Dermal skin protectants and vehicles

Abstract

A dermal skin protectant and carrier comprising a combination of two polydimethylsiloxane components of different viscosities, wherein the difference between the two polydimethylsiloxane components of different viscosities is about 2,000,000 cP or greater; and comprising at least one active ingredient.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 755,719, filed November 5, 2018, with the United States Patent and Trademark Office, and the benefit of U.S. Patent Application No. 62 / 846,763, filed May 13, 2019, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] This invention generally relates to topical skin protectant materials, particularly dermal or nail skin protectant materials, which also serve as carriers for excipients and other therapeutic compounds, suitable for topical administration onto the skin surface for skin protection and for providing a carrier for additives or therapeutic agents on the skin surface. Dermal skin protectant materials comprise at least two polydimethylsiloxane components of different viscosities for application to the skin surface and at least one excipient. Background Technology

[0004] The dermis, or skin, is the first line of defense against external attacks. Therefore, skin is often the component most vulnerable to environmental hazards. Among the most common skin ailments are cuts, bruises, rashes, fungal infections, bacterial infections, viral infections, and other disorders. While nails and hair, which cover the skin, offer some protection, additional protection is necessary in certain situations.

[0005] Skin protective materials typically attempt to form a barrier on the skin, thereby allowing the body to heal the skin without further damage. For example, when a person has an incision, the application of a bandage uses a clean, protective covering material to protect the healing tissue, and many of these bandages include wound-closing or healing-promoting compounds or antibacterial materials, or both. Therefore, bandages provide physical protection as well as adding compounds that promote the healing of the underlying damaged tissue.

[0006] However, physical bandages can further irritate the skin through their adhesive material, or in other cases, they simply cause irritation to the wound itself. Therefore, there are instances where bandages are wrapped around the wound rather than adhered to it, or where the wound is simply left open to prevent further damage.

[0007] Furthermore, most bandages contain a limited aggregate of compounds on the skin surface facing the wound. There are many reasons for this limitation, but bandages containing therapeutic materials have not been widely used to date.

[0008] This invention relates to novel skin protectants and materials for topical dermal application, as well as methods of their manufacture, which provide new and useful methods for skin and nail protection and for the application of therapeutic agents through dermal contact. These materials can be applied epidermally or provided within bandages and are applied to or above the skin as creams, ointments, foams, gels, liquids, cosmetics, polishes, or wherein the material is embedded within a bandage. Summary of the Invention

[0009] Embodiments of this disclosure detail novel and useful dermal application materials comprising first and second polydimethylsiloxane products, which, when combined, form a unique material for dermal application. In preferred embodiments herein, at least one therapeutic agent may be advantageously combined into a material in which the material is applied epidermally, wherein the therapeutic agent is transdermally transferred to the patient.

[0010] In a preferred embodiment, a dermal skin protectant and carrier comprises 12,500 cP of polydimethylsiloxane at 25%-99% and 2,500,000 cP of polydimethylsiloxane at 1%-50%; and at least one therapeutic agent mixed therein.

[0011] A dermal skin protectant and carrier comprising 1,000 cP of polydimethylsiloxane at 25%-99% and 2,500,000 cP of polydimethylsiloxane at 1%-50%; and at least one therapeutic agent mixed therein.

[0012] In a preferred embodiment, the skin protectant and carrier have first and second polydimethylsiloxane products having a viscosity difference of at least 2,000,000 cP, and preferably a difference of about 2,500,000 cP. In a preferred embodiment, the difference is 2,500,000 cP ± 1%, 2%, 3%, 5%, 10%, or any number within the range.

[0013] In a preferred embodiment, the dermal skin protectant and carrier comprise first and second polydimethylsiloxanes, the first polydimethylsiloxane having a viscosity between 1,000 and 25,000 cP, and the second polydimethylsiloxane having a viscosity between 2,000,000 cP and 3,000,000 cP; and at least one therapeutic agent incorporated therein.

[0014] A dermal skin protectant and carrier comprising two polydimethylsiloxane polymers and a therapeutic agent; the first polydimethylsiloxane polymer having the formula Me3-O-[SiMe2]n-Me3, where n is the number of repeating units, and having a viscosity between about 1,000 and 25,000 cP; and the second polydimethylsiloxane polymer having a formula where n is greater than that of the first polydimethylsiloxane polymer, and having a thicker viscosity between about 2,000,000 cP and 3,000,000 cP; wherein the first polydimethylsiloxane polymer comprises between 10% and 99% of the total mass of the formulation, and the second polydimethylsiloxane polymer comprises between 1% and 90% of the total mass of the formulation.

[0015] A dermal skin protectant and carrier comprising two polydimethylsiloxane polymers and a therapeutic agent; the first polydimethylsiloxane polymer has the formula Me3-O-[SiMe2]n-Me3 with an "n" repeating unit, and the second polydimethylsiloxane polymer has a higher viscosity and a larger "n" repeating unit than the first polydimethylsiloxane polymer; the ratio of the first polydimethylsiloxane polymer to the second polydimethylsiloxane polymer is between 100:1 and 1:10. Preferably, the ratio is between about 75:1 and about 1:2, or about 50:1 and about 1:1.

[0016] A method for formulating a dermal skin protectant and a carrier includes: mixing a first amount of a first polydimethylsiloxane component and at least one excipient or surfactant in a centripetal mixer; mixing the first polydimethylsiloxane component and at least one excipient or surfactant at 3,000 RPM for 10 minutes; adding a portion of a second polydimethylsiloxane component with a viscosity 2,000,000 cP greater than that of the first polydimethylsiloxane to the mixture, wherein the second polydimethylsiloxane is mixed in several increments; wherein each increment uses an equal portion of the original amount of the second polydimethylsiloxane, which is incorporated into the mixture at 3,000 RPM for 5 minutes, and then another increment of the second polydimethylsiloxane is added until all the second polydimethylsiloxane is incorporated into the mixture. In a preferred embodiment, the second polydimethylsiloxane is divided into 2, 3, 4, 5, or 10 increments for mixing into the first mixture.

[0017] In a preferred embodiment, the combination of the first polydimethylsiloxane and the second polydimethylsiloxane is combined with the active ingredient. In some embodiments, the active ingredient is provided in a dosage suitable for over-the-counter sale. In some embodiments, the dosage or active ingredient needs to be sold under a prescription.

[0018] In some embodiments, preferably, different release profiles are identified for different purposes. Therefore, the dermal skin protectant and carrier may comprise low-viscosity to high-viscosity polydimethylsiloxane in a 1:10 ratio, up to a 100:1 ratio, and all ratios in between. Different concentrations allow for different physical properties, including different physiological characteristics (solid or gel-like), and different release rates.

[0019] In a preferred embodiment, the material is a wound care material comprising first and second polydimethylsiloxanes, the first polydimethylsiloxane having a viscosity between 1,000 and 25,000 cP, and the second polydimethylsiloxane having a viscosity between 2,000,000 cP and 3,000,000 cP, and at least one therapeutic agent incorporated therein, wherein the therapeutic agent is selected from the group consisting of: antibiotic materials, sulfur-containing compounds, skin healing compounds, bone growth promoting compounds, antimicrobial agents, local anesthetics, antifungal agents, and CoQ. 10 Vitamin D, chlorhexidine, FDA-approved compounds identified at https: / / www.fda.gov / downloads / AboutFDA / CentersOffices / CDER / UCM135688.pdf, chitosan, hemostatic materials, anti-inflammatory agents, topical steroids, anti-inflammatory compounds, silver nitrate, essential oils, skin protectants, pain relievers or blockers, zinc oxide, small molecules, nitroglycerin, nicotine, hormones or combinations thereof.

[0020] In some preferred embodiments, the material is indicated for vaginal application, wherein the material may be provided as a lubricant, or wherein the material is incorporated as an antifungal agent, including but not limited to clotrimazole, econazole, miconazole, terbinafine, fluconazole, ketoconazole, mophotericin, nystatin, sporanox, difulcan, terazol, intraconazole, mycostatin, boric acid, tioconazole, or another known antifungal agent (including those listed below), whether natural or synthetic, its derivatives or prodrugs or combinations thereof. In some preferred embodiments, the antifungal agent is suitable for any skin tissue and may include the antifungal agents described above or one of the following: undecanoic acid, tolnaftate, imidazole, luliconazole, tavaborole, allylamine, amorolfine, oxiconazole, gluconazole, ciclopirox, naftifine, amphotericin B, sulconazole, butenafine, sertaconazole, efinacanazole, and other known natural or synthetic antifungal compounds, or combinations thereof. In some embodiments, the material further comprises at least one skin-protecting therapeutic agent. In some embodiments, the material further comprises at least one deodorant or antiperspirant material. In some preferred embodiments, the material comprises at least one anesthetic component.

[0021] In some preferred embodiments, the material for application to the nasal mucosa and the carrier comprises first and second polydimethylsiloxanes, the first polydimethylsiloxane having a viscosity between 1,000 and 25,000 cP, and the second polydimethylsiloxane having a viscosity between 2,000,000 cP and 3,000,000 cP; and at least one therapeutic agent incorporated therein, selected from skin protectants, steroids, anti-inflammatory agents, antihistamines, or suitable therapeutic agents for intranasal administration.

[0022] In some preferred embodiments, the material is applied to the skin surface, or to the nail or hair material, wherein the adhesive properties of the material provide a barrier layer on the underlying surface and also allow the release of therapeutic agents from the material onto the underlying skin, nail, or hair.

[0023] In some preferred embodiments, for any of the topical applications, the material comprises an essential oil.

[0024] In some preferred embodiments, the material may further comprise an antimicrobial compound for any of the topical applications described above. In some other embodiments, the material may further comprise an odor-eliminating material or an odor-masking material.

[0025] In some preferred embodiments, the material is defined as a skin-protective material; advantageously combined with one or more excipients to form a barrier and used as a carrier for releasing the skin-protective agent, as an antimicrobial agent for treating rashes, for pain relief in conjunction with zinc oxide, as a carrier for small molecules, as a carrier for nitroglycerin, and may also include, but is not limited to: testosterone; nicotine, hormones, antinausea agents, estrogen replacements, fentanyl (or other pain relievers), scopaline, vasopressin, MAOI antidepressants, ADHD, vitamin B12. 12 5-THP, visual pigment-A, or combinations thereof.

[0026] In some preferred embodiments, the material is a skin protectant for the lips. In preferred embodiments, the material for lip care also comprises excipients selected from the group consisting of: moisturizing creams, fragrances, pigments, essential oils, zinc oxide, gloss-enhancing humectants or lipsticks, and combinations thereof.

[0027] In a preferred embodiment, a polydimethylsiloxane-based dermal skin protectant and carrier comprises a first polydimethylsiloxane material with a viscosity between about 1,000 cP and 25,000 cP, a second polydimethylsiloxane material with a viscosity between about 2,000,000 and 3,000,000 cP, and at least one active agent.

[0028] In another embodiment, any of the polydimethylsiloxane skin protectants in the above embodiments, wherein at least one active agent is selected from the group consisting of: antibiotic materials, antimicrobial and antifungal agents; FDA-authored compounds identified at https: / / www.fda.gov / downloads / AboutFDA / CentersOffices / CDER / UCM135688.pdf; hemostatic materials; anti-inflammatory agents; topical steroids; essential oils, skin protectants, pain relievers, zinc oxide, hormones, and combinations thereof.

[0029] In some preferred embodiments, the material is a hair and scalp treatment material for treating fungal, yeast, mold, bacterial, or viral infections of hair, hair follicles, and scalp or dermal tissue.

[0030] In some preferred embodiments, the material is a nail treatment agent for topical application to the nail surface. In preferred embodiments, the nail application is in the form of a gel, cream, foam, solid, or liquid, and / or may also contain a hardening agent to allow it to form as nail polish.

[0031] A composition comprising a first polydimethylsiloxane material with a viscosity between about 1,000 cP and 25,000 cP, a second polydimethylsiloxane material with a viscosity between about 2,000,000 and 3,000,000 cP, and at least one activator.

[0032] In one embodiment, the composition comprises a dermal skin protectant and a carrier, wherein at least one active agent is selected from the group consisting of antimicrobial agents, anesthetics, hemostatic agents, anti-inflammatory agents, deodorants, analgesics, UV protectants, and combinations thereof. In one embodiment, the composition comprises two or more active agents combined together in a dermal skin protectant and a carrier.

[0033] In one embodiment, the composition wherein the ratio of the first polydimethylsiloxane to the second polydimethylsiloxane is between 100:1 and 1:10. In one embodiment, the composition wherein the ratio of the first polydimethylsiloxane to the second polydimethylsiloxane is between 50:1 and 1:5. In one embodiment, the composition wherein the ratio of the first polydimethylsiloxane to the second polydimethylsiloxane is between 40:1 and 1:2. In one embodiment, the composition wherein the concentration of at least one surfactant is between 0.5% and 10%.

[0034] In one embodiment, the composition further comprises a second activator.

[0035] In one embodiment, the composition further comprises at least one antifungal agent, antiviral agent, or antibacterial agent.

[0036] In one embodiment, the composition further comprises at least one local anesthetic.

[0037] In one embodiment, the composition further comprises at least one deodorant.

[0038] In one embodiment, the composition further comprises at least one essential oil. In another embodiment, the composition further comprises a plant extract.

[0039] In one embodiment, the composition further comprises at least one antimicrobial agent. In a preferred embodiment, the antimicrobial agent is a specific agent against bacteria, fungi, or viruses. In another preferred embodiment, the antimicrobial agent is benzalkonium chloride or hexadecylpyridine chloride.

[0040] In another embodiment, a method for formulating the skin protectant of the above embodiments includes placing all of the first polydimethylsiloxane component into a mixing container and adding a certain amount of therapeutic agent thereto; mixing the two components at 3,000 RPM for about 10 minutes in a centripetal mixer; after mixing for 10 minutes, adding the second polydimethylsiloxane, wherein one-fifth of the total concentration of the second polydimethylsiloxane is added in equal parts; and then mixing in increments of 3,000 RPM for five minutes until all of the second polydimethylsiloxane has been added and mixed for five minutes.

[0041] In one embodiment, the method further includes adding at least one active agent together with the first polydimethylsiloxane and the therapeutic agent before mixing the components.

[0042] In one embodiment, the method further includes incorporating the first and second therapeutic agents and any excipients into the first polydimethylsiloxane prior to incorporating the second polydimethylsiloxane.

[0043] In another embodiment, a polydimethylsiloxane-based antifungal agent delivery composition comprises: a first polydimethylsiloxane with a viscosity between 1,000 cP and 25,000 cP, a second polydimethylsiloxane with a viscosity between 2,000,000 cP and 3,000,000 cP, and an effective amount of the antifungal agent composition. In a preferred embodiment, the antifungal composition is selected from the group consisting of: clotrimazole, econazole, miconazole, terbinafine, fluconazole, ketoconazole, mophotericin, nystatin, succinate, diflubenzuron, terconazole, itraconazole, miconidine, boric acid, tiaconazole, undecanoic acid, tonaphthyl ester, imidazole, ruliconazole, tavaborone, allylamine, amorolfine, oxiconazole, glucagon, ciclopirox, naftifine, amphotericin B, thioconazole, butenafine, sertaconazole, ifluconazole, derivatives or prodrugs thereof, and combinations thereof. In one embodiment, the antifungal composition is nystatin. In one embodiment, the antifungal composition further comprises aloe vera. In one embodiment, the antifungal composition is clotrimazole. In one embodiment, the antifungal composition is applied to the skin surface, nail surface, or hair.

[0044] In another embodiment, a polydimethylsiloxane-based antibacterial agent delivery composition comprises: a first polydimethylsiloxane with a viscosity between 1,000 cP and 25,000 cP, a second polydimethylsiloxane with a viscosity between 2,000,000 cP and 3,000,000 cP, and an effective amount of the antibacterial agent composition. In one embodiment, the antifungal agent composition is applied to a skin surface, nail surface, or hair.

[0045] In another embodiment, a polydimethylsiloxane-based skin composition for treating burned skin comprises a first polydimethylsiloxane with a viscosity between 1,000 cP and 25,000 cP, a second polydimethylsiloxane with a viscosity between 2,000,000 cP and 3,000,000 cP, and an effective amount of skin care material and an effective amount of local anesthetic. In one embodiment, the skin care material is selected from the group consisting of chitosan, sulfadiazine, silver sulfadiazine, silver nitrate, silver nanoparticles, and combinations thereof. In one embodiment, the local anesthetic is selected from the group consisting of: benzocaine, butamben, tetracaine, benzyl alcohol, capsaicin, dibucaine, diclofenac, dyclonine, ethyl chloride, hexylresorcinol, lidocaine, prilocaine, methyl salicylate, menthol, pramoxine, proparacaine, triethanolamine, and combinations thereof.

[0046] In another embodiment, a polydimethylsiloxane composition for local wound healing comprises: a first polydimethylsiloxane with a viscosity between 1,000 cP and 25,000 cP, a second polydimethylsiloxane with a viscosity between 2,000,000 cP and 3,000,000 cP, and an effective amount of the wound healing composition. In one embodiment, said wound healing composition is selected from the group consisting of: bacitracin; neomycin; polymyxin B, epidermal growth factor, triamcinolone acetonide, and combinations thereof.

[0047] A polydimethylsiloxane composition for hemostatic treatment comprises: a first polydimethylsiloxane with a viscosity between 1,000 cP and 25,000 cP, and a second polydimethylsiloxane with a viscosity between 2,000,000 cP and 3,000,000 cP, and an effective amount of the hemostatic composition. In one embodiment, the composition, wherein the hemostatic composition is selected from the group consisting of: tranexamic acid, chitosan, human fibrinogen, human thrombin, non-human fibrinogen or thrombin, synthetic fibrinogen or thrombin, keratin, aluminum chloride, ferric sulfate, ferrous sulfite, chitosan, soft talc or other clays and combinations thereof.

[0048] A polydimethylsiloxane composition for treating acne, comprising a first polydimethylsiloxane with a viscosity between 1,000 cP and 25,000 cP, a second polydimethylsiloxane with a viscosity between 2,000,000 cP and 3,000,000 cP, and an effective amount of an active ingredient selected from the group consisting of benzoyl peroxide, azelaic acid, salicylic acid, retinoids, and antibiotics, including but not limited to tetracycline, clindamycin, and erythromycin and combinations thereof.

[0049] A polydimethylsiloxane composition for treating hemorrhoids, comprising a first polydimethylsiloxane with a viscosity between 1,000 cP and 25,000 cP, a second polydimethylsiloxane with a viscosity between 2,000,000 cP and 3,000,000 cP, and an effective amount of an active ingredient selected from the group consisting of: phenylephrine hydrochloride, promocaine HCl, corticosteroids, and combinations thereof.

[0050] A polydimethylsiloxane composition for delivering plant extracts to the surface of the dermis, comprising: a first polydimethylsiloxane with a viscosity between 1,000 cP and 25,000 cP, a second polydimethylsiloxane with a viscosity between 2,000,000 cP and 3,000,000 cP, and an effective amount of plant extract.

[0051] A polydimethylsiloxane composition for a cannabinoid delivery system comprises a first polydimethylsiloxane with a viscosity between 1,000 cP and 25,000 cP, and a second polydimethylsiloxane with a viscosity between 2,000,000 cP and 3,000,000 cP; and at least one therapeutic agent mixed therein. In a preferred embodiment, the first polydimethylsiloxane comprises between 10% and 99% of the total weight of the composition, and the second polydimethylsiloxane comprises between 1% and 90% of the total weight of the composition. In a preferred embodiment, the extract comprises terpenes.

[0052] A polydimethylsiloxane composition for use as a therapeutic anti-inflammatory material, comprising: a first polydimethylsiloxane with a viscosity between 1,000 cP and 25,000 cP, a second polydimethylsiloxane with a viscosity between 2,000,000 cP and 3,000,000 cP, and an effective amount of an active ingredient selected from the group consisting of diphenhydramine, corticosteroids or other anti-inflammatory compounds and combinations thereof.

[0053] A polydimethylsiloxane composition for delivering ferrous sulfite comprises a first polydimethylsiloxane with a viscosity between 1,000 cP and 12,500 cP, a second polydimethylsiloxane with a viscosity between 2,000,000 cP and 3,000,000 cP, and an effective amount of ferrous sulfite material. In one embodiment, the ferrous sulfite material is a Monsel's solution.

[0054] A polydimethylsiloxane composition comprising a first polydimethylsiloxane material having a first viscosity and a second polydimethylsiloxane material having a second viscosity, wherein the difference between the first viscosity and the second viscosity is at least 2,000,000 cP; and further comprising at least one active agent incorporated into the first and second polydimethylsiloxanes. In a preferred embodiment, the active agent is a therapeutic agent selected from the group consisting of: benzalkonium chloride, hexadecylpyridine chloride, nystatin, sulfur-containing compounds, colloidal silver compounds, ferrous sulfite; hemostatic agents, including fibrinogen, thrombin, and chitosan; treatments for mucositis, sulfur-containing compounds, antimicrobial agents, local anesthetics, antifungal agents, and CoQ. 10 Vitamin D, chlorhexidine, chitosan, hemostatic materials, anti-inflammatory agents, topical steroids, antihistamines, silver nitrate, peppermint, cinnamon, wintergreen, chlorine, antifungal agents, skin protectants, deodorants, anesthetics, steroids, essential oils, odor masking or prevention, skin protectants, antimicrobial and antibacterial agents, pain relievers, zinc oxide, small molecules for therapeutic treatment in mammals, nitroglycerin, testosterone, nicotine, hormones, nausea treatment, estrogen replacement therapy, transdermal styraxine, vasopressin, MAOI antidepressants, ADHD, vitamin B1 12 5-THP, visual pigment-A and their combinations.

[0055] A method for manufacturing a dermal skin protectant and a carrier comprising: a first polydimethylsiloxane material with a viscosity between about 1,000 cP and 25,000 cP, and a second polydimethylsiloxane material with a viscosity between about 2,000,000 and 3,000,000 cP; and at least one active agent; the method comprising: placing the first polydimethylsiloxane component in a mixing container and adding an amount of active agent thereto, and mixing the combination at 3,000 RPM for about 10 minutes in a centripetal mixer; after mixing at least one active agent into the first polydimethylsiloxane, adding the second polydimethylsiloxane to a mixing chamber, wherein the second polydimethylsiloxane is added in equal increments of one-fifth of the total concentration of the second polydimethylsiloxane, and then mixing in increments of 3,000 RPM for five minutes until all the second polydimethylsiloxane has been added and mixed for five minutes.

[0056] Use of any of the dermal skin protectants and carriers provided in the embodiments, comprising applying the dermal skin protectant and carrier to a dermal surface. Attached Figure Description

[0057] Figure 1 A diagram depicting the formula of PDMS (polydimethylsiloxane) having n repeating siloxane units.

[0058] Figure 2 Release curves of several different blends of this disclosure are depicted regarding the release of benzalkonium chloride over a 24-hour period.

[0059] Figure 3 Release curves of several different blends of this disclosure are depicted regarding the release of plant extracts over a 24-hour period.

[0060] Figures 4A-4C An embodiment of a bandage comprising certain layers of material having a skin protectant is depicted. Detailed Implementation

[0061] As used in this article, the term “about” means within 10% of the specified number.

[0062] This section describes dermal skin protectants, as well as carriers and protectant products that provide carriers for excipients used in the treatment of ailments and barrier materials that provide skin protection.

[0063] In a preferred embodiment, the dermal skin protectant, as well as the carrier and protectant, comprises a first polydimethylsiloxane product having a first viscosity. Figure 1The general formula for polydimethylsiloxanes having a repeating unit number of “n” is described in detail. The larger the repeating unit number “n”, the greater the viscosity of the material. Dermal skin protectants, as well as carriers and protectants, also contain a second polydimethylsiloxane product having a second viscosity, wherein the viscosity of the second polydimethylsiloxane product is at least 2,000,000 cP greater than that of the first polydimethylsiloxane product. cP units (centipoises) are units of dynamic viscosity. The combination of the two viscosities provides a material that provides a barrier when applied to the skin surface and has strong mucosal adhesion properties, wherein the material will adhere to the dermal skin surface and is resistant to removal due to strong adhesion. This material forms a barrier of polydimethylsiloxane material contained on the skin surface. However, it also acts as a reservoir for excipients used to treat one or more of the ailments described herein.

[0064] The material, when applied to the skin, provides a barrier that offers a degree of protection against elemental exposure. For example, dermal skin protectants, along with their carriers and protectants, can be in the form of ointments, gels, foams, liquids, solids, polishes, films, varnishes, creams, ointments, etc., for direct application, or can be added to bandages, wound dressings, or suppositories, feminine hygiene products (such as tampons or panty liners), or can be in solid powder form. Each of these forms allows application to the skin surface, where the dermal skin protectant, along with its carrier and protectant, forms a protective coating on the skin surface. Subsequently, the material infused (or dissolved in) polydimethylsiloxane is released into the dermal tissue, where the efficacy of such products allows for the treatment of underlying skin conditions.

[0065] As used herein, the terms “activator,” “additive,” or “excipient” are used together to mean any material added to the local carrier product of embodiments of the invention, other than the polydimethylsiloxane component. This term includes additional excipients and therapeutic agents, and also includes flavoring agents, coloring agents, preservatives, binders, carriers, viscosity-enhancing materials, etc., which may be suitable for dispersion from materials or for formulation of compositions suitable for a predetermined use in one or more forms.

[0066] As used herein, the term "therapeutic agent" means an additive to a material intended for delivery to an application surface or skin to produce a therapeutic response in the skin, nails, or hair.

[0067] For example, in some embodiments, therapeutic agents, as non-limiting examples, may include: benzalkonium chloride, cetylpyridine chloride, nystatin, sulfur-containing compounds, colloidal silver compounds, ferrous sulfite; hemostatic agents, including fibrinogen, thrombin, and chitosan; agents for treating mucositis, sulfur-containing compounds, promoting healing, promoting bone growth, antimicrobial agents, and local anesthetics, including but not limited to benzocaine or lidocaine, antifungal agents, and CoQ. 10Vitamins, such as vitamin D, chlorhexidine, FDA-approved monograph compounds, chitosan (hemostatic / antimicrobial properties), hemostatic materials, anti-inflammatory agents, topical steroids, antihistamines, silver nitrate, peppermint, cinnamon, wintergreen, chlorine as used in odor and antifungal or antibacterial oils, antifungal agents, skin protectants; deodorants, anesthetics, steroids, essential oils, odor masking or preventative agents, skin protectants, antimicrobial and antibacterial agents, pain relievers, zinc oxide, small molecules used for therapeutic treatment in mammals, nitroglycerin, testosterone or other steroids, nicotine, hormones, nausea treatment, estrogen replacement, fentanyl patches, transdermal fentanyl, vasopressin, MAOI antidepressants, ADHD, vitamin B12. 12 5-THP, visual pigment-A and their combinations.

[0068] The key component of the dermal skin protectant and carrier disclosed herein is polydimethylsiloxane, also known as polydimethylsiloxane or PDMS, which is a silicone-based polymer. Polydimethylsiloxane has a wide range of applications, such as in antiperspirants, skin creams, lotions, sunscreens, bath oils, hair care products, lubricants, and as a coating for oral products. In skin care products, polydimethylsiloxane is widely used, and its properties, including hydrophobicity, viscosity range, lubricating properties, low surface tension, transparency, odorlessness, inertness, and miscibility with a variety of other materials, serve as the basis for many cosmetic formulations.

[0069] In fact, many cosmetic formulations rely on polydimethylsiloxanes of various viscosities, which are used to fill in uneven textures and fine lines, such as in primers, foundations, or lotions. Additionally, silicone oils, like sunscreens or other skin lotions, provide a protective layer on the skin.

[0070] Polydimethylsiloxane is also used in hair care products to provide smoothness, particularly in conditioners or detangling products. In fact, incorporating polydimethylsiloxane into these products helps to make hair smooth and easier to reduce or remove tangles. Furthermore, in many hair care products, polydimethylsiloxane is used to leave shine or luster on the hair.

[0071] PDMS has a typical formula:

[0072]

[0073] The number of repeating units “n” affects the viscosity of the material. Polydimethylsiloxane products are typically sold in various formulations based on their viscosity. Here, we combine at least two polydimethylsiloxanes of different viscosities, one with a viscosity between about 1,000 cP and 50,000 cP, and a second with a viscosity between about 2,000,000 cP and 3,000,000 cP, and preferably about 2,500,000 cP. When purchasing these materials, a typical analytical certificate will provide the viscosity, as determined by a spin test, and each analysis will provide a specification limit for the certificate material, typically within about 10%, or about 5%, or about 1% of the specified specification. For example, for a viscosity of 2,500,000 cP, based on actual analysis of the solid material, the materials used in the examples herein comprise a specification range of 2,312,500 to 2,687,500 cP.

[0074] The FDA has approved polydimethylsiloxane for use in personal care products and it is generally considered safe for use. In fact, the FDA has listed at least 16 entries for topical, transdermal, and oral applications of polydimethylsiloxane. Therefore, polydimethylsiloxane has a known and expected safety profile with the FDA.

[0075] The viscosity difference of polydimethylsiloxanes lies solely in the number of repeating polymer units in the molecule. For example, polymers with a larger number of repeating units will tend to restrict motion and will therefore have a higher viscosity than polymers with a lower number of repeating units. However, when these polydimethylsiloxane products are commercially available, in almost every instance the material is sold according to its viscosity, ranging from approximately 1% to 10% of the specified viscosity. Therefore, as those skilled in the art will understand, we define them herein by their viscosity.

[0076] When formulating the dermal skin protectants and carrier products used in this invention, several considerations must be evaluated, namely: the release rate of the active ingredient, adhesion, and the aesthetics and tactile response of the material, to produce a superior product. As detailed in Formulations 1-9 below and Table 3, we tested two different basic formulations: one using 1,000 cP of polydimethylsiloxane component with 2,500,000 cP of polydimethylsiloxane, and a second in which 1,000 cP of polydimethylsiloxane was replaced by 12,500 cP of polydimethylsiloxane. We also tested variants using 25,000 and 50,000 cP of polydimethylsiloxane mixed with 2,500,000 cP of polydimethylsiloxane. Finally, we tested 1,000 and 12,500 cP of polydimethylsiloxane with lower amounts of 1,500,000 cP of polydimethylsiloxane.

[0077] We tested variants of polydimethylsiloxane blended with a second polydimethylsiloxane at various ratios to evaluate combinations that provide maximum and minimum adhesion.

[0078] Adhesion and release profiles are helpful in generating skin protectant materials with appropriate adhesion to the skin and an appropriate release rate based on the adhesion. For example, in cases where the material is likely to wash off quickly, Table 3 below details several different formulations of this disclosure, each with different amounts of force (peak adhesion) and (total adhesive work), providing a value for each material relative to its adhesion. These values ​​are calculated using benzalkonium chloride as the active ingredient, but our tests confirm that additional excipients or removal of benzalkonium chloride do not significantly alter these values, and therefore the values ​​in Table 3 can be used to understand the effect of different amounts of the two polydimethylsiloxane materials when combined. Those with higher adhesion will typically remain on the skin surface for a longer time compared to formulations with lower peak adhesion. Therefore, formulations using a larger percentage of 2,500,000 cP of polydimethylsiloxane have much larger peak adhesion and will therefore have greater adhesion to the skin surface.

[0079] At the same time, for many applications, a balance must be maintained between peak adhesion and the rate at which benzalkonium chloride (or other active ingredients) dissolves from the material. Figure 2 The rates of dissolution of the surfactant (in this case, benzalkonium chloride) from three different formulations are detailed, and those with a larger amount of 2,500,000 cP of polydimethylsiloxane exhibit slower rates of dissolution of benzalkonium chloride from the carrier. At a 1:1 ratio, the chloride release rate is almost half that of the release curves in the other two tests of this disclosure. Therefore, although the product with only 1,000 cP of polydimethylsiloxane has the fastest release curve in the 0–5 hour range, its total release at 24 hours is almost identical to that of the product with a 1:4 product ratio. Furthermore, the adhesion of the 1:4 ratio product is significantly and markedly improved compared to the 1,000 cP material.

[0080] Over 24 hours, the release profile of the 1:1 ratio product reached over 40 ppm chloride per gram for a dermal skin protectant. The importance of these release profiles lies in assessing two aspects of the release rate: the rate that allows for the release of benzalkonium chloride (the active agent) while balancing the need for adhesion to maintain the material on the skin surface. For example, if a single 1,000 cP of material is too easily washed off the skin surface (e.g., within 30 minutes), its rapid release rate is insufficient because it will not provide enough time for the active agent to be released or to provide the desired skin protectant properties. Therefore, a skin protectant with strong adhesion is desired because it is necessary to both maintain the material on the skin surface and allow for the timed release of the active ingredient.

[0081] To confirm the release profile, a second surfactant was tested to determine the release profile, such as... Figure 3 The description refers to the release of plant extracts from the material. Figure 3 Detailed Explanation and Figure 2 Those finding a similar set of results, namely that the lowest viscosity materials exhibited faster release profiles, were nearly identical to those of products using a 4:1 ratio of low to high viscosity polydimethylsiloxane. In fact, although not depicted in the figure, fluoride release was also tested in similar studies, and the same general principles were confirmed regarding release. Therefore, several different materials all showed similar and consistent release profiles from the materials.

[0082] For the purpose of application to the skin surface as a paste, ointment, gel, liquid, solid, or foam, the dermal skin protectant and carrier disclosed herein must also have a profile that allows the material to be applied at room temperature. In practice, ease of application is required to ensure proper application of the material and also to facilitate its final use. If over-the-counter products require specialized application treatment, materials that require heating or refrigeration or application with a specialized applicator are likely to face a burden from the professionals who will apply these materials, or even lower acceptability. In fact, as with many products, simplicity is essential for the proper use of the material. Therefore, the material is preferably in the form of a gel or paste consistency, which can be applied directly to the skin surface. For example, an applicator can apply a thin film of the material, such as those in solid or gel-like deodorant products. Alternatively, the material can be in a tube and squeezed out for application, or in a container, such as a topical ointment. Finally, once the material is applied to the skin surface, the polydimethylsiloxane adheres to the skin surface. The material will remain largely on the surface until it has been intentionally or unintentionally rubbed off by friction and contact with clothing or other surfaces.

[0083] The combination of the first and second silicone polydimethylsiloxane materials provides a smooth and clean tactile coating on the skin surface. In effect, the combination of polydimethylsiloxane products creates a barrier skin protectant that helps form a lubricating or smooth texture on the skin surface. Therefore, the formation of a protective barrier layer on the skin surface allows the underlying skin to heal. Furthermore, because the protective layer is on the skin surface, excipients or specific active therapeutic agents are released from the protective layer into the skin, aiding in tissue relief or treatment. Unless the excipient (and / or therapeutic agent) is a macromolecular additive entangled with the polydimethylsiloxane itself, it will be released from the carrier material.

[0084] The main components of the skin protectant and carrier material are first and second polydimethylsiloxane materials. In some embodiments, a third or more polydimethylsiloxanes may be added. In a preferred embodiment, this combination of polydimethylsiloxane materials includes at least one excipient. For example, depending on the desired texture and desired application form, it may be suitable for addition to fillers or texturers, flow agents. Some examples may include natural or synthetic waxes, such as beeswax or plant-based waxes, fats, oils, etc. (A synthetic alternating copolymer of methyl vinyl ether (MVE) and maleic anhydride) or other excipients added to enhance the texture and physical properties of the material after formation.

[0085] For example, benzalkonium chloride can be added to therapeutic materials for its use as a preservative and disinfectant, and due to its antiseptic properties. However, when used in sufficient concentrations, it acts as a preservative on skin tissue and can help reduce bacterial communities that may be present, for example, on wounds.

[0086] Therefore, when the materials of the present invention are used on the skin surface, in addition to their ability to cover, coat, and provide a barrier, the inclusion of certain healing promoters can improve skin healing and improve the rate of healing. Those skilled in the art will recognize that the amounts of the healing-promoting agents, as identified in the specification, can be advantageously incorporated into the material.

[0087] When considering the application of materials to the skin surface in the case of open or scabbed wounds, the care of the damaged tissue is important for healing (speed of healing and reduction of infection) and for reducing the presence of scar tissue. In this article, we utilize materials as described, and incorporate additional active ingredients, to aid in promoting healing, reducing infection, and using certain materials to help reduce scar tissue. For example, those skilled in the art will recognize that antibacterial materials will reduce local infection, and other materials can cleanse the wound. Furthermore, certain materials, including certain essential oils, shea butter, and similar materials, coat, protect, and promote wound healing, and also promote collagen formation to reduce or eliminate scar tissue.

[0088] In some cases, wounds can also be painful, and therefore, it makes sense to use anesthetic components in materials to relieve pain. For example, benzocaine and lidocaine, as well as similar materials, can be added for contact or timed release to relieve surface pain. Of course, even in the absence of a wound, these materials are suitable for release onto the skin surface to provide immediate relief of pain there.

[0089] In some cases, pain doesn't just originate from a wound, but can stem from long-term musculoskeletal problems, thus requiring the formulation of additional pain medications to alleviate it. For example, plant extracts have been used for centuries to relieve pain. Morphine continues to be used in the medical industry. Reagents can be used in certain applications where they are incorporated into materials and released as active agents. For instance, for some users, slow release allows for pain management over extended periods. In other applications, faster release profiles can be utilized when immediate pain medication is needed.

[0090] In some cases, it is necessary to dry the skin surface to allow adhesion to another material. Therefore, those skilled in the art will recognize the need for and use of desiccants to assist in such pursuits.

[0091] As indicated above, the materials specified herein are suitable for use on skin tissue when an open wound is present. Therefore, it is advantageous to apply certain hemostatic materials to the wound to improve bleeding control and wound healing. Thus, the application of hemostatic active ingredients to polydimethylsiloxane materials allows for the release of these hemostatic components.

[0092] For example, such as Figures 4A-4C Depicting, in Figure 4A The image depicts a bandage (100) containing two adhesive elements (101) sandwiching a wound covering element (102) in the middle. Figure 4B Provides the side profile of the layers of the bandage (100), which includes a backing layer (103), an adhesive (101), or such Figure 4C The non-adhesive bonding method (106) and the cover element (102) comprising a top coating (104) and an intermediate coating (105) are then used. Figure 4C These layers, depicted as separate covering elements (102), are shown in greater clarity.

[0093] For example, the top coating (104) may be an absorbent material, such as cotton or other suitable natural or synthetic polymers. This adhesive material may also contain materials of this disclosure embedded in or coated with a polydimethylsiloxane component. Alternatively, no polydimethylsiloxane material may be added to this layer.

[0094] Similar to the top coating (104), the intermediate coating (105) may comprise an absorbent material or may comprise a polydimethylsiloxane material of the present disclosure. In such embodiments, the polydimethylsiloxane material may comprise a number of active ingredients and excipients as disclosed herein to aid in wound coverage, allow wound healing, and absorb fluid flow from the wound.

[0095] In some embodiments, inflammation within the body is extremely painful or makes movement difficult or impossible. We can utilize polydimethylsiloxane materials as carriers of anti-inflammatory active ingredients to allow for release of the anti-inflammatory components at the site of injury. Due to the durable adhesion and ability of the materials to the skin, the anti-inflammatory components will be released into the skin. The release rate can be controlled by varying the excipients, the amount of each polydimethylsiloxane, and the relative viscosity of each polydimethylsiloxane, and this will allow for a long-lasting release of the anti-inflammatory effect to reduce swelling, irritation, and inflammation at the site of injury.

[0096] However, in some cases, the anti-inflammatory ingredients are not strong enough to address the underlying problem. One type of medicine often used as the second strongest material is topical steroidal application. Many approved steroidal compounds, corticosteroids, can be incorporated into polydimethylsiloxane materials for use. Examples include hydrocortisone, desonide, fluocinolone acetonide, aclomethasone dipropionate, hydrocortisone valerate, prednisolone, fluticasone propionate, flumethasone dipropionate, desoxymethasone, mometasone furoate, betamethasone valerate, fluocinolone acetonide, clobetasol propionate, difluralasone diacetate, betamethasone dipropionate, halobetasol propionate, clobetasol propionate, flumethasone dipropionate, and other similar corticosteroids, salts, or derivatives thereof.

[0097] In addition to reducing inflammation, corticosteroids can be used for other applications, including treating rashes, dermatitis, itching, eczema, psoriasis, and other similar lesions. Other steroids, such as testosterone, progesterone, estrogen, and steroid analogs, have other therapeutic uses and can also be used for topical purposes.

[0098] Of course, these steroids or corticosteroids can be applied in solid, liquid, gel, ointment, aerosol, or other forms as indicated herein. These allow application to the skin surface, and the material is then released through or onto the skin. For example, nasal application would allow coating the nasal passages, providing lubrication, and also allowing targeted delivery of the medicine to this location. For example, gels, balms, aerosols, liquids, etc., can be formulated for nasal application. Solids can be applied to the tip of the nose or the opening of the nasal passages to impart these properties and may include other excipients such as certain essential oils, UV-protective materials, or simply additional skin-protective materials to prevent dryness, redness, and cracking of nasal tissue.

[0099] Fungal infections can occur in multiple areas of the body, including those commonly known as tinea cruris, tinea pedis, or other similar names. Additionally, there are often additional fungal, bacterial, and / or viral infections on or under the nails, or around the feet, toes, and joints. Application of the polydimethylsiloxane materials of this invention will include an antifungal composition that reduces skin irritation and provides an antifungal agent to eliminate underlying fungi. Furthermore, additional excipients can be appropriately tailored to the intended use of the treatment to reduce moisture, soothe skin irritation, and promote skin healing.

[0100] The nails of the hands and feet, as well as the skin adjacent to or beneath them, are susceptible to infection by fungi, bacteria, or viruses. The nail matrix is ​​where nail cells multiply and keratinize before incorporating into the nail or toenail. The stratum corneum is the skin fold where the finger or toe meets the nail and protects the matrix, the area beneath the nail fold, and covers the lunula. The nail plate is the nail itself, and beneath it lies the nail bed or the soft tissue beneath the nail. Nail infections, especially those affecting the nail itself, include various fungal infections such as onychomycosis, including distal lateral subungual onychomycosis (DLSO), where fungi spread from the skin and invade the underside of the nail. White superficial onychomycosis (WSO) is another infection caused by fungi directly invading the surface of the nail plate and subsequently infecting the nail bed. Proximal subungual onychomycosis (PSO) occurs when fungi invade the stratum corneum and nail fold. Intraungual onychomycosis (EO) occurs when fungi reach the nail via the skin and invade the nail plate. Additional fungal infections can originate from yeasts (Candida), which also affect the nail itself and the surrounding dermal tissue that supports the nail.

[0101] Bacterial infections of the nails, including but not limited to paronychia, can affect the nail plate and surrounding tissues through bacterial invasion. Bacteria, including Pseudomonas aeruginosa, can cause certain infections, including green nail syndrome. Other bacterial infections may include staphylococcal infections.

[0102] Nail tissue can also be submerged by yeast and mold spores. In some applications, it is necessary to provide therapeutic agents that can eliminate mold or yeast spores or prevent them from colonizing certain nail tissues.

[0103] For many nail treatments, the goal is not only to treat the visual infection but also to eradicate the microbial community that forms in the dermal tissue beneath or adjacent to the nail. Materials applied to the nail and adjacent dermal skin allow the therapeutic agent to reach the damaged or infected tissue and treat the problem. Some materials are applied as nail polish, incorporating broad-spectrum antimicrobial agents or agents for treating fungal, bacterial, mold, yeast, or viral infections. For example, ciclopirox ol has previously been used in nail polish for topical application, which allows penetration of the nail plate and into the nail bed to treat underlying fungi. The examples described herein can be used for paint or nail polish application, creating additional adhesion to the nail and the surrounding or subungual dermal tissue to release the therapeutic agent and treat the underlying problem.

[0104] Additional fungal infections are also common in and around the lips and mouth, such as thrush. Embodiments of this disclosure can be applied to these skin surfaces and release therapeutic agents onto the outer surfaces of the lips and mouth to treat this and other fungal infections. Similarly, bacterial and viral infections, including herpes, can be treated with antibacterial or antiviral therapeutic agents, or symptoms can be relieved with certain materials that can be applied through the dermal materials described herein. Furthermore, lip-based care may include moisturizers and sunscreens, which, due to their tendency to be easily removed by the movement of the tongue and lips, will benefit the adhesive properties of the embodiments of this disclosure, as well as the release of skin protectants and excipients from these materials.

[0105] Vaginal fungi are also prevalent and a major source of irritation worldwide. Many current treatments require the use of suppositories, and in some cases, additional topical application is needed to reduce and eliminate fungal infections. The materials disclosed herein can be used both externally and internally to reduce fungal infections and associated treatment irritation. For example, the materials can enhance lubricating properties, reduce itching, alleviate odor, and protect the skin from primary or irritating effects, while also delivering antifungal materials to treat sources of irritation.

[0106] In some embodiments, the infection is bacterial rather than fungal. Different therapeutic agents are needed to treat bacterial infections instead of fungal ones, but some agents are broad-spectrum antimicrobial agents effective against both fungal and bacterial infections. While the above addresses bacterial infections of the nails, many antibiotics are known for treating additional dermal and mucous membrane skin surfaces. These antibacterial agents are in soaps, creams, lotions, etc., and are generally easy to apply. However, in many cases, they are also easily removed from the treated surface, and therefore their efficacy is sometimes limited. Therefore, adding an antibacterial agent to the dermal skin protectant material of this disclosure can enhance the material's residence time on the skin surface and additionally treat or prevent bacterial formation on the skin surface.

[0107] Therefore, as identified in the embodiments, the materials of this invention provide skin-protective properties by forming a barrier on the skin surface and then conferring additional properties by releasing additional excipients and / or active ingredients. For typical skin problems, including skin irritation, dry skin, rashes, insect bites, bacterial, viral, and fungal infections, in contrast to systemic (oral) methods for treatment, this material provides a physical barrier to protect and prevent further skin damage, while also conferring therapeutic release to the individual and absorption of the active ingredient at the site of skin and through the dermis.

[0108] In some embodiments, the material is advantageously used as a skin barrier comprising a UV-protective material. Those skilled in the art will recognize that UV materials are frequently used in commercially available sunscreens, where polydimethylsiloxane materials provide a barrier protection and coating for the skin, and are added as excipients to prevent further UV damage to the skin surface. Zinc oxide, PABA, escargot, cinnamic acid esters, benzophenone, avobenzone, and other materials can be used in these embodiments.

[0109] In some embodiments, it may be further advantageous to also impart insect repellent excipients to the polydimethylsiloxane material. For example, the material can be applied as a spray, solid, liquid, or gel to provide a barrier to the skin and may include one or more components of an insect repellent, including DEET, cypermethrin, permethrin, pyrethrin, methyl phthalate, benzaldehyde, mosquito repellent, dimethyl phthalate, ethylhexane glycol, icardin, chlorfenapyr, IR3535, methofluthrin, SS220, tricyclodecentyl allyl ether, 2-undecanetone, birch, callicarpa (Callicarpa), myrica, catnip oil, nepeta lactone, citronella, lemon eucalyptus, neem oil, lemongrass, tea tree oil, tobacco, and other known natural oils for repelling pests and insects.

[0110] In some embodiments, a portion of a plant extract is included. A plant extract is intended to refer to a material comprising a portion of a material extracted from a plant, containing at least one or more of certain terpene molecules. These may be diluted with another carrier oil or solvent as needed.

[0111] Cannabinoids, including those for topical infusion, readily penetrate the skin. Therefore, the carrier materials defined herein effectively deliver cannabinoid compounds and other compounds to the skin, effectively relieving pain and inflammation at the application site. Because cannabinoids do not enter the bloodstream with this inhalation method, topically applied cannabinoids have a very limited ability to cross the blood-brain barrier (unless administered internally) and therefore possess almost no psychoactive properties. Thus, these topically applied materials effectively treat the dermis and deliver therapeutic agents and other materials topically and to these skin layers, for example, for treating ailments that are both localized and dermal in nature, and for relieving conditions such as those on or in the skin. Therefore, the embodiments described herein can utilize materials for topical application to slowly release active cannabinoids or terpenes from a polydimethylsiloxane carrier for treating the body. For example, applying a topically applied dermal material to the skin surface allows the release of molecules to the skin surface for therapeutic effects. Additionally, molecules can be applied to the nasal passages for inhalation through the nasal mucosa. However, dermal materials can be applied to the body, where the use of plant extracts allows the delivery of plant extract components to the body. For example, when used to reduce seizures, application to the body may allow for a suitable slow delivery. To reduce nausea, headache, or aches and pains, topical application may target the treatment area in the material as described herein.

[0112] Nicotine patches, gummies, and other forms of administration are widely used as smoking cessation products. The materials described in the embodiments herein can be used as carriers of nicotine and applied topically to provide nicotine replacement. Some formulations may provide slow release, while others may provide rapid release. In some embodiments, nicotine may be a food material, such as a gummies or tablets, or applied topically to the body.

[0113] Hormone replacement therapy can help men and women who need to replace or enhance sex hormones for any reason. While many hormones are offered for contraception, and others for reasons of low testosterone or low or inappropriate estrogen, hormones are also used in sex-transition individuals. Therapies can also be provided in the form of medication described in this article.

[0114] Nausea remains a major concern for many due to pharmaceutical and environmental factors. Some medications or treatments include nausea as it is a common side effect. Meanwhile, those without other medical treatments face environmental issues, including seasickness, motion sickness, and altitude sickness. Each of these problems can be addressed with various active ingredients to reduce the occurrence of nausea or better control symptoms that do occur, such as transdermal senna.

[0115] High blood pressure remains a prevalent problem in today's fast-paced society. Appropriate therapeutic materials or the use of traditional herbs and essential oils can reduce stress, which can alleviate or relieve high blood pressure. In other cases, more targeted medications are needed to control blood pressure.

[0116] High blood pressure and other health factors can also cause angina, which may require medication to control. For example, polydimethylsiloxane delivery mediators can be used to administer certain nitroglycerin molecules.

[0117] Therefore, those skilled in the art will recognize from the appropriately sized list of examples defined herein and the examples defined in the non-limiting test examples below that many small molecules are suitable for delivery of therapeutic agents from the polydimethylsiloxane delivery mediators of this disclosure. Indeed, as envisioned, the materials herein can act as carriers and reservoirs and be applied topically to the skin or mucous membrane surface, with the therapeutic agent transdermally transferred to the skin for uptake by the body.

[0118] However, the embodiments also identify non-therapeutic purposes, where the material is a carrier for flavoring agents, pigments, gloss agents, UV protection, insect repellents, etc. For example, lip care may include gloss, flavoring agents, pigments, or another soothing or coating material. Therefore, it can act as a simple barrier or be added along with active ingredients, much like common over-the-counter materials in current lip care product lines.

[0119] Formulation of polydimethylsiloxane materials

[0120] Dermal skin protectants, along with their carriers and protective materials, can be formulated under conditions that prevent bacterial growth or spoilage. Of course, enhanced safety and extended shelf life can be provided through specific processing or post-treatment steps or by including certain antibacterial agents. The materials can be formulated and then sterilized using common procedures known to those skilled in the art in the field of dermal care products, including heating, ozone, ethylene oxide, radiation, etc. Alternatively, sterilization is not necessary.

[0121] In preferred embodiments, the material is formulated as a liquid, paste, or gel, in each case having a consistency sufficient for application to the skin surface. Other formulations may have a more solid consistency, wherein the applicator allows for the application of a thin layer, similar to the application of a deodorant or lip protectant. Other applications may include aerosols, wherein small particles are placed under pressure and can be sprayed onto the skin surface. Other forms known to those skilled in the art can be used to create a protective layer of material onto the skin surface.

[0122] Method for manufacturing polydimethylsiloxane dermal skin protectants and carrier products

[0123] Mixtures of two polydimethylsiloxanes with different viscosities, especially those with such significant viscosity differences, present considerable obstacles in the preparation and mixing of the components. In practice, it is not simply a matter of adding all the components to a mixing tank and mixing / stirring the components to produce an instant formulation. Several different approaches were tested to allow the components to be thoroughly mixed until a suitable process was achieved.

[0124] As an example, the components of Example 1 below were tested in several different mixing applications. Initially, all components were placed together in a single mixing container and mixed using a magnetic stir bar. Mixing was impossible due to the viscosity of the materials. Further tests attempted to use rotating / rotating mixing blades. However, the viscosity of the materials made this difficult, except for a minimum quantity of 2,500,000 cP, and the blades introduced a significant amount of air into the product. We selected a bladeless mixing system that utilizes centripetal force to assist mixing, and these strategies proved effective in the following examples for mixing two silicone materials of different viscosities and additional excipients.

[0125] Example

[0126] Example 1

[0127] The Flacktek mixer was used to mix the following compounds: polydimethylsiloxane (2,500,000 cP); polydimethylsiloxane (1,000 cP); and benzalkonium chloride. Initially, 17.1 g of 1,000 cP polydimethylsiloxane was added to the mixing vessel. Next, 1 g of benzalkonium chloride was added to the mixing vessel. The two compounds were mixed at 3,000 RPM for 10 minutes. Next, 1.9 g of 2,500,000 cP polydimethylsiloxane was added in five increments of 0.38 g. After each increment was added, the formulation was mixed for five minutes per increment.

[0128] The subsequent formulation examples were prepared following the same procedure as in Example 1. The table below lists the component ratios used in the specific formulation examples.

[0129] Table 1:

[0130]

[0131] Example 6

[0132] The Flacktek mixer was used to mix the following compounds: polydimethylsiloxane (2,500,000 cP); polydimethylsiloxane (12,500 cP); and benzalkonium chloride. Initially, 17.1 g of 12,500 cP polydimethylsiloxane was added to the mixing vessel. Next, 1 g of benzalkonium chloride was added to the mixing vessel. The two compounds were mixed at 3,000 RPM for 10 minutes. Next, 1.9 g of 2,500,000 cP polydimethylsiloxane was added in five increments of 0.38 g. After each increment was added, the formulation was mixed for five minutes per increment.

[0133] Table 2:

[0134]

[0135] Adhesion of the nine polydimethylsiloxane film formulations described above was measured using the tensile testing method as described in the literature. A Brookfield CT3 texture analyzer was used at room temperature (23 ± 1 °C). 20 g samples were used in containers, and measurements were taken within 2 minutes of filling the containers. Peak adhesion (n = 6) was measured for each formulation. These values ​​are reported in Table 3 below. Total adhesion work (n = 6) was measured for each formulation. These values ​​are reported in Table 3 below. Under these tests, larger negative numbers indicate larger peak adhesion or larger total adhesion work.

[0136] Table 3:

[0137] formulation Peak adhesion force (N) Total adhesion work (N·second) 1 -1.5±0.03 -0.68±0.02 2 -5.4±0.15 -2.0±0.03 3 -12.9±1.2 -5.3±0.09 4 -28.5±2.7 -10.8±0.32 5 -41.2±1.7 -16.5±0.60 6 -9.9±0.33 -3.7±0.06 7 -13.8±0.28 -6.6±0.14 8 -18.6±1.7 -10.9±0.30 9 -35.3±4.0 -16.0±0.65

[0138] Examples of polydimethylsiloxane antifungal agent delivery

[0139] The Flacktek mixer was used to mix the following compounds: polydimethylsiloxane (2,500,000 cP); polydimethylsiloxane (1,000 cP); and nystatin. Initially, 10.1 g of 1,000 cP polydimethylsiloxane was added to the mixing cup. Next, 0.4 g of nystatin was added to the mixing cup. The two compounds were mixed at 3,000 RPM for 10 minutes. Next, 9.5 g of 2,500,000 cP polydimethylsiloxane was added in five increments of 1.9 g. After each increment was added, the formulation was mixed for five minutes per increment.

[0140] The Flacktek mixer was used to mix the following compounds: polydimethylsiloxane (2,500,000 cP); polydimethylsiloxane (1,000 cP); nystatin; and aloe vera. Initially, 10.1 g of 1,000 cP polydimethylsiloxane was added to the mixing cup. Next, 0.1 g of nystatin was added to the mixing cup. Next, 0.2 g of aloe vera was added to the mixing cup. The three compounds were mixed at 3,000 RPM for 10 minutes. Next, 9.5 g of 2,500,000 cP polydimethylsiloxane was added in five increments of 1.9 g. After each increment was added, the formulation was mixed for five minutes per increment.

[0141] The Flacktek mixer was used to mix the following compounds: polydimethylsiloxane (2,500,000 cP); polydimethylsiloxane (1,000 cP); and clotrimazole. Initially, 10.1 g of 1,000 cP polydimethylsiloxane was added to the mixing vessel. Next, 0.1 g of clotrimazole was added to the mixing vessel. The two compounds were mixed at 3,000 RPM for 10 minutes. Next, 9.5 g of 2,500,000 cP polydimethylsiloxane was added in five increments of 1.9 g. After each increment was added, the formulation was mixed for five minutes per increment.

[0142] Example of polydimethylsiloxane burn treatment delivery

[0143] The Flacktek mixer was used to mix the following compounds: polydimethylsiloxane (2,500,000 cP); polydimethylsiloxane (1,000 cP); chitosan; sulfadiazine; silver nitrate; silver nanoparticles; and benzocaine. Initially, 10.1 g of 1,000 cP polydimethylsiloxane was added to the mixing vessel. Next, 0.1 g of chitosan was added to the mixing vessel. Next, 40 mg of sulfadiazine was added to the mixing vessel. Next, 40 mg of silver nitrate was added to the mixing vessel. Next, 40 mg of silver nanoparticles was added to the mixing vessel. Next, 1 g of benzocaine was added to the mixing vessel. The six compounds were mixed at 3,000 RPM for 10 minutes. Next, 9.5 g of 2,500,000 cP polydimethylsiloxane was added in five increments of 1.9 g. After each increment was added, the formulation was mixed for five minutes per increment.

[0144] The Flacktek mixer was used to mix the following compounds: polydimethylsiloxane (2,500,000 cP); polydimethylsiloxane (1,000 cP); and silver sulfadiazine. Initially, 10.1 g of 1,000 cP polydimethylsiloxane was added to the mixing vessel. Next, 40 mg of silver sulfadiazine was added to the mixing vessel. The two compounds were mixed at 3,000 RPM for 10 minutes. Next, 9.5 g of 2,500,000 cP polydimethylsiloxane was added in five increments of 1.9 g. After each increment was added, the formulation was mixed for five minutes per increment.

[0145] The Flacktek mixer was used to mix the following compounds: polydimethylsiloxane (2,500,000 cP); polydimethylsiloxane (1,000 cP); and silver nitrate. Initially, 18.1 g of 1,000 cP polydimethylsiloxane was added to the mixing vessel. Next, 40 mg of silver nitrate was added to the mixing vessel. The two compounds were mixed at 3,000 RPM for 10 minutes. Next, 1.5 g of 2,500,000 cP polydimethylsiloxane was added in five increments of 0.3 g. After each increment was added, the formulation was mixed for five minutes per increment.

[0146] Example of polydimethylsiloxane wound healing therapy delivery

[0147] The Flacktek mixer was used to mix the following compounds: polydimethylsiloxane (2,500,000 cP); polydimethylsiloxane (1,000 cP); bacitracin; neomycin; and polymyxin B. Initially, 9.5 g of 1,000 cP polydimethylsiloxane was added to the mixing vessel. Next, 1.45 g of bacitracin was added to the mixing vessel. Next, 70 mg of neomycin was added to the mixing vessel. Next, 14 mg of polymyxin B was added to the mixing vessel. The four compounds were mixed at 3,000 RPM for 10 minutes. Next, 9.5 g of 2,500,000 cP polydimethylsiloxane was added in five increments of 1.9 g. After each increment was added, the formulation was mixed for five minutes per increment.

[0148] The Flacktek mixer was used to mix the following compounds: polydimethylsiloxane (2,500,000 cP); polydimethylsiloxane (1,000 cP); bacitracin; and polymyxin B. Initially, 17.5 g of 1,000 cP polydimethylsiloxane was added to the mixing vessel. Next, 1.45 g of bacitracin was added to the mixing vessel. Next, 14 mg of polymyxin B was added to the mixing vessel. The three compounds were mixed at 3,000 RPM for 10 minutes. Next, 1.5 g of 2,500,000 cP polydimethylsiloxane was added in two increments of 0.75 g. After each increment was added, the formulation was mixed for five minutes per increment.

[0149] The Flacktek mixer was used to mix the following compounds: polydimethylsiloxane (2,500,000 cP); polydimethylsiloxane (1,000 cP); bacitracin; epidermal growth factor; and polymyxin B. Initially, 9.5 g of 1,000 cP polydimethylsiloxane was added to the mixing vessel. Next, 1.45 g of bacitracin was added to the mixing vessel. Next, 1 mg of epidermal growth factor was added to the mixing vessel. Next, 14 mg of polymyxin B was added to the mixing vessel. The four compounds were mixed at 3,000 RPM for 10 minutes. Next, 9.5 g of 2,500,000 cP polydimethylsiloxane was added in five increments of 1.9 g. After each increment was added, the formulation was mixed for five minutes per increment.

[0150] The Flacktek mixer was used to mix the following compounds: polydimethylsiloxane (2,500,000 cP); polydimethylsiloxane (1,000 cP); and triamcinolone acetonide. Initially, 9.5 g of 1,000 cP polydimethylsiloxane was added to the mixing cup. Next, 100 mg of triamcinolone acetonide was added to the mixing cup. The two compounds were mixed at 3,000 RPM for 10 minutes. Next, 9.5 g of 2,500,000 cP polydimethylsiloxane was added in five increments of 1.9 g. After each increment was added, the formulation was mixed for five minutes per increment.

[0151] Example of delivery of polydimethylsiloxane for hemostasis.

[0152] The Flacktek mixer was used to mix the following compounds: polydimethylsiloxane (2,500,000 cP); polydimethylsiloxane (1,000 cP); and tranexamic acid. Initially, 9.5 g of 1,000 cP polydimethylsiloxane was added to the mixing vessel. Next, 1 g of tranexamic acid was added to the mixing vessel. The two compounds were mixed at 3,000 RPM for 10 minutes. Next, 9.5 g of 2,500,000 cP polydimethylsiloxane was added in five increments of 1.9 g. After each increment was added, the formulation was mixed for five minutes per increment.

[0153] The Flacktek mixer was used to mix the following compounds: polydimethylsiloxane (2,500,000 cP); polydimethylsiloxane (1,000 cP); and chitosan. Initially, 9.5 g of 1,000 cP polydimethylsiloxane was added to the mixing cup. Next, 1 g of chitosan was added to the mixing cup. The two compounds were mixed at 3,000 RPM for 10 minutes. Next, 9.5 g of 2,500,000 cP polydimethylsiloxane was added in five increments of 1.9 g. After each increment was added, the formulation was mixed for five minutes per increment.

[0154] The Flacktek mixer was used to mix the following compounds: polydimethylsiloxane (2,500,000 cP); polydimethylsiloxane (1,000 cP); human fibrinogen; and human thrombin. Initially, 9.5 g of 1,000 cP polydimethylsiloxane was added to the mixing cup. Next, 0.5 g of human fibrinogen was added to the mixing cup. Next, 1.5 g of human thrombin was added to the mixing cup. The three compounds were mixed at 3,000 RPM for 10 minutes. Next, 9.5 g of 2,500,000 cP polydimethylsiloxane was added in five increments of 1.9 g. After each increment was added, the preparation was mixed for five minutes per increment.

[0155] The Flacktek mixer was used to mix the following compounds: polydimethylsiloxane (2,500,000 cP); polydimethylsiloxane (1,000 cP); and kaolin. Initially, 9.5 g of the 1,000 cP polydimethylsiloxane was added to the mixing cup. Next, 1 g of kaolin was added to the mixing cup. The two compounds were mixed at 3,000 RPM for 10 minutes. Next, 9.5 g of the 2,500,000 cP polydimethylsiloxane was added in five increments of 1.9 g. After each increment was added, the formulation was mixed for five minutes per increment.

[0156] Examples of polydimethylsiloxane ferrous sulfate delivery

[0157] The Flacktek mixer was used to mix the following compounds: polydimethylsiloxane (2,500,000 cP); polydimethylsiloxane (1,000 cP); and ferrous sulfite powder. Initially, 9.5 g of 1,000 cP polydimethylsiloxane was added to the mixing cup. Next, 4 g of ferrous sulfite powder was added to the mixing cup. The two compounds were mixed at 3,000 RPM for 10 minutes. Next, 9.5 g of 2,500,000 cP polydimethylsiloxane was added in five increments of 1.9 g. After each increment was added, the formulation was mixed for five minutes per increment before adding the next increment of 2,500,000 cP polydimethylsiloxane.

[0158] Polydimethylsiloxane acne treatment

[0159] The Flacktek mixer was used to mix the following compounds: polydimethylsiloxane (2,500,000 cP); polydimethylsiloxane (1,000 cP); and salicylic acid. Initially, 15.5 g of 1,000 cP polydimethylsiloxane was added to the mixing vessel. Next, 0.4 g of salicylic acid was added to the mixing vessel. The two compounds were mixed at 3,000 RPM for 10 minutes. Next, 3.5 g of 2,500,000 cP polydimethylsiloxane was added in three increments of 1.67 g. After each increment was added, the formulation was mixed for five minutes per increment.

[0160] The Flacktek mixer was used to mix the following compounds: polydimethylsiloxane (2,500,000 cP); polydimethylsiloxane (1,000 cP); and benzoyl peroxide. Initially, 9.5 g of 1,000 cP polydimethylsiloxane was added to the mixing vessel. Next, 0.4 g of benzoyl peroxide was added to the mixing vessel. The two compounds were mixed at 3,000 RPM for 10 minutes. Next, 9.5 g of 2,500,000 cP polydimethylsiloxane was added in five increments of 1.9 g. After each increment was added, the formulation was mixed for five minutes per increment.

[0161] Polydimethylsiloxane treatment for hemorrhoids

[0162] The Flacktek mixer was used to mix the following compounds: polydimethylsiloxane (2,500,000 cP); polydimethylsiloxane (1,000 cP); phenylephrine HCl; and promocaine HCl. Initially, 9.5 g of 1,000 cP polydimethylsiloxane was added to the mixing vessel. Next, 0.1 g of phenylephrine HCl was added to the mixing vessel. The two compounds were mixed at 3,000 RPM for 10 minutes. Next, 0.1 g of promocaine HCl was added to the mixing vessel. The three compounds were mixed at 3,000 RPM for 10 minutes. Next, 9.5 g of 2,500,000 cP polydimethylsiloxane was added in five increments of 1.9 g. After each increment was added, the formulation was mixed for five minutes per increment.

[0163] Polydimethylsiloxane plant extract delivery system

[0164] The Flacktek mixer was used to mix the following compounds: polydimethylsiloxane (2,500,000 cP); polydimethylsiloxane (1,000 cP); and plant extract. Initially, 18.5 g of the 1,000 cP polydimethylsiloxane was added to the mixing cup. Next, 0.4 g of the plant extract was added to the mixing cup. The two compounds were mixed at 3,000 RPM for 10 minutes. Next, 0.5 g of the 2,500,000 cP polydimethylsiloxane was added in single increments, and the formulation was mixed for five minutes.

[0165] The Flacktek mixer was used to mix the following compounds: polydimethylsiloxane (2,500,000 cP); polydimethylsiloxane (1,000 cP) and plant extract. Initially, 9.5 g of the 1,000 cP polydimethylsiloxane was added to the mixing cup. Next, 0.4 g of the plant extract was added to the mixing cup. The two compounds were mixed at 3,000 RPM for 10 minutes. Next, 0.4 g of the plant extract was added to the mixing cup. The three compounds were mixed at 3,000 RPM for 10 minutes. Next, 9.5 g of the 2,500,000 cP polydimethylsiloxane was added in five increments of 1.9 g. After each increment was added, the formulation was mixed for five minutes per increment.

[0166] The Flacktek mixer was used to mix the following compounds: polydimethylsiloxane (2,500,000 cP); polydimethylsiloxane (1,000 cP); and plant extract. Initially, 9.5 g of the 1,000 cP polydimethylsiloxane was added to the mixing cup. Next, 0.4 g of the plant extract was added to the mixing cup. The two compounds were mixed at 3,000 RPM for 10 minutes. Next, 9.5 g of the 2,500,000 cP polydimethylsiloxane was added in five increments of 1.9 g. After each increment was added, the formulation was mixed for five minutes per increment.

[0167] Polydimethylsiloxane anti-inflammatory delivery system

[0168] The Flacktek mixer was used to mix the following compounds: polydimethylsiloxane (2,500,000 cP); polydimethylsiloxane (1,000 cP); and diphenhydramine. Initially, 9.5 g of 1,000 cP polydimethylsiloxane was added to the mixing vessel. Next, 0.2 g of diphenhydramine was added to the mixing vessel. The two compounds were mixed at 3,000 RPM for 10 minutes. Next, 9.5 g of 2,500,000 cP polydimethylsiloxane was added in five increments of 1.9 g. After each increment was added, the formulation was mixed for five minutes per increment.

[0169] The Flacktek mixer was used to mix the following compounds: polydimethylsiloxane (2,500,000 cP); polydimethylsiloxane (1,000 cP); and hydrocortisone. Initially, 9.5 g of 1,000 cP polydimethylsiloxane was added to the mixing vessel. Next, 0.2 g of hydrocortisone was added to the mixing vessel. The two compounds were mixed at 3,000 RPM for 10 minutes. Next, 9.5 g of 2,500,000 cP polydimethylsiloxane was added in five increments of 1.9 g. After each increment was added, the formulation was mixed for five minutes per increment.

[0170] Polydimethylsiloxane lip treatment

[0171] The Flacktek mixer was used to mix the following compounds: polydimethylsiloxane (2,500,000 cP); polydimethylsiloxane (1,000 cP); diphenhydramine. Initially, 18.5 g of the 1,000 cP polydimethylsiloxane was added to the mixing cup. Next, 0.2 g of vitamin E was added, followed by 1 g of sunflower seed oil and 0.1 g of peppermint oil. The compounds were mixed at 3,000 RPM for 10 minutes. Next, 0.5 g of the 2,500,000 cP polydimethylsiloxane was added in one increment, and the formulation was mixed for five minutes.

[0172] In another embodiment, coconut oil is used instead of sunflower seed oil, and citrus oil is used instead of peppermint oil.

[0173] In another example, 0.2 grams of zinc oxide was further blended with peppermint oil. In yet another example, tea tree oil replaced peppermint oil.

[0174] Nail treatment

[0175] The Flacktek mixer was used to mix the following compounds: polydimethylsiloxane (2,500,000 cP); polydimethylsiloxane (1,000 cP); and diphenhydramine. Initially, 17.5 g of the 1,000 cP polydimethylsiloxane was added to the mixing cup. Next, 0.2 g of vitamin E was added, followed by 1 g of sunflower seed oil and 0.1 g of peppermint oil. The compounds were mixed at 3,000 RPM for 10 minutes. Next, 1.5 g of the 2,500,000 cP polydimethylsiloxane was added in three increments of 0.5 g. After each increment, the formulation was mixed for five minutes per increment.

[0176] discuss

[0177] When we evaluated each formulation, a pattern emerged regarding the ability of the material to act against corrosive substances as more high-viscosity 2,500,000 cP polydimethylsiloxane was incorporated into the formulation, with respect to formulations of liquid, gel, paste, and foam materials. However, with increasing viscosity, in the case of increased amounts of 2,500,000 cP polydimethylsiloxane, formulations of solid-based products increased, such as those incorporating gelatin or materials that form solid or near-solid materials for formulations suitable for application in the form of stick applicators, similar to many deodorant products. For fluid materials, in mixtures of 100:1 to 4:1 (low viscosity: high viscosity polydimethylsiloxane), the mixture is easily applied to the skin surface, for example, as a paste, ointment, or gel. The consistency allows for application from a tube or bucket of material, or spraying from a pump bottle. The material can then be applied to the skin surface as if using a petroleum-based product or emulsion.

[0178] However, in samples of 1,000 cP and 2,500,000 cP polydimethylsiloxane at a 1:1 ratio, the consistency and usability of the material are significantly reduced for liquid, gel, paste, or foam applications. At a 1:1 ratio, the material will preferably be applied to the skin surface as a solid. However, including other excipients and even larger quantities of 2,500,000 cP polydimethylsiloxane creates new materials that can be used in solid applicators or as improved materials for inclusion in bandages or filler materials.

[0179] Therefore, the amount of each of the first and second polydimethylsiloxane products varies depending on the final formulation, whether it is a liquid, gel, paste, foam, gummy, or solid consistency.

[0180] Therefore, based on the data, the optimal formulation comprises a first polydimethylsiloxane with a viscosity between 1 and 25,000 cP and a second polydimethylsiloxane with a viscosity between 2,000,000 and 3,000,000 cP, wherein the materials are blended with a lower viscosity material comprising between about 10% and 99% by mass of the formulation and a higher viscosity material comprising between about 90% and 1% by mass of the formulation.

[0181] Attempting to increase the formulation to more than 90% of a high-viscosity polydimethylsiloxane results in a material that is completely unprocessable. This makes the material difficult to manipulate, and reduces its ability to add active ingredients or provide any barrier value as a skin protectant. Therefore, the embodiments described herein preferably use a high-viscosity polydimethylsiloxane in the range between 1% and 90%, with preferred ranges between 1% and 75%, or between 5% and 70%, or between 10% and 65%, or between 10% and 60%, or between 35% and 55%, or between 40% and 50% of the total mass of the formulation.

[0182] In some embodiments, a polydimethylsiloxane-based dermal skin protectant and carrier comprises primarily the following: a first polydimethylsiloxane material with a viscosity between about 1,000 cP and 25,000 cP, and a second polydimethylsiloxane material with a viscosity between about 2,000,000 and 3,000,000 cP; and at least one excipient. In some embodiments, at least one excipient is also present.

[0183] In some embodiments, a polydimethylsiloxane-based dermal skin protectant and carrier comprises: a first polydimethylsiloxane material with a viscosity between about 1,000 cP and 25,000 cP, and a second polydimethylsiloxane material with a viscosity between about 2,000,000 and 3,000,000 cP; and one, two, or three active agents. In some embodiments, the carrier comprises one, two, or three additional excipients.

Claims

1. A polydimethylsiloxane-based dermal skin protectant and carrier, comprising a first polydimethylsiloxane material with a viscosity between about 1,000 mPa·s (cP) and 25,000 mPa·s (cP), and a second polydimethylsiloxane material with a viscosity between about 2,000,000 and 3,000,000 mPa·s (cP); and at least one active agent; Polydimethylsiloxane has the following formula: The number of repeating units "n" affects the viscosity of the material; and the term "about" means within 10% of a specified number.

2. The dermal skin protectant and carrier according to claim 1, wherein the at least one active agent is selected from the group consisting of: antimicrobial agents, anesthetics, hemostatic agents, anti-inflammatory agents, deodorants, analgesics, UV protectants, and combinations thereof.

3. The dermal skin protectant and carrier according to claim 2, wherein two or more active agents are combined together in the dermal skin protectant and carrier.

4. The dermal skin protectant and carrier according to claims 1 to 3, wherein the ratio of the first polydimethylsiloxane to the second polydimethylsiloxane is between 100:1 and 1:

10.

5. The dermal skin protectant and carrier according to claims 1 to 4, wherein the concentration of the at least one active agent is between 0.1% and 10%.

6. The dermal skin protectant and carrier according to claim 2, wherein the antimicrobial agent is an antifungal agent, an antiviral agent, or an antibacterial agent.

7. The dermal skin protectant and carrier according to claims 1 to 6, further comprising at least one essential oil.

8. The dermal skin protectant and carrier according to claims 1 to 7, further comprising an agent selected from the group consisting of benzalkonium chloride, hexadecylpyridine chloride, and combinations thereof.

9. The dermal skin protectant and carrier according to claim 1, which is a polydimethylsiloxane-based antifungal agent delivery composition, comprising: a first polydimethylsiloxane with a viscosity between 1,000 mPa·s(cP) and 25,000 mPa·s(cP), and a second polydimethylsiloxane with a viscosity between 2,000,000 mPa·s(cP) and 3,000,000 mPa·s(cP), and an effective amount of an antifungal agent composition, said antifungal agent composition being selected from the group consisting of: clotrimazole, econazole, miconazole, terbinafine, fluconazole, ketoconazole, mop Hotericin, nystatin, sporanox, difulcan, terazol, intraconazole, mycostatin, boric acid, tioconazole, undecanoic acid, tolnaftate, imidazole, luliconazole, tavaborole, allylamine, amorolfine, oxiconazole, gluconazole, ciclopirox, naftifine, amphotericin B, sulconazole, butenafine, sertaconazole, efinacanazole, and combinations thereof, wherein the antifungal composition optionally further comprises aloe vera.

10. The dermal skin protectant and carrier according to claim 1, which is a polydimethylsiloxane-based skin composition suitable for treating burned skin, comprising a first polydimethylsiloxane with a viscosity between 1,000 mPa·s(cP) and 25,000 mPa·s(cP), a second polydimethylsiloxane with a viscosity between 2,000,000 mPa·s(cP) and 3,000,000 mPa·s(cP), and an effective amount of skin care material and an effective amount of local anesthetic, wherein the skin care material is selected from the group consisting of chitosan, sulfadiazine, silver sulfadiazine, silver nitrate, silver nanoparticles and combinations thereof, and / or wherein the local anesthetic... The anesthetic agents selected are from the following groups: benzocaine, butamben, tetracaine, benzyl alcohol, capsaicin, dibucaine, diclofenac, dyclonine, ethyl chloride, hexylresorcinol, lidocaine, prilocaine, methyl salicylate, menthol, pramoxine, proparacaine, triethanolamine, and combinations thereof.

11. The dermal skin protectant and carrier according to claim 1, wherein the carrier is: (a) A polydimethylsiloxane composition suitable for local wound healing, comprising: a first polydimethylsiloxane with a viscosity between 1,000 mPa·s(cP) and 25,000 mPa·s(cP), and a second polydimethylsiloxane with a viscosity between 2,000,000 mPa·s(cP) and 3,000,000 mPa·s(cP), and an effective amount of a wound healing composition selected from the group consisting of: bacitracin; neomycin; polymyxin B; epidermal growth factor; triamcinolone; and combinations thereof; (b) A polydimethylsiloxane composition suitable for hemostatic therapy, comprising: a first polydimethylsiloxane with a viscosity between 1,000 mPa·s(cP) and 25,000 mPa·s(cP), and a second polydimethylsiloxane with a viscosity between 2,000,000 mPa·s(cP) and 3,000,000 mPa·s(cP), and an effective amount of a hemostatic composition selected from the group consisting of: tranexamic acid, chitosan, human fibrinogen, human thrombin, non-human fibrinogen or thrombin, synthetic fibrinogen or thrombin, keratin, or combinations thereof; or (c) A polydimethylsiloxane composition for delivering ferrous sulfite, comprising a first polydimethylsiloxane with a viscosity between 1,000 mPa·s(cP) and 25,000 mPa·s(cP), a second polydimethylsiloxane with a viscosity between 2,000,000 mPa·s(cP) and 3,000,000 mPa·s(cP), and an effective amount of ferrous sulfite material.

12. The dermal skin protectant and carrier of claim 1 which is a dimethicone-based dermal skin protectant and carrier consisting essentially of: A first polydimethylsiloxane material with a viscosity between about 1,000 mPa·s (cP) and 25,000 mPa·s (cP), and a second polydimethylsiloxane material with a viscosity between about 2,000,000 and 3,000,000 mPa·s (cP); and at least one excipient selected from the group consisting of moisturizing creams, fragrances, pigments, essential oils, zinc oxide, wetting agents, and combinations thereof.

13. The dermal skin protectant and carrier according to claim 1, wherein the carrier is: (a) A polydimethylsiloxane composition suitable for the treatment of acne, comprising: a first polydimethylsiloxane with a viscosity between 1,000 mPa·s (cP) and 25,000 mPa·s (cP), and a second polydimethylsiloxane with a viscosity between 2,000,000 mPa·s (cP) and 3,000,000 mPa·s (cP), and an effective amount of an acne treatment agent selected from the group consisting of benzoyl peroxide, azelaic acid, salicylic acid, corticosteroids, retinoids, antibiotics, and combinations thereof; or (b) A polydimethylsiloxane composition suitable for the treatment of hemorrhoids, comprising: a first polydimethylsiloxane with a viscosity between 1,000 mPa·s(cP) and 25,000 mPa·s(cP), and a second polydimethylsiloxane with a viscosity between 2,000,000 mPa·s(cP) and 3,000,000 mPa·s(cP), and an effective amount of a hemorrhoid treatment agent selected from the group consisting of phenylephrine hydrochloride, promocaine HCl, corticosteroids, and combinations thereof.

14. A method for formulating a dermal skin protectant and carrier according to any one of claims 1 to 13, comprising placing all of the first polydimethylsiloxane component into a mixing container and adding thereto an amount of the therapeutic agent; mixing the two components at 3,000 RPM for about 10 minutes in a centripetal mixer; after mixing for about 10 minutes, adding the second polydimethylsiloxane into a mixing chamber, wherein the second polydimethylsiloxane is added in equal increments of one-fifth of the total concentration, and then mixing in increments of 3,000 RPM for five minutes until all of the second polydimethylsiloxane has been added and mixed for five minutes; and wherein the term "about" means within 10% of a specified number.

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