SOFT CHEWABLE PHARMACEUTICAL PRODUCTS
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.