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. 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 at a concentration of about 2.9% to 4% (w/w).;
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.
2. The solid soft chewable veterinary composition of claim 1 , wherein the composition further comprises soybean oil.
3. The solid soft chewable veterinary composition of claim 1 , wherein the carrier further comprises a lubricant agent which is magnesium stearate.
4. The solid soft chewable veterinary composition of claim 1 , wherein the composition further comprises a flavoring which is pork or liver.
5. The solid soft chewable veterinary composition of claim 4 , wherein the flavoring is present in a concentration of about 10% to about 20% (w/w).
6. The solid soft chewable veterinary composition of claim 1 , wherein the filler is present in a concentration of about 10% to about 20% (w/w).
7. The solid soft chewable veterinary composition of claim 1 , wherein the forming agent is present at a concentration of about 1% to 40% (w/w).
8. The solid soft chewable veterinary composition of claim 1 , wherein the composition comprises a pharmaceutically acceptable salt of the isoxazoline active ingredient.
9. 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 at a concentration of about 2.9% to 4% (w/w);
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.
10. 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 at a concentration of about 2.9% to 4% (w/w);
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.
11. The solid soft chewable veterinary composition of claim 1 , wherein the effect is about 100% against ticks about 48 hours after administration to the animal.
12. The solid soft chewable veterinary composition of claim 8 , wherein the effect is about 100% against ticks about 48 hours after administration to the animal.
13. The solid soft chewable veterinary composition of claim 9 , wherein the effect is about 100% against ticks about 48 hours after administration to the animal.
14. The solid soft chewable veterinary composition of claim 1 , wherein the effect is achieved at a dosage of about 8 mg/kg - 20 mg/kg of isoxazoline active ingredient.
15. The solid soft chewable veterinary composition of claim 8 , wherein the effect is achieved at a dosage of about 8 mg/kg - 20 mg/kg of isoxazoline active ingredient.
16. The solid soft chewable veterinary composition of claim 9 , wherein the effect is achieved at a dosage of about 8 mg/kg - 20 mg/kg of isoxazoline active ingredient.
17. The solid soft chewable veterinary composition of claim 1 , wherein the composition is effective against ticks for at least 58 days after administration to the animal.
18. The solid soft chewable veterinary composition of claim 8 , wherein the composition is effective against ticks for at least 58 days after administration to the animal.
19. The solid soft chewable veterinary composition of claim 9 , wherein the composition is effective against ticks for at least 58 days after administration to the animal.