Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Specially adapted for ruminant animal
Reexamination Certificate
1993-02-01
2001-10-23
Bawa, Raj (Department: 1619)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Specially adapted for ruminant animal
C424S482000, C424S442000, C424S451000, C424S469000, C424S484000, C424S485000, C424S488000, C514S965000
Reexamination Certificate
active
06306427
ABSTRACT:
The present invention relates to a process for the incorporation of active principles (i.e., active ingredients) into pellets and pellets made by such a process. It relates more particularly to the preparation of “special pellets” containing active principles protected against the enzymes of the rumen of ruminants, and optionally containing active ingredients unprotected with respect to degradation in the rumen. It also relates more particularly to the preparation of pellets intended for incorporation into the feed of ruminants.
“Pellet” means a nutrient unit or granule for animals obtained either by extrusion of a feed mixture through a die or by alternative pelletization techniques. Pellets are preferably in the form of rods, preferably cylindrical in shape, and have average sizes preferably from about 4 to 100 mm in length, more preferably 4 to 20 mm in length, and preferably from about 2 to 30 mm in diameter, more preferably 4 to 10 mm in diameter. These pellet sizes are preferred because they are easy to handle and administer and because they are not dust-forming.
The present invention is capable of solving the prior art problems associated with the incorporation of “granules” containing medicinal or nutritional compounds into “pellets” intended for incorporation into animal feed. These granules are incapable of undergoing conventional pelletization techniques due to sensitivity to temperature, pressure and shearing.
Pelletizing machines permit shaping by forcing a feed mixture through a perforated plate or die in the presence of steam. A feed mixture is passed through a perforated plate or die by means of a press. The press forces the feed mixture to be extruded through the holes in the perforated plate. On emerging from the perforated plate, the cylinders of feed mixture obtained are cut spontaneously or by a mechanical means. During the forced passage of the feed mixture through the die, products having low thermal resistance or mechanical strength undergo degradation due both to the pressure exerted and to the heat formed by friction and/or by the addition of steam. Steam promotes cohesion of the various meal or grain (floury) ingredients of the base feed mixture.
The problem has already been addressed in various earlier references. Among these earlier references is European patent application number EP 231,817 which describes a process for preparing “agglomerated feeds” based on vitamins or on compounds essential to human or animal health. Compounds having low thermal resistance or mechanical strength are often mixed with molasses and then undergo the action of steam in order to effect their cohesion and shaping. When these compounds undergo an increase in temperature during passage through pelletizing machines, they are at least partially destroyed due to the simultaneous action of steam and pressure.
EP 231,817 attempts to solve this problem in manufacturing such agglomerated feeds by spraying a solution or suspension of one or more vitamins, one or more drugs, and optionally a fat, onto a base core. This process only permits a coating of the base substance with the solution or suspension. This process is easy to carry out when using pulverulent or liquid products, such as vitamins or drugs. These products are easy to use in the form of a solution or suspension. However, the same does not apply when the product takes the form of larger agglomerated nutrient granules. When the material sensitive to heat and/or compression takes the form of granules having an average diameter of approximately 0.3 to 5 mm, as in the granules included in the pellets of the present invention, the aforementioned process is not easy to carry out.
French publication FR 2,338,653, describes a process for preparing feed-stuffs, onto which an enzyme suspension, preferably of proteases, in a liquid or molten fat, is sprayed. This process, similar to that taught in the European application referred to above, obtains “pellets” onto which the temperature-sensitive substance is deposited at the periphery by a spraying technique.
The problem which the present invention is capable of solving is to provide medicinal and/or nutritional additives, sometimes referred to herein as active principles or ingredients, which cannot be destroyed in the rumen of ruminants, in “special pellets” which are directly assimilable by the animals. The present invention also solves the problem of forming pellets directly assimilable by ruminant animals which contain medicinal and/or nutritional additives, such as amino acids and vitamins, protected against degradation in the rumen or paunch combined with such nutritional or medicinal additives present in an unprotected form.
The pellets of the invention are also capable of being mixed with conventional animal foodstuffs or ruminant feed pellets, whereby a homogeneous mixture of the pellets and conventional ruminant feed is maintained without separation.
In particular, the present invention provides pellets for use in the nutritional or medicinal supplementation of ruminants, each of the pellets comprising: granules of protected active principle, each of the granules having an average diameter of 0.3 to 5 mm and each of the granules comprising an active principle selected from vitamins, amino acids and drugs and a protective agent which protects the active principle from degradation in the rumen of ruminants, the granules of protected active principle being admixed with a binding agent capable of being solubilized, crosslinked or melted to form the pellets, the pellets being of a size, density and shape such that the pellets can be homogeneously maintained in admixture with conventional ruminant pellet feed, i.e., the pellets are miscible in all proportions with the conventional pellet feed. The pellets of the invention may also contain an active principle which is not protected from degradation in the rumen of ruminants.
Examples of the active-ingredient additives protected against degradation in the rumen include amino acids such as methionine and lysine, vitamins and also other nutritional or medicinal additives.
It is known that some amino acid supplementation is essential in the feeding of ruminants since some amino acids are limited in the ruminants' normal daily nutritional intake. These limited amino acids include methionine and lysine. These substances, when administered orally to ruminants, are destroyed in the rumen by the action of the digestive enzymes and microorganisms present in this organ. It has been discovered that, for the compounds to be utilizable by the animal and beneficial thereto, they must pass through the rumen without damage and disintegrate in or after the abomasum, so that the active substance may be released in the intestine and passed into the body. The product to be administered is protected with a substance which makes it capable of passing through the rumen without substantial damage but which allows disintegration in or after the abomasum.
Known coating compositions include a combination of a substance sensitive to pH variations, particularly a substance selected from synthetic basic copolymers, with at least one hydrophobic substance which may be selected, for example, from fatty acids or their derivatives and hydrophobic polymers. Such compositions are described in French Patents FR 78/23,966 (2,401,620), FR 78/23,968 (2,401,621) and FR 81/18,954 (2,514,261).
The main groups of coating agents include copolymers of vinylpyridine and styrene with a hydrophobic substance, preferably stearic acid and/or a water-insoluble polymer, for example ethylcellulose.
The group of coating agents involving enzymatic digestion includes chitosan and/or zein, combined with a hydrophobic substance, preferably stearic acid, and optionally a water-insoluble polymer, preferably ethylcellulose.
The granules which include protected active principles take the approximate form of spherical particles having a mean diameter of between about 0.3 and 5 mm, preferably 0.5 to 3 mm, particularly about 2 mm. Granules of this size are not conducive to being spra
Annonier Claude
Autant Pierre
Laffay Jean-Claude
Porte Hugues
Ruel Jacques
Bawa Raj
Finnegan Henderson Farabow Garrett & Dunner L.L.P.
Rhone-Poulenc Nutrition Animale
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