ANTI-INFLAMMATORY, DISINFECTING AND ACCELERATED HEALING GEL FOR WOUNDS AND LESIONS

Abstract

A composition and process for use in wound healing and a process for making such a composition has a smectite gelling agent free of heavy and translon metals mixed with hydrogen peroxide and with water. The smectite gelling agent is a synthetic aluminosilicate having the formula (Na).sub.x(Al.sub.2—XMg.sub.x)2Si.sub.2O.sub.10(OH).sub.2.n(H.sub.2O) or Na.sub.x(Mg.sub.3—XLi.sub.x)3Si.sub.4O.sub.10(OH).sub.2 where X is between 0.1 and 0.5. The smectite gelling agent has a concentration between 1-7% w/w of the total composition. The hydrogen peroxide has a concentration of 1-6% w/w of the total composition. The smectite gelling agent, the hydrogen peroxide and water are mixed together in a mixer.

Claims

1. A process for use in wound healing, the process comprising: mixing a smectite gelling agent in a mixer with water and hydrogen peroxide to form a mixture, wherein the mixture is free of heavy metals; and applying the mixture to the wound.

2. The process of claim 1, wherein the mixer is selected from the group consisting of a tumbling closed container, a rolling closed container, a cowl dissolver, a paddle mixer, a colloid mill, an ultrasonification mixer and combinations thereof.

3. The process of claim 1, the step of mixing comprising: mixing the hydrogen peroxide with the water prior to the step of mixing the smectite gelling agent with hydrogen peroxide.

4. The process of claim 3, wherein the hydrogen peroxide is mixed in an amount of 1-6% w/w with the water.

5. The process of claim 4, wherein the hydrogen peroxide is mixed between 2-5% w/w with the water.

6. The process of claim 1, wherein the smectite gelling agent is a synthetic aluminosilicate having the formula (Na).sub.x(Al.sub.2—XMg.sub.x)2Si.sub.2O.sub.10(OH).sub.2.n(H.sub.2O), where X is between 0.1 and 0.5.

7. The process of claim 1, wherein the smectite gelling agent is a synthetic aluminosilicate having the formula Na.sub.x(Mg.sub.3—XLi.sub.x)3Si.sub.4O.sub.10(OH).sub.2, where X is between 0.1 and 0.5.

8. The process of claim +, wherein (OH) is substituted wholly or partially with a fluoride ion.

9. The process of claim 7, wherein (OH) is substituted wholly or partially with a fluoride ion.

10. The process of claim 1, wherein the smectite gelling agent has a concentration between 1 and 7% w/w of the mixture.

11. The process of claim 10, wherein the smectite gelling agent has a concentration between 2 and 3% w/w of the mixture.

12. A composition for use in wound healing comprising: a smectite gelling agent free of heavy and transition metals; a hydrogen peroxide mixed with the smectite gelling agent; and water.

13. The composition of claim 12, wherein the hydrogen peroxide is 1-6% w/w of the total composition.

14. The composition of claim 13, wherein the hydrogen peroxide is between 2-5% w/w of the total composition.

15. The composition of claim 12, wherein the smectite gelling agent is a synthetic aluminosilicate having the formula (Na).sub.x(Al.sub.2—XMg.sub.x)2Si.sub.2O.sub.10(OH).sub.2.n(H.sub.2O) where X is between 0.1 and 0.5.

16. The composition of claim 12, wherein the smectite gelling agent is a synthetic aluminosilicate having the formula Na.sub.x(Mg.sub.3—XLi.sub.x)3Si.sub.4O.sub.10(OH).sub.2where X is between 0.1 and 0.5.

17. The composition of claim 15, wherein (OH) is substituted wholly or partially with a fluoride ion.

18. The composition of claim 16, wherein (OH) is substituted wholly or partially with a fluoride ion.

19. The composition of claim 12, wherein the smectite gelling agent has a concentration between 1-7% w/w of the total composition.

20. The composition of claim 19, wherein the smectite gelling agent has a concentration between 2-3% w/w of the total composition.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0037] The present invention is a disinfecting gel that also unexpectedly promotes healing. The gel is an excellent disinfectant the can be used to treat fungal and bacterial infections. The gel is applied topically and, in the case of minor superficial wounds, eliminates the infection without internal medications which can have potential serious side effects on the liver. The most unexpected facet of the present invention is the promotion of healing when applied to a wound and its anti-inflammatory effects. Medical literature recommends against applying hydrogen peroxide to wounds as a disinfectant because it is cytotoxic to healthy cells as well as bacteria so that it slows healing. The gelled hydrogen peroxide of the present invention not only disinfects the wound but speeds up healing by three to four days, depending on the size of the wound, by skipping the inflammatory stage of healing. It also skips the inflammatory phase by initiating wound contraction over a twenty-four hour period. Usually wound contraction is initiated two weeks after the wound has formed. The phases of wound healing are (1) hemostasis; (2) inflammation; (3) proliferation or granulation; and (4) remodeling or maturation.

[0038] The process of hemostasis is similar to the circumstance where a source of damage to a house has been removed. Before work can start, utility workers must come in and cap damaged gas or water lines. Similarly, in wound healing, damaged blood vessels must be sealed. In wound healing, the platelet is the cell which acts as the utility worker sealing off the damaged blood vessels. The blood vessels themselves constrict in response to injury, but the spasm ultimately relaxes. The platelets secrete vasoconstrictive substances to aid in this process, but their prime role as to form a stable clot that seals the damaged vessel. Under the influence of adenosine diphosphate leaking from damaged tissue, the platelets aggregate and adhere to the exposed collagen. They also secrete factors which interact with and stimulate the intrinsic clotting cascade through the formation of thrombin which, in turn, initiates the formation of thrombin from fibrinogen. The fibrin mesh strengthens the platelet aggregate into a stable hemostatic plug. Finally, platelets also secrete cytokines, such as platelet-derived growth factor, which is recognized as one of the first factors secreted in initiating the subsequent steps. Hemostasis occurs within minutes of the initial injury, unless there are underline clotting disorders.

[0039] The inflammation phase is the second stage of wound healing. Clinically, inflammation is present as a eyrthema, swelling and warmth that is often associated with pain. This stage usually lasts up to four days post-injury. In the wound healing analogy, the first job to be done once the utilities are capped is to clean up the debris. This job is for non-skilled laborers. The non-skilled laborers in a wound are the neutrophils or polymorphonucleosytes. The inflammatory response causes the blood vessels to become leaky so as to release plasma and the polymorphonucleocytes into the surrounding tissue. The neutrophils phagocytize debris and microorganisms and provide the first line of defense against infection. They are aided by local mast cells. As fibrin is broken down as part of this clean-up, the degradation products attract the next cell involved. The next task of rebuilding a house is complex and requires someone to direct this activity or a contractor. The cell which acts as a “contractor” in wound healing is the macrophage. Macrophages are able to phagocytize bacteria and provide a second line of defense. They also secrete a variety of chemical chemotactic and growth factors, such as fibroblast growth factor, epidermal growth factor, transforming growth factor beta (TGF- and interleukin-1) which appears to direct the next stage.

[0040] The next step of wound healing is the proliferative phase that includes proliferation, granulation and contraction. The granulation stage starts approximately four days after wounding and usually lasts until day twenty-one in acute wounds (depending on the size of the wound). It is characterized clinically by the presence of pebbled red tissue in the wound base and involves replacement of dermal tissues and sometimes subdermal tissues in deeper wounds, as well as contraction of the wound. In the wound healing analogy, once the site has been cleared of debris, under the directions of the contractor, the framers move to build the framework of the new house. Subcontractors can now install new plumbing and wiring on the framework while siders and roofers can finish the exterior of the house. The “framer” cells are the fibroblasts which secrete the collagen framework and in which further dermal regeneration occurs. Specialized fibroblasts are responsible for wound contraction. The “plumber” cells are the parasites which regenerate the outer layers of capillaries and the endothelial cells so as to produce the lining. This process is called angiogenesis. The “roofer” and “sider” cells are the keratinocytes that are responsible for epithelialization. In the final stage of epithelialization, contracture occurs as the keratinocytes differentiate to form the protective outer layer or stratum corneum.

[0041] The final stage of wound healing is the remodeling or maturation phase. Once the basic structure of the house is completed, indoor finishing may begin. This is similar in wound healing in which repair involves remodeling the dermal tissues to produce greater tensile strength. The principle cell involved in this process is the fibroblasts. Remodeling can take up to two years after wounding and explains why apparently healed wounds can break down so dramatically and quickly if attention is not paid to the initial causative factors.

[0042] It is believed that the synthetic smectite clay is responsible for mediating the deleterious effects of hydrogen peroxide on unhealthy cells but must also sequester some of the signaling molecules that initiate the inflammation phase of healing. It further appears that as the water in the gel evaporates, the smectite clay forms a protective layer over the wound. This coating of clay also keeps the wound humidified due to the natural tendencies of smectites to absorb moisture from the air. In addition, the wound heals with less scarring such that the clay also plays a role in promoting the third and fourth stages of healing. This is due to the fact that when the wound skips the inflammation stage, less, trauma is experienced by the wound.

[0043] In experiments conducted on the present invention, new and unexpected results have been achieved. As such, this proves the efficacy of the present invention. The experiments conducted on the composition of the present invention are described hereinafter.

EXAMPLE 1

[0044] In this example, the subject experienced chronic toenail fungus. The subject had previously attempted every treatment option available. The fungus had not been eliminated. The person started to apply the gel of the present invention which contained 3% w/w hydrogen peroxide and 2.5% smectite gelling agent to the nail. After five weeks, the healthy cuticle was restored and the diseased nail moved away from the cuticle.

EXAMPLE 2

[0045] A second subject experienced athletes' foot periodically over many years. The athletes' foot outbreaks resulted in an itchy rash, bleeding cracks between the toes, and blisters on the soles of the foot. In the past, attempts to treat the malady with over-the-counter drugs would result in a cessation of symptoms in about three weeks. The subject applied the gel of the present invention containing 3% w/w hydrogen peroxide and 2.5% w/w smectite gelling agent twice daily. The symptoms disappeared in only three days.

EXAMPLE 3

[0046] A third subject who was clearing brush encountered briers and received multiple scratches on their arms. The gel of the present invention containing 3% w/w hydrogen peroxide and 2.5% w/w smectite gelling agent was applied to only one arm while the other arm was left untreated as a control arm. The cuts on the control arm became red and inflamed and did not go into the second stage of healing for about three days. The control arm cuts required about two weeks to heal. The cuts treated with the gel of the present invention never became inflamed and began healing almost immediately. They healed in a week with almost no scarring. Similar healing of wounds has been experienced by dozens of individuals when employing the gel of the present invention.

EXAMPLE 4

[0047] An individual was working on his barn and received a splitter in his finger. The subject thought that he had extracted all of the splitter but, the next day, the wound was inflamed and a small pustule had formed. A small amount of the gel of the present invention containing 3% w/w hydrogen peroxide and 2.5% w/w smectite gelling agent was applied to the wound. Within an hour the inflammation began to subside. The inflammation was completely gone the next day and the wound completely healed in four days.

[0048] In all of the examples referenced hereinabove, it was determined that more than 7% w/w of smectite gelling agent was incorporated into the composition, the composition was too viscous to apply and use. If less than 1% w/w smectite gelling agent was used, the composition became too liquid. It was so non-viscous that would be too thin to apply. When less than 1% of the hydrogen peroxide was utilized, the disinfectant properties of the hydrogen peroxide would disappear. In those circumstances where greater than 6% of the hydrogen peroxide was used, the conventional negative effects from high concentrations of hydrogen peroxide appeared, such as skin bleaching and delayed healing. In all circumstances and examples of the present invention, the remainder of the composition would be water. Typically, the hydrogen peroxide was of a quality that could be purchased over-the-counter. As such, the over-the-counter hydrogen peroxide will typically contain 3% hydrogen peroxide with the remainder being water. The water in the hydrogen peroxide solution is used to form the remainder of the composition when the smectite gelling agent is incorporated therein.

[0049] In experiments conducted with the present invention, the smectite gelling agent is a synthetic aluminosilicate having the formula (Na).sub.x(Al.sub.2—XMg.sub.x)2Si.sub.2O.sub.10(OH).sub.2.n(H.sub.2O) where X is between 0.1 and 0.5. Alternatively, the smectite gelling agent can be a synthetic aluminosilicate having the formula Na.sub.x(Mg.sub.3—XLi.sub.x)3Si.sub.4O.sub.10(OH).sub.2 where X is between 0.1 and 0.5. The hydroxyl group (OH) can be substituted wholly or partially with a fluoride ion.

[0050] In the process of the present invention, the smectite gelling agent will be mixed with hydrogen peroxide and water together in a mixer. Under all circumstances, this mixture will be free of heavy metals. In particular, the mixer can be a tumbling closed container, a rolling closed container, a cowl dissolver, a paddle mixer, a colloid mill, and ultrasonicification mixer or combinations thereof. The hydrogen peroxide is mixed with water prior to the step of mixing the smectite gelling agent with the hydrogen peroxide. The smectite gelling agent of the present invention is formed from LAPONITE™. Laponite is a synthetic smectite clay that has many technological applications which go beyond the conventional uses of clays in pharmaceuticals and cosmetics. In biomedical applications, particularly in nanomedicine, LAPONITE™ has great potential. LAPONITE™ is a two-dimensional nanomaterial composed of disk-shaped nanoscale crystals that have a high-aspect ratio. These disks can strongly interact with many types of chemical entities (from small molecules or ions, to natural or synthetic polymers, or to different inorganic nanoparticles) and can also be easily functionalized and readily degraded in the physiological environment to the rise to non-toxic and even bioactive products.

[0051] In the present invention, it was unexpectedly discovered that the gel, composed of a synthetic silicate nanoparticle and an oxidizing aqueous agent and selected water-dispersible polymers will form a stable gel that will disinfect minor wounds of the skin and accelerate healing and self-assembly into a nanocomposite barrier film that protects the wound while healing occurs. This silicate nanoparticle appears to unexpectedly interfere with messenger molecules that initiate inflammation of the wound. This inflammation adds about three extra days to the healing process. The oxidizing media disinfects the wound so as to negate the need for the inflammation step. Further, the silicate self-assembles with the selected water-dispersible polymer to form a highly-ordered nanocomposite film that is impermeable to oxygen and bacteria.

[0052] As such, the present invention is a gel composed of a synthetic silicate of high purity (having no transition metal impurities) dispersed in an aqueous oxidizing agent and selected polymers that can be used to disinfect minor wounds to the skin, accelerate healing, and form a protective self-assembly nanocomposite barrier film that protects the wound during healing. The silicate is a synthetic aluminosilicate, such as “LAPONITE”™. The aqueous oxidizing agent can be 1-6% w/w hydrogen peroxide or 1-5% w/w providone-iodine. The water dispersible polymer can be polyvinylpyrrolidone, polyvinyl alcohol, polyvinyl acetate, polyethylene oxide, and natural polysaccharides, such as Gum Arabic. The polymer would be between 0.1-5% w/w of the composition.

[0053] The foregoing disclosure and description of the invention is illustrative and explanatory thereof. Various changes in the details of the described process or in the components of the described composition can be made within the scope of the present invention without departing from the true spirit of the invention. The present invention should only be limited by the following claims and their legal equivalents.