WO2008104076A1

WO2008104076A1 - Electrocolloidal silver and echinacea root antimicrobial formulation

Info

Publication number: WO2008104076A1
Application number: PCT/CA2008/000383
Authority: WO
Inventors: Aroll Exama
Original assignee: Aroll Exama
Priority date: 2007-03-01
Filing date: 2008-02-28
Publication date: 2008-09-04

Abstract

The present invention relates to an antimicrobial formulation comprising electrocolloidal silver and Echinacea root extract in suspension. The antimicrobial formulation may be used for oral or topical administration to reduce infections and inflammations in a subject. A method for producing the antimicrobial formulation comprising the steps of generating electrocolloidal silver in a solution of water and a suspension of Echinacea root extract, and incorporating the admixture in a pharmaceutically acceptable carrier is provided. Oral, gel and cream formulations are described.

Description

Title: Electrocolloidal silver and Echinacea root antimicrobial formulation

BACKGROUND OF THE INVENTION

(a) Field of the Invention The present invention relates to an antimicrobial formulation which comprises a suspension of electrocolloidal silver and Echinacea root extract. More specifically, the invention relates to an antimicrobial formulation comprising a suspension of electrocolloidal silver and Echinacea root in a pharmaceutically acceptable carrier suitable for oral or topical administration and useful for reducing infections and inflammations in a subject.

(b) Description of Prior Art

United States Patent No. 7,018,660 entitled "Pharmaceutical compositions and methods for managing skin conditions" relates to a formulation for the cleansing of skin to facilitate the prevention, treatment, and management of skin conditions, such as seborrheic dermatitis, psoriasis, folliculitis, rosacea and other inflammatory skin conditions. This product includes an acidic component of a hydroxyacid or tannic acid, or a salt thereof, to exfoliate a portion of the skin, a stabilized hydrogen peroxide to facilitate cleansing of the skin without substantial irritation thereof, and an antimicrobial agent consisting of either an antibacterial agent, an antimicrobial agent, an antiviral agent or a combination thereof, in an amount sufficient to inhibit or reduce microorganisms on the skin. Echinacea is one possible antimicrobial agent that can be used in the present formulation. However, this formulation, limited to dermatological purposes, essentially works as a skin cleansing and sanitizing composition for topical inflammations and is only minimally intended for the treatment of skin infections. Moreover, the hydrogen peroxide present in the formulation can easily cause skin irritation and discomfort in some subjects.

Great Britain Application No. 2,189,394 A entitled "Process for preparing a storage-stable concentrate" consists of a concentrate that can be mixed with hydrogen peroxide to become an effective disinfectant for water, foodstuff, animal feeds, equipment and packages for example. The concentrate includes an inorganic acid with a pH less than 1.6, a silver compound or electrocolloidal silver, an organic acid stabilizer such as tartaric, lactic, salicylic, or citric acid, and optionally gelatin. This invention combines the well-known germicidal effect of silver and hydrogen peroxide in a formulation to cause a synergy of the two disinfecting agents. This formulation is indeed a very efficient antiseptic: however, because it is highly corrosive, its use is limited to disinfection and sterilization for household, industry or hospital purposes and cannot be employed for dermatological means.

United States Patent No. 6,231 ,848 entitled "Topical Products as prophylactic of curative agents for bacterial skin infections" relates to topical products to be used as prophylactic or curative agents for bacterial skin infections, containing at least one polymeric complex consisting of hydrogen peroxide, a suitable polymer for the complex formation thereof, possibly another bactericidal compound and possibly a metal salt or a metal colloid. The invention therefore resides in various combinations of these four components destined to provide various degrees of antimicrobial control to the formulation. Electrocolloidal silver is one possible metal colloid used in this invention, providing antibacterial properties to the formulation and the incorporated bactericidal active compound is chosen from aldehydes, alpha- hydroxy carboxylic acids, polyhydroxylated aromatic compounds and hydroxyarylcarboxylic acids. The efficacy of the product depends on the formulation's composition: however, the limited amount of the antimicrobial compound and electrocolloidal metal incorporated in the formulation greatly restricts the antibacterial properties of the final product. Moreover, apart from being limited to dermatological purposes, this formulation can cause skin irritation and discomfort because of its high hydrogen peroxide concentration.

United States Patent No. 6,673,374 entitled "Pharmaceutical compositions and methods for managing skin conditions" relates to a pharmaceutical composition and methods for treating inflammatory skin conditions. The composition includes hydrogen peroxide, one or more moisturizing agents and an anti-inflammatory agent. The composition can be used to treat medical conditions such as various types of dermatitis, psoriasis, folliculitis, rosacea, acne, eczema and the like. An antimicrobial agent is typically also present in the formulation in an amount from about 0.01 to 1.5 weight percent. The antimicrobial agent inhibits the formation, and may further reduce, the presence of microbes that cause redness, inflammation, and irritation of the skin. One potential antimicrobial agent is Echinacea: however, the very low proportion of this component in the formulation prevents it from offering high antimicrobial capacities.

United States Patent No. 7,115,287 entitled "Topical medicament and method of use" relates to a topical formulation for the treatment of dermatologic conditions in both humans and animals. The medicament includes a mixture of Vitamin A, Vitamin D, Vitamin E, lanolin, petroleum jelly, electrocolloidal silver, tea tree oil, zinc oxide and cornstarch in appropriate proportions. Ingredient proportions may be varied to form an ointment or a paste having a thicker consistency than the ointment. This formulation comprises electrocolloidal silver, which presents advantageous effect of killing bacteria and viruses in affected tissue and functions as an all- natural antibiotic in the formulation. However, being only present as 2 ml of a 10-ppm electrocolloidal solution in a 120 ml formulation, it cannot provide high protection against infections and effectively reduced related inflammations. Moreover, only comprising one antimicrobial compound, the resulting formulation cannot benefit from synergic antibacterial and antiviral properties with other agents.

Antimicrobial formulations able to reduce skin infections and inflammations are therefore highly desirable. SUMMARY OF THE INVENTION

In accordance with the present invention there is provided an antimicrobial formulation comprising a suspension of electrocolloidal silver and Echinacea root extract in a pharmaceutically acceptable carrier. In a preferred embodiment, the formulation is for oral or topical administration and is used to reduce infections and inflammations in a subject. In further embodiments, the pharmaceutically acceptable carrier is an aqueous solution, a cream or a gel. The present invention also provides a dressing wherein the antimicrobial formulation of the invention is dispersed onto a wound- contacting surface of the dressing.

The invention also provides a method for producing the antimicrobial formulation, the method comprising the steps of generating electrocolloidal silver in a solution of water and a suspension of Echinacea root extract, and incorporating the admixture in a pharmaceutically acceptable carrier.

Also in accordance with the present invention, there is provided a method for reducing infections and inflammations in a subject comprising contacting an inflamed and/or infected area with a therapeutically effective amount of antimicrobial formulation.

Other embodiments of the invention describe the use of a therapeutically effective amount of the antimicrobial formulation to reduce infections and inflammations in a subject. For the purpose of the present invention, the following terms are defined below:

The term "electrocolloidal" designates the two products issued of silver electrolysis, which are silver ions in a solution and metallic silver particles in suspension in a solution. Depending on the solution's ratio of ions to silver particles, the solution will be considered either as an ionic silver solution when more silver ions are present in the solution (high silver ions / silver particles ratio), or the solution will be considered a colloidal silver solution when silver particles are predominant in the solution (low silver ions / silver particles ratio). All references referred to herein are hereby incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 shows the results of the efficacy test of the gel formulation of the present invention against four different types of bacteria. Units are log (CFU/g).

Figure 2 shows the results of the efficacy test of the cream formulation of the present invention against 4 different types of bacteria. Units are log (CFU/g).

DETAILED DESCRIPTION OF THE INVENTION In accordance with the present invention, there is provided an antimicrobial formulation to reduce infections and inflammations in a subject comprising electrocolloidal silver and Echinacea root extract in suspension in a pharmaceutically acceptable carrier for oral or topical administration.

This formulation is highly recommended for the treatment of flu, bronchitis, acne, wounds, otitis, pharyngitis, conjunctivitis, gastroenteritis, traveler's diarrhea, bronchitis, wounds and cuts or any minor infections and/or inflammations. Indeed, the invention provides both antibacterial and antiviral properties and can be ingested, in its liquid formulation, to treat internal infections and inflammations or either topically applied, in its cream or gel formulation, to treat an affected dermatological tissue.

The two main compounds of the formulation are electrocolloidal silver and Echinacea. Being non-toxic and harmless to children in pharmaceutically acceptable doses, those two agents provide high antimicrobial properties to the invention and work in synergy to treat most commonly encountered viral or bacterial-related infections and inflammations in humans. It can be used in two different manners: as a curative treatment for an occurring infection and/or inflammation through repeated daily ingestion of the formulation over a limited period of time or as a preventive treatment through daily intake of a limited amount of the formulation. Moreover, in the case of a viral medical condition, such as the flu, it is recommended to consume the formulation in the first 24 hours following the initial manifestation of symptoms, before the virus becomes uncontrollable. However, even if taken 24 to 48 hours after the beginning of the infection, the formulation still allows diminution of the symptoms, shortens the duration of the disease and prevents secondary infections such as bronchitis and pneumonia. In the case of a bacterial infection, the intake of the formulation 24 to 48 hours after the first manifestation of symptom produces a decreased antimicrobial effect but is still effective. It is recommended to ingest the product about 30 minutes before meals and to avoid mixing the product with juices or water as the components of those liquids might interfere with the compounds of the formulation.

There are two types of products marketed as electrocolloidal silver, which are silver ions in a solution and metallic silver particles in suspension in a solution. Depending on the solution's ratio of ions to silver particles ratio, the solution will be considered either as an ionic silver solution when more silver ions are present in the solution (high silver ions / silver particles ratio), or the solution will be considered a colloidal silver solution when silver particles are predominant in the solution (low silver ions / silver particles ratio). In a preferred embodiment, the electrocolloidal silver is an ionic silver solution. Colloidal silver consists of, more precisely, a suspension of submicroscopic metallic silver particles in an electrocolloidal base, such as demineralized water. It resists sedimentation, diffusion and filtration, thus differing from precipitates. It is a gluelike, yellowish, translucent homogenous material. The electrocolloidal silver solution is produced through electrolysis of a silver electrode in a demineralized water filled chamber. This solution has the advantageous effect of killing bacteria and viruses that may be present on or in the affected tissue, therefore allowing it to function in the above formulations as an all-natural antibiotic. Indeed, the antimicrobial properties of electrocolloidal silver are caused by the presence of Ag⁺ ions in the silver solution. These ions are very reactive and instantly respond to the presence of negatively charged molecules in their surrounding environment. In fact, these ions have the ability to bind in an irreversible manner to enzymes and other active molecules at a cell's surface. Because of their high propensity to bind to sulfhydryl groups, silver ions destabilize cell membranes, inactivate proteins and inhibit enzyme action. Therefore, when applied in an area presenting bacteria or virus-caused infections or inflammations, the free silver ions will attach to the membrane of the microbial cells leading to the therapeutic effect.

The Echinacea plant variety has been popular in both Europe and America as a herbal medicine. Echinacea has been attributed with the ability to boost the body's immune system and ward off infections, particularly the common cold. Depending on which species is used, herbal medicinals can be prepared from the above-ground parts and/or the root. The primary use of Echinacea in the formulation is to accelerate the electrolysis reaction while maintaining the quality and efficacy of the solution. The electrocolloidal silver and Echinacea components, both previously described, are the basis of the formulation of the present invention. The other compounds are mainly incorporated to improve the taste and/or efficacy of the formulation, to obtain a desired texture or to add hydrating properties to the product. In some embodiments, Stevia extract is used to mask the metallic taste of the formulation. In other embodiments, shea butter is used to expand the use of the formulation. Silver is recognized for drying biological tissues when used too frequently, its utilization is therefore limited and is not recommended for chronic conditions such as diabetes or in long- term hospitalized patients. The shea butter comprised in the cream formulation of the present invention compensates for that aspect of the included silver. Indeed, shea butter's biological activities include moisturizing abilities, minor skin ailments healing properties due to its exceptionally large healing fractions (fatty extract) compared to other oils. Moreover, shea butter will also be useful in preventing contamination by antibiotic resistant bacteria in health care facilities. In fact, in order to be effective, silver must be adsorbed by the surface on which it is applied. The liquid or gel formulations are easily washable: therefore, the cream formulation of the present invention will allow silver to be more substantially adsorbed, thereby exerting a longer effect in preventing surface contamination by antibiotic resistant bacteria in health care facilities. The application of a dressing comprising the antimicrobial formulation on the skin of a patient is also a good alternative.

Accordingly, the present invention provides an antimicrobial formulation comprising a suspension of electrocolloidal silver and Echinacea root extract in a pharmaceutically acceptable carrier. In a preferred embodiment, the formulation is for oral or topical administration and is used to reduce infections and inflammations in a subject. In further embodiments the pharmaceutically acceptable carrier is an aqueous solution, a cream or a gel. Further embodiments include the use of other pharmaceutically acceptable carriers known to one skilled in the art such as ointments, lotions (i.e. an emulsion or a dispersion), solutions, foams, or sprays. The Echinacea root extract may comprise root particles of

Echinacea angustotifolia, Echinacea atrorubens, Echinacea laevigata, Echinacea pallida, Echinacea paradoxa, Echinacea purpurea, Echinacea sanguinea, Echinacea simulata and Echinacea tennesseensis.

In one embodiment of the present invention, the root particles of Echinacea comprise Echinacea root powder, minced Echinacea root or combinations thereof.

In accordance with the present invention, the electrocolloidal silver comprises a suspended solution of 5 to 30 ppm silver ions. In one embodiment, the solution is demineralized and deionized purified water. In another embodiment, the electrocolloidal silver comprises a suspended solution of 10 to 12 ppm silver ions. In one embodiment, the solution is demineralized and deionized purified water.

In one embodiment the pharmaceutically acceptable carrier of the antimicrobial formulation comprises water. In another embodiment, the antimicrobial formulation is for oral administration and the pharmaceutically acceptable carrier of the antimicrobial formulation comprises water. Other embodiments include the use of purified water or aqueous solutions.

In accordance with another preferred embodiment of the present invention, the formulation comprising water as a pharmaceutically acceptable carrier further comprises Stevia leaves extract. In one embodiment the Stevia leaves extract includes powdered Stevia leaves; minced Stevia leaves or combinations thereof. In a preferred embodiment, the antimicrobial formulation comprising purified water as a pharmaceutically acceptable carrier further comprises Stevia leaves extract and is for oral administration.

In accordance with a preferred embodiment of the present invention, the pharmaceutically acceptable carrier of the antimicrobial formulation is a gel. In a further preferred embodiment the antimicrobial formulation is for topical administration and the pharmaceutically acceptable carrier of the antimicrobial formulation is a gel.

In accordance with another embodiment, the gel formulation comprises Carbopol™ and a jellifying copolymer. In some embodiments Carbopol™ comprises less than 1% of the formulation.

In accordance with another embodiment, the jellifying copolymer comprises triethanolamine. In a further embodiment, the triethanolamine comprises less than 1 % of the formulation.

In one embodiment of the present invention, the pharmaceutically acceptable carrier of the antimicrobial formulation for topical administration is a cream. In accordance with a preferred embodiment of the present invention, the cream formulation for topical administration comprises moisturizing agents, Carbopol™, jellifying agents or combinations thereof.

In one embodiment, the moisturizing agent of the cream formulation for topical administration is shea butter, which comprises commercially whitened shea butter; natural shea butter or combinations thereof. In a further embodiment, the moisturizing agent comprises less than 25% of the formulation. Other embodiments include the use of other moisturizing agents known to those skilled in the art. In accordance with another embodiment of the present invention, the jellifying agents of the cream formulation comprise propylene glycol, novomer EC-1 , triethanolamine and Carbopol™. In one embodiment, the jellifying agents comprise less than 2% of the formulation. In another embodiment, the jellifying agents comprise less than 1.5% of the formulation. In a preferred embodiment, the jellifying agents comprise less than 1% of the formulation. Other embodiments include the use of other jellifying agents known to those skilled in the art.

In accordance with still another embodiment of the present invention, the propylene glycol comprises 0,0625 % of the formulation, the novomer EC-1 comprises 0,0625 % of the formulation, the triethanolamine comprises 0,125 % of the formulation and Carbopol™ comprises 0,25 % of the formulation.

The present invention also provides a dressing which comprises the antimicrobial formulation of the invention dispersed onto a wound- contacting surface of the dressing. In a further embodiment, antimicrobial formulation is dispersed onto one or multiple layers of the dressing. In some embodiments, the wound-contacting surface of the dressing is made of linen or cotton fiber. Other embodiments include additional dressings known in the art such as a patch device, a fixed reservoir, an application chamber, a tape, a sticking plaster, or the like which remains on the skin at the site of application for a prolonged period of time. The invention also provides a method for producing the antimicrobial formulation, the method comprising the steps of generating electrocolloidal silver in a solution of water and a suspension of Echinacea root extract, and incorporating the admixture in a pharmaceutically acceptable carrier. Other embodiments of the invention contemplate the use of methods known to a person skilled in the art for producing electrocolloidal silver. In one embodiment, the method for generating electrocolloidal silver comprises passing a current through an electric circuit with a silver electrode in a chamber filled with a solution of deionized water and a suspension of Echinacea root extract. Other embodiments include the use of a solution of deionized and demineralized water. The Echinacea root extract may comprise particles of minced Echinacea root; powdered Echinacea root or combinations thereof. In a preferred embodiment of the present invention, Echinacea root particles are water-brewed before being incorporated in the solution. In one embodiment, the Echinacea root particles are water-brewed by infusing 1 g of minced Echinacea root in half a cup of water for 10 minutes.

In one embodiment of the present invention, the pharmaceutically acceptable carrier in which the admixture of electrocolloidal silver and Echinacea root is incorporated is a cream. In some embodiments, the antimicrobial cream formulation comprises a mix of shea butter, Carbopol™, jellifying agents and combinations thereof. In accordance with another embodiment of the present invention, the shea butter of the formulation comprises commercially whitened shea butter; natural shea butter or combinations thereof. In further embodiments of the present invention, the jellifying agents of the formulation comprising cream as a carrier comprises propylene glycol, novomer EC-1 , triethanolamine and a copolymer of acrylic acid and alkyl acrylate. In a preferred embodiment, the jellifying agents are incorporated progressively in the cream after the incorporation of the antimicrobial formulation. Also in accordance with the present invention, there is provided a method for reducing infections and inflammations in a subject comprising contacting an inflamed and/or infected area with a therapeutically effective amount of antimicrobial formulation. In one embodiment of the present invention, contacting the inflamed and/or infected problem area is done by oral administration or by topical application of the antimicrobial formulation. In accordance with a preferred embodiment of the present invention, the oral administration of the formulation can be done sublingually, by swallowing the formulation or by gargling the formulation.

In accordance with a preferred embodiment of the present invention, the oral administration of the formulation is to be repeated 3 times a day for a 4-day course when administered within the first 24 hours after the onset of symptoms, or 4 times a day for a 3-5 day course when administered 24-48 hours after the onset of symptoms. Other embodiments include courses of treatment at different frequencies of administration and for shorter or longer periods of time.

In one embodiment of the present invention, the topical application of the formulation can be done by direct application of a pharmaceutically acceptable amount of the cream or gel antimicrobial formulation on the skin of a subject or by applying a dressing of the antimicrobial formulation on the skin of a subject.

In accordance with a preferred embodiment of the present invention, the topical application of the cream/gel antimicrobial formulation or of the dressing is to be repeated 3 times a day for a 4-day course or 4 times a day for a 3-day course for an antibacterial treatment. Other embodiments include courses of treatment at different frequencies of administration and for shorter or longer periods of time.

In accordance with a further preferred embodiment of the present invention, the topical administration of the gel formulation is to be repeated twice a day (morning and night) in cases of acne. In accordance with another preferred embodiment, the topical application of the dressing is to be repeated once a day or once every two days in cases of light bleeding. In still another preferred embodiment, the topical administration of the cream formulation is to be repeated whenever the skin is dry.

In accordance with one embodiment of the present invention, there is provided the use of a therapeutically effective amount of the antimicrobial formulation to reduce infections and inflammations in a subject. In a preferred embodiment, the use of the formulation comprises contacting an inflamed and/or infected area with a therapeutically effective amount of the oral, gel or cream antimicrobial formulation. In accordance with a preferred embodiment of the present invention, contacting the inflamed and/or infected area is done by oral administration or by topical application. In some embodiments, use of the antimicrobial formulation by oral administration can be done sublingually, by swallowing the formulation or by gargling the formulation. In accordance with a preferred embodiment of the present invention, the oral administration of the formulation is to be repeated 3 times a day for a 4-day course when administered within the first 24 hours after the onset of symptoms or 4 times a day for a 3 to 5-day course when administered 24 to 48 hours after the onset of symptoms. Other embodiments include courses of treatment at different frequencies of administration and for shorter or longer periods of time.

In one embodiment of the present invention, the topical application can be done by direct application of a pharmaceutically acceptable amount of the cream or gel antimicrobial formulation on the skin of a subject or by applying a dressing of the antimicrobial formulation on the skin of a subject. In accordance with a preferred embodiment of the present invention, the topical application of the cream/gel antimicrobial formulation is to be repeated 3 times a day for a 4-day course or 4 times a day for a 3-day course for an antibacterial treatment. Other embodiments include courses of treatment at different frequencies of administration and for shorter or longer periods of time.

In accordance with still a preferred embodiment of the present invention, the topical application of the dressing is to be repeated twice a day in cases of acne, whenever the skin is dry or once a day or once every two days in cases of light bleeding.

The present invention will be more readily understood by referring to the following examples, which are given to illustrate the invention rather than to limit its scope. EXAMPLE 1

Preparation of a liquid formulation. Electrocolloidal silver is obtained through the use of current passing through an electric circuit comprising a silver electrode in a chamber filled with a solution of purified (deionized and demineralized) water. Indeed, an electric current is passed across the silver electrode, which is immersed in deionised water: as the current passes, metallic silver (Ag⁰) migrates from the electrode into the water and converts to silver ions (Ag⁺), therefore creating electrocolloidal silver. Here, previously water-brewed minced Echinacea root particles or Echinacea root powder, as well as Stevia Leaves extract, as minced leaves or powdered leaves, are incorporated in the solution of purified water before the start of the electrolysis. The minced Echinacea root particles are water-brewed by infusing 1 g of minced Echinacea root particle in half a cup of boiling water for 10 minutes.

Posology. The liquid formulation of the invention is ingested in a 5 ml dosage, ingested sublingually or by gargling, 3 times a day for a 4-day course when administered within the first 24 hours after the onset of symptoms. Ingestion of a total of 60 ml of the formulation normally gets rid of all the symptoms. In case of high temperature or fever, a 5 ml oral dose should be repeated every hour until temperature comes back to normal or until the fever disappears. After a drop in temperature and/or fever, administration of a 5ml dose should be repeated 4 times a day. Ingestion of a total 100 ml of the formulation normally gets rid of all the symptoms. In case of otitis, fill both ears with the liquid and maintain for 3 minutes while administering the formulation as indicated. This formulation should not be mixed with water or juice.

Results. The results are presented in Tables 1a and 1b. The responses of the subjects to the treatment constitutes direct evidence that liquid formulation is effective in treating various infections and inflammations of bacterial or viral origin.

Table 1a: Results of the treatment of various medical conditions in 10 subjects (Canada) with the liquid formulation of electrocolloidal silver and Echinacea root.

Table 1b: Results of the treatment of various medical conditions in 19 subjects (Switzerland) with the liquid formulation of electrocolloidal silver and Echinacea root.

EXAMPLE 2

Preparation of gel formulation. The gel formulation is made starting from the electrocolloidal silver and Echinacea root solution. As previously detailed, the electrolysis of a silver electrode in a deionised-water filled chamber allows production of electrocolloidal silver. In the present invention, the solution of deionised water of the chamber also comprises a suspension of Echinacea root powder, or water-brewed minced Echinacea root, before the launch of the reaction. The minced Echinacea root particles are water-brewed by infusing 1 g of Echinacea root particles in half a cup of boiling water for 10 minutes. Carbopol™ and a jellifying copolymer are incorporated in the formulation following the end of the electrolysis. The Carbopol™ compound is in fact a combination of acrylic acid and alkyl acrylate, available in a powder-like form. The jellifying copolymer, which in one embodiment is triethanolamine, allows a modification of the solution's structure in order to create a very stable and malleable gel, whereas Carbopol™ is responsible for thickening the solution. For optimal results, Carbopol™ and the jellifying copolymer should not represent more than 1 % of the total formulation. The produced gel is stable at room temperature for up to two years.

Posoloqy. The gel formulation of the invention should be delicately applied on the affected area.

Results. The results are presented in Figure 1 and in Tables 2 and 3. Figure 1 shows the results of an efficacy test against 4 bacterial strains chosen on the basis of their resistance to certain antibiotics (methicillin resistant Staphylococcus aureus, vancomycin resistant Enterococcus aeruginosa and Clostridium difficile). A strong reduction in the number of bacterial cells was observed after 10 minutes for each bacterial strain (between 3.98 and 5.30 log CFU/g).

As presented in Table 2, the gel formulation allows a quick recovery of the skin's superficial infections and inflammations by simply rubbing the affected area with the gel formulation. The gel formulation should be applied twice a day (morning and night) in cases of acne.

Table 2: Results of the treatment of topical infections and inflammations with the gel formulation of electrocolloidal silver and Echinacea root.

Table 3 shows the results of microbial inhibition challenge test performed according to the US pharmacopoeia protocol using 5 microorganisms. After a contact time of 24 hours, a reduction in the microbial load between 1.49 and 3.06 log CFU/g (depending on the microbial species) can be observed. This is followed by a gradual reduction in the number of microbial cells up to the end of the 28 day experimental time. On day 28, no microbial growth was detected in the samples. This inhibition was complete since day 7 for S. aureus, A. niger and C. albicans and on day 14 for P. aeruginosa.

Table 3: Results of the microbial inhibition (challenge test) (log) by the gel formulation of electrocolloidal silver and Echinacea root.

nd : undetected (lower than detection threshhold)

EXAMPLE 3

Preparation of cream formulation. As previously detained, the basis of this formulation resides in a solution of electrocolloidal silver and Echinacea root. The electrocolloidal silver is produced by electrolysis of a silver electrode in a deionised water filled chamber. However, in the case of this invention, minced Echinacea root or Echinacea root powder is incorporated in the solution prior to the start of the chemical reaction. If minced Echinacea root is used, the particles are water-brewed by infusing 1 g of Echinacea in half a cup of boiling water for 10 minutes. Obtaining a cream- like formulation starting from the produced solution necessitates the incorporation of various compounds in the solution: Carbopol™ for thickening the formulation, shea butter in order to grant hydrating properties to the product and four different jellifying agents to obtain the desired consistency. These compounds are mixed in a specific order: first, Carbopol™ and shea butter are mixed together (Phase 1) in order to prevent shea butter to blend directly with electrocolloidal silver and produce silver proteinate, a compound having the tendency to precipitate. The second step comprises mixing the electrocolloidal silver and Echinacea root solution with the rest of the Carbopol™ to incorporate, the Carbopol™ reacting with the silver and preventing it from reacting with the shea butter (Phase 2). Following this, the Phase 1 and Phase 2 solutions are blended in and the jellifying agents are progressively incorporated, first propylene glycol, then novomER EC-1 and finally triethanolamine. Posoloqy. The cream formulation of the invention should be delicately applied on the affected area.

Results. Figure 2 shows the results of an efficacy test against 4 bacterial strains chosen on the basis of their resistance to certain antibiotics (methicillin resistant staphylococcus aureus, vancomycin resistant enterococcus aeruginosa and Clostridium difficile). A strong reduction in the number of bacterial cells was observed after 10 minutes for each bacterial strain (between 2.22 and 5.79 log CFU/g).

The results of the effect of the cream formulation on various types of bacteria during a 28 days time period are presented in Table 4. After 24 hours, a reduction in the microbial concentration is already apparent, the concentration having diminished from 1.99 to 3.59 log CFU/g. The microbial concentration continues to diminish over time, finally reaching a point of impossible detection for both S. Aureus and A. Niger after the 7^th day, and for P. Aeruginosa and C. Albicans after the 14^th day. This microbial inhibition continues over time, reaching the point of impossible detection on day 21 for E. coli 0157 :H7, the type of bacteria showing the most colliodal silver cream resistance.

Table 4: Results of the microbial inhibition (challenge test) (log CFU/g) by the cream formulation of electrocolloidal silver and Echinacea root.

nd : undetected (lower than detection threshhold)

While the invention has been described in connection with specific embodiments thereof, it will be understood that it is capable of further modifications and this application is intended to cover any variations, uses, or adaptations of the invention following, in general, the principles of the invention and including such departures from the present disclosure as come within known or customary practice within the art to which the invention pertains and as may be applied to the essential features hereinbefore set forth, and as follows in the scope of the appended claims.

Claims

CLAIMS:

1. An antimicrobial formulation comprising a suspension of electrocolloidal silver and Echinacea root extract in a pharmaceutically acceptable carrier.

2. The antimicrobial formulation according to claim 1 , wherein said Echinacea root extract is from root particles of Echinacea angustotifolia, Echinacea atrorubens, Echinacea laevigata, Echinacea pallida, Echinacea paradoxa, Echinacea purpurea, Echinacea sanguinea, Echinacea simulata and Echinacea tennesseensis.

3. The antimicrobial formulation according to claim 2, wherein said root particles of Echinacea comprises Echinacea root powder; minced Echinacea root or combinations thereof.

4. The antimicrobial formulation according to claim 1 , wherein said electrocolloidal silver comprises a suspended solution of 5 to 30 ppm silver ions.

5. The antimicrobial formulation according to claim 1 , wherein said electrocolloidal silver comprises a suspended solution of 10 to 12 ppm silver ions.

6. The antimicrobial formulation according to claim 4 and 5, wherein said solution is demineralized and deionized purified water.

7. The antimicrobial formulation for oral administration according to claim 1 , wherein said pharmaceutically acceptable carrier is purified water.

8. The antimicrobial formulation according to claim 1 , wherein said formulation further comprises Stevia leaves extract.

9. The antimicrobial formulation according to claim 8, wherein said Stevia leaves extract comprises powdered Stevia leaves; minced Stevia leaves or combinations thereof.

10. The antimicrobial formulation according to claim 1 , wherein said pharmaceutically acceptable carrier is a gel.

11. The antimicrobial formulation according to claim 10, further comprising Carbopol™ and a jellifying copolymer.

12. The antimicrobial formulation according to claim 11, wherein said jellifying copolymer comprises triethanolamine.

13. The antimicrobial formulation according to claim 11 , wherein said jellifying copolymer comprises less than 1% of the formulation.

14. The antimicrobial formulation according to claim 11 , wherein said Carbopol™ comprises a combination of acrylic acid and alkyl acrylate.

15. The antimicrobial formulation according to claim 11 , wherein said Carbopol™ comprises less than 1% of the formulation.

16. The antimicrobial formulation for topical administration according to claim 1 , wherein said pharmaceutically acceptable carrier is a cream.

17. The antimicrobial formulation according to claim 16, further comprising a moisturizing agent, Carbopol™, jellifying agents or combinations thereof.

18. The antimicrobial formulation according to claim 17, wherein said moisturizing agent comprises shea butter.

19. The antimicrobial formulation according to claim 18, wherein said shea butter comprises commercially whitened shea butter; natural shea butter or combinations thereof.

20. The antimicrobial formulation according to claim 18, wherein said shea butter comprises less than 25% of the formulation.

21. The antimicrobial formulation according to claim 17, wherein said jellifying agents are propylene glycol, novomere EC-1 , triethanolamine and Carbopol™.

22. The antimicrobial formulation according to claim 21 , wherein said propylene glycol, novomere EC-1, triethanolamine and Carbopol™ comprise less than 1% of the formulation.

23. The antimicrobial formulation according to claim 21 , wherein said Carbopol™ is a copolymer of acrylic acid and alkyl acrylate.

24. The antimicrobial formulation according to claim 21 , wherein said propylene glycol comprises 0,0625 % of the formulation.

25. The antimicrobial formulation according to claim 21 , wherein said novomer EC-1 comprises 0,0625 % of the formulation.

26. The antimicrobial formulation according to claim 21 , wherein said triethanolamine comprises 0,125 % of the formulation.

27. The topical formulation according to claim 21 , wherein said Carbopol™ comprises 0,25 % of the formulation.

28. A dressing which comprises the antimicrobial formulation of any one of claims 1 to 27 dispersed onto a wound-contacting surface of the dressing.

29. The dressing according to claim 28, wherein said antimicrobial formulation is dispersed onto one or multiple layers of the dressing.

30. The dressing according to claim 28, wherein said wound-contacting surface is made of linen or cotton fiber.

31. A method for producing the antimicrobial formulation of claim 1 , said method comprising the steps of generating electrocolloidal silver in a solution of water and a suspension of Echinacea root extract, and incorporating the admixture in a pharmaceutically acceptable carrier.

32. The method according to claim 31 , wherein generating electrocolloidal silver comprises passing a current through an electric circuit with a silver electrode in a chamber filled with a solution of deionized water and a suspension of Echinacea root extract.

33. The method according to claim 31 and 32, wherein said Echinacea root extract comprises particles of minced Echinacea root; powdered Echinacea root or combinations thereof.

34. The method according to claim 33, wherein said minced Echinacea root is water-brewed before being incorporated in the solution.

35. The method according to claim 34, wherein said water-brewing of the minced Echinacea root comprises the step of infusing minced Echinacea root in water.

36. The method according to claim 31 , wherein said pharmaceutically acceptable carrier is water.

37. The method according to claim 36, wherein said water further comprises Stevia leaves extract.

38. The method according to claim 37, wherein said Stevia leaves extract comprises powdered Stevia leaves; minced Stevia leaves or combinations thereof.

39. The method according to claim 31 , wherein said pharmaceutically acceptable carrier is a gel.

40. The method according to claim 39, wherein said gel further comprises a mix of Carbopol™ and a jellifying copolymer.

41. The method according to claim 40, wherein said Carbopol™ consists of a combination of acrylic acid and alkyl acrylate.

42. The method according to claim 40, wherein said jellifying copolymer is triethanolamine.

43. The method according to claim 31 , wherein said pharmaceutically acceptable carrier is a cream.

44. The method according to claim 43, wherein said cream further comprises a mix of shea butter and jellifying agents.

45. The method according to claim 44, wherein said shea butter comprises commercially whitened shea butter; natural shea butter or combinations thereof.

46. The method according to claim 44, wherein said jellifying agents comprise propylene glycol, novomer EC-1 , triethanolamine or Carbopol™.

47. The method according to claim 46, wherein said Carbopol™ comprises a combination of acrylic acid and alkyl acrylate.

48. The method according to claim 44, wherein said jellifying agents are progressively incorporated in the cream after the incorporation of the antimicrobial formulation.

49. A method for reducing infections and inflammations in a subject, which comprises contacting an inflamed and/or infected area with a therapeutically effective amount of the antimicrobial formulations of any one of claims 1 to 27.

50. The method according to claim 49, wherein contacting the inflamed and/or infected area comprises oral administration or topical application.

51. The method according to claim 50, wherein the oral administration can be done sublingually, by swallowing the formulation or by gargling the formulation.

52. The method according to claim 51 , wherein said oral administration of the formulation is to be repeated 3 times a day for a 4-day course when administered within 24 hours of the onset of symptoms or 4 times a day for a 3 to 5-day course when administered 24 to 48 hours after of the onset of symptoms.

53. The method according to claim 50, wherein the topical application can be done by direct application of a pharmaceutically acceptable amount of the cream or gel antimicrobial formulation on the skin of a subject or by applying a dressing of the antimicrobial formulation on the skin of a subject.

54. The method according to 53, wherein said topical application of the gel antimicrobial formulation is repeated twice a day in cases of acne.

55. The method according to 53, wherein said topical application of the cream formulation is to be repeated whenever the skin is dry.

56. The method according to claim 53, wherein said application of a dressing of the antimicrobial formulation is to be repeated once a day or once every two days in cases of light bleeding.

57. The use of a therapeutically effective amount of the antimicrobial formulation of any one of claims 1 to 27 to reduce infections and inflammations in a subject.

58. The use according to claim 57, which comprises contacting an inflamed and/or infected area with a therapeutically effective amount of the antimicrobial formulation of any one of claims 1 to 27.

59. The use according to claim 58, wherein contacting the inflamed and/or infected area comprises oral administration or topical application.

60. The use according to claim 59, wherein the oral administration can be done sublingually, by swallowing the formulation or by gargling the formulation.

61. The use according to claim 60, wherein said oral administration of the formulation is repeated 3 times a day for a 4 day-course when administered within 24 hours of the onset of symptoms or 4 times a day for a 3 to 5-day course when administered 24 to 48 hours after the onset of symptoms.

62. The use according to claim 59, wherein the topical application comprises direct application of a pharmaceutically acceptable amount of the cream or gel antimicrobial formulation on the skin of a subject or by applying a dressing of the antimicrobial formulation on the skin of a subject.

63. The use according to claim 62, wherein said topical application of the gel antimicrobial formulation is to be repeated twice a day in cases of acne.

64. The use according to claim 62, wherein said topical application of the cream formulation is repeated whenever the skin is dry.

65. The use according to claim 62, wherein said application of a dressing of the antimicrobial formulation is to be repeated once a day or once every two days in cases of light bleeding.