Patent Application
20240033129
Transdermal and topical patches and masks represent well-established means for sustained release of therapeutic agents. Satisfactory adhesion of the patch to the skin is directly linked to the efficacy, quality, and safety of the therapeutic treatment. Reduction in the surface area of contact as a result of patch lift, or even the patch falling off, diminishes the delivery of therapeutic ingredient from the patch. Poor adhesion can result in improper dosing of patients. It is well known that current patches detach several times during use.
Generally speaking, adhesion is guaranteed by a specialized class of materials called ‘pressure-sensitive adhesives’ (PSAs) that are defined as adhesives capable of bonding to surfaces with the application of light pressure and, when removed, do not leave any visually noticeable residues. A PSA can be used as main constituent of the formulation (i.e., it serves as a carrier for the active ingredient, assures the control of drug release and, at the same time, confers adhesion properties to the dosage form) or merely added to assure the intimate contact between the dosage form and the skin. Patches can be classified as matrix (drug-in-adhesive) systems, or reservoir, or membrane-controlled systems.
Many aqueous base patches have thick plasters because they contain moisture; therefore, aqueous base patches can be difficult to attach to the skin for long durations. Furthermore, the vaporization of moisture from the patches can cause changes in adhesion and physical properties. Aqueous based preparations are typically significantly heavier in weight and thickness vs non aqueous patches. Aqueous based preparations can have poor adhesive properties. In addition, many ingredients within the adhesive matrix are difficult to dissolve in water and thus not completely dissolved in aqueous patches. Aqueous based patches are heavier and thicker than non-aqueous patches. The thickness and weight can impact movement and may rub on clothing, increasing the likelihood of peeling/detaching from the skin.
Currently there are several prevalent types of pressure-sensitive bioadhesives in use in the U.S. market: polyacrylate copolymers (acrylics), polysiloxanes (silicones), polyisobutylenes (PIBs), hot melt, urethanes, hydrocolloids, and hydrogels. Each of these types of adhesive can be modified according to the drug or ingredients being administered, the length of application time desired and dosage strength.
Breaching of the skin barrier is essential for delivering active and/or inactive agents. The major limitation of topical and transdermal ingredient delivery is the difficulty of permeation of said active and/or inactive agent through the skin, especially overcoming the most outer layer of the non-viable epidermis—the stratum corneum. The stratum corneum is about 15-20 μm in thickness and is comprised of keratin-rich corneocytes surrounded by the lipids. The stratum corneum layer is arranged in a brick and mortar like structure where corneocytes occupy the majority of stratum corneum volume and the space between the corneocytes is filled with a lipid matrix which provides pathways for percutaneous absorption. The stratum corneum is highly selective and only few molecules (small and relatively lipophilic) can pass through it. The stratum corneum is supported by viable epidermis, dermis and subcutaneous connective tissue, and these layers could potentially offer additional barriers to ingredient transport. Furthermore, most of the mainstream permeation enhancers are synthetic chemical-based enhancers which can cause skin irritation, toxicity, and allergic response.
There are mainly three possible routes for percutaneous penetration of active and/or inactive agents which include:
Among these options, the intercellular lipid domain of the stratum corneum is the main pathway for the skin penetration of most active and/or inactive agents. To achieve therapeutically effective active and/or inactive agent levels at the proper site following transdermal or topical ingredient delivery, the barrier properties of the stratum corneum must be modified to enable sufficient permeation of the active and/or inactive agents. The most commonly applied approach to alter the stratum corneum barrier properties is the application of permeation enhancers.
The invention relates to therapeutic patches comprising:
In an advantageous embodiment, the adhesive layer is an acrylic based adhesive, and optionally an acrylic based additive. Advantageously, the adhesive layer is an acrylic based adhesive containing copolymers of butyl and 2 ethyl hexyl acrylates. In other embodiments, the adhesive layer is a silicone-based, hydrocolloid-based, or hydrogel-based adhesive.
Active agents of the adhesive layer can include topical pain-relieving agents such as lidocaine, menthol, hemp oil extract or CBD, and capsaicin. Other active agents of the invention include topical antibiotics, prescription, and over-the-counter drugs.
Skin care agents such as hemp oil extract or CBD, hyaluronic acid, ceramides, and collagen can be used in the patches of the invention. Other skin care agents which can be incorporated are one or more of: anti-wrinkle or skin-tightening agents; anti-aging agents; moisturizing agents; skin brightening or depigmentation agents; anti-inflammatory agents; anti-acne agents; DNA repair agents; skin lipid barrier repair agents; anti-cellulite agents; wound-healing agents; stretch-mark/scar removing agents; plumping agents; hair growth retardation agents and hair growth stimulating agents; dark circle reduction or de-puffing agents; collagen synthesis or blood circulation enhancing agents; antioxidants; sebum-controlling agents; pore-minimizing agents, and skin detox or exfoliation agents.
Skin penetration enhancing agents are optionally included in the patches of the invention in the adhesive layer. These agents can include essential oils and terpenes such as d-limonene, menthol/peppermint oil and eucalyptus. Other penetration enhancing agents useful include piperine such as tetrahydropiperine (THP), surfactants such as polysorbate 80, fatty acids such as oleic acid. Lastly, a skin metabolism inhibitor such as Fluvastatin, or a physical enhancer that causes stripping or hydration of the stratum corneum can be added to the adhesive.
The invention is a patch configured to be applied to the skin of a user, the patch comprising:
The patch can include a film or paper, silicone, or non-silicone coated release liner.
The invention also includes a method of manufacturing a therapeutic patch comprising the steps of:
The invention also includes a method of manufacturing a therapeutic patch comprising the steps of:
The invention further includes a method of treating pain in a subject in need of pain relief comprising applying the therapeutic patch to the subject wherein said active agent is a pain-relieving agent. Additionally, included is a method of delivering a pain-relieving agent to a subject, said method comprising:
The invention further includes a method of treating the skin in a subject in need of skin care treatment comprising applying the therapeutic patch to the subject wherein said active agent is a skin care agent. Additionally, included is a method of delivering a skin care agent to a subject, said method comprising:
The subject invention relates to highly elastic patches for delivery of an active agent to the skin. According to the United States Pharmacopeia, ‘transdermal systems’ are designed to deliver the drug(s) through the skin to the systemic circulation. As used herein, the term “patches” includes ‘masks,’ ‘plasters,’ and ‘tapes,’ that deliver a therapeutic agent topically, or transdermally—i.e., allowing systemic administration of the active agent(s).
The patches of the invention are typically thin, lightweight and like a second skin. They can be applied to highly contoured parts of the body including joints and are customizable. They can be cut to any size to accommodate different pain points on the body. Three critical properties of a patch that will determine how effective it is include:
The subject patches are highly elastic, breathable, water resistant, and skin friendly. They are designed to be a second layer of skin and expand and contract along with the skin without restricting freedom of movement. In advantageous embodiments, the patches comprise a fabric made of nylon and spandex (elastane or lycra) and have an acrylic adhesive matrix (drug/ingredient in adhesive) coating. The patches are self-adhesive due to the adhesive, e.g., acrylic layer. The patches are designed to be similar in thickness and elasticity as the dermis of the skin. The patches are stretchable in all directions (4-way stretch), i.e., in both directions along a substantially orthogonal transverse axis of the patch.
The elasticity of the patches can reach 200%, which is greater than or comparable with the elasticity of human muscles and joints. The patches, with the adhesive coating layer, is placed on a protective paper or polyester backing in order to protect the adhesive coating. The patches can be dyed any color and cut into any shape/size. The patches contour to any body part or joint without friction on clothing and risk of detaching. The patches permit sustained release of active and/or inactive agents to the skin, and have strong compatibility with the skin. In advantageous embodiments, the patches permit the active and/or inactive agents to penetrate into the skin effectively through the use of one or more penetration enhancing agents.
The subject therapeutic patches comprises: a fabric layer made of synthetic fibers elastic in both directions along a substantially orthogonal transverse axis of the patches, an adhesive layer deposited on said face side of the fabric layer, an active agent dispersed in said adhesive layer, and optionally a skin penetration enhancing agent dispersed in said adhesive layer.
The Fabric
The fabric of the patch of the invention is substantially deformable and stretchable but sufficiently elastic along two substantially orthogonal axes. The therapeutic patch is typically an elongate strip of material (cut from a roll of tape for instance). The patch is elastic in both directions along a substantially orthogonal transverse axis of the patch. In other words, the patch is stretchable in four orthogonal directions along the major plane of a major face of the patch. To give it its stretchable and elastic properties, the fabric layer is composed of an elastic material such as an elastomer and/or a stretchable fabric. In an advantageous embodiment, the fabric layer is composed of a nylon and/or polyethylene terephthalate (PET and RPET) a polyester fabric, as well as spandex or similar material. RPET has a higher tensile strength and modulus of elasticity than virgin PET. To achieve the desired level of elasticity the fabric layer is advantageously composed of a combination of nylon or RPET, and spandex. In an advantageous embodiment, the fabric layer comprises between approximately 95% and approximately 70% by weight of RPET or nylon, and between 5% and approximately 30% by weight of spandex, more advantageously between approximately 90% and approximately 80% by weight of RPET or nylon, and between approximately 10% and approximately 20% by weight of spandex, and most advantageously approximately 83% by weight of RPET or nylon, and approximately 17% by weight of spandex.
In an advantageous embodiment, the fabric layer of the tape is woven from yarns of RPET or nylon, and spandex. The yarns are woven or knit via a weft, warp, twill, or any other type of weave known in the art of fabric production for stretchable fabrics. The type of weave can create a symmetrical fabric (such as a plain weave) where the fabric layer comprises a face side and back side that are substantially similar at least visually. The type of weave creates an asymmetric fabric (such as a twill weave) where the back and face sides are different.
If the density of the fabric is too low it becomes too floppy and difficult to handle. In advantageous embodiments, the fabric comprises a density of between approximately 170 gsm and approximately 300 gsm, even more advantageously between approximately 190 gsm and approximately 250 gsm, and most advantageously between approximately 200 gsm.
Also, in an advantageous embodiment, the patch comprises a fabric layer formed from a yarn of nylon or RPET of a grade of between approximately 50D and approximately 120D, more advantageously between approximately 65D and approximately 105D. Whilst the yarn of spandex in the fabric layer is of a grade of between approximately 20D and approximately 60D, more advantageously between approximately 30D and approximately 50D and most advantageously approximately 40D.
In a further advantageous embodiment, a printed ink design is provided on the side of the fabric layer opposing the adhesive layer. The printed ink design in addition to being aesthetic also improves the resistance and increases the elasticity of the patch. See patch materials in US 2018/0042775 A1 hereby incorporated by reference in its entirety.
The fabrics utilized in the patches of the invention advantageously are made of:
In an advantageous embodiment, the fabric is 80% nylon and 20% spandex, 90% nylon and 10% spandex, 85% nylon and 15% spandex, or 75% nylon and 25% spandex, 190 gsm-210 gsm (advantageously 200 gsm), and is weft or warp knit material. Weft knit is most advantageous. Weft knitting is a knitted piece of fabric where the stitches run from left to right horizontally across the fabric. It is usually knitted with one piece of yarn. Weft knits have moderate to great amounts of crosswise stretch and lengthwise stretch. The stretch capability of the fabric is 150-200+%, e.g., greater than 150%, greater than 175%, or greater than 200%.
Advantageous Fabric Specifics:
Spandex, Lycra or Elastane
The Adhesive
The patch of the invention has a strong tack property when applied to the skin. Tack relates to the ability of an adhesive to form the initial bond with the skin on brief contact under light pressure.
The patch also has strong shear adhesion, or holding power, with the skin. Shear adhesion or shear resistance is defined as the ability to resist flow/movement when shear forces are applied. For a patch to perform well, the shear adhesion or shear resistance property has to guarantee that the adhesive will remain attached to the skin for a specific period of time despite stresses caused by both body movements and cloth frictions.
Further, the patch of the invention can have a low to high peel strength, depending on the area of application and use. Peel Strength relates to its ability to resist removal by peeling. Finally, the peeling-off procedure should be easy and painless, without leaving patch residues and causing skin damage. The patch is safe and gentle to remove from the skin.
The adhesive can be an acrylic based adhesive, or any other form well known in the art of patch technology and it can be applied/coated to the fabric layer via any suitable method. In an advantageous embodiment, a medical grade acrylic-based, silicone-based, hydrocolloid-based, or hydrogel-based adhesive is used. The adhesive can be a heat sensitive adhesive or advantageously, a pressure sensitive adhesive. The adhesive can be applied evenly and uniformly over the entire or a substantial portion of the surface of the fabric layer, or alternatively in regions or intervals such as in transverse and uniformly spaced strips.
PSAs are classified according to their chemical structure (see Venkatraman S, Gale R. Skin adhesives and skin adhesion. 1. Transdermal drug delivery systems. Biomaterials 1998; 19(13):1119-36) or the physical form in which they are supplied. In the latter case, PSAs can be categorized as solvent based (non-aqueous), water based, and hot melt.
Three major categories of PSAs are acrylic-based PSAs, silicone-based PSAs, and polyisobutylenes (PIBs). Other materials which can be used in the patches of the invention include polyurethane, hydrocolloids, and hydrogels. Hydrocolloid PSA's are often used for acne treatment and wound dressings that are occlusive and adhesive and can form a gel with water. Hydrogel dressings have similar properties in a gel consistency. Various hydrocolloid gels and dressings have been used in wound management to maintain moisture and aid in debridement of necrotic tissue. Hydrogels contain large amounts of water and matrices that acquire adhesive properties as a result of their moisture content. The adhesive selected for use in the subject invention is chosen based on the particular application and active agent being delivered.
PIB-Based Adhesives
PIB-based adhesives (PIB-PSAs) can be compounded by blending high- and medium-molecular-weight PIBs, or adding low-molecular-weight polybutylene to this blend. The former formulation is characterized by low peel adhesion values, which decrease as the percentage of the medium-molecular-weight PIB increases. In the latter, the use of low-molecular-weight polybutylene permits to expand the formulation range of the PIB blends conferring to the matrix adhesive properties in terms of tack and peel adhesion.
The main disadvantages in using PIBs are related to their easy oxidation and low air and water vapor permeability. The latter feature can be favorably exploited to enhance the drug flux through the skin; on the other hand, the skin maceration can occur, especially when the patch remains in the same position for prolonged period of time.
Silicon-Based Adhesives
Silicon-based PSAs are made up of a long chain polymer (polydimethyl siloxane) and a silicate resin. The resin has a high glass transition, while the polymer has a notably low glass transition. The raw material is provided as a mixture of these components and the adhesive properties of the final product depend on their ratio. Since the silanols of such PSAs are susceptible to react with amines, several products have been trimethylsilylated to improve the chemical compatibility and, therefore, patch stability in the presence of cationic drugs and excipients. The silicon-based PSAs excel in drug diffusivity.
Acrylic-Based Adhesives
Acrylic-based PSAs are obtained by combining ‘hard’ and ‘soft’ monomers at different ratios in order to tune up the final characteristics of the polymer. A third monomer can also be added to improve cohesive properties of the matrix. The large variety of substituted monomers (Table below) allows the incorporation of specific functional groups into the acrylic-based adhesives as well as the synthesis of polymers having versatility in physicochemical properties. Due to the presence of saturated functional groups, the acrylic-based PSAs are more resistant to oxidation with respect to PIB-PSAs; moreover, they are colorless, transparent and do not turn yellow on exposure to sunlight.
Acrylic-Based Dry Adhesive
In an advantageous embodiment of the invention, the adhesive used in the patch of the invention is a dry solvent based (non-aqueous) adhesive and includes an adhesive base as well as adhesive additive.
Adhesive Base
The adhesive base is a medical grade solvent based acrylic adhesive contain:
Adhesive Additive
In an advantageous embodiment, an adhesive additive is added to the adhesive base formula to make the peeling-off procedure easier and painless, without leaving residues and causing skin damage.
Medical grade solvent based acrylic adhesive contain:
Both the acrylic adhesive base (high peel strength) and the acrylic adhesive additive (low peel strength) contain copolymers of butyl and 2 ethyl hexyl acrylate. They are both the same composition chemically. The acrylic adhesive additive (low peel version) is held in the reactor longer to create higher molecular weight polymer and has more melamine crosslinker than the higher peel version. They can be blended in any ratio to achieve peel strengths between 2 and 32 oz/in., advantageously 20 or better.
The relative amounts of adhesive base to adhesive additive can be: 25-75% adhesive base and 25-75% adhesive additive. In an advantageous embodiment, the relative amounts are: 75% adhesive base and 25% adhesive additive.
Active and Inactive Ingredients
The patches of the subject invention can include one or more of the active agents:
Prescription and OTC Drug Active Ingredients
The patches of the subject invention can include one or more of the following:
Other Active Ingredients, Inactive Ingredients & Cosmetic Ingredients
Penetration Enhancers for Topical and Transdermal Delivery
The patches of the invention optionally includes penetration enhancers, (also referred to as permeation enhancers), dispersed in the adhesive layer. Penetration enhancing agents permit the active and/or inactive agents to penetrate into the skin effectively by transiently enhancing skin permeability without damaging viable cells.
The permeation enhancers selected should possess the following properties: pharmacologically inert, non-irritating, non-toxic, non-allergenic, compatible with the active and/or inactive agents, have good solvent properties, odorless, tasteless, colorless, and allow the skin to quickly regain to its natural barrier.
The two major categories of permeation enhancers for transdermal and topical ingredient delivery are chemical/synthetic permeation enhancers and natural permeation enhancers. In an advantageous embodiment of the invention, natural essential oils, and terpenes such as d-limonene, menthol/peppermint oil and eucalyptus are used. Other natural permeation enhancers of the invention include fatty acids such as oleic acid and piperine such as tetrahydropiperine (THP).
Chemical Permeation Enhancers
Chemical permeation enhancers are molecules that interact with the constituents of skin's outermost and rate limiting layer, the stratum corneum, and increase its permeability. Chemical based permeation enhancers are synthetic and include alcohols (ethanol, 2-propanol, caprylic alcohol), sulphoxides (dimethyl sulphoxide, dimethylacetamide), azone (1-dodecylazacycloheptan-2-one, laurocapran), pyrrolidones (2-pyrrolidone, N-methyl-2-pyrrolidone), urea, fatty acids and derivatives (lauric acid, myristic acid, caprylic acid, oleic acid), polyols (propylene glycol, glycerol), surfactants (ionic: SLS and non-ionic: polysorbates), chelating agents (EDTA, citric acid) polyols (propylene glycol, glycerol), surfactants (ionic: SLS and non-ionic: polysorbates), and chelating agents (EDTA, citric acid).
Natural Permeation Enhancers
Natural permeation enhancers work by changing the structure of the stratum corneum barrier and interaction with intercellular stratum corneum lipids to increase diffusivity of active and/or inactive agents. Polarity, molecular weight (<500 Da), concentration of active and/or inactive compounds in formulation, solubility of molecules in oil and water and composition of preparation significantly affect their penetration through the skin. Therefore, only a minority of molecules with specific physio-chemical properties can cross the skin sufficiently. Among them are essential oils and their active constituents (terpenes, terpenoids). Essential oils and terpenes (primarily extracted from essential oils) have been widely investigated as safe and suitable skin permeation enhancers for both hydrophilic and hydrophobic ingredients. Other natural permeation enhancers include piperine such as tetrahydropiperine (THP) and cosmoperine.
The permeation enhancers of the invention for transdermal and topical ingredient delivery can vary based on the area of application and sensitivity of skin in that specific area of the body. The anatomical structure of skin (thickness, composition of intercellular stratum corneum lipids, number of skin shafts, density of hair follicles, vascular anatomy, and collagen fiber arrangement) differs between people and different areas of the body. Those differences in the structure of the skin affect the quantity and ease of penetration of the active and/or inactive agents through the skin. For example, the skin on the face is thinner and more susceptible to irritation compared to other areas of the body with thicker skin, like the back. For a face application, a natural permeation enhancer with low irritation is used, such as d-limonene.
In an advantageous embodiment, a skin permeation enhancer is added to the adhesive base formula to allow the active and/or inactive agents to penetrate into the skin effectively. Advantageously, the permeation enhancer is a natural permeation enhancer containing essential oils or terpenes. More advantageously, the natural permeation enhancer contains d-limonene, menthol/peppermint oil, or eucalyptus. In other embodiments, the permeation enhancer includes fatty acids such as oleic acid, piperine such as tetrahydropiperine or surfactants such as polysorbate 80.
Natural Permeation Enhancers Include:
Method of Producing the Patch
Patches of the invention can be made by preparing and mixing the adhesive formula as outlined in the batching procedure (see Examples below). The adhesive formula is then applied to the release liner. The coated liner is carried through an oven until dry, where all solvents and water are evaporated, and cross linking or fusing of copolymers of adhesive formula occurs. The 4 way stretch fabric is then laminated to the coated liner. The coated fabric is left to cure for 48-120 hours. When applicable, liner is then printed. Fabric is kiss cut or die cut into the patch shapes. A Perforation(s) or kiss cut(s) is then added to the liner. Product is placed into heat seal bags and sealed before final packaging occurs.
Methods of Using the Patches of the Invention
The patches of the invention are highly versatile and can incorporate a wide variety of agents (see active agent list above).
An advantageous embodiment of the invention are pain relief patches.
Pain Relief Patches
Pain relief patches of the invention comprise:
Advantageously the fabric used for the pain relief patch is 80%-90% nylon and 10%-20% spandex, 190 gsm-210 gsm, and is weft or warp knit material.
Adhesives
Advantageous adhesives used in the pain relief patches are:
Active Agents
Active agents of a pain relief patch can include one or more of:
Inactive Agents
Inactive agents of the patch optionally include one or more of:
Penetration Enhancing Agents
Penetration enhancing agents of a pain relief patch can include one or more of:
Examples of pain relief patches are as follows:
Skin Care Patches
Skin care patches of the invention comprise:
Advantageously the fabric used for the skin care patch is 80%-90% nylon and 10%-20% spandex, 190 gsm-210 gsm, and is weft or warp knit material.
Adhesives
Advantageous adhesives that are used in the skin care patches of the invention include:
Active Agents
Active agents of the skin care patch can include one or more of:
The skin care agents used in the skin care patches of the invention are selected from the group consisting of:
Penetration Enhancing Agents
Penetration enhancing agents of skin care patches can include one or more of:
Examples of skin care patches are as follows:
Hormone Therapy Patches
Hormone therapy patches of the invention comprise:
Advantageously the fabric used is 80%-90% nylon and 10%-20% spandex, 190 gsm-210 gsm, and is weft or warp knit material.
Active agents are selected from:
Active Agents
Adhesives
Advantageous adhesives that are used in the hormone therapy patches of the invention include:
Penetration Enhancing Agents
Penetration enhancing agents of a hormone therapy patch can include one or more of:
An example of a hormone therapy patch is below.
Anti-Depressant Patches
Anti-depressant patches of the invention comprise:
Advantageously the fabric used is 80%-90% nylon and 10%-20% spandex, 190 gsm-210 gsm, and is weft or warp knit material.
Advantageous active agents are as follows.
Active Agents
Adhesives
Advantageous adhesives that are used in the anti-depressant patches of the invention include:
Penetration Enhancing Agents
Penetration enhancing agents of an anti-depressant patch can include one or more of:
An example of an anti-depressant patch is below.
The following Examples are illustrative, but not limiting of the compounds, compositions, and methods of the present invention. Other suitable modifications and adaptations of a variety of conditions and parameters normally encountered which are obvious to those skilled in the art are within the spirit and scope of this invention.
Mixing Preparation for Pain Patch with Lidocaine
The batching takes place in a suitable kettle equipped with propeller mixer agitation. A batch can be made at room temperature; no heating is required. In a suitable side vessel with propeller agitation, charge ingredients in the following order, allowing each to dissolve/disperse before adding the next:
Add adhesive (e.g., acrylic) to mixing drum. Verify the weight of the adhesive in the drum and start mixer at 70%.
Carefully add in active agent (e.g., Lidocaine) and increase mixer to 100%. Allow to mix for 30 minutes after active agent is added.
Add polybutene (where indicated) and mix slowly.
Add the alcohol dispersion of ingredients to the liquid adhesive base in the main vessel and mix to incorporate.
Allow to mix for at least 30 minutes, or until completely dissolved. 17
Patch Production
Coating of the adhesive formula matrix on the release liner. The coater spreads the adhesive matrix formula using knife over steel roll or knife over rubber rolls. The coater can accommodate a wide variety of coat weights and thickness, from 0.5 mils to 100 mils.
In-Line coating thickness measurement to ensure coating thickness accuracy.
The coated liner is carried through an oven to dry, fuse or cross link the formulas to provide an impervious smooth surface.
Example of lidocaine patch:
Pain Patch with Menthol
Batching procedure takes place in a suitable kettle equipped with propeller mixer agitation. Batches can be made at room temperature; no heating is required.
In a suitable side vessel with propeller agitation, charge ingredients in the following order, allowing each to dissolve/disperse before adding the next:
Add adhesive (e.g., acrylic) to mixing drum. Verify the weight of the adhesive in the drum and start mixer at 70%.
Carefully add in active agent (e.g., menthol) and increase mixer to 100%. Allow to mix for 30 minutes after OTC drug is added.
Add the alcohol dispersion of ingredients to the liquid adhesive base in the main vessel and mix to incorporate.
Allow to mix for at least 30 minutes, or until completely dissolved.
Using a patch production similar to that described in Example 1, an example of a menthol patch product is:
Ingredients
It will be readily apparent to those skilled in the art that numerous modifications and additions can be made to both the present compounds and compositions, and the related methods without departing from the invention disclosed.
This application claims priority to U.S. Provisional Application No. 63/199,146, filed Dec. 9, 2020, and U.S. Provisional Application No. 63/201,589, filed May 5, 2021, the content of each of which is incorporated herein by reference in its entirety. The subject invention relates to highly elastic patches and masks for delivery of therapeutic agents through the skin.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2021/062349 | 12/8/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63201589 | May 2021 | US | |
| 63199146 | Dec 2020 | US |
