# US 9,040,571 B2 · Veterinary formulation for administration of a water-insoluble drug to a target animal through a water distribution system

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- Number: US 9,040,571 B2
- Document ID: US9040571B2
- Status: Granted
- Kind: B2
- Application number: 12/259,844
- Filed: 2008-10-28
- Published: 2009-03-05
- Granted: 2015-05-26
- Earliest claimed: 1999-09-03
- Assignees: Elanco Animal Health Ireland Limited
- Applicants: Peter Frank Ekhart; Mario Van Wandelen; Jan Matthijs Jetten
- Inventors: Peter Frank Ekhart; Mario Van Wandelen; Jan Matthijs Jetten
- Web page: https://patentgrep.com/patent/US9040571B2

## CPC

- A61K 9/1075: {Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers (A61K9/0026 takes precedence)}
- A61K 31/415: 1,2-Diazoles
- A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K 47/44: Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin (synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14)
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 33/10: Anthelmintics
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

This invention concerns a method for the preparation of a suspoemulsion formulation, which can be easily produced on an industrial scale and which allows the reproducible and effective administration of one or more water-insoluble veterinary drugs through water distribution systems. The water-insoluble veterinary drug, in finely ground form, is dispersed in a water immiscible liquid, followed by homogenization of this system into a water phase. To facilitate the preparation of a stable formulation, one or more stabilizing agents such as emulsifiers, thickeners, anti-oxidants and anti-microbials can be used. The resulting suspoemulsion shows excellent long term storage stability and a good “in use” stability after dilution in a vessel and during all handling and transport in the water distribution system.

## Claims

### Claim 1

A method of preparing a suspoemulsion suitable, optionally after dilution, for administering flubendazole through a water distribution system, comprising mixing flubendazole with a water-immiscible liquid in such a manner that the mixture of active compound and water-immiscible liquid has a density between 0.85 and 1.2, and suspending said mixture in an aqueous carrier.

### Claim 2 (depends on 1)

A method according to claim 1, in which the flubendazole and the water-immiscible liquid are used in a weight ratio between 10:90 and 75:25.

### Claim 3 (depends on 1, 2)

A method according to any one of claim 1 or 2, in which the water-immiscible liquid has a lower density than water.

### Claim 4 (depends on 1, 2, 3)

A method according to any one of claim 1, 2 or 3, in which said mixture or the suspension thereof in the aqueous carrier comprises one or more stabilising agents belonging to the group of emulsifiers, surfactants, thickeners, anti-oxidants and anti-microbials.

### Claim 5 (depends on 1, 2, 3, 4)

A method according to any one of claim 1, 2, 3 or 4, in which said water-immiscible liquid is a vegetable oil.

### Claim 6 (depends on 1, 2, 3, 4, 5)

A method according to any one of claim 1, 2, 3, 4 or 5 in which the average particle size of the flubendazole is between 1 and 30 μm.

### Claim 7

A suspoemulsion suitable, optionally after dilution, for administering flubendazole through a water distribution system, comprising a homogeneous suspension in water of a mixture of the flubendazole and a water-immiscible liquid, said mixture having a density between 0.85 and 1.2.

### Claim 8 (depends on 7)

A suspoemulsion according to claim 7, comprising one or more of the following features:
a) the flubendazole and the water-immiscible liquid are used in a weight ratio between 10:90 and 75:25;
c) the water-immiscible liquid is a vegetable oil;
d) the suspoemulsion comprises one or more stabilising agents selected from emulsifiers, surfactants, thickeners, anti-oxidants and anti-microbials;
e) the weight ratio between said mixture of flubendazole, a water-immiscible liquid and said water is between 80:20 and 10:90;
f) the density of the mixture of flubendazole and water-immiscible liquid is between 0.95 and 1.05.