APPETISING MEDICAMENTS FOR ORAL ADMINISTRATION IN SOLID FORM FOR PREVENTION AND/OR TREATMENT OF CARDIAC INSUFFICIENCY IN ANIMALS

• US 20110189283A1
• Filed: 07/23/2009
• Published: 08/04/2011
• Est. Priority Date: 07/23/2008
• Status: Abandoned Application

• Current Assignee: Virbac
• Original Assignee: Virbac
• Inventors: Derrieu, Guy, Corvaisier, David
• Application Number:
  US13/055,357
• Publication Number:
  US 20110189283A1
• Time in Patent Office: Days
• US Class Current: 424/477
• CPC Class Codes: A23K 40/30 by encapsulating; by coating
• CPC Class Codes: A23K 50/40 for carnivorous animals, e.g. cats or dogs
• CPC Class Codes: A61K 31/197 the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid carnitine A61K31/205
• CPC Class Codes: A61K 31/4164 1,3-Diazoles
• CPC Class Codes: A61K 9/0056 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 Class Codes: A61K 9/2072 characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms A61K9/0004, A61K9/0056, A61K9/0065 take precedence
• CPC Class Codes: A61K 9/2853 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
• CPC Class Codes: A61K 9/2866 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/288 Compounds of unknown constitution, e.g. material from plants or animals oils, fats, waxes, shellac A61K9/282
• CPC Class Codes: A61K 9/2886 having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer of the type active core-drug layer-inactive layer A61K9/209
• CPC Class Codes: A61K 9/2893 Tablet coating processes mechanical aspects A61J3/06
• CPC Class Codes: A61K 9/4825 Proteins, e.g. gelatin gelatin capsule shells with substantial amounts of other macromolecular substances A61K9/4816
• CPC Class Codes: A61K 9/4891 Coated capsules; Multilayered drug free capsule shells with drug coating for immediate release A61K9/4808; osmotic devices A61K9/0004
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system

Abstract

The invention relates to the use of a coating composition for application to a solid veterinary pharmaceutical composition for oral administration for the prevention and/or treatment of cardiac insufficiency in animals, by a method of film coating comprising a powder appetizing material, a binder and a solvent. The invention further relates to a coating method by film coating of solid veterinary pharmaceutical compositions for oral administration for the prevention and/or treatment of cardiac insufficiency in animals and appetizing medicaments for animals comprising a solid veterinary pharmaceutical composition for oral administration for the prevention and/or treatment of cardiac insufficiency in animals made from pimobendan and an appetizing coating arranged around said composition comprising an appetizing material and a binder.

Claims

1. A method of coating a solid veterinary pharmaceutical composition with a coating composition, the method comprising:

film-coating the solid veterinary pharmaceutical composition comprising at least one compound for treating cardiac insufficiency, with the coating composition,

wherein the coating composition comprises;

between 30 and 90% inclusive by weight of an appetizing material for a target animal, in pulverulent form, with respect to a total weight of binder and the appetizing material;

at least one binder selected from the group consisting of a polyvinyl alcohol polymer, a polyvinylpyrrolidone polymer, a copolymer of vinylpyrrolidone, a copolymer of vinyl acetate, polyvinyl acetate phthalate, a cellulose, a cellulose derivative, alginic acid, an alginic acid salt, zein, hyaluronic acid, a pectin, gum arabic, gum tragacanth, karaya gum, xanthan gum, a carrageenan, a pullulan polymer, an agar polymer, chitosan, a chitosan derivative, a carbomer, acrylic acid crosslinked with a polyalkenyl ether, a polycarbophil, a copolymer of methyl vinyl and of maleic anhydride, a nonionic polyoxyethylene/polyoxy-propylene block copolymer, a monosaccharide, a disaccharide, a polysaccharide, and a polyol;

it being understood that, when the binder comprises one or more mono-, di- and/or polysaccharides, a percentage by weight of the mono-, di- or polysaccharides represents 50% or less, of a total weight of binders;

at least one solvent selected from the group consisting of water, methanol, ethanol, isopropanol, propylene glycol, and glycerol;

and

wherein the solid veterinary pharmaceutical composition

is suitable for oral administration, and

is indicated for preventing and/or treating cardiac insufficiency in an animal.

2. The method of claim 1, wherein the solid veterinary pharmaceutical composition comprises pimobendan.

3. The method of claim 1, wherein the appetizing material is at least one selected from beer yeast, a meat meal, a fish meal, a powdered cheese, a milk derivative, and liver powder.

4. The method of claim 1, wherein the appetizing material comprises particles having a mean diameter of less than 500 μ

m.

5. The method of claim 1, wherein the coating composition further comprises:

at least one additive selected from a plasticizer;

a stabilizing agent;

a preservative;

a filler;

a surfactant;

a colorant, and a porogenic agent.

6. The method of claim 1, wherein the solid veterinary pharmaceutical composition is suitable for a domestic carnivorous animal.

7. The method of claim 6, wherein the domestic carnivorous animal is a dog or a cat.

18. The method of claim 2, wherein the appetizing material is at least one selected from beer yeast, a meat meal, a fish meal, a powdered cheese, a milk derivative, and liver powder.

19. The method of claim 1, wherein the appetizing material comprises particles having a mean diameter of less than 400 μ

m.

20. The method of claim 1, wherein the appetizing material comprises particles having a mean diameter of between 50 and 100 μ

m.

8. A process for preparing a solid veterinary pharmaceutical composition for oral administration coated with at least one appetizing material, the process comprising:

(1) applying to the solid veterinary pharmaceutical composition a layer of a coating composition comprising the at least one appetizing material for a target animal in a pulverulent form, a binder, and a solvent, to obtain a coated composition;

(2) drying the coated composition obtained in (1); and

(3) optionally, repeating (1) and (2);

to produce a solid veterinary pharmaceutical appetizing composition suitable for oral administration for preventing and/or treating cardiac insufficiency in an animal,

wherein the appetizing material represents at least 5% by weight of the solid veterinary pharmaceutical appetizing composition

and wherein the solid veterinary pharmaceutical composition;

prevents and/or treats cardiac insufficiency in an animal; and

comprises at least one compound for treating cardiac insufficiency.

9. The process of claim 8, wherein the solid veterinary composition comprises pimobendan.

10. The process of claim 8, wherein the solid veterinary pharmaceutical composition is a tablet, a compressed tablet, a hard gelatin capsule, a soft capsule, a pill, a lozenge, granules, a chewing gum, or a pastille.

11. The process of claim 10, wherein the solid veterinary pharmaceutical composition is a hard gelatin capsule.

12. The process of claim 8, wherein the solid veterinary pharmaceutical composition is scored.

13. The process of claim 8, further comprising, prior to (1),

(0) coating the solid veterinary pharmaceutical composition with a primer film from a solution or suspension comprising at least one binder and at least one solvent and/or acceptable additive.

14. A solid veterinary pharmaceutical appetizing composition, comprising:

a solid veterinary pharmaceutical composition comprising at least one active principle comprising a compound for treating cardiac insufficiency; and

a coating positioned around the solid veterinary pharmaceutical appetizing composition, which comprises;

an appetizing material in pulverulent form; and

at least one binder selected from the group consisting of a polyvinyl alcohol polymer, a polyvinylpyrrolidone polymer, a copolymer of vinylpyrrolidone, a copolymer of vinyl acetate, polyvinyl acetate phthalate, a cellulose, a cellulose derivative, alginic acid, an alginic acid salt, zein, hyaluronic acid, a pectin, gum arabic, gum tragacanth, karaya gum, xanthan gum, a carrageenan, a pullulan polymer, an agar polymer, chitosan, a chitosan derivative, a carbomer, acrylic acid crosslinked with a polyalkenyl ether, a polycarbophil, a copolymer of methyl vinyl and of maleic anyhydride, a nonionic polyoxyethylene/polyoxy-propylene block copolymer, a monosaccharide, a disaccharide, a polysaccharide, and a polyol;

it being understood that, when the binder comprises one or more mono-, di- and/or polysaccharides, a percentage by weight of the mono-, di- or polysaccharides represents 50% or less, of a total weight of binders,

wherein the coating comprising between 30 and 90% inclusive by weight of an appetizing material, with respect to a total weight of the coating,

an appetizing material represents representing at least 5% by weight of the solid veterinary pharmaceutical appetizing composition for oral administration,

the solid veterinary pharmaceutical appetizing composition is for oral administration and prevents and/or treats cardiac insufficiency in an animal.

15. The composition of claim 14, wherein the active principle of the solid veterinary pharmaceutical composition is pimobendan.

16. The composition of claim 14, suitable for a cat or a dog.

17. A method of manufacturing a solid veterinary pharmaceutical composition comprising pimobendan, the method comprising

combining pimobendan with contents within the solid veterinary pharmaceutical appetizing composition of claim 14.