% w/w,
 the humectant is present in a concentration of about 4% to about 7.5% w/w,   the filler is present in a concentration of about 10% to about 20% w/w,   the surfactant is present in a concentration of about 2% w/w,   the lubricating agent is present in a concentration of about 0.75% w/w, and   the flavoring is present in a concentration of about 20% w/w.   
     
     
         38 . A method for controlling a flea or tick infestation in an animal comprising administering to the animal an effective amount of a soft chewable veterinary composition 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; and
 i) corn starch or pre-gelatinized corn starch; 
 ii) a flavoring agent of pork, liver, beef or an artificial food-like flavoring; 
 iii) a forming agent which is polyethylene glycol; 
 iv) a solvent; 
 v) a surfactant which is sodium lauryl sulfate; 
 vi) a humectant which is glycerol; 
 vii) optionally an antioxidant; and 
 viii) optionally a preservative. 
   
     
     
         39 . A method for controlling a flea or tick infestation in an animal comprising administering to the animal an effective amount of a soft chewable veterinary product 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; and   b) a forming agent, a surfactant, a filler and a humectant.   
     
     
         40 . The method of  claim 39 , wherein the forming agent is PEG 3350, the surfactant is sodium lauryl sulfate, the filler comprises corn starch, and the humectant is glycerol. 
     
     
         41 . The method of  claim 39 , wherein the animal receives a dosage of the soft chewable veterinary product every 2 months, 3 months, 4 months, 5 months or 6 months. 
     
     
         42 . The method of  claim 40 , 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.