Orally-administered dosage form for animals, preparation method

Details Orally-administered dosage form for animals, preparation method Orally-administered dosage form for animals, preparation method

1996-08-01

1997-11-04

Page, Thurman K.

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Particulate form

424494, 424495, 424497, 424498, A61K 914

Patent

active

056837224

DESCRIPTION:

BRIEF SUMMARY
The present invention relates to a dosage form designed to allow the oral administration of chemical or medicinal substances, such as vitamins, trace elements, amino acids, nutritive substances, vaccines, and the like, to domestic or wild animals.
The present invention also relates to the method for producing the said dosage forms.
Systems which allow the oral administration of medicaments to domestic animals or to animals reared intensively, or to wild animals, which are difficult or dangerous to restrain, are already known.
Such systems are the subject of patent applications or patents (Patent EP 0 240 826, Patent EP 0 208 528 and Patent Application EP 0 421 863).
The bait described in Patent EP 0 240 826 is obtained by a first casting, at the bottom of the mould, of a support, comprising a lipid compound (having a melting point of between 20.degree. and 60.degree. C.), a compound designed to stabilize the shape of the bait and an attractive and palatable compound for the animals, introducing the active substance on the solidified support layer, and then a second casting of the said support, so as to cover completely the said active substance.
The system has the disadvantage of exhibiting low mechanical strength and brittleness in the vicinity of the junction of the two castings and makes it unsuitable for large-scale distribution methods (aerial release, for example, for treating large numbers of wild animals, over large areas).
Patent EP 208 528 describes a bait for fish and crustacea consisting essentially of a water-insoluble polymer having a melting point of less than 110.degree. C. (polyamides or ethylene copolymers, EVA, in particular), of an attractive substance and of edible oil or of molasses (0 to 20%).
The bait according to this Patent EP 208 528 are obtained by extrusion at 90.degree.-110.degree. C. of a dry mixture of the polymer, the attractive substance and optionally the edible oil.
International Application WO 89/12393 describes pesticidal compositions comprising EVA, a bioactive agent, a source of proteins/sugars/lipids and optionally 0 to 20% edible oil, an attractive substance, a colorant, a preservative, a repelling agent and a biomarker.
The compositions according to this International Application PCT WO 89/12393 may be in the form of blocks or of tablets and are also prepared by extrusion of the abovementioned composition, either by melting the polymer (capable of melting at a temperature<110.degree. C.) followed by the mixing of the latter with the other ingredients, or by heating, up to the melting point of the polymer, a mixture of all the ingredients in a dry form.
Patent Application EP 421 863 describes systems comprising two parts: an envelope in tubular form, obtained by extrusion and comprising at least one attractive substance, at least one agglomerating substance (polysaccharides, starches or polymers such as EVA) and optionally a hydrophobic substance (oil) and inside the cavity of the envelope, a binding substance (mixture of fatty substances having a melting point which is not too high) containing an active ingredient, the binding substance taking the internal shape of the envelope. Such an envelope has a high mechanical and thermal strength which allows, in particular, distribution by aerial release.
The compositions or systems of the prior art are generally designed such that they have a good resistance to handling and to shocks and/or good attractiveness for animals, facilitating the effective consumption of the active ingredient(s) included in these systems.
However, in general, the compositions described in these documents do not allow the active ingredients a residence time in the buccal cavity sufficient to ensure the efficacy of some drugs or when it is essential to obtain a certain contact time, especially for certain treatments. Furthermore, they do not ensure for the active ingredients sufficient stability, in particular those of biological origin.
Application EP 458 751 describes a system comprising a central core comprising cyclic amino acids, a first

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