Soft chewable pharmaceutical products

Patent metadata

Field	Value
Publication number	US-11337917-B2
Application number	US-201715634924-A
Country	US
Kind code	B2
Filing date	Jun 27, 2017
Priority date	Apr 4, 2012
Publication date	May 24, 2022
Grant date	May 24, 2022

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.

First claim

What is claimed is:

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.

Assignees

• Intervet Inc

Inventors

• Roepke Rainer
• Schmidt Carsten
• Alteheld Susi
• Hang Carina

Classifications

• A61K9/5123

  Organic compounds, e.g. fats, sugars · CPC title

• A61K31/35

  having six-membered rings with one oxygen as the only ring hetero atom · CPC title

• A61P33/14

  Ectoparasiticides, e.g. scabicides · CPC title

• A61K47/12

  Carboxylic acids; Salts or anhydrides thereof · CPC title

• A61K9/0056 Primary

  Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals · CPC title