IP Library › Granted Patent US 11,253,593
Granted Patent B2
US 11,253,593 · App. 13/414,495 · Granted Feb 22, 2022

Granulated anthelmintic preparations and delivery systems

Inventors: Douglas Robert Cleverly (Auckland, NZ); Debashis Mukhopadhyay (Brockville Dunedin, NZ)
Assignee: Argenta Innovation Limited
A61K45/06A61K9/0095A61K9/1611A61K9/1617A61K31/4184A61K31/425
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Quick Facts
Patent No.
US 11,253,593
App. No.
13/414,495
Granted
Feb 22, 2022
Kind
B2
Abstract

The present invention relates to anthelmintic compositions comprising two or more anthelmintic active agents selected from one or more of the following groups; imidazothiazoles such as levamisole, benzimidazoles such as oxfendazole, or fenbendazole, macrocylic lactones such as ivermectin or avermectin, salicylanilides, and praziquantel. The composition being in the form of stable granules that are readily dispersible in water so as to provide a homogenous mixture of the anthelmintic agents suitable for administration. Methods of preparing the composition are also described.

Claims (54)

1. A method of preparing a liquid delivery formulation for treating an animal comprising the steps of

(a) providing one or more packs of multi-active granules, each multi-active granule comprising a combination of a macrocyclic lactone and a gum, a wetting agent, and one or more compositions each including an anthelmintic active and an agent, wherein the one or more compositions are selected from the group consisting of:

(i) a benzimidazole and a suspending agent for the benzimidazole; and

(ii) an imidazothiazole and a suspending agent; and

(b) mixing the multi-active granules from the one or more packs with an aqueous liquid to form a thixotropic or pseudoplastic composition prior to treating the animal;

wherein each multi-active granule comprises about 30, 35, 40, 45, 50, 55, 60, 65 or 70% w/w of the anthelmintic agents; and

wherein the multi-active granules, in the one or more packs, are stable for at least 6 months at room temperature.

2. A method of claim 1 , wherein a suspending agent is added to the aqueous liquid; or

wherein the suspending agent is a gum; or

wherein the aqueous liquid is water: or

wherein the aqueous liquid is an anthelmintic concentrate; or

wherein the aqueous liquid contains avermectin and/or milbemycin in a liquid concentrate form; or

wherein the liquid delivery formulation is suitable for administration to animals for up to one month after mixing; or

wherein the mixing of each of the multi-active granules with the aqueous liquid is performed at the site of animal administration; or

further comprising a step before the providing step of determining the treatment needs of one or more animals; or

further comprising administering the liquid delivery formulation to one or more animals; or

wherein each multi-active granule comprises

from about 10 to about 40% w/w benzimidazole, and

from about 10 to about 60% w/w levamisole HCL; or

wherein each multi-active granule comprises 15, 20, 25, 30, 35 or 40% w/w macrocyclic lactone; or

wherein each multi-active granule further comprises a particulate source of one or more minerals; or

wherein each multi-active granule comprises a suspending agent; or

wherein each multi-active granule further comprises an anionic surfactant.

3. A method of claim 1 wherein the suspending agent of (a)(i) is a non-colloidal agent.

4. A method of claim 3 wherein the non-colloidal agent is silicon dioxide.

5. A method of forming an anthelmintic composition comprising the steps of:

providing two or more total anthelmintic actives comprising a macrocyclic lactone and one or more further anthelmintic actives selected from the group consisting of praziquantel, one or more imidazothiazoles, and, one or more benzimidazoles,

providing a suspending agent, wherein the suspending agent comprises a gum, and mixing the macrocyclic lactone with the suspending agent to form a suspension,

if the anthelmintic actives comprise a benzimidazole or praziquantel, providing a wetting agent and mixing the benzimidazole or the praziquantel with the wetting agent,

combining the suspension with the one or more further anthelmintic actives and a wetting agent if a benzimidazole is present to form an anthelmintic active mixture, and

optionally adding additional suspending agent or rheology modifier comprising a gum, and

granulating the anthelmintic active mixture to form a granulated combination of multi-active granules each comprising more than one anthelmintic active that has a shelf life of at least 6 months at room temperature, and

wherein, when subsequently mixed with water the granulated combination of anthelmintic actives forms a stable thixotropic or pseudoplastic mixture.

6. A method of claim 5 , further comprising combining a stabilizing agent with the anthelmintic actives prior to granulation.

7. A method of claim 6 wherein the stabilizing agent is a gum; or wherein the granules further comprise a particulate source of one or more minerals; or wherein the granules comprise about 30, 35, 40, 45, 50, 55, 60, 65 or 70% w/w of the anthelmintic actives.

8. The method of claim 5 , wherein the granulated combination of anthelmintic actives is stable for at least 6 months.

9. The method of claim 5 , wherein the granules further comprise a dispersant.

10. A method of claim 9

wherein the wetting agent is polysorbate 80; or

wherein the dispersant is colloidal silicon dioxide.

11. A method of claim 5 , wherein a suspending agent is added to the water: or

wherein the suspending agent is a gum; or

wherein the water contains avermectin and/or milbemycin in a liquid concentrate form; or

wherein the thixotropic or pseudoplastic mixture is suitable for administration to animals for up to one month after mixing; or

wherein the mixing of each of the multi-active granules with the water is performed at the site of animal administration; or

further comprising a step before the providing step of determining the treatment needs of one or more animals; or

further comprising administering the thixotropic or pseudoplastic mixture to one or more animals; or

wherein each multi-active granule comprises

from about 10 to about 40% w/w benzimidazole, and

from about 10 to about 60% w/w levamisole HCL: or

wherein each multi-active granule comprises 15, 20, 25, 30, 35 or 40% w/w macrocyclic lactone; or

wherein each multi-active granule further comprises a particulate source of one or more minerals; or

wherein each multi-active granule comprises a suspending agent; or

wherein each multi-active granule further comprises an anionic surfactant.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 11, 2019
From: ARGENTA MANUFACTURING LIMITED
To: ARGENTA INNOVATION LIMITED
Reel/Frame 047967/0464 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 4, 2012
From: CLEVERLY, DOUGLAS ROBERT; MUKHOPADHYAY, DEBASHIS
To: ARGENTA MANUFACTURING LIMITED
Reel/Frame 028312/0091 →
Priority Claims (3)
NZ 579544 · Sep 7, 2009 · national
NZ 579545 · Sep 7, 2009 · national
NZ 579546 · Sep 7, 2009 · national
Continuity (2)
Continuation In Part PCTIB2010054005 · Sep 7, 2010
Related Publication 20120238516A1 · Sep 20, 2012
Cited By (1)
US 12,544,336