Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
2001-10-05
2004-04-06
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C424S439000
Reexamination Certificate
active
06716448
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention is broadly concerned with improved daily ration feed products for household pets including minor amounts of ivermectin. More particularly, the invention is concerned with such feed products, and methods of preparing the products, wherein the feeds contain a sufficient quantity of ivermectin so that when household pets consume the feeds on a daily basis, therapeutically effective amounts of ivermectin are established and maintained in the bloodstreams of the animals. In this way, conventional ivermectin dosing regimes are eliminated, and the pets receive proper quantities of ivermectin as a part of their normal diets.
2. Description of the Prior Art
Ivermectin is a known oral and injectable medication used as a wormer, heartworm preventative and to kill certain mites (mange). Ivermectin is a mixture of (10E,14E,16E,22Z)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-6′-[(S)-sec-butyl]-21,24-dihydroxy-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.1
4,8
.0
20,24
]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(perhydropyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-&agr;a-L-arabino-hexopyranosyl)-3-O-methyl-&agr;a-L-arabino-hexopyranoside and (10E,14E,16E,22Z)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6′-isopropyl-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.1
4,8
.0
20,24
]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(perhydropyran)-12-yl2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-&agr;a-L-arabino-hexopyranosyl)-3-O-methyl-&agr;a-L-arabino-hexopyranoside CAS: #70288-86-7
Ivermectin is conventionally provided in tablet form or for larger animals as pastes and injectable liquids. Generally, animals are treated with relatively large doses of ivermectin on a periodic basis. In the case of dogs and cats, tablets/chewables are given once a month by mouth year round for heartworm prevention. Higher doses are used to eliminate other parasites.
While ivermectin is generally considered safe at recommended dosage levels, if these are exceeded side effects such as tremors, staggering, dilated pupils, loss of body weight or death may occur. As a consequence of normal dosing regimes for ivermectin, the treated animals necessarily receive a relatively large quantity of the drug which is to remain effective for an extended period. This in turn means that shortly after treatment the animal has a very high concentration of ivermectin in its bloodstream, with this concentration tailing off during the remainder of the period. This is to be contrasted with a more preferable treatment protocol wherein a substantially constant level of ivermectin is maintained on a continuing basis.
U.S. Pat. No. 6,190,591 describes a single-extruder process for the production of controlled release particles which may be tableted. Various encapsulants including pharmaceuticals, nutraceuticals, nutritional compounds, biologically active components, flavorants, fragrances, detergents and surface-active compositions are described, at relatively large quantities in the particles of at least 1% and preferably from about 3-50%. Hence, the '591 patent is not concerned with complete feeds, but rather encapsulant particles. The process described in this patent make use of an elongated extruder where water and lipid are successively injected into the barrel, followed by water evaporation from the barrel and final addition of encapsulants. Such equipment is generally not suited to the production of a daily ration feed or similar product, given the need to uniformly distribute an active in the latter type of product.
There is accordingly a need in the art for improved feeds providing ivermectin to domesticated household pets in a manner which will avoid periodic, relatively large ivermectin doses and maintain a substantially constant level of ivermectin in the bloodstreams of the treated pets.
SUMMARY OF THE INVENTION
The present invention overcomes the problems outlined above and provides improved ivermectin-containing daily ration feed products for domesticated household pets such as cats and dogs, and methods of preparing such feeds. Generally speaking, the feeds of the invention are produced by extrusion and contain respective quantities of protein, fat and starch, together with a relatively minor amount of ivermectin. Through use of the feed products of the invention, a household pet consuming the feeds on a daily basis receives a maintenance quantity of ivermectin, so that the therapeutic effects thereof are realized. Normally, the ivermectin should be present in the extruded feeds at a level of at least about 2 &mgr;g/kg of feed product, more preferably from about 2-1500 &mgr;g/kg of feed product, and most preferably from about 5-1000 &mgr;g/kg of feed product. In other types of products within the ambit of the invention, the ivermectin may be present at a level of up to about 0.75% by weight, more preferably up to about 0.5% by weight, and still more preferably up to about 0.1% by weight. Preferably, the ivermectin content of the feeds should be maintained for a period of at least about six months, more preferably at least about nine months, and most preferably from about nine to twenty-four months, at ambient temperature storage conditions.
A wide variety of extruded feeds can be used in the context of the invention. For example, typical dry extruded product having a moisture content of less than about 10% by weight can be produced with added ivermectin. Similarly, semi-moist feeds having a moisture content on the order of 15-30% by weight are also suitable. In extruded feeds of these types, it is preferred that the ivermectin content be substantially uniformly dispersed throughout the feed. Alternately, pillow-type feeds can be produced having a soft, flowable matrix center surrounded by a shell of self-sustaining feed material; in such a case, the ivermectin content may be present only in the soft center matrix. In most cases, the feed products of the invention should contain from about 5-15% by weight moisture (wet basis), 15-30% by weight protein, more preferably from about 18-25% by weight protein; from about 3-24% by weight fat, more preferably from about 5-20% by weight fat; and from about 5-80% by weight starch, more preferably from about 20-50% by weight starch. Generally, the extruded feeds should have a bulk density of from about 30-700 g/l, more preferably from about 140-400 g/l, and a water activity of from about 0.1-0.99, more preferably from about 0.6-0.75.
An important goal of the invention is to provide ivermectin-containing daily ration feeds which when consumed on a daily basis by household pets will establish and maintain a therapeutic amount of ivermectin in the bloodstreams of the animals. In this way, the need for periodic dosing with relatively large amounts of ivermectin is completely avoided, yet the beneficial effects of the drug remain. To this end, the feeds should have sufficient ivermectin therein so that, when a domesticated household pet consumes the feed at a rate of from about 10-40 g of the feed per kg of the consuming pet's weight, the desired therapeutic amount of ivermectin is achieved.
During extrusion processing in accordance with the invention, starting farinaceous feed ingredients are fed into the elongated barrel of an extruder including at least one elongated, axially rotatable, helically flighted screw with an endmost extrusion die. During passage through the extruder barrel, the ingredients are subjected to elevated temperature, agitation and shear in order to cook the product. In preferred forms of the invention, the starting ingredients are first preconditioned prior to passage into the extruder barrel. Generally, during preconditioning the starting mixture is subjected to a temperature of from about 20-98° C. (more preferably from about 90°-97° C.) for a period of from about 15-600 seconds (more preferably from about 170-190 seconds). The purpose of precon
Cabrera Francisco A.
Huber Gordon R.
Jones David R.
Kuenzi John C.
Kuenzi Kevin D.
Hovey & Williams, LLP
Howard Sharon
Page Thurman K.
Rubicon Scientific LLC
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