Alimentary integrator

Drug – bio-affecting and body treating compositions – Inorganic active ingredient containing – Alkali metal or alkaline earth containing

Reexamination Certificate

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C424S717000, C426S072000, C514S023000, C514S474000, C127S029000, C536S001110, C549S315000

Reexamination Certificate

active

06416791

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to an alimentary integrator and a method which are particularly useful in treating or preventing diseases or conditions involving; degenerative forms, weakening of the immune system and stepped-up organic deterioration.
BACKGROUND OF THE INVENTION
It is a well-known fact that atmospheric and environmental (including electromagnetic) pollution, radiation in general, an irregular diet (with an excess of peroxidated food fats) and food alterations themselves (preservatives, genetically modified substances, etc.), cigarette smoke, prolonged emotional stress and immune and inflammatory reactions are a continual source of free radicals which cause damage to the organism on the cellular level by way of chemical oxidizations of lipids and proteins (oxidated stress). The same angiogenesis, triggering off a hyperoxygenation of the new cytoplasmatic capillary vessels is itself a source of oxidizing stress. The general effects thus produced in the organism are mainly the following: a weakening of the immune system; a stepped-up physiological organic deterioration, and the production of degenerative forms.
In this way biological, physical and chemical alterations are formed that can cause damage to the cellular membrane and to the DNA.
In fact, in the presence of oxidizing stress, the NA
+
—K
+
pump does not perform its task correctly and there occurs an imbalance of the four fundamental cations which are needed to maintain cellular functioning, namely sodium, potassium, calcium and magnesium.
Especially in the presence of degenerative diseases and in particular neoplastic forms. Sodium NA
+
(a prevalent cation in extracellular fluids) tends to substitute potassium K
+
inside the cell with a resulting serious imbalance find alteration of the NA—K pump.
It is known by Varmus et al. (“Genes and the Biology of Cancer”—Scientific American Library, 1993) that the production of degenerative forms is bound to an anomalous cellular behaviour deriving from oxidizing stress that can originate a monotonic polymerization, that is to say uncontrolled proliferation and growth. Although there are different types of degenerative pathologies, the processes that determine them look like the same.
In fact, the oxiding stress causes an imbalance in the concentration of K
+
and Na
+
cations and a malfunctioning, of the Na
+
—Ka
+
pump and consequent heavy loss of electrolytes not only in the Na—K pump but also in the concentration of the other electrolytes, i.e., calcium and magnesium. Said features were pointed out by Von Euler H. et al. (“Cancer biochemistry—La biochimica dei tumori.” Cap.II. pp. 78-84 Einaudi -Torino, 1945).
The importance of potassium in the regulation of cellular metabolism was pointed out by Dallaporta B. et al. (“Potassium leakage during the apoptotic degradation phase”. The Journal of Immunology, 1998, pp. 5605-5615), by Hughes F. et al. (“Intracellular K
+
Suppresses the Activation of Apoptosis in Lymphocytes”.—The Journal of Biological Chemistry, Vol. 272, n. 48, 1997, pp. 30567-30576) and by Bortner C. et al. (“Efflux in the Activation of Apoptosis”—The Journal of Biological Chemistry, Vol. 272, n. 51, 1997, pp. 32436-32442) relating to the cellular apoptosis and by Moran et al. (“Biochemistry” 2nd edition, Prentice Hall, Inc., 1994) relating the rule of co-factor of potassium in the enzymatic catalysis.
U.S. Pat. No. 4,760,138 to So et al. deals with carbonating agents for beverages and uses the calcium ion for medicinal or nutritive supplementation of calcium in the diet.
U.S. Pat. No. 5,424,074 to Koli et al. recognizes the need for potassium in the body, but offsets its deficiency and attendant adverse retention of sodium by a composition combining a magnesium compound with a potassium compound and both an effervescing agent and a neutralizing agent, desirably having ingredients that mask the objectionable taste of potassium.
U.S. Pat. No. 5,626,883 to Paul recognizes the need for ascorbic acid in the body and avoids the initial transitory suppression of human natural killer cells which occurs when ascorbic acid is administered alone, by combining a water soluble form thereof, such as ascorbic acid, niacinamide ascorbate or a metal ion salt of ascorbic acid, with a fat soluble ascorbyl ester and desirably also an ascorbic acid metabolite or precursor.
The aforesaid compound are composed from a very great number of components and their preparation isn't very simple.
SUMMARY AND OBJECTS OF THE INVENTION
A first aspect of the invention concerns an alimentary integrator which comprises a compound formed from potassium bicarbonate and an anti-oxidant agent comprising ribose, or ribose and I-ascorbic acid.
In one embodiment, the integrator comprises potassium ribosate formed from potassium bicarbonate and ribose, such as two, three, or four parts by weight of potassium bicarbonate and one part by weight of ribose.
The two components of the potassium ribosate may be in associated corresponding single dosage form, combinable at the time of use for obtaining an extemporary solution of the integrator.
In an alternative embodiment, the integrator comprises potassium ribose ascorbate formed from potassium bicarbonate, ribose and I-ascorbic acid, such as two or four parts by weight of potassium bicarbonate, one part by weight of I-ascorbic acid and an amount of ribose corresponding to 0.1-10%, especially about 2%, by weight of the sum of the weights of the potassium bicarbonate and I-ascorbic acid. The three components of the potassium ribose ascorbate may be in associated corresponding single dosage form, combinable at the time of use for obtaining an extemporary solution of the integrator.
Specifically, the alimentary integrator comprises a compound selected from potassium ribosate and potassium ribose ascorbate, such as wherein the potassium ribosate is formed from two to four parts by weight of potassium bicarbonate and one part by weight of ribose, or wherein the potassium ribose ascorbate is formed from two or four parts by weight of potassium bicarbonate, one part by weight of I-ascorbic acid and an amount of ribose corresponding to 0.1-10% by weight of the sum of the weights of the potassium bicarbonate and I-ascorbic acid. The two components of the potassium ribosate, or the three components of the potassium ribose ascorbate, as the case may be, may be in associated corresponding single dosage form, combinable at the time of use for obtaining an extemporary solution of the integrator.
A second aspect of the invention concerns a method of treating or preventing a potassium deficiency based disease or condition in a subject involving weakening of the immune system, stepped-up physiological organic deterioration or the production of cellular degenerative forms, by administering to the subject an effective amount of an alimentary integrator which comprises a compound formed from potassium bicarbonate and an anti-oxidant agent comprising ribose, or ribose and I-ascorbic acid. In particular, the integrator comprises potassium ribosate formed from potassium bicarbonate and ribose, or potassium ribose ascorbate formed from potassium bicarbonate, ribose and I-ascorbic acid.
Specifically, the method comprises administering to the subject an effective amount of an alimentary integrator which comprises a compound selected from potassium ribosate and potassium ribose ascorbate, such as wherein the potassium ribosate is formed from two to four parts by weight of potassium bicarbonate and one.part by weight of ribose, or the potassium ribose ascorbate is formed from two or four part s by weight of potassium bicarbonate, one part by weight of I-ascorbic acid and an amount of ribose corresponding to 0.1-10% by weight of the sum of the weights of the potassium bicarbonate and I-ascorbic acid.
The two components of the potassium ribosate, or the three components of the potassium ribose ascorbate, as the case may be, may be in associated corresponding single dosage form, combinable at the time

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