Patent Application
20250228792
The present invention provides a water-based formulation of a discreet liquid patch that offers a pain-free and effective treatment for cold sores. The patch is designed to be applied to the affected lesion and remain in contact with it for a time sufficient for complete re-epithelialization of the sore. The patch includes an adhesive layer that is substantially free of hydrocolloid particles and does not have any backing layer. The formula comprises an active compound or ingredients from the group consisting of Docosanol, Acyclovir, Penciclovir, Lysine, or similar, and a water-based adhesive.
The water-based adhesive used in the formulation may be any suitable water-soluble polymer that exhibits excellent adhesion properties, allowing the patch to adhere to the skin and remain in place for the desired duration of treatment. The adhesive may include polymers such as polyvinyl alcohol, polyethylene oxide, polyacrylamide, polyvinylpyrrolidone, or other water-based polymers. These water-based adhesives provide a non-irritating, comfortable, and safe adhesion to the skin while delivering the active ingredients.
The thickness of the patch may range from 5 microns to 1,300 microns. The invention uses biocompatible polymer materials in the adhesive layer, such as acrylate monomers polymerized through a micro-emulsion polymerization process, to ensure compatibility with the skin and reduce the risk of skin irritation or allergic reactions. However, other suitable biocompatible polymers may also be used, such as polyethylene oxide, polyvinylpyrrolidone, or polyvinyl alcohol, or any other suitable biocompatible polymer that meets the desired properties of the patch.
This formulation is specifically designed for the treatment of cold sore lesions, providing a unique and novel approach to managing cold sore outbreaks. The water-based adhesive in combination with active ingredients offers a non-invasive, comfortable, and convenient treatment option for cold sores, with the distinct benefit over existing prior art of being sting-free.
Herpes Labialis, commonly known as cold sores, is a type of infection caused by the herpes simplex virus (HSV) that primarily affects the lips. HSV-1 and 2 infections are characterized by a high frequency of recurrence and are highly contagious. Cold sores can cause physical pain, discomfort, and disfigurement, especially in those patients with a high frequency of recurrence. Those afflicted with the virus often feel embarrassed by the appearance of the lesions.
The global seroprevalence of HSV-1 in adults is currently estimated to be between 67% and 87%, resulting in more than 3.7 billion cases of cold sores annually. The Centers for Disease Control and Prevention (CDC) estimates that the prevalence of HSV-1 in the United States for people between the age of 14 and 49 years old was 47.8% between 2015-2016, with the highest prevalence in individuals aged 60 years and older [1]. Cold sores, which are caused by the herpes simplex virus, are a common manifestation of HSV-1 infection. The first sign of a cold sore is usually a tingling, burning, or itching sensation on or around the lips, beginning about 12-24 hours before the cold sore develops. The area becomes red, swollen, and painful as the blisters form. Over 2-3 days, the blisters rupture and ooze fluid that is clear or slightly yellow. After the blisters break, a scab forms that can last several days. Treatment options for cold sores include antiviral medication, which can be applied directly to the sores or taken orally [3]., and OTC topical applications such as creams, gels and material backed patches. Furthermore, the majority of people who have had cold sores will suffer recurring outbreaks, with more than 50 million adults in the United States experiencing two or more outbreaks per year. A typical outbreak will generally regress within 7-10 days, with complete healing in 12-14 days, although a scar or erythema may persist.
The uncomfortable and sensitive lesions of Herpes Labialis are painful when touched and interfere with patients' daily routines, such as eating and drinking. Additionally, the unsightly nature of the lesions, coupled with the discomfort, often causes patients to feel embarrassed.
Although 90% of the population is exposed to the virus in their lifetime, there is a social element of antipathy to the virus that adds to this embarrassment.
Patients often have trouble restraining themselves from touching cold sore lesions which can result in the spread of the infection, exacerbate the lesion, and increase healing times. However, creating a barrier or a layer on the surface of the lesion that protects against outside influences, such as bacteria, dirt, and physical agitation, can reduce the sensitivity to the affected area and improve the patient's ability to perform daily routines. The most common method to create this layer on the surface of the lesion is by using a hydro-colloidal based patch. Patches create a preventative barrier and can eliminate/reduce this influence with less sensation experience.
The formulation or composition of the patch is an essential part of providing a lighter and more flexible/stable patch that is less prominent while still providing significant healing and usage time properties. Most commercial patches include a formulation consisting of an adhesive layer and a material backing substrate layer. The adhesive layer is typically made from a hydrocolloidal composition that combines with moisture produced by the lesion and turns into a gel-like substance, while the backing layer provides structural support. Some commercial patches are also non-hydrocolloid compositions; however, they are non-medicated. Abreva is the most well-known non-hydrocolloid-based patch and is non-medicated. Common hydrocolloidal patches include Compeed and Polysporin, both non-medicated.
Canadian Patent No. CA 2609259 discloses a hydrocolloid base patch, which includes a backing layer for treating Herpes Labialis. U.S. patent application No. 20070026056A1 also discloses a backing of a flexible sheet of water-insoluble material.
Hydrocolloid base patch formulations with or without active ingredients can become unsightly as the lesion underneath produces a buildup of organic material in a gel-like substance, causing the patch to become thicker and often destabilizing the adhesion of the patch and resulting in a more visible patch.
Non-hydrocolloidal base patch formulations without active ingredients would not experience the gelling of organic materials but they do not effectively manage the moisture produced by the lesion. The moisture builds up beneath the patch and destabilizes the adhesive, separating the patch from the skin. It becomes more visible and uncomfortable, and likewise a hotspot for activity and increased bacterial load. Additionally, the lack of active ingredients slows down the healing process. The application of hydrocolloid base and non-hydrocolloid base patches is not easy and can interfere with the physical appearance, potentially aggravating the area further, and increasing the risk of infection at the affected site.
U.S. Pat. No. 11,311,494B2, which focuses on alcohol-based compositions for a discreet liquid cold sore patch to treat cold sore lesions addresses the above-mentioned challenges with the existing product landscape. However, such formulations can be problematic because the stinging sensation of alcohol-based adhesives can be intolerable for patients, especially young children. Therefore, there is a need for a pain-free water-based compound/formulation that can effectively manage the moisture produced by the lesion, speed up the healing process, and reduce the risk of infection while maintaining a pain-free (sting-free) formulation.
The present invention provides a water-based translucent protective barrier that also delivers an anti-viral compound for the treatment of cold sores/viral lesions. A major benefit of water-based formulations is that the resulting product is sting-free while providing the additional benefits of being flexible, providing a lighter and more stable patch compared to the industry standard products, with significant healing and usage time properties without triggering more infection. The liquid discreet patch formulation includes a translucent liquid adhesive, at least one active ingredient, a non-active ingredient, and an optional anti-bacterial ingredient. The translucent liquid adhesive is composed of a water-based formulation, defined as being between 75-90% water by weight, which includes the non-active ingredients. The liquid discreet patch does not require an additional backing layer.
The formulation of the liquid discreet patch includes mixing one or more non-active ingredients at specific temperature and mixing conditions to form a translucent liquid adhesive. Other ingredients such as the active ingredients and the anti-bacterial compound can be mixed separately at specific temperature and mixing conditions to form a translucent liquid. Furthermore, the two separate mixtures combine to form the liquid discreet patch formulation.
A preferred embodiment of the invention comprises the active ingredient selected from a group consisting of anti-viral compounds, amino acids, and vitamins such as Docosanol, L-lysine, Acyclovir, Penciclovir, Zinc, and Magnesium. Whereas, at least one active ingredient can be combined with the water-based translucent liquid adhesive to form the translucent liquid discreet patch. The optional anti-bacterial compounds such as Benzalkonium Chloride and Benzethonium Chloride and/or natural compounds like Silver, Tea tree oil, Honey, Eucalyptus oil, Garlic, Cinnamon, Turmeric, Manuka oil, Aloe vera, Grapefruit seed extract can be mixed with the liquid discreet patch formulation.
According to another aspect of the invention, the liquid discreet patch is applied as a liquid on top of a part of the skin/anatomical lesion surface, principally the lips and/or facial area, for the treatment of viral lesions or cold sores. Once the patch is air-dried, it forms a protective translucent film barrier to prevent additional spread of the virus and contamination from bacteria, microorganisms and fine particles.
According to another aspect of the invention, the translucent nature of the liquid patch reduces the physical appearance of lesions, and the nature of the patch allows for the use of facial makeup without negatively affecting the properties of the patch. The patch is maintained in contact with the cold sore/lesion to improve healing time, reduce the spread of the virus, and reduce the time to complete re-epithelization, as compared to an untreated cold sore/viral outbreak.
A principal characteristic of the present invention, is its use of a water-based adhesive in order to provide a product that is pain free during application as well as during standard wear.
The preceding and additional characteristics of the invention are fully explained in the claims, with the following description detailing one or more examples of how the invention may be used. The description of the invention provided herein is only illustrative and not exhaustive, and it should be understood that the principles of the invention can be employed in various ways.
The present invention concerns a pain-free, water-based composition formulated for the effective treatment of cold sores and viral lesions. The composition is specifically designed to offer a pain-free product that accelerates the healing process, minimizes discomfort, and prevents secondary spread of infection.
More specifically, the present invention relates to formulation of the liquid discreet patch comprising of a translucent liquid adhesive, at least one active ingredient, a non-active ingredient, and an optional anti-bacterial compound. The translucent liquid adhesive is composed of a water-base formulation, that is, where water is used as the primary solvent, and/or diluent, and includes the non-active ingredient(s), whereas, the liquid discreet patch does not require an additional backing layer.
According to a preferred embodiment, the formulation comprises, the translucent liquid adhesive, which is composed of a water-based adhesive, for the specific purpose of reducing and/or eliminating pain most often represented by a stinging sensation at the time and area of application. The water base composition of the translucent liquid adhesive further includes at least one non-active ingredient selected from the group consisting of polyurethane, cyanoacrylate, acrylates, vinyl acetate, silicone, 2-ethylhexyl acrylate (2-EHA), N-vinylpyrrolidone (NVP), acrylic acid, vinyl acetate, butyl acrylate, polyvinyl alcohol (PVA), polyvinylpyrrolidone (PVP), polyacrylamide (PAM), hydroxyethyl cellulose (HEC), carboxymethyl cellulose (CMC), ethylene-vinyl acetate (EVA), acrylonitrile-butadiene-styrene (ABS), styrene-acrylic (SA), vinyl acetate-ethylene (VAE), and acrylic acid-ethylene (AE). More specifically, composition comprises suitable weights of total formulation; Polyurethane, 0-25% Cyanoacrylate, 0-10% Acrylates, 0-20% Vinyl acetate, 0-20% Silicone, 0-10% 2-ethylhexyl acrylate (2-EHA), 0-20% N-vinylpyrrolidone (NVP), 0-10% Acrylic acid, 0-10% Butyl acrylate, 0-20% Polyvinyl alcohol (PVA), 0-10% Polyvinylpyrrolidone (PVP), 0-10% Polyacrylamide (PAM), 0-10% Hydroxyethyl cellulose (HEC), 0-10% Carboxymethyl cellulose (CMC), 0-10% Ethylene-vinyl acetate (EVA), 0-20% Acrylonitrile-butadiene-styrene (ABS), 0-20% Styrene-acrylic (SA), 0-20% Vinyl acetate-ethylene (VAE), 0-20% Acrylic acid-ethylene (AE), 0-20%. In certain situations, the non-active ingredients can also be combined with the active ingredients during preparation of formulation.
According to another preferred embodiment, the formulation of the present invention also contains at least one the active ingredient selected from group consisting of anti-viral, amino acids and vitamin ingredients such as Docosanol, L-lysine, Acyclovir, Penciclovir, Zinc, and Magnesium. More specifically, composition comprises suitable weights of total formulation; Docosanol 0% to 10%, L-lysine 0% to 10%, Penciclovir 0% to 5%, Acyclovir 0% to 5%,
According to the present invention, the formulation of the liquid discreet patch may further include an additional antibacterial compound/ingredient selected from the group consisting of Silver, Zinc oxide, Copper oxide, Titanium dioxide, Magnesium oxide, Chitosan, Carbon, Quaternary ammonium salts, Triclosan, Chlorhexidine, Iodine complexes, Polyhexamethylene biguanide (PHMB), Benzalkonium chloride, Cetylpyridinium chloride, and Tea tree oil, not limited to nanoparticle variants. More specifically, composition comprises suitable weights of total formulation; Silver nanoparticles: 0.01%-5%, Zinc oxide nanoparticles: 0.5%-5%, Copper oxide nanoparticles: 0.01%-1%, Titanium dioxide nanoparticles: 0.5%-5%, Magnesium oxide nanoparticles: 0.01%-1%, Chitosan nanoparticles: 0.1%-1%, Carbon nanoparticles: 0.1%-1%, Quaternary ammonium salts: 0.5%-5%, Triclosan: 0.1%-1%, Chlorhexidine: 0.1%-1%, Iodine complexes: 0.1%-1%, Polyhexamethylene biguanide (PHMB): 0.01%-0.5%, Benzalkonium chloride: 0.1%-1%, Cetylpyridinium chloride: 0.1%-1%, Tea tree oil: 0.5%-2%.
According to the present invention, the liquid discreet patch is applied on to the surface of the lesion as a liquid, positioning the discreet patch on to a lesion surface and once dry, maintaining contact between the discreet dried film patch with the lesion surface for at least 1 hour, but no longer than 12 hours. Subsequent patches may be applied as needed and maintained in contact with the lesion surface, until such time as epithelialization of the lesion surface is completed.
More specifically, the liquid discreet patch is applied as a liquid over the affected dermal region, typically of the mouth and facial area. The liquid discreet patch formulation is designed to dry and form a flexible, porous, translucent film barrier that allows moisture to pass through the patch and evaporate to maintain adhesion and a dry surface area. The liquid discreet patch can also help prevent the growth and spread of the virus by acting as a barrier for external aggravations such as physical touch, bacteria, dirt, etc. reducing interaction and reducing/eliminating discomfort.
In accordance with the invention, the liquid discreet patch is characterized by consisting of a single layer with absence of any additional secondary or tertiary structures or elements such as a backing layers and wound dressings. The liquid discreet patch is configured to deliver the active ingredients at the site of the cold sore outbreaks or lesions and improves upon existing products with a pain-free water-based adhesive composition.
Accordingly, according to a preferred embodiment, the formulation of the present invention where the thickness of the liquid discreet patch is configured in between 5 and 1300 microns to maintain translucent nature and low visibility of the patch after application on to the surface of the lesion.
According to a preferred embodiment, the liquid discreet patch can be applied to a clean surface area as soon as the afflicted recognizes an oncoming outbreak and should remain in contact with the cold sore/lesion for a time up to 12 hours but no less than 2 hours. The patch can be maintained in contact with the lesion surface until such time as the outbreak has been healed and/or the associated sensations and side effects have subsided.
In accordance with the invention, the liquid discreet patch can be prepared by a two-step process at room temperature. The First step consists of the mixing of one or more the non-active ingredients while stirring at room temperature for about 30 minutes until it gets dissolves with mixing speed is 300-1000 rpm. The second step consist of the mixing of active ingredients and anti-bacterial compounds and/or non-active ingredients separately in the order deter-mined by the formulation at room temperature with a mixing speed of 300-1000 rpm. A total mixing time is 60 minutes or until all the ingredients dissolve completely to obtained a transparent solution.
Several Examples are set forth below. The claims should not be considered to be limited to the details thereof.
Water-Based Liquid Patch with Docosanol 10%:
Water-Based Liquid Patch with L-Lysine 10%:
Water-Based Liquid Patch with Docosanol 10% and Silver Nanoparticles:
Water-Based Liquid Patch with Docosanol 10% and Silver Nanoparticles:
Water-Based Liquid Patch with Docosanol 10% and L-Lysine:
Water-Based Liquid Patch with Penciclovir 5%, Magnesium 2%, and Zinc 1%:
Water-Based Liquid Patch with Acyclovir 5% and Zinc 5%:
Water-Based Liquid Patch with Docosanol 10%, Magnesium 1%, and Zinc 0.001%:
Water-Based Liquid Patch with Penciclovir 1% and Zinc 10%:
Water-Based Liquid Patch with Acyclovir 1% to 5%:
Water-Based Liquid Patch with Penciclovir 1% to 5%:
Water-Based Liquid Patch with L-Lysine 5% to 10%:
| Number | Date | Country | |
|---|---|---|---|
| 63459953 | Apr 2023 | US |
