Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form
Reexamination Certificate
1998-03-30
2002-10-29
Webman, Edward J. (Department: 1617)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
C424S452000, C424S465000
Reexamination Certificate
active
06471969
ABSTRACT:
The invention relates to a two-phase preparation for use at differential times containing a product A for the first phase and a product B for the second phase which comprise, independently of each other, at least one representative of the unsaturated fatty acids and/or at least one representative of the group of trace elements and minerals and/or at least one representative of the group of vitamins and/or at least one representative of the group of bioactive plant substances, e.g. polyphenoles, bioflavonoids or dietary fiber, and/or at least one amino acid and/or amino acid derivative, product A and/or product B optionally additionally containing soy lecithin, with the proviso that product A and product B differ from each other in their quantitative and/or their material composition. The preparation can be used as a food supplement (dietary supplement) or as a drug.
In particular, the invention relates to a two-phase preparation for use at differential times comprising a product A and a product B which include, independently of each other, at least one representative of the unsaturated fatty acids, one representative of the group of trace elements and minerals and one representative of the group of vitamins, product A and/or product B optionally additionally containing soy lecithin, and/or at least one representative of the group of bioactive plant substances and/or at least one amino acid and/or amino acid derivative which is used as a food supplement (dietary supplement).
It is generally known that the nutrients carbohydrates as well as the dietary fats are mainly used to cover the body's energy requirement. Proteins are important building components for cells and endogenous active substances such as enzymes and certain hormones. Polyunsaturated fatty acids, vitamins, minerals and trace elements as well as bioactive plant substances such as flavonoids are becoming more and more important for health and fitness.
Vitamins, minerals and trace elements, polyunsaturated fatty acids and bioactive plant substances such as flavonoids are essential regulators in the metabolism and nutrients protecting health. However, a one-sided diet, stringent weight reduction diets, preference of high-calorie foods of low nutrient density and the high degree of processing of many foods but also the partial impoverishment of the soils with respect to important minerals make an optimal supply with all the necessary nutrients difficult. In addition, due to adverse environmental effects, smoking, consuming alcohol and medicaments as well as stress, there is an increased demand of some essential nutrients, for example magnesium, zinc, vitamin E, vitamin C, B-type vitamins and beta carotene. A food complementary nutrient substitution therefore contributes to a sufficient supply of nutrients, an optimal protection of health and well-being, as does a well-balanced nutrition which is high-roughage and low-fat. The reference “Empfehlungen für die Nährstoffzufuhr” [Recommendations for the supply with nutrients], Deutsche Gesellschaft für Ernährung, 5th edition, 1991, Umschau Verlag, Frankfurt/Main, describes recommendations for the body's supply with nutrients.
Vitamins are essential nutritional components which are more or less indispensable for the normal body functions of heterotroph organisms and which have to be supplied as required since they are only available either from outside sources or under the influence of milieu factors (e.g. intestinal flora). Their specific biocatalytic effect is to replace the active component of enzymes which is subject to metabolical consumption. From science it is for example known that B-type vitamins participate in the intermediary metabolism as coenzymes and that vitamins C, E and beta carotene mainly function as antioxidants. A deficiency due to an insufficient supply or resorption, a disorder of the intestinal flora or the metabolism, the effects of antivitamins or an increased consumption lead to hypovitaminosis and avitaminosis.
Furthermore, minerals and trace elements are essential regulators in the metabolism. Calcium is the most important mineral building substance for bones and teeth. A sufficient supply of calcium up until the age of 30 is the best protection against osteoporosis during old age. After that, sufficient food calcium ensures that the depot in the bones is not unduly strained. For women calcium is often a critical nutrient. Zinc, magnesium and B-type vitamins are high-performance elements which activate enzymes and thus allow the metabolism of carbohydrates, fats and proteins. Silicon favorably contributes to the stability and maintenance of skin, hair and nails. Furthermore, it is scientifically undisputed that zinc fulfills an essential function in the body's immune system and the skin metabolism.
Polyunsaturated fatty acids from purely vegetal sources such as for example evening primrose oil and linseed oil, contain linolic acid and &agr;- and &ggr;-linolenic acid, which are important starting substances for biologically active regulators, as for example eicosanoids and prostaglandins, and ensure a healthy equilibrium in the metabolism. Eicosanoids and prostaglandins, also referred to as tissue hormones, are currently being studied extensively by scientists for their health stabilizing effects. The favorable effect of polyunsaturated fatty acids on the cholesterol metabolism and healthy skin function as well as on inflammatory processes is known. It is furthermore known that polyunsaturated fatty acids of the type of &ohgr;-3 (icosapentenoic acid, &agr;-linolenic acid) and &ohgr;-6 (linolic acid, &ggr;-linolenic acid) fatty acids have a favorable effect on migraine, rheumatism, neurodermatitis, psoriasis, premenstrual syndrome and regeneration processes induced by physical strain during exercise (cf. A. Berg, D. König, H. Schlachter, J. Keul,
Deutsche Zeitschrift für Sportmedizin
[German Magazine of Sports Medicine], Volume 44 (1993), Special Issue, and literature cited therein).
Carrot, broccoli and citrus extracts are natural sources of vitamins and minerals and contain the so-called secondary plant substances, which are also referred to as bioactive plant substances in the special branch of science whose significance has been recognized and is now being examined as well. These natural plant substances also include bioflavonoids which effectively support the impact of vitamin C with respect to the power of resistance, the vascular walls and the connective tissue. It is also known that bioflavonoids have antioxidant properties and therefore synergistically complement the effect of vitamins C, E and beta carotene. Green tea as well is an excellent source of these vegetal antioxidants (e.g. polyphenols) (cf. B. Watzl, C. Leitzmann
Bioaktive Substanzen in Lebensmitteln
[Bioactive substances in foodstuffs], Hippokrates Publishing House, Stuttgart, 1995).
In addition to their function as building blocks for proteins, amino acids are precursors of biologically effective compounds, for example serotonin, growth and stress hormones. They are also said to have anticatabolic properties (cf. in this connection K. R. Gei&bgr;, M. Hamm
Handbuch Sporternährung [Handbook of sports nutrition], Rowohlt Publishing House,
1992).
A great number of food supplements are commercially available which contain individual vitamins (e.g. vitamin E preparations) or combinations thereof (e.g. multivitamin preparations) and/or individual minerals and trace elements (e.g. magnesium or iron preparations) or combinations thereof (e.g. multimineral capsules). There are also preparations with polyunsaturated fatty acids alone or in combination with vitamins and minerals. For example, a preparation may contain many different vitamins and some selected minerals which cover the daily requirement of these nutrients.
Another commercially available preparation is characterized as a supplementary balanced diet for covering a specific increased demand of essential nutrients, in particular in view of a purpose-specific nutrit
Hamm Michael
Schlachter Herbert
Birch & Stewart Kolasch & Birch, LLP
Webman Edward J.
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