The present invention relates to an oral composition in the form of a combined iron-bacteria preparation, which is particularly intended for treating animals, especially young animals. The invention relates also to a method of producing the composition.

In the production of domestic animals, primarily pigs and calves, it is known that the young animals are often attacked by intestinal infections, so-called enteritis. Intestinal infections of this kind are particularly troublesome since the animals are afflicted within a short period after birth. Mortality is great in newly born, animals, particularly pigs, usually 10-20%, but not seldom substantially greater. The losses to animal producers are estimated at hundreds of millions of crowns yearly, as a result of piglet mortality in Sweden alone. A major cause of this mortality is the mentioned intestinal infections. The newly born animal is born with sterile intestines, but already takes up bacteria at its first contact with its surroundings. Certain types of these bacteria are useful, and will come to be a part of the normal intestinal flora, whereas other types are injurious and can give rise to different forms of illness. The lactic acid-producing bacteria are a part of the normal intestinal flora and may be regarded as useful, and of these the most usual are the lacto-bacillae and the streptococci. In a normal intestinal content, which may be said to be dominated by lacto-bacillae, there is a great number of lactic acid- producing bacteria. On the other hand, when the intestinal flora is deficiently and unhealthily composed, the number of lactic acid-producing bacteria is usually low. The type of bacteria which first becomes established appears to be of very great importance to the newly born animal. If the

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intestinal content is dominated to a suitable extent by lactic acid-producing bacteria from the start, an injuriou form of intestinal flora can seldom be developed to a troublesome extent. One method of preventing the develop- ment of defective intestinal flora is to treat the animal with antibiotics. Such a method is not desirable, however, since it can easily ^* lead to the development of resistance in pathogenic organisms. Another method is that of vaccina tion, which, can seldom give permanent positive results in livestock.

It is known that a culture of lactic acid-producing bacter may be administered to the animal immediately after birth, thereby artificially guiding the development of the in- tes inal flora in a desired direction. Such preparations are generally given orally in the form of solutions. An example of such preparations is the Swedish "L-i-mun". From practical experience it has been found that the pro- fylactic effect e.g. of "L-i-mun" is very good.

Another not inconsiderable problem in bringing up livestoc is that the young animal is usually afflicted by anaemia caused by iron deficiency. The rate of growth after birth in a young animal, such as a piglet, or calf, is generally high, and one result of this is that its iron requirement is greater than when it is mature. To avoid the often fateful anaemia condition, the young animal is conventiona ly dosed with some iron preparation, since the iron conte in its fodder during this time is not usually available to cover its extra needs, especially during the suckling peri i.e. during the very first days of its life. The necessary iron treatment is generally given in the form of injection or as a solution via the mouth.

Oral dose administration in animals, e.g. piglets, is usually carried out in the following manner: The piglet is held with one hand, the mouth being opened by a finger of the same hand. With the other hand the preparation in question is squirted from a spray bottle directly into the pharynx of the piglet. The quantity of liquid is usually 2 ml, irrespective of the type of treatment. A disadvantage of treating animals such as piglets by per-or administration is that the treatment is relatively laborious, and the need of using more than one kind of preparation, e.g. iron preparations and bacteria suspensions, increases the labour involved to a corresponding extent.

A condition for good results being obtained with a bacteria preparation is that the bacteria are alive when the preparation is squirted into the mouth of the animal. Such preparations are therefore usually made up so that they must first be dissolved in water and then used within a definite, and usually short time. This is the case with "L-i-mun" preparation for example. Iron preparations, e.g. for piglets, are usually sold in the form of preserved solutions or as injection solutions.

Since the treatment of young animals with a bacteria suspension as well as with an iron preparation is of the upmost importance for the animal effectively to ward off anaemia and other sicknesses, it is also highly desirable to simplify the administration of the preparations, and - the most obvious way of doing this is by putting the active components from different preparations together into one composition. Such a combined preparation must furthermore have certain definite attributes such as simple handling, general compatability to the animal (no components which -

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can be unsuitable for it) and a sufficiently long shelf life.

A combination of a soluble iron compound and a suitable bacteria preparation in the form of a simple mixture is not viable, however, since soluble iron compounds are usually very toxic to bacteria. After the solution of such a preparation in water, the number of living bacteria in the solution tapers off very rapidly, and thus does not enable the inplantation of an appropriate bacteria culture in the animal.

The present invention solves the above mentioned problems by both prophylactic bacteriological treatment and the iron treatment being carried out with a so-called combina¬ tion preparation. The advantage herewith is that treatment with the combination preparation is very much cheaper and less laborious than separate treatments with single prepa¬ rations. Furthermore, since the composition in accordance with the invention, is non-aqueous, there is solved the problem of the bacteria dying on the addition of water.

The invention thus relates to an oral composition in the form of a combined iron-bacteria preparation, particularly intended for treating animals, including a bacteria con¬ centrate and at least one iron compound, allowing appropri¬ ate resorption in the animal, the composition being charac¬ terized in that said ingredients are incorporated in a non- aqueous ointment base containing hydrofobic substances and possibly conventional agents such as preserving agents etc.

The invention also relates to a method of producing said composition, characterized in that the bacteria concentrate and at least one iron compound allowing appropriate resorp-

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tion in- the animal, possibly together with conventional agents such as preserving agents and the like, are dis¬ persed in a non-aqueous ointment base containing hydro¬ fobic substances, the dispersion being suitably carried out in a dispersion mill.

Suitable iron compounds are those of dextran, sulphate, tartrate, citrate, gluconate, malate, lactate or mixtures thereof.

According to a preferred embodiment of the invention, the bacteria concentrate comprises lactic acid-producing bacteria.

As examples of hydrofobic substances which have been found to provide excellent results may be mentioned fats, particularly coconut fat and lards. Since the hydrofobic substances must be accepted orally, they must naturally be non-toxic and edible. The use of hydrofobic substances in the ointment base eliminates any tendency of the bacteria to disperse, thus ensuring in that the administra¬ ted dose retains its strength without any mortality of the bacteria.

T e use of an ointment-like substance combining an iron preparation as well as a bacterial preparation for per-or administration must be regarded as completely surprising to one skilled in the art, since the conventional use of ointments has always been cutaneous.

The combination preparation in accordance with the in¬ vention has been found to have many valuable properties, heightening in a surprising manner the technical value of the preparation in relation to other known preparations.

It has thus been found that the combination preparation ha a very good shelf life, even at temperatures which normall destroy a bacterial preparation. Furthermore, the prepara¬ tion is completely resistant to moisture and air, which otherwise are disastrous for both iron and bacteria pre¬ parations of known kinds. The consistency of the prepara¬ tion, resulting from its character of an ointment, prevent the animal from ejaculating the given dose, which is very usual, e.g. with per-orally administered solutions.

In field experiments-, an entirely unexpected effect has furthermore been established, this effect being that the bacteria additive facilitates the ability of the animal to take up iron. This leads, inter alia, to an increased myoglobin production in the muscle structure and thereby to better development.

A non-restrictive embodiment of a preparation in accordance with the invention is provided below by way of illustratio and was produced starting from the following ingredients: Bacteria concentrate in powder form containing 1x10 living bacteria (cells)per gram ready preparation:

2,0 g

Iron dextran: 60 g Mixed fats: 48 g

Starch: 8 g

Milk powder: 4 g

Suitable quantity of antitoxicant, e.g. Ξ vitamin:

0,1 g The ingredients were dispersed in a mill until a creamy ointment was obtained. 1 g of this preparation contained

9 1x10 living bacteria and 200 mg iron.

The preparation thus produced is suitably packaged in a

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possibly transparent tube, which may suitably be graduated Per-oral administration is carried out so that the animal' mouth is opened whereon a squeeze of the tube causes the desired amount to be pressed out. Since the preparation is a fatty ointment, there is also the advantage that it clings to the mouth of the animal, particularly on the teeth and in the pharynx, the animal then having great difficulty in getting rid of it. When the animal sub¬ sequently consumes fodder, the preparation automatically accompanies the fodder into the stomach and can exercise the desired functionwithout having become deteriorated. This form of dosing is furthermore very easy to administer Other per-oral forms of treatment are obvious to one skilled in the art, as well as other modifications and variations of the invention, which is only restricted by the following claims.

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