Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Capsules
Reexamination Certificate
2000-07-27
2002-04-09
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Capsules
C424S489000, C424S439000
Reexamination Certificate
active
06368621
ABSTRACT:
I claim priority under 35 U.S.C. § 119 for European application Nr. 99810681.9-2114 which is hereby incorporated by reference in its entirety and for all purposes.
The invention relates to a preparation according to the preamble of claim
1
, in particular for the use as a medication and/or as a food supplement.
The human body relies on the supply of a series of essential substances which it is not in the position to synthesise itself. There is a risk of an under-nourishment of these substances with an insufficient or one-sided food intake. In spite of a sufficient and balanced food intake, an undersupply of certain substances may occur under certain stress situations. Stress situations occur to the first degree with particular physical exertion, such as for example with serious sports, or also during pregnancy and breastfeeding.
Also during pregnancy and breastfeeding there are a series of substances which are necessary for the healthy development of the child and for the health of the mother. One of the most important substances from the class of vitamins has been shown to be folic acid. As medical studies show there is a clear connection between folic acid deficiency symptoms and the feared neural tube defect with newborn children, such as e.g. published by R. D. Williams, FDA Consumer, May 1994, page 11-12 and O. Tönz, Schweizer Apothekerzeitung, 1996, 17, pages 424-426.
More recent trials indicate the conclusion that a sufficient supply of polyunsaturated fatty acids in free form and/or as glycerides is likewise not to be neglected during pregnancy and breastfeeding
Polyunsaturated fatty acids can belong to three different families which differ by way of the position of the first double bonding, calculated from the methyl end of the fatty acids. In medical studies
&ohgr;-3-polyunsaturated fatty acids (linolenic acid family);
&ohgr;-6-polyunsaturated fatty acids (linoleic acid family) and
&ohgr;-9-fatty acids have shown to be physiologically important.
The polyunsaturated fatty acids of the &ohgr;-3 and &ohgr;-6 type are precursors for forming important tissue hormones such as e.g. prosetaglandine or leukotriene. Several independent studies render the conclusion that a higher intake of polyunsaturated fatty acids from the &ohgr;-6 and &ohgr;-3 series improves the sharpness of vision of newborn children and generally encourages the infant brain development. With this, 5,8,11,14-eicosatetranoic acid and docosahexaenoic acid as metabolites of linoleic and linolenic acids appear to play a particular role (D. Kunze, 49. DGF Annual Meeting on 01.09.1993 in Karlsruhe).
The female body by way of pregnancy is subjected to an increased oxidative stress. Oxidative stress is indicated as an increased activity of free radicals. This may either be caused by way of a higher production of free radicals or by way of the undersupply of protective anti-oxidatively acting substances. Amongst other things the increased oxidative stress in vivo is held to be responsible for the pregnancy-induced high blood pressure, as cited in S. J. Wisdom, R. Wilson, J. H. McKillop, J. J. Walker, Am. J. Obstet, Gynecol., 12/1991, page 1701-1704. In particular in pregnancy there exists the requirement for anti-oxidatively acting substances.
The term antioxidant agents is to be understood as organic compounds which inhibit or prevent the undesired changes in other substances caused by the effect of oxygen and other oxidative processes. Tocopherols, carotinoids, tocotrienols, ascorbic acids, selenium, polyphenols, flavonoides, flavones are known as radical scavengers or participate closely with the respiratory chain and thus protect the functional and structural intactness of lipids and other important substances such as blood, biomembranes and cell contents.
Iron has a particular importance with regard to minerals and trace elements. The iron requirement of mother and child is an important factor of prenatal and postnatal health on account of the build-up of special foetal haemoglobin, whose conversion after birth serves in filling the iron store in kidney and liver.
Bivalent iron salts—in the oral administering form—are to be seen as the most effective iron intake substances. The degree of iron uptake is however relatively small. In order to ensure a sufficient bio-availablity the administering of high quantities of iron salts is often necessary. High quantities of iron salts and in particular the free iron ions arising by way of dissociation leads to incompatibility reactions such as sickness, vomiting and diarrhea or constipation. Trivalent iron salts as iron suppliers are practically ineffective since in the intestines they break down into iron oxide or iron hydroxides.
A further problem which is linked to the administering of Fe(II) are lipid-peroxidation processes of unsaturated fatty acids which apart from other causes also run their course under the catalytic effect of iron (II). By way of the lipid peroxidation there arise mutagenic and carcinogenic substances such as e.g. &agr; and &bgr; unsaturated aldehydes. However also damage to cell membranes and other cell components may be led back to these oxidisation processes.
Anti-oxidant agents act as radical scavengers with lipid peroxidation procedures and in this manner may end chain reactions. On the other hand the substances used as radical scavengers change themselves with the “neutralisation”. In any event this is not desirable in the case that vitamins as essential substances are to be supplied to the body.
The auto-oxidation of unsaturated fatty acids in the presence of oxygen and catalysts plays a decisive and in its effects not desired role when fats or oils become rancid (S. Ullmann's Encylopedia of Industrial Chemistry, Eds. L. Kandy, J. F. Rounsville, G. Schulz, 5
th
ed., Vol A 10, pages 190 onwards., 1987). This process is encouraged or accelerated by the presence of metal catalysts.
In particular, free fatty acids and volatile carbonyl compounds such as e.g. aldehydes and keto-compounds arising by way of the auto-oxidation are responsible for the unpleasant accompanying taste and odour of aged fat.
The primary products formed by auto-oxidation, such as hydroperoxides, the acid number and the number of volatile carbonyl compounds, in particular the aldehydes, serve as a measurement parameter and for fixing limit values for the storage and manufacture.
The formulation of a preparation which contains a combination of polyunsaturated fatty acids in free or chemically bonded form and physiologically effective iron salts, in particular iron (II) salts, is for reasons of the reactivity of the substances and the instability of such preparations resulting therefrom burdened with great difficulties and has until now not been realised.
The object of the present invention is the avoidance of disadvantages of the state of the art.
In particular it is the object to combine physiologically effective iron-containing compounds with unsaturated fatty acids in a free or chemically bonded form into a preparation without there occuring a considerable reduction of the physiological effectiveness of one or both components. The combination should be possible without preceding complicated protective steps such as e.g. a micro-encapsulation of individual or of all components.
A further object lies in the preparation of a storage-stable, multi-component preparation which apart from physiologically effective iron-containing compounds and unsaturated fatty acids in free and/or chemically bonded form further contains physiologically effective components, and in particular is used for manufacturing a medication and/or a food supplement for the prevention and treatment of deficiencies.
These objects are achieved by the characterising features of patent claim
1
.
In particular they are achieved by a preparation which contains at least one physiologically effective iron complex and at least one unsaturated fatty acid in free and/or chemically bonded form.
“Physiologically effective” is to be understood in that the iron complex on the one hand does not create any or
Engel Dieter
Kokkinis Georg
Bennett Rachel M.
Meyer Jerald L.
Nath Gary M.
Nath & Associates PLLC
Page Thurman K.
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