Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Ester doai
Reexamination Certificate
2001-07-09
2003-05-27
Killos, Paul J. (Department: 1625)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Ester doai
C514S570000, C514S573000
Reexamination Certificate
active
06569900
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to fulvic acid and its use in the treatment of various conditions.
Humic substances are ubiquitous in nature and arise from the decay of plant and animal residues in the environment (MacCarthe et al. 1990). These substances can be divided into humic acid, fulvic acid and human on the basis of the solubility in water as a function of pH. Fulvic acid is the fraction that is soluble in water under all pH conditions and is in general lower in molecular size and weight and lower in colour intensity than humic acids.
Humic substances commonly account for 50% of the dissolved organic carbon concentrations in stream water, of which 90 to 95% are fulvic acids. Humic acids are 3 to 5 times more abundant in soils than fulvic acids (Stevenson, 1982), whereas fulvic acids are 9 to 10 times more abundant in water than humic acids (Malcolm, 1985).
Humic acids have been successfully used in the treatment of:
(i) hyperacidity and other gastric disturbances in humans (Reichert, 1966, Gramsch, 1961)
(ii) inflammation (Salz 1974, Motohisa et al., 1974)
(iii) anemia and hypercholesterolemia (Soloveyva and Lotosh 1984)
(iv) Von Willebrand disease (Lopez-Fernandez et al., 1992)
The possible application of fulvic acid in the treatment of human and animal diseases has, up to now, not been investigated.
Wang et al (1996) studied the interaction between fulvic acids and active oxygen free radical and found fulvic acids from peat were able to scavenge both superoxide and hydroxyl radical. It has also been shown that fulvic acids prevent the absorption of mutagens through the rat small intestine using a highly mutagenic furanone found in chlorinated water and an in vitro everted rat gut sac system (Clark and Chipman, 1995).
Although the presence of fulvic acids in the drinking water of certain parts of China has been coupled to the incidence of Kashin-Beck disease, this only occurred in conjunction with a selenium deficient diet (Peng and Xu, 1987).
U.S. Pat. Nos. 4,999,202 and 5,204,368 disclose compositions having bacterial and bacteriostatic properties containing a fulvic acid, salt or derivative thereof as the active ingredient. These compositions are described as being useful as disinfectants.
SUMMARY OF THE INVENTION
According to one aspect of the invention, there is provided a pharmaceutical composition comprising a fulvic acid, salt, ester or derivative thereof as the active ingredient.
The pharmaceutical composition may be provided for oral or topical administration to a subject.
In the case of topical administration, the composition may be provided in the form of a solution, paste, ointment, powder or any other form suitable for topical administration.
The subject may be a human or an animal.
Further according to the invention, there is provided the use of a fulvic acid, salt, ester or derivative thereof, in the treatment of a condition of a subject. The condition may, for example, be inflammation, acne, eczema or bacterial or fungal or viral infections.
The treatment of the condition may be by oral or topical administration.
The subject is typically a human or an animal.
The fulvic acid is preferably a fulvic acid derived from a wet coal oxidation process of the type described in U.S. Pat. No. 4,912,256. Such a fulvic acid is hereinafter referred to as “oxifulvic acid or OFA”.
Bergh et al. (1997) identified almost 50 different compounds, most of which were carboxylic acids, in oxifulvic acid. The compounds were mostly ordinary physiological metabolites with no evidence of any toxic compound in the product mixture.
A typical functional group analysis of oxifulvic acid is given below:
Total acid groups: 11.5-15.5 meq/g
Carboxylic groups: 8.5-12.5 meq/g
Phenolic groups: 2.3-3.7 meq/g
In an example of the invention, a composition for topical application to a human or animal Comprises 4.5 percent, or 9.0 percent, by mass of oxifulvic acid in an aqueous cream.
REFERENCES:
patent: A1097990 (1995-02-01), None
patent: A1213665 (1999-04-01), None
patent: A1-2850685 (1980-06-01), None
patent: A2244215 (1991-11-01), None
patent: A6087752 (1994-03-01), None
patent: A11009674 (1999-01-01), None
patent: A1-9749288 (1997-12-01), None
Dekker Johannes
Medlen Constance Elizabeth
Birch & Stewart Kolasch & Birch, LLP
Enerkom (Proprietary Limited
Killos Paul J.
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