# US 10,117,849 B2 · Monensin water dispersible granules by wet granulation

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- Number: US 10,117,849 B2
- Document ID: US10117849B2
- Status: Granted
- Kind: B2
- Application number: 15/556,654
- Filed: 2016-04-22
- Published: 2018-02-15
- Granted: 2018-11-06
- Earliest claimed: 2015-04-28
- Assignees: Elanco US Inc.
- Applicants: Elanco US Inc.
- Inventors: Kim Ewing Melville Agnew; Constantine Paul Benikos; William Austin Hewitt; Edward John Key; John Malcolm Lloyd
- Web page: https://patentgrep.com/patent/US10117849B2

## CPC

- A61K 31/35: having six-membered rings with one oxygen as the only ring hetero atom
- A61K 9/0095: {Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches (A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006)}
- A61K 9/1611: {Inorganic compounds}
- A61K 9/1623: {Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules}
- A61K 9/1629: {Organic macromolecular compounds}
- A61K 9/1694: {resulting in granules or microspheres of the matrix type containing more than 5% of excipient}
- A61P 1/14: Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
- A61P 3/00: Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00)
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- 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

The present disclosure provides a water dispersible granule formulation comprising from about 5% to about 80% (w/w) of monensin; from about 1% to about 20% (w/w) of one or more surfactants; from about 1% to about 30% (w/w) of one or more binders; from about 1% to about 90% (w/w) of one or more fillers; and water up to about 2% (w/w). The present disclosure also provides a process for the preparation of a water dispersible monensin granule formulation. The present disclosure further provides a method of administering a therapeutically effective amount of a water dispersible monensin granule formulation to an animal.

## Claims

### Claim 1

A water dispersible granule formulation comprising
from about 5% to about 80% (w/w) of monensin;
from about 1% to about 20% (w/w) of one or more surfactants selected from alkyl sulphates, sodium lauryl sulphate, sulphonates, sodium dodecylbenzene sulphonate, carboxylates, dioctyl sodium sulfosuccinate, quaternary ammonium salts, benzalkonium chloride, alkyl betaines, cocamidoalkyl betaines, polyoxyethylene glycol sorbitan alkyl esters, alkyl polyglucoside, polysorbates, alkoxylates, and combinations thereof;
from about 1% to about 30% (w/w) of one or more binders selected from lignosulphonates, sodium lignosulphonate, and combinations thereof;
from about 1% to about 90% (w/w) of one or more fillers selected from lactose monohydrate, glucose, sucrose, sugars, mannitol, modified sugars, celluloses, magnesium silicate monohydrate, amorphous alumina silicate, and combinations thereof; and
water up to about 2% (w/w); wherein the formulation does not comprise a disintegrant.

### Claim 2 (depends on 1)

The formulation of claim 1, comprising
from about 35 to about 55% (w/w) of monensin,
from about 1% to about 5% (w/w) of alkyl polyglucoside,
from about 5% to about 15% (w/w) of sodium lignosulphonate,
from about 20% to about 40% (w/w) of magnesium silicate monohydrate, and
from about 10% to about 30% (w/w) of amorphous alumina silicate.

### Claim 3 (depends on 1)

The formulation of claim 1, comprising monensin at about 43% (w/w), alkyl polyglucoside at about 1% (w/w), sodium lignosulphonate at about 8% (w/w), and magnesium silicate monohydrate at about 18% (w/w), and amorphous alumina silicate at about 27% (w/w).

### Claim 4

A method of treatment comprising providing a therapeutically effective amount of a water dispersible granule formulation to a volume of drinking water of an animal;
wherein the water dispersible granule formulation comprises:
from about 35 to about 55% (w/w) of monensin,
from about 1% to about 5% (w/w) of alkyl polyglucoside,
from about 5% to about 15% (w/w) of sodium lignosulphonate,
from about 20% to about 40% (w/w) of magnesium silicate monohydrate, and
from about 10% to about 30% (w/w) of amorphous alumina silicate;
wherein the formulation does not comprise a disintegrant.

### Claim 5 (depends on 4)

The method of claim 4, wherein the treatment further comprises increasing milk production efficiency.

### Claim 6 (depends on 4)

The method of claim 4, wherein the treatment further comprises treating or reducing occurrence of ketosis.

### Claim 7 (depends on 4)

The method of claim 4, wherein the treatment further comprises treating or reducing occurrence of bloat.