Drug – bio-affecting and body treating compositions – Inorganic active ingredient containing – Heavy metal or compound thereof
Reexamination Certificate
2000-04-18
2001-07-10
Dees, Jose' G. (Department: 1616)
Drug, bio-affecting and body treating compositions
Inorganic active ingredient containing
Heavy metal or compound thereof
C424S405000, C424S439000, C514S859000, C514S861000, C514S863000, C514S925000, C514S928000, C514S931000, C514S934000, C514S937000, C514S938000, C514S969000
Reexamination Certificate
active
06258385
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to the use of electron active molecular crystals comprising tetrasilver tetroxide (Ag
4
O
4
) for the treatment and cure of dermatological conditions or diseases.
The present invention is related to concepts previously elucidated and disclosed in U.S. Pat. No. 5,336,499 (1994); U.S. Pat. No. 5,571,520 (1996) and U.S. Pat. No. 5,676,977 (1997). Said concepts have also been published in an article entitled “Silver (II, III) Disenfectants” (
Soap/Cosmetics/Chemical Specialties,
1994; March, pp. 52-59).
The aforementioned references disclose that said tetrasilver tetroxide devices kill and/or inhibit a wide variety of pathogens ranging from gram positive and negative bacteria (e.g.,
E coli
and
Staphylococcus aureus
), algae and mold (e.g., Chorella and
Candida albicans
) and the AIDS virus. Said references also contain detailed descriptions of the mechanism via which said molecular crystal devices operate. The instant inventor also presented his subsequent results and concepts at a Seminar entitled “Incurable Diseases Update” (Weizmann Institute of Science, Rehovot, Israel, Feb. 11, 1998). The title of his presentation was “Beyond Antibiotics, Non Toxic Disinfectants and Tetrasil Mademark of applicant for the tetroxide)”.
In the aforecited article it was shown that the effects of the electron transfer involved with respect to the tetroxide, phenomenally, rendered it a more powerful germicide than other silver entities. The instant inventor holds patents for multivalent silver anti microbials, e.g., U.S. Pat. No. 5,017,295 for Ag(II) and U.S. Pat. No. 5,223,149 for Ag (III); and while these entities are stronger anti microbials than Ag (I) compounds they pale by comparison to the tetroxide and so does colloidal silver which derives its germicidal properties from trace silver (I) ions it generates in various environments. Accordingly, the oligodynamic properties of these entities may be summarized as follows, which is referred to as the Horsfal series:
Ag
4
O
4
>Ag(III)>Ag(II)>>>>Ag(I)
The other unique property of the tetroxide was that it did not stain organic matter such as skin in like manner as Ag(I) compounds do. In addition, it was light stable.
The main object of this invention is to utilize tetrasilver tetroxide molecular devices to cure dermatological diseases or conditions.
Another object of this invention is to use tetrasilver tetroxide molecular devices to control those dermatological conditions or diseases which cannot be cured completely by said devices.
Still another object of this invention is to use tetrasilver tetroxide molecular devices to reduce the time of affliction of dermatological conditions or diseases.
Still another object of this invention is to utilize said devices in the aforesaid dermatological applications without staining the skin.
SUMMARY OF THE INVENTION
This invention relates to a molecular scale device comprising a single crystal of tetrasilver tetroxide (Ag
4
O
4
). Several trillion of these molecules may be employed in various pharmaceutical formulations and therapies to effectuate the treatment and cure of various dermatological conditions and diseases. These conditions and diseases vary and include eczema, psoriasis, dermatitis, disease induced skin ulcers, undefined tropical diseases, shingles, rashes, bedsores, cold sores, blisters, boils, herpes simplex, acne, pimples, skin chafing, cracking, itchiness, skin peeling, and warts.
More particularly, the invention relates to a method for treating dermatological skin disease comprising applying a composition comprising tetrasilver tetroxide directly to the affected skin areas, said composition being free of added oxidizing agent.
Even more particularly, the invention relates to a method for treating dermatological skin conditions selected from the group consisting of eczema, psoriasis, dermatitis, ulcers, shingles, rashes, bedsores, cold sores, blisters, boils, herpes, acne, pimples, skin chafing, cracking, skin itch, skin peeling and warts comprising applying tetrasilver tetroxide directly to the affected skin area.
DESCRIPTION OF THE INVENTION
The crystal lattice of the Ag
4
O
4
molecular device operates against pathogens by transferring electrons from its two monovalent silver ions to the two trivalent silver ions in the crystal contributing to the death of pathogens by traversing their cell membrane surface. This in effect “electrocutes” the pathogens. The electrons are forced out of their balanced crystals by such labile groups as NH, NH
2
, S—S and SH comprising pathogen cell membrane surface. However, normal cells will not be affected because they do not proliferate fast enough to expose these labile bonds.
The K
A
of Ag
4
O
4
is 7.9×10
−13
, therefore the molecule will not be disturbed unless more stable complexes are formed with such ligands as those comprising the pathogen cell membrane surface in a dynamic state. Indeed the end result of the electron transfer, which is a redox reaction, results in the monovalent Ag ions being oxidized to Ag(II) and the trivalent Ag ions being reduced to the same end product, Ag(II). Accordingly, the well-known affinity for monovalent silver for certain elements such as sulfur and nitrogen is far exceeded here, for divalent silver will not merely bind to these elements as does silver, but will actually form chelate complexes with their ligands. The molecular crystal attraction for the cell membrane surfaces is thus driven by powerful covalent bonding forces.
The electron transfer can be depicted by the following redox half reactions:
Ag
+
-
e
=
Ag
+
2
Ag
+
3
+
e
=
Ag
+
2
It was found by rigorous testing that silver tetroxide was comparatively non toxic. Since said oxide was effective at PPM concentrations in killing pathogens, commercial concentrates were formulated with 2% of the tetroxide. For acceptance of said oxide in commerce for which an EPA registration number was obtained (no. 3432-64), it was necessary for the oxide to undergo a series of toxicity tests, for which a 3% concentrate was used and evaluated by a certified laboratory employing good laboratory practice (GLP) according to the Code of Federal Regulations.
The results were as follows:
Acute Oral Toxicity
LD
50
Greater than 5,000 mg./Kg.
Acute Dermal Toxicity
LD
50
Greater than 2,000 mg./Kg.
Primary Eye Irritation
Mildly irritating
Primary Skin Irritation
No irritation
Skin Sensitization
Non Sensitizing
Subsequent evaluations showed that unless persons were prone to silver allergies, the pure tetroxide could be applied to the skin without any ill effects or evidence of irritation, despite the fact that said oxide is a powerful oxidizing agent. This can perhaps be explained by its stability manifested by its aforecited K
A
.
It was previously postulated in earlier patents relating to the various uses of the oxide that it was required to use it in combination with an excess of strong oxidizing agent such as a persulfate in order to effectively kill pathogens. However, the additional presence of oxidizing agent tends to be irritating to the skin. It has been found in accordance with the present invention that the additional oxide is unnecessary and in fact undesirable for the purpose of treating the skin diseases described herein. Therefore, the present invention contemplates application of the oxide to the skin in the absence of the additional oxidizer and the use of formulations which are free of added additional oxidizing agent such as a persulfate.
A preferred mode of application of the oxide of the invention is as a topical agent, either directly as a powder or in non-sprayable or sprayable form. Non-sprayable forms can be semi-solid or solid forms comprising a carrier indigenous to topical application and having a dynamic viscosity preferably greater than that of water. Suitable formulations include, but are not limited to, suspensions, emulsions, creams, ointments, powders, liniments, salves and the like. If desired, these may be sterilized or mixed with auxiliary agents, e.g., thix
Choi Frank
Dees Jose' G.
Marantech Holding LLC
Pennie & Edmonds LLP
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