Multilayer tablet

Details Multilayer tablet Multilayer tablet

1998-09-11

2001-07-03

Dudash, Diana (Department: 1619)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Tablets, lozenges, or pills

C424S472000, C435S252100, C435S252900, C435S255200

Reexamination Certificate

active

06254886

ABSTRACT:

The invention relates to multilayer tablets which are constructed of two, three or more layers, one layer containing probiotic micro-organisms, while the other layers contain foodstuff ingredients valuable in nutritional physiology, such as vitamins, minerals, etc. The tablets are distinguished by a high stability and/or efficacy over a long period with respect to the micro-organisms used and are thus very well suited for keeping in storage.
Many people, in particular in the economically and industrially highly developed countries, often complain about temporary or chronic digestive symptoms, caused by a damaged or disordered intestinal flora. The causes of these “affluent society disorders” are usually stress situations, medicaments or drug abuse, sequelae of antibiotic treatments or alternatively very often false nutrition. Acute and drastic symptoms can be treated using known pharmaceuticals which can comprise not only suitable pharmaceutical active ingredients but also appropriate natural enzymes or intestine-specific micro-organisms.
In the case of constant, slight disorders of the intestinal tract not directly to be described as illness, however, even the regular consumption of suitable, specially chosen foodstuffs or nutritional supplement preparations based on micro-organisms is often sufficient to alleviate or to eliminate the symptoms which cause a disordered or damaged intestinal flora. However, even in the case of intact or healthy intestinal flora, the supply of probiotic micro-organisms, in particular in connection with antioxidants, can lead to immunostimulating action.
Yoghurt and sour milk products for these reasons are also enjoying increasing popularity. Most of these products valuable for nutrition, which contain suitable micro-organism cultures for the purpose mentioned, are, however, fresh goods and can thus only be stored with cooling and even then only for a few days.
Products which offer the appropriate micro-organisms as a monopreparation are not permissible as a foodstuff or foodstuff supplement in many countries, because they do not contain any substances valuable in nutritional physiology, such as minerals, fats, vitamins, carbohydrates, proteins, bulk materials or trace elements, such as are present precisely in adequate amounts in foodstuffs.
Moreover, it was found that dry preparations based on probiotic micro-organisms positively stimulating the intestinal flora, in particular if they contain foodstuff additives of the abovementioned type, are extremely unstable with respect to their content of biologically active micro-organisms. Even in products which exclusively contain appropriate cultures without such additives, in some cases after only short periods dramatic losses of live micro-organisms would be found (“Probiotics, the Friendly Bacteria”; Heath Which?, 1997, 134).
It was thus the object to make available preparations in the foodstuffs sector, in particular for the constantly growing market “functional food”, which on the one hand contain an adequate amount of foodstuff ingredients valuable in nutritional physiology, such as vitamins, minerals, bulk materials, etc., but on the other hand contain a large number of probiotically active micro-organisms stabilizing the intestinal flora, which remain stable despite these additives.
This object was achieved by the provision of a multilayer tablet for the foodstuffs sector. In this tablet, the probiotic micro-organisms are made available in a separate layer. The other foodstuff additives are present in a further layer or a number of other layers. Surprisingly, the stability of the probiotic micro-organisms in the tablets according to the invention is often even higher than in the known preparations which are not permissible under foodstuffs law, which exclusively contain probiotic cultures.
The invention thus relates to a multilayer tablet for the foodstuffs sector, which within a carrier material contains substances valuable in nutritional physiology, and which is characterized in that it consists of at least two separate layers, in one layer exclusively probiotic micro-organisms being present.
Layer tablets having three layers are particularly advantageous. It has turned out as a matter of fact that even with respect to the stability of the other additives, which can be substances of different type, which are more or less sensitive and have a mutual effect, or interfere, such as, for example, vitamins (e.g. &bgr;-carotene, vitamin C, vitamin B complex), proteins, sugar alcohols having a reducing action (e.g. sorbitol, mannitol), oxidation-sensitive enzymes or coenzymes or else alternatively physiologically active plant extracts, good results are obtained with multilayer tablets. By means of the multilayer construction of the tablets according to the invention, it is thus possible not only to markedly increase the stability and storability of the micro-organisms used, but also that of the other substances which are prone to instability on interaction with one another. The invention thus relates to a corresponding three-layer tablet. However, tablets having three or more layers, i.e., for example, three, four or five layers, are also possible.
The prerequisite for good stability with respect to the number of live and active micro-organisms in the tablet according to the invention, apart from the multilayer construction of the tablet (where the micro-organisms are present in a separate layer without any other of the foodstuff additives mentioned), is the necessity that the said layer, in particular the carrier material used, in which the micro-organisms are embedded, has a water content of not more than 0.1%.
This can be brought about by drying the carrier material very carefully before mixing with the micro-organism culture (as a rule at 100-120° C. over a period of at least 60 minutes). The invention thus relates to a corresponding multilayer tablet, which is characterized in that the water content of the probiotic layer is at most 0.1%.
Carrier materials, or a tablet base, used for the individual layers are the substances customary for tablets and coated tablets, which are well known in the prior art, i.e., for example, the following compounds, providing, according to the country in which the tablets are used, they are permissible under foodstuffs law: starch (e.g. maize starch), talc, microcrystalline cellulose, lactose, highly disperse silica, polyvinylpyrrolidone or cellulose powder. Other constituents of the tablet base (e.g. binders and disintegrants) which can also be employed are, for example, carbohydrates, such as mannitol, sorbitol, xylitol, glucose, sucrose, fructose, maltose, dextrose, maltodextrin, kaolin or cellulose derivatives such as methylcellulose, hydroxypropylcellulose or hydroxypropylmethylcellulose, as well as calcium carbonate, calcium, magnesium or glyceryl stearate and also colourants and flavourings. The proportionate composition of these base substances depends on the one hand, of course, on the desired content of actual active substances, such as micro-organisms, vitamins, enzymes, bulk materials etc., and on the other hand on criteria which determine the mechanicophysical properties of the tablet or of its layers, such as, for example, hardness, compressibility, size, shape etc.
In most cases, the proportion of the carriers and auxiliaries mentioned (e.g. lubricants and release agents, aromatic substances, colourants, flavourings, stabilizers, antioxidants) is between 1 and 80% based on the total tablet, which according to the invention has a mass of between 0.5 and 1.5 g, preferably approximately 1 gramme. The proportion of the auxiliaries is 1 to 20%.
The amount of the micro-organisms which are employed in tabletting typically according to the invention is between 10
8
and 10
10
active micro-organisms per tablet. A lower content of cultures no longer guarantees the desired effect on the intestinal flora. The construction and the manner of production of the tablets according to the invention ensure that losses of live cultures are barely to be observed

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