Benzimidazole non-aqueous compositions
View Patent ↗The present invention provides a stable veterinary oral composition which comprises one or more surfactants, a water-miscible solvent, optionally an oil and an effective amount of each of a benzimidazole antihelmintic compound, such as triclabendazole and a macrocyclic lactone, such as moxidectin. Said composition is useful for treating and controlling endo- and ectoparasitic infection and infestation in a homeothermic animal.
1. An oral veterinary composition which comprises:
a benzimidazole compound;
moxidectin;
one or more surfactants in an amount between 30% w/v and 60% w/v;
a pharmaceutically acceptable oil in an amount of about 25-65% w/v; and
a water miscible solvent,
wherein the composition is non-aqueous.
2. The composition according to claim 1 wherein said benzimidazole is selected from the group consisting of: thiabendazole; cambendazole; parbendazole; mebendazole; fenbendazole; oxfendazole; oxibendazole; albendazole; albendazole sulfoxide; thiophanate; febantel; netobimin; and triclabendazole.
3. The composition according to claim 1 wherein the water-miscible solvent is selected from the group consisting of: an alkylene glycol; a polyalkylene glycol; an alcohol; and a mixture thereof.
4. The composition according to claim 1 wherein the composition comprises about 2-10% w/v of a benzimidazole and about 0.01-2.0% w/v of a macrocyclic lactone.
5. The composition according to claim 2 wherein said benzimidazole is triclabendazole.
6. The composition according to claim 1 wherein the oil is propylene glycol dicaprylate/dicaprate.
7. The composition according to claim 1 wherein the oil is caprylic/capric triglyceride.
8. A process for the preparation of a composition according to claim 1 which comprises: admixing one or more surfactants and an oil to form a uniform mixture; dissolving moxidectin in said mixture to form a solution; and mixing said solution with a benzimidazole and a water-miscible solvent, thereby forming said composition.
9. The process according to claim 8 wherein said benzimidazole is triclabendazole.
10. The composition according to claim 1 wherein the one or more surfactants are present in a total amount between 40% w/v and 60% w/v.
11. The composition according to claim 1 wherein one of the one or more surfactants is Polysorbate 80 which is present in an amount between 30% w/v and 60% w/v.
12. The composition according to claim 11 , wherein Polysorbate 80 is present in an amount between 40% w/v and 60% w/v.
13. The composition according to claim 1 wherein one of the one or more surfactants is PEG-35 Castor Oil.
14. The composition according to claim 13 , further comprising sorbitan monooleate.
15. The composition according to claim 1 , wherein one of the one or more surfactants is PEG-400.
16. The composition according to claim 15 , further comprising sucrose monolaurate.
17. The oral veterinary composition of claim 1 which comprises Polysorbate 80, a water-miscible solvent, propylene glycol dicaprylate/dicaprate, a benzimidazole anthelmintic compound and moxidectin, wherein the composition is non-aqueous.
18. The composition according to claim 17 , further comprising sorbitan monooleate.