WO2001049303A1 - Multivalent electron active compositions and methods of making and using same - Google Patents
Multivalent electron active compositions and methods of making and using same Download PDFInfo
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- WO2001049303A1 WO2001049303A1 PCT/US2000/029116 US0029116W WO0149303A1 WO 2001049303 A1 WO2001049303 A1 WO 2001049303A1 US 0029116 W US0029116 W US 0029116W WO 0149303 A1 WO0149303 A1 WO 0149303A1
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- oxide
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Definitions
- the present invention relates to electron active compounds and compositions that have polyvalent cations in their crystal lattices.
- the present invention also includes a method of making such electron active compounds.
- the present invention also relates to methods for the prevention, treatment, or management of conditions, or symptoms thereof, by administering one or more such compounds or compositions. 0
- Tetrasilver tetroxide has been demonstrated to possess unique properties arising from electrostatic concepts of metal cation interaction. Such silver molecules have also been disclosed for various uses, as they are reported to be non-toxic to animals and 5 humans. M. Antelman, "Anti-Pathogenic Multivalent Silver Molecular Semiconductors,” Precious Metals, vol. 16:141-149 (1992); M. Antelman, “Multivalent Silver Bactericides,” Precious Metals, vol. 16:151-163 (1992).
- tetrasilver tetroxide activated with an oxidizing agent is disclosed for use in bactericidal, fungicidal, and algicidal use, such as in municipal and industrial water treatment applications and for the treatment of AIDS.
- a variety of sources also report the use of certain divalent silver compounds for water treatment, as well as the use of such compounds, typically in combination with certain oxidizing agents, metals, or other compounds, as disinfectants, bactericides, algicides, and fungicides.
- One source also reports a single in vitro study of the use of such compounds for the treatment of AIDS.
- These sources include M. Antelman, "Silver (II, III) Disinfectants," Soap/Cosmetics/Chemical Specialties, pp. 52-59 (Mar., 1994), and U.S. Patent Nos. 5,017,295; 5,073,382; 5,078,902; 5,089,275; 5,098,582; 5,211,855; 5,223,149; 5,336,416; and 5,772,896.
- U.S. Patent No. 5,336,499 discloses tetrasilver tetroxide and persulfate compositions having certain in vitro anti-pathogenic properties, i.e., bactericidal, fungicidal, Q viricidal, and algicidal, in certain concentrations as low as 0.3 ppm, particularly in nutrient broth cultures.
- the persulfate is disclosed as being an oxidizing agent that activates the tetroxide crystals.
- U.S. Patent No. 5,571,520 discloses the use of molecular crystals of tetrasilver tetroxide, particularly with oxidizing agents to enhance the efficiency of such devices, for killing pathogenic microorganisms, such as staph infections. Amounts of 10 ppm sodium persulfate as an oxidizing agent were used with certain amounts of silver tetroxide in the reported in vitro testing. One human study involved in vivo curing of a gynecological yeast infection with 10 ppm of the silver tetroxide and 40 ppm sodium persulfate.
- U.S. Patent No. 5,676,977 discloses intraveneously injected tetrasilver tetroxide crystals used for destroying the AIDS virus, AIDS synergistic pathogens, and immunity suppressing moieties (ISM) in humans.
- the crystals were formulated for a single injection at about 40 ppm of human blood.
- This reference also discloses the compositions cause hepatomegaly, also known as enlarged liver, albeit with no reported loss of liver function.
- Another property of the tetrasilver tetroxide is that it does not stain organic matter such as skin in like manner as Ag(I) compounds do. In addition, it is light stable.
- Bi(_H, V) oxide synthetic routes for making Bi(_H, V) oxide are detailed and reviewed in Gmelins Handbuch Der Anorganischen Chemie, vol. 16:642 (1964). Also, Co(II,III) oxide, Fe(II,III) oxide, Mn(II,III) oxide, and Pr(HI,IV) oxide can all be found in nature. These five multivalent metal oxides are also all available commercially.
- the present invention relates to pharmaceutical compositions that include a therapeutically effective amount of at least one electron active compound, or a pharmaceutically acceptable derivative thereof, that has at least two polyvalent cations, at least one of which has a first valence state and at least one of which has a second, different valence state.
- the pharmaceutical composition may have antipathogenic efficacy.
- the at least one electron active compound includes a metal oxide.
- the metal oxide includes at least one of bismuth, cobalt, copper, iron, manganese, praseodymium, or a combination thereof.
- the metal oxide includes at least one of Bi(IILN) oxide, Co(II,III) oxide, Cu(I,III) oxide, Fe(II,III) oxide, Mn(II,IH) oxide, Pr(III,_N) oxide, or a combination thereof.
- the metal oxide can include Ag(I,III) oxide.
- the pharmaceutical composition does not include tetrasilver tetroxide.
- the pharmaceutical composition does not include tricobalt tetroxide.
- the pharmaceutical composition may include at least two different electron active compounds.
- the compound may be in powder or granular form.
- the first valence and the second valence of the at least two polyvalent cations differ by at least 1, preferably by 1 or 2. In another preferred embodiment, the first valence and the second valence of the at least two polyvalent cations differ by more than 2.
- the electron active compound has at least one polyvalent cation which has an EMF 0X of at least about + 0.1 Volts.
- the amount of the at least one electron active compound is present in an amount from about 1 ppm to 500,000 ppm, based on the weight of the composition.
- the pharmaceutical composition can include a pharmaceutically acceptable carrier.
- the composition can also include an oxidizing agent, preferably present in an amount sufficient to enhance the efficacy of the active compound but insufficient to cause skin irritation.
- the oxidizing agent includes a peroxy acid salt of a persulfate.
- the at least one compound has antimicrobial efficacy, preferably of at least about 20%. In another embodiment, the antimicrobial efficacy is at least about 50%. In yet another embodiment, the antimicrobial efficacy is at least about 80%. In these embodiments, about 100 ppm of the at least one compound is placed in contact for about 10 minutes with microbes having a cell density of approximately 75,000 CFU/mL.
- an aspect of the present invention is a pharmaceutical composition
- tetracopper tetroxide compound contains two copper(I) ions, two copper(III) ions, and four oxygen atoms in a crystal lattice.
- Another aspect of the present invention is a method of preventing, treating, or managing a condition of a patient which includes administering a therapeutically effective amount of at least one of the electron active compounds described herein, or a pharmaceutically acceptable derivative thereof, to prevent, treat, or manage the condition, oi a symptom thereof.
- the method excludes tetrasilver tetroxide.
- the patient is a mammal, preferably, a human.
- the electron active compound(s) can be administered topically, parenterally, or transdermally, preferably in an amount from about 5 ppm to 500,000 ppm, based on the weight of the composition.
- at least two different electron active compounds are administered.
- the method can include administering one or more additional different therapeutic agents, present in an amount sufficient to facilitate the prevention, treatment, or management of the condition.
- the one or more additional therapeutic agents may optionally be administered concurrently with the electron active compound(s).
- Another aspect of the present invention relates to a method of facilitating the killing of a pathogen which includes administering a therapeutically effective amount of at least one electron active compound, or a pharmaceutically acceptable derivative thereof, that has at least two polyvalent cations, at least one of which having a first valence state and at least one of which having a second different valence state.
- the present invention also involves a method of inhibiting the growth of a pathogen which comprises administering a therapeutically effective amount of at least one electron active compound, or a pharmaceutically acceptable derivative thereof, that has at least two polyvalent cations, at least one of which having a first valence state and at least one of which having a second different valence state.
- these methods exclude the administration of tetrasilver tetroxide.
- the pathogen can include a gram-positive bacillus or coccus; a gram-negative bacillus or coccus; an acid-fast bacterium; another type of bacterium; a fungus; a parasitic microbe; a virus; or a combination thereof.
- Tetracopper tetroxide containing two copper(I) ions, two copper(III) ions, and four oxygen atoms, is one preferred electron active compound, while the administration of tetrasilver tetroxide for treating certain conditions is excluded.
- the present invention relates to a process for preparing tetracopper tetroxide, which includes: combining a copper(I)-containing compound and a caustic solution to form a reactant solution; and heating the reactant solution to a temperature and for a time sufficient to produce a detectable amount of the tetracopper tetroxide compound.
- the copper(I)-containing compound includes a non- solvated inorganic copper(I) oxide, such as cuprous oxide.
- the caustic solution generally contains a strong caustic base and a peroxy acid salt.
- the strong caustic base includes a hydroxide salt
- the peroxy acid salt includes a persulfate.
- condition should be understood to refer to a traditionally identified disease, as well as a disorder, an affliction, or an ailment, particularly including those noted herein.
- prevent refers to stopping or hindering a condition, symptom, or pathogen causing a condition, in a patient who is at risk of suffering from such a condition. This also includes reducing the frequency or severity, or both, of the occurrence of such conditions or one or more symptoms thereof.
- the terms “manage,” “managing,” and “management,” as used herein, includes controlling those conditions which cannot be cured completely, reducing the time of affliction of such conditions, and the like.
- the compositions prevent, treat, or manage such conditions without superficially discoloring the skin, i.e., no discoloration to the naked eye.
- the invention relates to the treatment or management, while in another embodiment the invention relates to the prevention, of the diseases or conditions disclosed and claimed herein.
- the terms also include the use of the compounds or compositions of the invention to facilitate the halting, diminishing, or inhibiting of the growth or proliferation of pathogens that may accentuate, amplify, exacerbate, or cause, either directly or indirectly, a condition and/or a symptom thereof.
- patient refers to animals, particularly to mammals. In one preferred embodiment, the term patient refers to humans.
- adverse effects include, but are not limited to, cardiac arrhythmia, cardiac conduction disturbances, appetite stimulation, weight gain, sedation, gastrointestinal distress, headache, dry mouth, constipation, diarrhea, drug-drug interactions, superficial discoloration of the skin, dry skin, hepatomegaly, fever, fatigue, and the like.
- cardiac arrhythmia includes, but is not limited to, ventricular tachyrhythmia, torsades de pointes, Q ⁇ prolongation, and ventricular fibrillation.
- terapéuticaally effective amount when used herein in connection with the compositions and methods of the invention, means that amount of electron active metal oxide compound(s) or composition(s), or a derivative thereof, which, alone or in combination with other drugs, provides a therapeutic benefit in the prevention, treatment, or management, of a condition.
- the effective amount is one or more metal oxide compounds or compositions as the sole active ingredient. Different therapeutically effective amounts may be applicable for each condition, as will be readily known or determined by those of ordinary skill in the art.
- substantially free means less than about 10 weight percent, preferably less than about 5 weight percent, more preferably less than about 1 weight percent, and most preferably less than about 0.1 weight percent.
- a composition may be substantially free of added oxidizing agent or of added persulfate according to the invention.
- valence state means at least about 75%, preferably at least about 90%, more preferably at least about 95%, most preferably at least about 99%.
- valence state should be understood to refer to the charge on a given ion or to the charge that may be assigned to a given ion based on its electronic state.
- inhibitor when referring to growth of an item, should be understood to refer to the act of stopping that growth, whether permanently or temporarily, or of reducing the rate of that growth, either permanently or temporarily.
- the tetrasilver tetroxide compounds mentioned in the background are one type of electron active compound having multivalent cations in its crystal lattice.
- Various additional electron active compounds have now also been identified, as well as methods for making and using the same for treating various pathogenic and non-pathogenic conditions or disorders.
- the electron active compounds of the present invention are believed to have unique crystal structures in that, in the case of the metal oxides, there are generally atoms of the same element in the crystal that have at least two different valences, typically at least one lower-valent metal cation and at least one higher-valent metal cation, for example, such as Co(II) and Co(III), respectively.
- Exemplary electron active metal oxide compounds according to the invention include, but are not limited to, Ag(I,III), Co(II,III), Pr(III,lN), Bi(III,N), Fe(II,III), Mn(II,III), and Cu(I,III) oxides.
- Tb(III,IN) oxide, Tb 4 O 7 , or tetraterbium heptoxide is one electron active metal oxide compound according to the invention.
- pharmaceutical compositions including one or more of such oxide compounds are useful for treating various conditions.
- the composition of such exemplary electron active metal oxides is shown in tabular form below: « e - total number of electrons believed to be exchanged; # - number of particular ion type per formula unit.
- the electron active compounds operate against pathogens by transferring electrons between their lower-valent ions and their higher-valent ions in the crystal, thereby contributing to the death of pathogens by traversing their cell membrane surface. It would seem that this, in effect, 5 "electrocutes" the pathogens. While these compounds have also been discovered to be suitable for use in the prevention, treatment, and management of other non-pathogenic conditions and disorders, such as autoimmune disorders, circulatory disorders, neurological disorders, and the like, the mechanism by which such conditions or disorders are prevented, treated, or managed has not yet been fully understood.
- the electrons in 0 proximity to pathogens are believed to be perturbed from their balanced crystals by such labile groups as ⁇ H, ⁇ H 2 , S-S, and SH, which can be present, for example, in a pathogen cell membrane. It is believed, however, that normal cells will not be significantly affected because they do not proliferate rapidly enough to expose these labile bonds sufficiently for the bonds to be substantially affected. 5
- the crystals in the electron active compounds are not believed to be disturbed unless more stable complexes are formed with ligands, for example, such as those comprising a pathogen cell membrane surface in a dynamic state.
- ligands for example, such as those comprising a pathogen cell membrane surface in a dynamic state.
- the end result of electron transfer which is a redox reaction, results in the lower-valent metal ions being oxidized to one valence state higher and the higher-valent metal ions being reduced to one 0 valence state lower.
- the oxidation of the lower-valent metal ions and the reduction of the higher-valent metal ions both result in ions having the same oxidation state.
- Examples of such an embodiment occur when the valence difference between the metal ions in the electron active molecular crystal is 2 and such examples include, but are not limited to, Ag(I,III), Bi(IIIN), and Cu(I,HI) oxides.
- the oxidation of the lower-valent metal ions and the reduction of the higher-valent metal ions result in ions having opposite oxidation states ⁇ e.g., ions with a +2 valence state are oxidized to +3, while the ions with a +3 valence state are reduced to +2).
- Examples of such an embodiment occur when the valence difference between the metal ions in the electron active molecular crystal is 1 and such examples include, but are not limited to, Co(II,III), Fe(II,i ⁇ ), Mn(II,III), and Pr(III,IN) oxides.
- the metal ion of certain electron active compounds may exhibit a distinct affinity for certain elements of ligands, for example, such as sulfur, oxygen, or nitrogen, particularly when present in a pathogen's cell membrane. In many cases, the metal ion will not merely bind to these elements, but will actually form chelate complexes with their ligands.
- the classic example of this is Ag(I,III) oxide, the monovalent silver ion of which has an affinity for sulfur and nitrogen and the oxidized/reduced divalent ion of which forms chelate complexes with, for example, mercapto or amino groups.
- the electron active compound attraction for the cell membrane surfaces, for example, of pathogens is believed to be driven by powerful electrostatic forces.
- the electron exchange may be depicted, for example, by the following series of redox half reactions:
- EMF 0X the voltage potential when oxidizing the higher-valent ion in the metal oxide crystal.
- EMF 0X the voltage potential when oxidizing the higher-valent ion in the metal oxide crystal.
- EMF 0X the voltage potential when oxidizing the higher-valent ion in the metal oxide crystal.
- EMF 1 ⁇ the electromotive force
- the affinity of the metal ion for sulfur affects EMF 1 ⁇ .
- the stability of a particular metal sulfide is an approximation of the affinity of a metal ion for sulfur.
- the following approximate association constants for sulfides indicate the trend in relative affinity of each metal ion for sulfur:
- the voltage that is discharged from a redox reaction of the electron active metal oxides of the present invention is the combination of the oxidation and reduction potentials ⁇ i.e., EMF ox - EMF 5 ). In the case of tetrasilver tetroxide, the "electrocution voltage” is 2.92 volts.
- the oxidation potentials, EMF 0X of exemplary metal oxides according to the present invention are tabulated below: Formula Metal cations EMF 0X
- iron-, cobalt-, and copper- based oxides are believed to be stronger antipathogenic agents or to form better pharmaceutical compositions than manganese-, bismuth-, and iron- based oxides, and in one embodiment they are preferred for this reason. Nevertheless, in certain cases, iron exhibits stronger antipathogenic characteristics, particularly antimicrobial characteristics, compared to manganese.
- Staphylococcus aureus bacteria in a culture having a cell density of 30,000 CFU/mL, exhibit significant mortality from exposure to 100 ppm of Bi(III,V) oxide for about 10 minutes, but no significant mortality from exposure to the same concentrations of Fe(II,III) and Mn(II,IH) oxides for the same contact time.
- This result might be explained by the far greater stability of bismuth(III) sulfide, and thus the far greater affinity of bismuth(i ⁇ ) for sulfur, than either of the iron(II) or manganese(II) analogs.
- the electron active metal oxide compounds and compositions of the present invention may be used in any form which sufficiently retains their antipathogenic character, or other non-pathogenic ability, to prevent, treat, or manage one or more of the conditions noted herein.
- these compounds or compositions may be used as antipathogenic agents, such as antimicrobial, antibacterial, antiviral, or anti-algal agents, or a combination thereof.
- the compounds or compositions may be used for preventing, treating, and/or managing various conditions that are non-pathogenic.
- non- pathogenic conditions are believed to include certain autoimmune disorders, neurological disorders, and circulatory disorders. While the exact mechanism of the activity of such compounds or compositions is not described herein, nonetheless, suitable prevention, treatment, and/or management of such non-pathogenic conditions may be obtained by administering the compounds or compositions of the invention as described herein and as will be readily apparent to one of ordinary skill in the art.
- compositions and methods of the invention advantageously prevent, treat, or manage dermatological diseases or conditions.
- the conditions against which the electron active compounds, such as metal oxides, of the present invention have utility include, but are not limited to, Madura foot, actinomycosis, oral actinomycosis, anthrax, food poisoning, botulism, wound infections, pseudomembranous colitis, colitis, gas gangrene, gangrene, tetanus, diphtheria, pharyngeal diphtheria, pleomorphic laryngeal diphtheria, cutaneous diphtheria, endocarditis, bacteremia, urinary tract infections, listerosis, meningitis, miscarriage, narcodiosis, acne, skin lesions, abscesses, toxic shock syndrome, prosthesis contamination, dental caries, plaque, gum disease, gingivitis, subacute endocarditis, bacterial pneumonia, otitis, sinusitis, cat scratch fever,
- the condition includes HIV (AIDS), or one or more symptoms.
- HIV HIV
- the invention includes the use of the compounds or compositions to prevent, treat, or manage each of these conditions individually or multiple conditions concurrently or sequentially.
- the prevention, treatment, or management of each condition should be understood as a separate embodiment.
- the pathogens which may be killed by, or the growth or proliferation of which may be halted, diminished, or inhibited by, the electron active metal oxides of the present invention include, but are not limited to, gram-positive bacilli and cocci; gram- negative bacilli and cocci; acid-fast bacteria; other bacteria; fungi; parasitic microbes, e.g., protozoa; and viruses. Examples of gram-positive bacilli and cocci include, but are not limited to,
- Actinomedurae Actinomyces israelii, Bacillus anthracis, Bacillus cereus, Clostridium botulinum, Clostridium difficile, Clostridium perfringens, Clostridium tetani, Corynebacterium, Enter ococcus faec ⁇ lis, Listeria monocytogenes, Nocardia, Propionibacterium acnes, Staphylococcus aureus, Staphylococcus epiderm, Streptococcus mutans, Streptococcus pneumoniae, and combinations thereof.
- Examples of gram-negative bacilli and cocci include, but are not limited to, Afipiafelis, Bacteriodes, Bartonella bac ⁇ lliformis, Bortadella pertussis, Borrelia burgdorferi, Borrelia recurrentis, Brucella, Calymmatobacterium granulomatis, Campylobacter, Escherichia coli, Francisella tularensis, Gardnerella vaginalis, Haemophilius aegyptius, Haemophilius ducreyi, Haemophilius influenziae, Heliobacter pylori, Legionella pneumophila, Leptospira interrogans, Neisseria meningitidia, Porphyromonas gingivalis, Providencia sturti, Pseudomonas aeruginosa, Salmonella enteridis, Salmonella typhi, Serratia marcescens, Shi
- acid-fast bacteria examples include, but are not limited to, Myobacterium avium, Myobacterium leprae, Myobacterium tuberculosis, and combinations thereof.
- Examples of other bacteria not falling into the other three categories include, but are not limited to, Bartonella henseiae, Chlamydia psittaci, Chlamydia trachomatis, Coxiella bumetii, Mycoplasma pneumoniae, Rickettsia akari, Rickettsia prowazekii, Rickettsia rickettsii, Rickettsia tsutsugamushi, Rickettsia typhi, Ureaplasma urealyticum, Diplococcus pneumoniae, Ehrlichia chafensis, Enterococcus faecium, Meningococci, and combinations thereof.
- fungi examples include, but are not limited to, Aspergilli, Candidae, Candida albicans, Coccidioides immitis, Cryptococci, and combinations thereof.
- parasitic microbes include, but are not limited to, Balantidium coli, Cryptosporidium parvum, Cyclospora cayatanensis, Encephalitozoa, Entamoeba histolytica, Enterocytozoon bieneusi, Giardia lamblia, Leishmaniae, Plasmodii, Toxoplasma gondii, Trypanosomae, trapezoidal amoeba, and combinations thereof.
- viruses include, but are not limited to, Arboviruses, Ebola virus, Guanarito virus, Hanta virus, Hantaan virus, Hepatitis A, Hepatitis B, Hepatitis C, Hepatitis E, other Hepatitis viruses, Herpes-type viruses, Poliovirus, West Nile virus, Echo virus, and combinations thereof.
- the antipathogenic or non-pathogenic compositions of the present invention may optionally further include the use of one or more additional therapeutic agents known to treat a condition, or a symptom thereof.
- additional therapeutic agents include, but are not limited to, chelating agents, vitamins, minerals, silica hydride microclusters, analgesics, SambucolTM, aspirin, and the like.
- the electron active metal oxide compounds of the present invention may also be used for water treatment, for example, as disclosed in U.S. Patent Nos. 5,223,194 and 5,336,416.
- the electron active metal oxides used for treating a body of water are any listed above, more preferably provided that the metal oxide does not include tetrasilver tetroxide. It is also more preferable, in the previous embodiment, that the metal oxide does not include tetracopper tetroxide.
- the administration of one or more active ingredients and/or optional therapeutic agent(s), in accordance with the methods of the invention may occur together, concurrently but separately, sequentially, or a combination thereof.
- the optional additional therapeutic agent is generally a compound other than an electron active metal oxide
- the antipathogenic or antimicrobial performance of certain metal oxides may be improved or enhanced by the presence of an oxidizing agent. This is particularly the case when the metal oxide compounds or compositions are present in low amounts, i.e., typically less than 45 ppm, and more commonly when present in an amount less than about
- an oxidizing agent may be included in certain compositions of the invention in small amounts when the compositions are administered by certain routes.
- the oxidizing agent includes a peroxy acid salt, preferably a Group I salt of a persulfate, more preferably potassium persulfate.
- the oxidizing agent includes the same peroxy
- the oxidizing agent may advantageously be present in the composition in amounts from about 1 ppm to 500 ppm, based on the weight of the composition. In alternate embodiments, there may be from about 5 ppm to 200 ppm or from about 10 ppm to 100 ppm of oxidizing agent, based on the weight of the composition.
- oxidizing agent(s) may tend to irritate the skin, particularly when the compound or composition including metal oxide(s) is present in large amounts, such as greater than 50 ppm, based on the weight of the composition. In one embodiment, as more compound or composition is administered, a correspondingly smaller amount of undesirable oxidizing agent(s) may tend to irritate the skin, particularly when the compound or composition including metal oxide(s) is present in large amounts, such as greater than 50 ppm, based on the weight of the composition. In one embodiment, as more compound or composition is administered, a correspondingly smaller amount of undesirable oxidizing
- the additional oxidizing agent is unnecessary and in fact undesirable for the purpose of treating certain conditions described herein, since the additional oxide may have or contribute to an undesirable side effect, for example, such as skin irritation when applied topically.
- the compositions minimize the amount of additional oxidizing agent
- the electron active metal oxides may be black in color, such that care must be taken when formulating suitable topical pharmaceutical compositions accordmg to the invention to inhibit blackening or superficial discoloration of the skin. Without being bound by theory, it is believed that larger amounts of such compositions promote increased superficial discoloration. Thus, in one embodiment, the pharmaceutical compositions preferably have an insufficient amount of metal oxide composition to cause visible skin discoloration.
- Acute Oral Toxicity LD 50 Greater than 5,000 mg/Kg
- the electron active compositions according to the invention may be combined with a carrier in an amount from about 5 ppm to 500,000 ppm, more preferably from about 50 ppm to 250,000 ppm of the electron active metal oxide composition, based on the weight of the composition.
- the compositions are provided in amounts from about 400 ppm to 100,000 ppm, from about 1,000 ppm to 70,000 ppm, from about 10,000 ppm to 50,000 ppm, or from about 20,000 ppm to 40,000 ppm, based on the weight of the composition.
- the compositions are formulated with about 25,000 ppm to 35,000 ppm of metal oxide, based on the weight of the composition. It will be readily understood by those of ordinary skill in the art that the ppm concentration of electron active compound(s), such as metal oxide, in the composition is based on the total weight of the composition.
- a preferred embodiment employs amounts of about 0.1 to 10 percent by weight, about 0.25 to 5 percent by weight, or about 2 to 4 percent by weight of the compounds or compositions of the invention.
- the compositions when applied topically, can be applied to the skin about 1 to 3 times per day until the condition is suitably cured or satisfactorily controlled.
- the composition may generally be topically applied at a dosage level of from about 1 mg to 1000 mg per cm 2 of skin surface, preferably about 10 mg to 500 mg per cm 2 of skin surface.
- a preferred carrier includes petroleum jelly, such as white petroleum jelly.
- a suitable white petroleum jelly is available from Penreco of Houston, TX.
- Tetrasilver tetroxide compositions for use accordmg to the invention have been commercially sold under the poorly named " Ag(II) OXIDE” tradename. They may be obtained from Aldrich Chemical Co., Inc., having a place of business in Milwaukee, WI.
- the chemical synthesis of tetrasilver tetroxide compounds can be performed according to the method described on page 148 in M. Antelman, "Anti-Pathogenic Multivalent Silver Molecular Semiconductors," Precious Metals, vol. 16:141-149 (1992) by reacting silver nitrate with potassium peroxydisulfate according to the following equation in alkali solutions:
- Tetracopper tetroxide also referred to herein as Cu(I,III) oxide or Cu 4 O 4
- This compound may be prepared as follows.
- Suitable copper-based starting materials for this reaction include at least one copper(I)-containing material.
- a water soluble copper(I) salt can be used.
- a water soluble copper(I) salt can be prepared by dissolving an inorganic copper(I) compound, for example, such as cuprous oxide, in an appropriate acid, for example, an organic acid, such as acetic acid. Since soluble copper(I) salts are not readily commercially available at the present time, however, a non-solvated inorganic copper(I) compound, such as cuprous oxide itself, can be used as the copper(I)-containing starting material.
- copper(I)-containing materials either inorganic, such as a copper(I) oxide, or organic, such as an organometallic copper(I) compound, or both, may be used, where the copper(I)-containing material(s) are sufficiently soluble in an aqueous or orgamc solution to allow reaction with other materials to form an electron active copper oxide compound.
- the copper(I)-containing starting material is combined with an aqueous caustic solution.
- This caustic solution preferably contains two components: a strong caustic base and a peroxy acid salt.
- a strong caustic base include Group I and Group II hydroxides, preferably sodium hydroxide or potassium hydroxide.
- suitable peroxy acid salts include Group I salts of persulfates, preferably potassium persulfate.
- the copper-based starting material is typically the limiting reagent in such a preparation.
- the ratio of each of the components in the caustic solution to that of the copper-based starting material is theoretically set by the stoichiometry of the particular reaction. In one preferred embodiment, there is a relative molar excess, i.e., an amount more than stoichiometrically necessary, of each of the components in the caustic solution with respect to the copper-based starting material.
- the relative molar excesses of the components may be at least about 50% and at least about 10%, respectively, preferably at least about 100%) and at least about 20%), respectively, more preferably, at least about 250%) and at least about 40%), respectively, most preferably at least about 500% and at least about 75%, respectively.
- the reactants may be added together in any manner that comports with typical laboratory procedure.
- the copper(I)-containing starting material is placed in a reactor, to which the strong caustic base and the peroxy acid salt are added, each typically in their own solutions. The solution containing the reactants is then
- the solution is heated for a time sufficient to facilitate the reaction, preferably to provide substantial completion of the reaction, preferably for at least about 5 minutes, more preferably for at
- the color change of the solution from its original color, red, to a color indicating a reaction has occurred, in this case black, may occur at the heated temperature or during or after cooling.
- the purification and isolation of the desired product can be accomplished by any suitable method available to those of ordinary skill in the art.
- the desired reaction product is primarily a solid, but may be dissolved or dispersed in at least part of the solution.
- the solution is carefully decanted off, and then the remaining product is washed multiple times with
- the solution is vacuum filtered to remove the filtrate, and the remaining product is sufficiently dried.
- the yield of solid tetracopper tetroxide material, based on the reactants, is typically at least about 10%, preferably at least about 45%, more preferably at least about
- Fe(II,III) oxide and Mn(II,III) oxide are commercially available from Aldrich Company of Milwaukee, WI, and Co(II,I ⁇ ) oxide and Pr(III,IV) oxide are commercially available from Noah Technologies of San Antonio, TX.
- Bi(III,N) oxide synthetic routes are detailed and reviewed in Gmelins Handbuch Der Anorganischen
- a prophylactic or therapeutic dose of electron active composition(s), or a derivative thereof, in the acute or chronic management of diseases and disorders described herein will vary with the severity of the condition to be prevented, treated, or managed and the route of administration.
- oral, mucosal (including rectal and vaginal), parenteral (including subcutaneous, intramuscular, bolus injection, and intravenous, such as by infusion), sublingual, transdermal, nasal, buccal, and like may be employed.
- a patient may gargle using the composition of the present invention.
- Dosage forms include tablets, troches, lozenges, dispersions, suspensions, suppositories, solutions, capsules, soft elastic gelatin capsules, patches, and the like.
- the dose, and perhaps the dose frequency, will also vary according to the age, body weight, and response of the individual patient. Suitable dosing regimens can be readily selected by those of ordinary skill in the art with due consideration of such factors.
- the total daily dosage for the conditions described herein is from about 0.1 mg to 1,000 mg of the active ingredient, i.e., one of the metal oxides described herein, or a derivative thereof.
- the daily dosage can be from about 1 mg to 500 mg, while in another embodiment, the daily dosage can be from about 2 mg to 200 mg of the metal oxide composition.
- a unit dosage can include, for example, 30 mg, 60 mg, 90 mg, 120 mg, or 300 mg of metal oxide composition.
- the active ingredient is administered in single or divided doses from one to four times a day, such as by topical administration.
- the compositions are administered by an oral route of administration.
- the oral dosage forms may be conveniently presented in unit dosage forms and prepared by any methods available to those of ordinary skill in the art of pharmacy.
- the therapy may be initiated at a lower dose, e.g.,
- Any suitable route of administration may be employed for providing the patient with an effective dosage of electron active metal oxide, or a derivative thereof.
- the most suitable route in any given case will depend on the nature and severity of the condition being prevented, treated, or managed.
- the metal oxide, or a derivative thereof can be combined as the active ingredient in intimate admixture with a pharmaceutical carrier according to conventional pharmaceutical compounding techniques.
- the carrier may take a wide variety of forms and may include a number of components depending on the form of preparation desired for administration.
- compositions of the present invention may include, but are not limited to, suspensions, solutions and elixirs; aerosols; or carriers, including, but not limited to, starches, sugars, microcrystalline cellulose, diluents, granulating agents, lubricants, binders, disintegrating agents, and the like.
- Suitable forms in which the electron active compounds or compositions of the present invention may be used include, but are not limited to, powder, granule, flake, solution, suspension, emulsion, slurry, aerosol spray, gel, paste, and combinations thereof.
- the form is a powder or solution.
- the solution may be aqueous, non-aqueous, or a combination thereof, preferably at least partially aqueous, more preferably substantially aqueous.
- the metal oxides are in an aqueous solution.
- the compositions of the invention may be applied topically, e.g., either directly as a powder or in non-sprayable or sprayable form.
- Non-sprayable forms can be semi-solid or solid forms including a carrier indigenous to topical application and preferably having a dynamic viscosity 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 any available auxiliary agents, carriers, or excipients, e.g., thixotropes, stabilizers, wetting agents, and the like.
- One or more thixotropic agents can be included in types and amounts sufficient to increase adhesion of topically applied compositions of the invention to the skin, so as to inhibit or prevent runoff or other loss of the composition from the treatment zone on the skin.
- Preferred vehicles for non-sprayable topical preparations include ointment bases, e.g. , polyethylene glycol-1000 (PEG-1000); conventional ophthalmic vehicles; creams; and gels, as well as petroleum jelly and the like.
- the carrier includes a petroleum jelly.
- the carrier is formulated as a cream, gel, or lotion.
- the carrier is 3 weight percent active ingredient, 36 weight percent heavy mineral oil, 47 weight percent petroleum jelly, and 14 weight percent Tivawax P, which is available from Tivian Laboratories, Inc., of Buffalo, RI.
- the composition may be a dry powder, such as with 5 weight percent active ingredient and 95 weight percent bismuth subgallate.
- topical preparations may also contain emollients, perfumes, and/or pigments to enhance their acceptability for various usages.
- compositions may also be formulated for parenteral administration by injection (subcutaneous, bolus injection, intramuscular, or intravenous, such as by infusion), and may be dispensed in a unit dosage form, such as a multidose container or an ampule.
- Compositions of the electron active metal oxide, or a derivative thereof, for parenteral administration may be in the form of suspensions, solutions, emulsions, or the like, in aqueous or oily vehicles, and in addition to the active ingredient may contain one or more formulary agents, such as dispersing agents, suspending agents, stabilizing agents, preservatives, and the like.
- a suitable dosage range can be, e.g., from about 0.5 mg (0.1 ppm) to about 1,000 mg (200 ppm) total dose, preferably from about 5 mg (1 ppm) to 400 mg (80 ppm). In one preferred embodiment, the total dose can be from about 50 mg (10 ppm) to 200 mg (40 ppm). It should be understood that any suitable amount of the composition according to the invention may be administered if effective to prevent, treat, or manage one or more conditions described herein.
- compositions of the present invention may be orally administered in discrete pharmaceutical unit dosage forms, such as capsules, cachets, soft elastic gelatin capsules, tablets, or aerosols sprays, each containing a predetermined amount of the active ingredient, as a powder or granules, or as a solution or a suspension in an aqueous liquid, a non-aqueous liquid, an oil-in-water emulsion, or a water-in-oil liquid emulsion.
- Such compositions may be prepared by any of the methods of pharmacy, but all methods include the step of bringing into association the active ingredient with the pharmaceutically acceptable carrier which constitutes one or more necessary ingredients.
- compositions are prepared by uniformly and intimately admixing the active ingredient with liquid carriers or finely divided solid carriers or both, and then, if necessary, shaping the product into the desired presentation.
- suitable types of oral administration include oral solid preparations, such as capsules or tablets, or oral liquid preparations.
- tablets may be coated by standard aqueous or nonaqueous techniques.
- a tablet may be prepared by compression or molding, optionally, with one or more accessory ingredients.
- Compressed tablets may be prepared by compressing in a suitable machine the active ingredient in a free-flowing form such as powder or granules, optionally mixed with a binder, lubricant, inert diluent, granulating agent, surface active agent, dispersing agent, or the like. Molded tablets may be made by molding, in a suitable machine, a mixture of the powdered compound moistened with an inert liquid diluent.
- each tablet, capsule, cachet, or gel cap contains from about 0.5 mg to about 500 mg of the active ingredient, while in another embodiment, each tablet contains from about 1 mg to about 250 mg of the active ingredient.
- the amount of active ingredient found in the composition may vary depending on the amount of active ingredient to be administered to the patient.
- transdermal delivery for example, via an abdominal skin patch.
- the metal oxide(s), or a derivative thereof, may be formulated as a pharmaceutical composition in a soft elastic gelatin capsule unit dosage form by using conventional methods well known in the art, such as in Ebert, Pharm. Tech, l(5):44-50 (1977).
- Soft elastic gelatin capsules have a soft, globular gelatin shell somewhat thicker than that of hard gelatin capsules, wherein a gelatin is plasticized by the addition of plasticizing agent, e.g., glycerin, sorbitol, or a similar polyol.
- plasticizing agent e.g., glycerin, sorbitol, or a similar polyol.
- the hardness of the capsule shell may be changed by varying the type of gelatin used and the amounts of plasticizer and water.
- the soft gelatin shells may contain an additional preservative, such as methyl- and propylparabens and sorbic acid, to prevent the growth of fungi, although this is not necessary since the compounds and compositions of the invention provide anti-fungal efficacy.
- the invention includes a compositions formulated as a gelatin shell with an electron active metal oxide compound of the present invention, completely free of added preservatives.
- the active ingredient may be dissolved or suspended in a liquid vehicle or carrier, such as vegetable or mineral oils, glycols such as polyethylene glycol and propylene glycol, triglycerides, surfactants such as polysorbates, or a combination thereof.
- the compounds of the present invention may also be administered by controlled release means, delivery devices, or both, as are well known to those of ordinary skill in the art, such as those described in U.S. Patent Nos.: 3,845,770; 3,916,899; 3,536,809; 3,598,123; 4,008,719; 5,674,533; 5,059,595; 5,591,767; 5,120,548; 5,073,543; 5,639,476; 5,354,556; and 5,733,566, the disclosures of which are hereby incorporated herein by express reference thereto.
- compositions can be used to provide slow or controlled-release of the active ingredient therein using, for example, hydropropyhnethyl cellulose in varying proportions to provide the desired release profile, other polymer matrices, gels, permeable membranes, osmotic systems, multilayer coatings, microparticles, liposomes, microspheres, or the like, or a combination thereof.
- Suitable controlled-release formulations available to those of ordinary skill in the art, including those described herein, may be readily selected for use with the tetrasilver tetroxide compositions of the invention.
- single unit dosage forms suitable for topical or oral administration such as gels, lotions, cremes, tablets, capsules, gelcaps, caplets, and the like, that are adapted for controlled-release are encompassed by the present invention.
- controlled-release pharmaceutical products have a common goal of improving drug therapy over that achieved by their non-controlled counterparts.
- the use of an optimally designed controlled-release preparation in medical treatment is characterized by a minimum of the active ingredient being employed to cure or control the condition in a minimum amount of time.
- Advantages of controlled-release formulations may include: 1) extended activity of the active ingredient; 2) reduced dosage frequency; and 3) increased patient compliance.
- controlled-release formulations are designed to initially release an amount of active ingredient that promptly produces the desired therapeutic effect, and gradual and continual release of other amounts of active ingredient to maintain this level of therapeutic effect over an extended period of time.
- the active ingredient should be released from the dosage form at a rate that will replace the amount of active ingredient being metabolized and excreted from the body.
- the controlled-release of the active ingredient may be stimulated by various inducers, for example pH, temperature, enzymes, water, or other physiological conditions or compounds.
- controlled-release component in the context of the present invention is defined herein as a compound or compounds, including polymers, polymer matrices, gels, permeable membranes, liposomes, microspheres, or the like, or a combination thereof, that facilitates the controlled-release of the active ingredient ⁇ e.g., tetrasilver tetroxide) in the pharmaceutical composition.
- active ingredient e.g., tetrasilver tetroxide
- compositions for use in the present invention include electron active metal oxides, or a derivative thereof, as the active ingredient, and may also contain a pharmaceutically acceptable carrier, and optionally, other therapeutic ingredients.
- Suitable derivatives include any available "pharmaceutically acceptable salts," which refer to a salt prepared from pharmaceutically acceptable non-toxic acids including inorganic acids, organic acids, solvates, hydrates, or clathrates thereof. Examples of such inorganic acids are nitric, sulfuric, lactic, glycolic, salicylic, and phosphoric.
- Appropriate organic acids may be selected, for example, from aliphatic, aromatic, carboxylic and sulfonic classes of organic acids, examples of which are formic, acetic, propionic, succinic, camphorsulfonic, citric, fumaric, gluconic, isethionic, lactic, malic, mucic, tartaric, para-toluenesulfonic, glycolic, glucuronic, maleic, furoic, glutamic, benzoic, anthranilic, salicylic, phenylacetic, mandelic, embonic (pa oic), methanesulfonic, ethanesulfonic, pantothenic, benzenesulfonic (besylate), stearic, sulfanilic, alginic, galacturonic, and the like.
- Particularly preferred acids are lactic, glycolic, and salicylic acids.
- the pharmaceutically acceptable salts preferably do not include halide-containing salts when tetrasilver tetroxide is present, as these salts are believed to facilitate breakdown of the oxide lattice present in the silver oxide compositions of the invention.
- a culture of Salmonella of cell density 500,000 CFU/mL was contacted for 10 minutes with approximately 4 ppm hexapraseodymium undecoxide (Pr 6 O n ), which is believed to contain two distinct oxidation states of praseodymium, Pr(III) and Pr(_N), in its crystal lattice, at a pH of about 9, followed with a culture adjusted to a pH of about 10.
- Pr 6 O n hexapraseodymium undecoxide
- the experiment was repeated with the same cell density oi Salmonella using about 5 ppm of tricobalt tetroxide (Co 3 O 4 ), which is believed to contain two distinct oxidation states of cobalt, Co(II) and Co(III), in its crystal lattice, at a pH of about 10.
- the percentage of bacterial colonies killed by this treatment was 92.8% after 10 minutes of contact with the oxide-containing composition.
- Example 1 The praseodymium oxide crystals of Example 1 were tested against the standard AOAC coliform culture used in water purification studies and having a 375,000 CFU/mL density. The results of this study are tabulated below:
- Example 3 The experiment of Example 3 was repeated with about 4 ppm of tricobalt tetroxide (Co 3 O 4 ) according to Example 2, at a contact time of about 5 minutes at a pH of about 7. The percentage of bacterial colonies killed by this treatment was 75%.
- tricobalt tetroxide Co 3 O 4
- Pr (III,_N) oxide Pr 6 O u
- the solution was subsequently diluted to yield a 100 ppm solution, based on the oxide component.
- Pr (HI,IV) oxide solution when put in contact with Staphylococcus aureus at 220,000 CFU/mL cell density, served to kill substantially all the bacteria (100% mortality) after 10 minutes of contact with the oxide-containing composition.
- a culture of E. coli bacteria having a cell density of 420,000 CFU/mL was contacted for about 10 minutes with about 6 ppm of Co (II,III) oxide, Co 3 O 4 , at a pH of about 7, also in the presence of 10 ppm potassium monopersulfate, which is commercially available under the trademark OXONE from DuPont De Nemours, Inc., of Wilmington, DE.
- the percentage of bacteria killed by this contact was 47.6%.
- the percentage of bacteria killed was 39.5%.
- a culture of E. coli bacteria having a cell density of 160,000 CFU/mL was contacted for about 10 minutes with about 100 ppm of Cu (I-IH) oxide, Cu 4 O 4 .
- the percentage of bacteria killed by this contact was 63.8%.
- the percentage of bacteria killed was 97.8%.
- EXAMPLES 10-13 In vitro treatment of E. coli with compositions of the invention Cultures of E. coli bacteria, each having a cell density around 100,000 CFU/mL, were each contacted for about 10 minutes with various electron active molecular metal oxide crystals according to the invention, resulting in the following percentages of bacteria killed:
- Mn (II,III) oxide Mn 3 O 4 28% These experiments were repeated using reduced triiron tetroxide, Fe 3 O 4 , concentrations and E. coli cultures, each having a reduced cell density of 75,000 CFU/mL, with variable OXON ⁇ TM concentrations.
- Fe (II,III) oxide was used in about 50 ppm concentration in the presence of about 200 ppm OXON ⁇ TM, the percentage of bacteria killed was about 73.3%).
- Fe (II,III) oxide was used in about 20 ppm concentration, in the presence of about 100 ppm OXON ⁇ TM, the percentage of bacteria killed was about 49.3%.
- This beaker was heated to approximately 90°C and was maintained from about 90°C and
- the solid product was purified and isolated by one of two methods: a) decanting off the solution, washing the remaining product at least seven times with distilled water, and drying the product; or b) vacuum filtering the solution and drying the product.
- the healing mechanism associated with the use of the metal oxides of the invention to treat and manage at least some skin diseases appears to involve mechanisms other than merely inhibiting or killing pathogens and curing infections that tend to aggravate disease and retard the natural healing process.
- the data indicate that healing is brought about even in cases where no abnormal bacteria counts or infection is evident.
- the electron active compound(s) may also act against auto-antibodies that trigger autoimmune reactions associated with diseased tissue, as well as against other non- pathogenic conditions or diseases, such as circulatory or neurological conditions or diseases.
Abstract
Description
Claims
Priority Applications (3)
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EP00973747A EP1250142A4 (en) | 2000-01-06 | 2000-10-20 | Multivalent electron active compositions and methods of making and using same |
JP2001549671A JP2003519189A (en) | 2000-01-06 | 2000-10-20 | Multivalent electron active composition, method for producing and using the same |
AU12222/01A AU1222201A (en) | 2000-01-06 | 2000-10-20 | Multivalent electron active compositions and methods of making and using same |
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US09/552,172 | 2000-04-18 | ||
US09/552,172 US6258385B1 (en) | 1999-04-22 | 2000-04-18 | Tetrasilver tetroxide treatment for skin conditions |
US21450300P | 2000-06-28 | 2000-06-28 | |
US60/214,503 | 2000-06-28 |
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PCT/US2000/029116 WO2001049303A1 (en) | 2000-01-06 | 2000-10-20 | Multivalent electron active compositions and methods of making and using same |
PCT/US2000/029115 WO2001049302A1 (en) | 2000-01-06 | 2000-10-20 | Compositions and methods for facilitating skin growth and managing skin conditions |
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GT (1) | GT200000184A (en) |
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Also Published As
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AU1222201A (en) | 2001-07-16 |
AR029184A1 (en) | 2003-06-18 |
WO2001049302A1 (en) | 2001-07-12 |
EP1246629A4 (en) | 2007-04-18 |
JP2003519187A (en) | 2003-06-17 |
AU1435901A (en) | 2001-07-16 |
TWI235661B (en) | 2005-07-11 |
JP2003519189A (en) | 2003-06-17 |
JP2003519188A (en) | 2003-06-17 |
EP1246630A4 (en) | 2007-04-18 |
AU1339601A (en) | 2001-07-16 |
EP1246629A1 (en) | 2002-10-09 |
WO2001049301A1 (en) | 2001-07-12 |
AU784593B2 (en) | 2006-05-11 |
CO5271678A1 (en) | 2003-04-30 |
EP1246630A1 (en) | 2002-10-09 |
EP1250142A4 (en) | 2007-07-11 |
GT200000184A (en) | 2002-04-16 |
AU784597B2 (en) | 2006-05-11 |
EP1250142A1 (en) | 2002-10-23 |
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