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.

Monomers in common use for the preparation of

acrylic pressure-sensitive adhesive copolymers and

their glass transition (T_g) values.

Soft monomers
T_g(° C.)
Hard monomers
T_g(° C.)

Butyl acrylate
−54
Methyl methacrylate
105

Isobutyl acrylate
−40
Vinyl acetate
29

2-Ethyl hexyl acrylate
−85
Styrene
100

Ethyl acrylate
−22
Acrylonitrile
100

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:

- Acrylate monomers
- Tackifiers. Tackifiers are usually resins included in the adhesive base
- Solvents. The solvents within our adhesive based include ethyl acetate, methyl ethyl ketone, and isopropanol. All solvents are completely removed during the manufacturing process when they are placed through the heat tunnel to cure the product. The coated product is tested for residual solvent levels before it is approved for final conversion and packaging. Solvent based adhesives are more compatible with most ingredients and provide a more uniform coating. Solvent based adhesives also dry faster allowing for quicker curing times and higher outputs.
- In an advantageous embodiment, the acrylic adhesive base contains copolymers of butyl and 2 ethyl hexyl acrylate.

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:

- Acrylate monomers.
- Tackifiers. Tackifiers are usually resins included in the adhesive base
- Solvents. The solvents within our adhesive additive include ethyl acetate, isopropyl alcohol, naphtha, and methanol. All solvents are completely removed during the manufacturing process when they are placed through the heat tunnel to cure the product. The coated product is tested for residual solvent levels before it is approved for final conversion and packaging.
- Solvent based adhesives are more compatible with most ingredients and provide a more uniform coating. Solvent based adhesives also dry faster allowing for quicker curing times and higher outputs.

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

- Fentanyl
- Buprenorphine
- Daytrana (transdermal Ritalin)
- Nicotine
- Antianginal (e.g., nitroglycerin)
- Anti-Depressants or anti-psychotics (e.g., Selegiline, Mirtazapine, Ensam)
- Amphetamines (e.g., Dextroamphetamine. Lisdexamfetamine)
- Anti-Nausea (e.g., Promethazine, Scopolamine)
- Estrogen and Testosterone
- Contraceptive Medication (e.g., Estrogen, Progestin)
- Blood Pressure Medication (e.g., Clonidine)
- Alzheimer's Treatment (e.g., Donepezil, Rivastigmine)
- Anorectal Preparations (e.g., Lidocaine, Hydrocortisone)
- Antiseptic and Germicides (e.g., Chlorhexidine, Povidone Iodine)
- Dermatological Agents (e.g., Lidocaine, Calamine)
- Topical Acne Agents (e.g., Clindamycin, Benzoyl Peroxide, Salicylic Acid, Sulfur)
- Topical Analgesics (e.g., Menthol, Capsaicin)
- Topical Anesthetics (e.g., Lidocaine, Fentanyl)
- Topical Anti-Infectives (e.g., Docosanol, Imiquimod)
- Topical Anti-Rosacea Agents (e.g., Azelaic Acid, Metronidazole, Brimonidine)
- Topical Antibiotics (e.g., Sodium Fusidate, Mupirocin)
- Topical Antifungals (e.g., Clotrimazole, Fluconazole)
- Topical Antihistamines (e.g., Doxepin, Diphenhydramine)
- Topical Antineoplastic (e.g., Fluorouracil, Imiquimod)
- Topical Antipsoriatics (e.g., Betamethasone, Calcipotriene, Tazarotene)
- Topical Antivirals (e.g., Penciclovir, Acyclovir)
- Topical Astringents (e.g., Witch Hazel)
- Topical Debriding Agents (e.g., Collagenase, Balsam Peru, Castor Oil, Trypsin)
- Topical Depigmenting Agents (e.g., Fluocinolone, Hydroquinone, Tretinoin)
- Topical Emollients (e.g., Emollients, Urea)
- Topical Keratolytic (e.g., Podofilox, Salicylic Acid)
- Topical Non-Steroidal Anti-Inflammatories (e.g., Diclofenac)
- Topical Photochemotherapeutic (e.g., 5-Fluorouracil, Diclofenac)
- Topical Rubefacient (e.g., Salicylates, Nicotinate Esters, Capsaicin)
- Topical Steroids (e.g., Clobetasol, Diflorasone, Amcinonide, Betamethasone, Desoximetasone, Fluocinonide, Halcinonide)
- Topical Steroids with Anti-Infectives (e.g., Aloe Vera, Hydrocortisone, Iodoquinol, Nystatin, Triamcinolone, Acyclovir)

The patches of the subject invention can include one or more of the following:

Other Active Ingredients, Inactive Ingredients & Cosmetic Ingredients

- Acrylate Copolymer
- Activated Charcoal
- Agave Extract
- AHA Fruit Acids
- Albizia Flower Extract
- Algae Extract
- Allantoin
- Almond Oil
- Aloe Barbadensis (aloe vera)
- Alpha Arbutin
- Alpha Olefin Sulfonate
- Alpha-Hydroxy Acid
- Aluminum Chlorohydrate
- Aluminum hydroxide
- Amaranthus Seed Extract
- Amla Oil
- Amodimethicone
- Anthemis nobilis Flower Extract
- Apigenin
- Apple Fruit Water
- Apricot Kernel Oil
- Argan Oil
- Argania spinosa Kernel Oil
- Argireline (ACETYL HEXAPEPTIDE-8)
- Arnica montana flower extract
- Arrowroot Starch
- Artichoke Leaf Extract
- Arugula Leaf Extract
- Ashwagandha Extract
- Avena sativa (Oat) Kernel Flour (Colloidal Oatmeal)
- Avobenzone
- Avocado
- Bacillus Ferment
- Bakuchi Fruit Extract
- Bakuchiol
- Bamboo Extract
- Baobab Oil
- Behentrimonium
- Behenyl Behenate
- Bentonite
- Benzocaine
- Benzophenone-4
- Benzoyl Peroxide
- Benzylalcohol-DHA
- Beta Glucan
- Beta-Hydroxy Acid (BHA)
- BHT
- BioJelly
- Bismuth Oxychloride
- Black cohosh
- Black Tea Extract
- Blood Orange
- Blue Flax Extract
- Boron
- Boswellia
- Brassica Alcohol and Glycerides
- Brassica Oil Copolymer
- Broad Spectrum CBD
- Butylene Glycol
- C12-15 Alkyl Benzoate
- Caffeine
- Calamine
- Calcium Carbonate
- Calendula
- Camelina Oil
- Camellia Sinensis Leaf Extract
- Camphor
- Candelilla Wax
- Cannabidiol
- Cannflavin (e.g., A and B)
- Caprylhydroxamic Acid GG
- Caprylic/capric Triglycerides
- Caprylyl Glycol
- Capsaicin
- Carbomer
- Carnauba Wax
- Carrot Cells
- Carrot Oil & Beta-Carotene
- Castile Soap
- Castor Oil
- CBD
- Ceramides
- Ceteareth-20
- Ceteareth-25
- Cetearyl Alcohol
- Cetrimonium Chloride
- Cetyl Alcohol
- Cetyl Palmitate
- Chamomilla recutita (Matricaria) Flower Extract
- Chamomile
- Chaparral Extract
- Charcoal
- Chaste Tree Berry (Vitex)
- Chickpea Extract
- Chlorphenesin
- Citric Acid
- Citronella Oil
- Citrus Combo
- Clay
- Clove Oil
- Cocamidopropyl Betaine
- Cocamidopropyl Hydroxysultaine
- Cocamidopropylamine Oxide
- Coco Betaine
- Coco Caprylate Caprate
- Coco Glucose
- Cocoa butter
- Coconut Oil
- Coconut Water
- Coenzyme Q10 (CoQ10)
- Coffee Seed Extract
- Collagen
- Collagen Protein, Hydrolyzed
- Colloidal Oatmeal
- Comfrey Root Extract
- Cranberry Fruit Water
- Cranberry Seed Oil
- Cucumber Fruit Extract
- Curcumin
- Cyclomethicone
- Cyclopentasiloxane
- d-limonene
- Dead Sea Mud
- Decyl Glucoside Sodium Lauroyl Lactylate
- Diclofenac
- Dihydroxyacetone (DHA)
- Diisooctyl Succinate
- Dimethicone
- Dipropylene glycol,
- Disodium Edta
- DMDM Hydantoin
- Edelweiss
- EDTA
- EGCG (green tea)
- Elastin
- Emu Oil
- Erythrulose
- Ethoxydiglycol
- Ethylhexyl Palmitate
- Evening Primrose
- Ferulic Acid
- Flavonoids (e.g., flavones, flavonols)
- Ginger Root Extract
- Ginkgo biloba Leaf Extract
- Gluconolactone SB
- Glucose-D
- Glycan Booster Peptide
- Glycerin
- Glyceryl Oleate
- Glyceryl Stearate
- Glycine-Benzoic Acid
- Glycol Distearate
- Glycol Stearate IP
- Glycolic Acid
- Glycoproteins
- Goji Berry Extract
- Goldenseal Extract
- Gotu Kola Extract
- Grapefruit Water
- Grape Seed Extract
- Grapeseed Oil
- Green Tea Extract
- HE-Cellulose, Modified
- Hectorite
- Hemp Oil Extract and Multiple Constituents Thereof
- Hemp Seed Oil
- Hemp Seed Protein
- Henna Extract
- Hexanediol CG
- Homosalate
- Honey Extract
- Honeysuckle Blend
- Horse Chestnut Extract
- HP Starch
- Humectants including aloe, glycerin, hyaluronic acid, propylene glycol, and silicone
- Hyaluronic Acid (high mol. weight)
- Hyaluronic Acid (low mol. weight)
- Hyaluronic Acid (medium mol. weight)
- Hydrocolloid
- HydroComplex
- Hydrogenated Polyisobutene
- Hydrolyzed Hyaluronic Acid
- Hydroxypropyl Guar
- Hydroxypropyl Methylcellulose
- Hyssop Extract
- Irish Moss Extract
- Isododecane
- Isoeicosane
- Isohexadecane
- IsoLanolin
- Isopropyl Myristate
- Isopropyl Palmitate
- Jojoba
- Kakadu Plum Extract
- Kaolin Clay
- Kelp Extract
- Keratin Protein, Hydrolyzed
- Knotgrass Flavonoids
- Kojic Acid
- Lactic Acid
- Lacto-Ceramide
- Lanolin
- Laureth-3
- Lauryl Laurate
- Lavender
- Lavender Essential Oil
- Lecithin
- Lemon balm extract (Melissa officinalis)
- Lentil Extract
- Licorice Root
- Lidocaine
- Lingonberry Stem Cells
- Lupine Protein, Hydrolyzed
- Lychee Extract
- Lycii Berry Extract
- Macadamia Nut Oil
- Magnesium Aluminum Silicate
- Magnesium chloride
- Magnesium Stearate
- Mallow Extract
- Mango Butter, USDA Certified Organic
- Manuka Honey
- Marrubium Extract
- Marshmallow Root Extract
- Marula Tetradecane
- Meadowfoam Seed Oil
- Menthol
- Methyl Gluceth-10
- Methyl Salicylate
- Methylsulfonylmethane (MSM)
- Milk Protein, Hydrolyzed
- Mineral Oil
- Mulberry Root Extract
- Murumuru Butter
- Myristic Acid
- Myristyl Myristate
- Natural Bisabolol
- Natural Ferulic Acid
- Natural Peptide
- Neroli Hydrosol
- Nettle Extract
- Niacinamide
- Oat
- Oatmeal Extract
- Octocrylene
- Octyldodecanol
- Orange Peel Butter
- Stem Cells
- Oxybenzone
- Ozokerite Wax
- Palmitic Acid
- Palmitoyl
- Panthenol
- Papaya Enzymes
- Paraben-DU
- Paullinia Cupana Seed Extract
- Pea Extract
- Pearl Powder
- PEG-150 Distearate
- PEG-40 Hydrogenated Castor Oil
- PEG-7 Glyceryl Cocoate
- PEG-8 Beeswax
- PEG-8 Dimethicone
- Pentylene Glycol
- Peppermint Oil
- Persia gratissima (Avocado) Oil
- Petroleum Jelly (Petrolatum)
- Phenoxyethanol
- Phenylpropanol EHG
- Phyto Ceramides
- Pineapple Enzymes
- Plankton Extract
- Polyamide 3
- Polybutene
- Polyethylene
- Polyglucose
- Polyglyceryl Oleate
- Polyhydroxystearic Acid
- Polyisobutene
- Polymethylsilsesquioxane
- Polyphenols
- Polyquaternium
- Polysilicone
- Polysorbate
- Potassium Sorbate
- Pramoxine
- Propanediol
- Propylene Glycol
- Protein-Hyaluronate Blend
- Provitamin B5 (d-panthenol)
- Pumice Powder
- Pumpkin Puree
- PVP (Polyvinylpyrrolidone)
- Quaternium-31
- Quercetin
- Quinoa Protein, Hydrolyzed
- Radish Root Ferment Filtrate
- Red Raspberry Seed Oil
- Repair VITA Oil
- Resveratrol
- Retinol
- Rhodiola
- Rhubarb Root Extract
- Rice Bran Beads
- Rice Quat
- Rice Starch
- Rose Essence Water
- Rose Flower Extract
- Rose Hip Oil
- Rosemary
- Rosemary Leaf Extract
- Saccharomyces
- Sage Extract
- Salicylic Acid
- Sea Buckthorn
- Sea Fennel
- Sea Kelp
- Sea Whip
- Sesame Seed Oil
- Shea Butter
- Shea Oil
- Silica
- Silicone
- Simmondsia chinensis (Jojoba) Seed Oil
- Sodium Benzoate
- Sodium Hyaluronate
- Sodium Hydroxide
- Sorbitan Stearate
- Sorbitol
- Soy-Rice Peptides
- Squalane
- Squalene
- Stearic Acid
- Stearoxy Trimethylsilane
- Stearyl Alcohol
- Stearyl Palmitate
- Sucrose Cocoate
- Sucrose Stearate
- Sugarcane Extract
- Sulfosuccinate
- Sulphur Mud
- Sunflower Oil
- Sunflower Wax
- Tapioca Starch
- Tara Gum Gel
- Tea Tree Oil
- Teprenone
- Titanium Dioxide
- Tocopheryl Acetate
- Tomato Lycopene
- Tribehenin
- Triethanolamine
- Triglyceride
- Trihydroxystearin
- Tripeptide-5
- Urea
- Vitamin A
- Vitamin B12
- Vitamin B3
- Vitamin C
- Vitamin E
- Walnut Shell Powder
- Water
- Watermelon Extract
- Wheat Protein, Hydrolyzed
- White Curcumin
- White Tea Extract
- Willow Bark Extract
- Witch Hazel
- Wrinkle Blur
- Yerba Mate Extract
- Yogurt Filtrate
- Zinc

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:

- Essential Oils:
- Ajuput
- Alpinia oxyphylla
- Anise
- Basil
- Black Cumin
- Cardamom
- Chamomile
- Chenopodium
- Citronella
- Clove
- Eryngium Bungei
- Eucalyptus
- Fennel
- Ginger
- Lavender
- Lilacin
- Melissa
- Mentha
- Menthol
- Myrtle Oils
- Niaouli
- Nutmeg
- Orange
- Peppermint
- Petit Grain
- Rosemary
- Sage
- Tea Tree
- Thyme
- Tulsi
- Turpentine
- Ylang

Terpenes:

- Anethole
- α-Bisabolol
- Borneol
- Camphor
- Carvacrol
- Carvone
- 1,8-Cineole
- 1,4-Cineole
- Cymene
- Eugenol
- Farnesol
- Fenchone
- Geraniol
- Limonene
- Linalool
- Menthol
- Menthone
- Nerolidol
- α-Pinene oxide
- Pulegone
- Rose oxide
- Safranal
- Terpinen-4-ol (4-terpinenol)
- α-Terpineol
- Tetra-hydrogeraniol
- Thymol
- Valen-cene
- Verbenon-e

Fatty Acids:

- Oleic
- Linoleic
- Palmitoleic
- Palmitic
- Stearic

Piperine:

- Tetrahydropiperine
- Cosmoperine

Method of Producing the Patch

There are several challenges and limitations when manufacturing a highly elastic patch with therapeutic agents. To have a high enough concentration of active ingredients in the adhesive matrix, the adhesive thickness, (i.e., coat weight) must be high and uniform throughout. Coating weight non-uniformities are one of the major loss categories in the web-coating process. Because the performance of the coating is a function of the actual coating weight, a uniform coating at the desired coating weight, over the entire substrate, is essential to producing a saleable quality product. The coating weight must be uniform within a roll, down-web and cross-web and give an average coating weight that is within specification. If the coating weight, uniformity, and roll average vary outside of limits, the product will not function as intended and will be scrapped, resulting in a yield loss, and increasing costs. Furthermore, adding a higher concentration of active ingredients without increasing the coat weight is extremely problematic. By doing so the percent of adhesive is reduced in the adhesive matrix, greatly affecting the adhesive characteristics. Tack, peel force and shear adhesion are greatly reduced to the point the product would not be suitable to be worn for long periods of time, on joints or during movement activities without peeling off. Reports to FDA reveal that Ineffective adhesion is a significant problem.²When patches lose adherence, patients may get less medication.

As someone trained in the art would understand, to overcome some of these coating challenges, a transfer coating technique is utilized to manufacture a web of multiple layers utilizing different adhesive formulas. These specific compounded formulas are applied to a release paper or film and then laminated to fabric; The coated web is then carried through an oven to dry, fuse or cross link the formulas to provide an impervious smooth surface. The major advantage of this process is that coating film (i.e., release liner) is suspectable to less defects before it is applied to the fabric. This technique is used for fabrics that are stretchy and can't be coated by direct coating method. Because they would distort under the tension applied to obtain a flat surface and the adhesive formula matrix would sink into knitted fabric and fabric stiffing would occur resulting in less fabric stretch and loss in tear strength.

Transfer coating has the unique benefit of being able to coat higher weights of adhesive compared to all other adhesive technologies. However, coating anything over 3 mil thickness often results in content uniformity issues across the web. Stretchable sports tapes and Kinesiology tapes are not subject to these challenges due to their low coat weights which are often 1-3 mil in thickness. For most applications, 4 ml and higher coat weights are required to provide therapeutic quantities of active ingredients. Coat weights of 4 mil or greater and are subject to these content uniformity challenges.

To ensure proper content uniformity, a knife over roll technique is used. The knife over roll system has a much higher accuracy vs other coating methods, and combined with the transfer coating method, can coat higher weights of adhesive. In the knife over roll system configuration, a suitably designed doctor blade is properly positioned on top of a high-precision roller. The gap between the bottom of the blade and the thickness of the fabric that passes over the roller controls primarily the coating weight. The roll may be a rubber covered or more advantageously, chromium-plated steel roll. Steel rolls can give more precise coat weights. The viscosity of the formula matrix directly affects the coat weight. Higher viscosity is required to produce a higher coat weight. Materials with a wide range viscosity (up to 40,000 cps) can be coated by the knife on roll technique.

The last critical step in the coating process is laminating the fabric to the coating film. A person skilled in the art will understand that good tension control of the web entering the lamination nip is of extreme importance for maintaining consistent and high quality in coating and laminating processes. For example, in coating, variation in web tension will lead directly to variations in coat weight and poor final product bonding. If either web is under tensioned, issues like wrinkle lines, blemishes, and fold-overs may occur in the web and show in the finished product. Too much tension may result in issues such as stretch lines in the web which may show up in the product. Additionally, too much tension in one of the webs may result in web curl in the finished product.

Laminating a highly stretchable fabric creates challenges for tension control over the web. Proper and consistent tension is critical to ensure no blemishes occur, and most importantly to ensure accurate content uniformity. Web guides on all current coating systems were not designed to control lateral (i.e., transverse) tension of a highly stretchable fabric that moves in both latitudinal and longitudinal directions. 4-way stretch fabric moves in latitudinal and longitudinal directions. Fabric that stretches in transverse direction will shift regardless of the web guides being utilized and regardless of the tension control thus creating content uniformity and in some cases blemishes. To overcome this, specially designed web guides were created to control fabric tension and movement along the transverse direction during the lamination process.

The finished product contains higher coat weights (4 mil or above), precise content uniformity, efficacious quantities of therapeutic delivery agents, proper bonding of the fabric layer to the adhesive matrix, and adhesive that is void of blemishes.

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:

- 1. a fabric layer stretchable in in both directions along a longitudinal axis and stretchable in both directions along a transverse axis,
- 2. an adhesive layer on said face side of the base layer,
- 3. a pain-relieving agent dispersed in said adhesive layer, and optionally
- 4. a penetration enhancing agent dispersed in said adhesive layer.

Advantageously the fabric used for the pain relief patch is 80%-90% nylon and 10%-20% spandex, 190 gsm-210 gsm, the weave is warp-based, the warp and weft threads are composed of both spandex and nylon.

Adhesives

Advantageous adhesives used in the pain relief patches are:

- Polyacrylate Copolymers (Acrylics)
- Polysiloxanes (Silicones)
- Polyisobutylenes (PIBs)
- Hot Melt
- Urethanes
- Hydrocolloids
- Hydrogels

Active Agents

Active agents of a pain relief patch can include one or more of:

- Allantoin
- Aluminum Acetate
- Benzocaine
- Calamine
- Camphor
- Capsaicin or Capsicum
- Cupric Sulfate
- Dexpanthenol
- Dibucaine
- Dibucaine Hydrochloride
- Diclofenac Sodium
- Eucalyptus Oil
- Glycol Salicylate
- Hemp oil extract or individual constituents thereof, e.g., Cannabinoids (125 compounds including CBD, CBN, CBC, CBG), Phenols (42 compounds including Spiro-Indans, Dihydrostilbenes, Dihydrophenanthrenes, Simple Phenols), Flavonoids (34 compounds including apigenin, quercetin, luteolin, vitexin, isovitexin, orientin), or Terpenes (120 compounds including myrcene, alpha-pinene, beta-pinene, caryophyllene, geraniol, humulene, limonene, linalool, eucalyptol)
- Histamine Dihydrochloride
- Hydrocortisone
- Lidocaine
- Menthol
- Methyl Salicylate
- Nonivamide
- Peppermint Oil
- Petrolatum
- Phenol
- Pramoxine Hydrochloride
- Sulfur
- Trolamine Salicylate
- Wintergreen Oil
- Zinc Acetate
- Zinc Oxide

Inactive Agents

Inactive agents of the patch optionally include one or more of:

- Alcohol
- Aloe Barbadensis (Aloe Vera) Leaf Juice
- Arnica Montana Flower Extract
- B-12 (Methylcobalamin)
- Black Cohosh
- Boswellia
- Calendula
- Chamomile
- Chaste Tree Berry (Vitex)
- D-Limonene
- Dipropylene Glycol
- Eucalyptus
- Folate/Folic Acid
- GABA
- Hemp oil extract or individual constituents thereof, e.g., Cannabinoids (125 compounds including CBD, CBN, CBC, CBG), Phenols (42 compounds including Spiro-Indans, Dihydrostilbenes, Dihydrophenanthrenes, Simple Phenols), Flavonoids (34 compounds including apigenin, quercetin, luteolin, vitexin, isovitexin, orientin), or Terpenes (120 compounds including myrcene, alpha-pinene, beta-pinene, caryophyllene, geraniol, humulene, limonene, linalool, eucalyptol)
- L-Theanine
- Lavender
- Lemon Balm
- Magnesium Chloride
- Melatonin
- Methylsulfonylmethane (MSM)
- Passionflower
- Polybutene
- Polysorbate 80
- Potassium Sorbate
- Sodium Benzoate
- Tocopheryl Acetate (Vitamin E)
- Vitamin B-6
- Vitamin C
- Water, And
- White Curcumin

Penetration Enhancing Agents

Penetration enhancing agents of a pain relief patch can include One or more of:

- Essential Oils (Chamomile, Eucalyptus, Melissa, Menthol, Orange, Peppermint, Rosemary, Tea Tree)
- Terpenes (Camphor, Limonene, Menthol, Menthone, Rose oxide, Thymol)
- Piperine (Tetrahydropiperine, Cosmoperine)

Examples of Pain Relief Patches are as Follows:

Pain Relief Patch #1

Permeation

Active Agent
Qty
Adhesive
Qty
Enhancer
Fabric
Qty
Liner

Lidocaine
4%
Acrylic
89%
Menthol
Nylon/Spandex
80%/20%
Paper

Pain Relief Patch #2

Permeation

Active Agent
Qty
Adhesive
Qty
Enhancer
Fabric
Qty
Liner

Menthol
6%
Acrylic
92%
Limonene
Nylon/Spandex
80%/20%
Film

Pain Relief Patch #3

Permeation

Active Agent
Qty
Adhesive
Qty
Enhancer
Fabric
Qty
Liner

Lidocaine
4%
Acrylic
85%
Menthol
Nylon/Spandex
80%/20%
Paper

Pain Relief Patch #4

Permeation

Active Agent
Qty
Adhesive
Qty
Enhancer
Fabric
Qty
Liner

Menthol
6%
Acrylic
82%
Limonene
Nylon/Spandex
80%/20%
Paper

Skin Care Patches

Skin care patches of the invention comprise:

- 1. a fabric layer stretchable in in both directions along a longitudinal axis and stretchable in both directions along a transverse axis,
- 1. an adhesive layer on said face side of the base layer,
- 2. an active agent dispersed in said adhesive layer and optionally,
- 3. a penetration enhancing agent dispersed in said adhesive layer.

Advantageously the fabric used for the pain relief patch is 80%-90% nylon and 10%-20% spandex, 190 gsm-210 gsm, the weave is warp-based, the warp and weft threads are composed of both spandex and nylon.

Adhesives

Advantageous adhesives that are used in the skin care patches of the invention include:

- Polyacrylate Copolymers (Acrylics)
- Polysiloxanes (Silicones)
- Polyisobutylenes (PIBs)
- Hot Melt
- Urethanes
- Hydrocolloids
- Hydrogels

Active Agents

Active agents of the skin care patch can include one or more of:

- Activated Charcoal
- Allantoin
- Aloe Vera
- Alpha Arbutin
- Apigenin
- Argireline (ACETYL HEXAPEPTIDE-8)
- Bakuchiol
- Bentonite & Kaolin Clay
- Chamomile Oil
- Clove Oil
- Collagen (hydrolyzed)
- CoQ10 (ubiquinol)
- EGCG (green tea)
- Evening Primrose
- Hemp oil extract or individual constituents thereof, e.g., Cannabinoids (125 compounds including CBD, CBN, CBC, CBG), Phenols (42 compounds including Spiro-Indans, Dihydrostilbenes, Dihydrophenanthrenes, Simple Phenols), Flavonoids (34 compounds including apigenin, quercetin, luteolin, vitexin, isovitexin, orientin), or Terpenes (120 compounds including myrcene, alpha-pinene, beta-pinene, caryophyllene, geraniol, humulene, limonene, linalool, eucalyptol)
- Hyaluronic Acid (high mol. weight)
- Hyaluronic Acid (low mol. weight)
- Hydrocolloid
- Lemon balm extract (Melissa officinalis)
- Licorice Root
- Manuka Honey
- Natural Salicylic Acid
- Niacinamide
- Papaya & Pineapple Enzymes
- Phyto Ceramides
- Plant Based Squalane
- Rosehip Oil
- Rosemary.
- Sea Buckthorn Oil
- Sea Whip
- Silicone
- Tea Tree Oil
- Vitamin A
- Vitamin B12
- Vitamin B3
- Vitamin C
- Vitamin E
- White Curcumin
- Witch Hazel
- Zinc

The skin care agents used in the skin care patches of the invention are selected from the group consisting of:

- Anti-Wrinkle or Skin-Tightening Agents, (e.g., Argireline, Bakuchiol, Sea Buckthorn Oil)
- Anti-Aging Agents (e.g., Coq10, Phyto Ceramides, Collagen, Hyaluronic Acid)
- Moisturizing Agents (e.g., Allantoin, Phyto Ceramides, Squalane, Rosehip Oil, Sea Whip, Evening Primrose)
- Skin Brightening or Depigmentation Agents (e.g., Niacinamide, Alpha Arbutin)
- Anti-Inflammatory Agents (e.g., Aloe Vera, Hemp Extract Oil or CBD, Chamomile Oil, EGCG, Lemon Balm, Licorice Root)
- Anti-Acne Agents (e.g., Clove Oil, Tea Tree Oil, Witch Hazel, White Curcumin)
- Dna Repair Agents (e.g., Photolysomes, Mitosomes, Endosomes)
- Skin Lipid Barrier Repair Agents (e.g., Vitamin E, Phyto Ceramides, Apigenin)
- Anti-Cellulite Agents (e.g., Coleus Forskohlii, Caffeine, Boswellia, Horse Chestnut, Amarantus, Olives, Black Pepper)
- Wound-Healing Agents (e.g., Manuka Honey, Silicone, Aloe Vera, Vitamin B12)
- Stretch-Mark/Scar Removing Agents (e.g., Manuka Honey, Silicone, Vitamin A)
- Plumping Agents; (e.g., Cupuacu Butter, Honey, Hyaluronic Acid, Vitamin C)
- Hair Growth Retardation Agents and Hair Growth Stimulating Agents (e.g., Aloe Vera, Ginseng, Onion, Rosemary, Honey, Hyaluronic Acid, Vitamin C, Melatonin)
- Dark Circle Reduction or De-Puffing Agents (e.g., Kojic Acid, Vitamin E, Peptides, Arnica, Retinol)
- Collagen Synthesis or Blood Circulation Enhancing Agents (e.g., DMAE, MSM, Retinoids, Alpha Hydroxy Acids, Beta Hydroxy Acids, Epidermal Growth Factor)
- Antioxidants (e.g., Zinc, Niacinamide, Glycolic Acid)
- Scbum-Controlling Agents (e.g., Vitamin A, Hydrocolloid)
- Pore-Minimizing Agents (e.g., Lactic Acid, Red Clover, Ribose)
- Skin Detox or Exfoliation Agents (Salicylic Acid. Bentonite & Kaolin Clay, Activated Charcoal, Willow Bark, Papaya & Pineapple Enzymes)

Penetration Enhancing Agents

Penetration enhancing agents of skin care patches can include one or more of:

- Essential Oils (Chamomile, Clove, Eucalyptus, Melissa, Menthol, Orange, Peppermint, Rosemary, Tea Tree)
- Terpenes (Camphor, Limonene, Menthol, Menthone, Rose oxide, Thymol)
- Fatty Acids (Oleic, Linoleic, Palmitoleic, Palmitic, Stearic)
- Piperine (Tetrahydropiperine, Cosmoperine)

Examples of skin care patches are as follows:

Skin Care Patch #1

Permeation
Liner

Active Ingredients
Adhesive
Fabric
Enhancer
Type

Apigenin, Argireline,
Silicone
Nylon/
Limonene
Fluoro-

Bakuchiol, Collagen,

Spandex

silicone

CoQ10 (ubiquinol),

EGCG (green tea),

Evening Primrose,

Hyaluronic Acid (high

and low molecular

weight), Niacinamide,

Phyto Ceramides,

Plant Based Squalane,

Sea Buckthorn Oil,

Vitamin E

Skin Care Patch #2

Permeation
Liner

Active Ingredients
Adhesive
Fabric
Enhancer
Type

Allantoin, Aloe Vera,
Silicone
Nylon/
Limonene
Fluoro-

Alpha Arbutin, Apigenin,

Spandex

silicone

Bakuchiol, Chamomile

Oil, Collagen, CoQ10

(ubiquinol), EGCG

(green tea), Evening

Primrose, Hyaluronic

Acid (low molecular

weight), Lemon

Skin Care Patch #3

Permeation
Liner

Active Ingredients
Adhesive
Fabric
Enhancer
Type

Activated Charcoal,
Hydrocolloid
Nylon/
Limonene
Film

Alpha Arbutin,

Spandex

Bakuchiol, Bentonite

Clay, Kaolin Clay,

Chamomile Oil, Clove

Oil, CoQ10 (ubiquinol),

EGCG (green tea),

Evening Primrose,

Hyaluronic Acid (low

molecular weight),

Lemon Balm Extract,

Licorice Root, Manuka

Honey, Natural Salicylic

Acid, Niacinamide,

Rosehip Oil, Sea Whip,

Tea Tree Oil, Vitamin A,

Vitamin E, Witch Hazel,

Zinc

Skin Care Patch #4

Permeation
Liner

Active Ingredients
Adhesive
Fabric
Enhancer
Type

Activated Charcoal,
Hydrocolloid
Nylon/
Limonene
Film

Alpha Arbutin,

Spandex

Bakuchiol, Bentonite

Clay, Kaolin Clay,

Chamomile Oil, Clove

Oil, CoQ10 (ubiquinol),

EGCG (green tea),

Evening Primrose,

Hyaluronic Acid (low

molecular weight),

Lemon Balm Extract,

Licorice Root, Manuka

Honey, Natural Salicylic

Acid, Niacinamide,

Rosehip Oil, Sea Whip,

Tea Tree Oil, Vitamin A,

Vitamin E, Witch Hazel,

Zinc

Skin Care Patch #5

Permeation
Liner

Active Ingredients
Adhesive
Fabric
Enhancer
Type

Manuka Honey, Aloe
Silicone
Nylon/
Limonene
Fluoro-

Vera, Vitamin A,

Spandex

silicone

Vitamin B12, Vitamin E,

Vitamin C, Rosehip Oil,

White Curcumin,

Lavender Oil

Skin Care Patch #6

Permeation
Liner

Active Ingredients
Adhesive
Fabric
Enhancer
Type

Apigenin, Argireline,
Silicone
Nylon/
Oleic Acid
Fluoro-

Bakuchiol, Collagen,

Spandex

silicone

CoQ10 (ubiquinol),

EGCG (green tea),

Evening Primrose, Hemp

Oil Extract, Hyaluronic

Acid (high and low

molecular weight),

Phyto Ceramides,

Vitamin E

Skin Care Patch #7

Permeation
Liner

Active Ingredients
Adhesive
Fabric
Enhancer
Type

Alpha Arbutin,
Hydrocolloid
Nylon/
Oleic Acid
Film

Bakuchiol, Bentonite

Spandex

Clay, Kaolin Clay,

Chamomile Oil, Clove

Oil, CoQ10 (ubiquinol),

EGCG (green tea),

Evening Primrose, Hemp

Oil Extract, Hyaluronic

Acid (low molecular

weight), Lemon Balm

Extract, Licorice Root,

Manuka Honey,

Niacinamide, Rosehip

Oil, Tea Tree Oil,

Vitamin A, Vitamin E,

Witch Hazel

Hormone Therapy Patches

Hormone therapy patches of the invention comprise:

- 1. a fabric layer stretchable in in both directions along a longitudinal axis and stretchable in both directions along a transverse axis,
- 2. an adhesive layer on said face side of the base layer,
- 3. a hormone therapy agent dispersed in said adhesive layer, and optionally
- 4. a penetration enhancing agent dispersed in said adhesive layer.

Advantageously the fabric used for the pain relief patch is 80%-90% nylon and 10%-20% spandex, 190 gsm-210 gsm, the weave is warp-based, the warp and weft threads are composed of both spandex and nylon.

Active Agents are Selected from:

Active Agents

- Estrogen
- Conjugated Estrogen
- Estradiol
- Progestin
- Estropipate
- Norethindrone Acetate
- Levonorgestrel
- Anastrozole
- Tamoxifen
- Letrozole
- Progesterone
- Testosterone

Adhesives

Advantageous adhesives that are used in the hormone therapy patches of the invention include:

- Polyacrylate Copolymers (Acrylics)
- Polysiloxanes (Silicones)
- Polyisobutylenes (PIBs)
- Hot Melt
- Urethanes
- Hydrocolloids
- Hydrogels

Penetration Enhancing Agents

Penetration enhancing agents of a hormone therapy patch can include one or more of:

- Essential Oils (Chamomile, Clove, Eucalyptus, Melissa, Menthol, Orange, Peppermint, Rosemary, Tea Tree)
- Terpenes (Camphor, Limonene, Menthol, Menthone, Rose oxide, Thymol)
- Fatty Acids (Oleic, Linoleic, Palmitoleic, Palmitic, Stearic)
- Piperine (Tetrahydropiperine, Cosmoperine)

An example of a hormone therapy patch is below.

Hormone Therapy Patch

Permeation

Active Agent
Qty
Adhesive
Qty
Enhancer
Fabric
Qty
Liner

Estradiol
0.025 mg
Acrylic
89%
Menthol
Nylon/Spandex
80%/20%
Film

Anti-Depressant Patches

Anti-depressant patches of the invention comprise:

- 1. a fabric layer stretchable in in both directions along a longitudinal axis and stretchable in both directions along a transverse axis,
- 2. an adhesive layer on said face side of the base layer,
- 3. an anti-depressant agent dispersed in said adhesive layer, and optionally
- 4. a penetration enhancing agent dispersed in said adhesive layer.

Advantageously the fabric used for the pain relief patch is 80%-90% nylon and 10%-20% spandex, 190 gsm-210 gsm, the weave is warp-based, the warp and weft threads are composed of both spandex and nylon.

Advantageous active agents are as follows.

Active Agents

- Selegiline
- Mirtazapine

Adhesives

Advantageous adhesives that are used in the anti-depressant patches of the invention include:

- Polyacrylate Copolymers (Acrylics)
- Polysiloxanes (Silicones)
- Polyisobutylenes (PIBs)
- Hot Melt
- Urethanes
- Hydrocolloids
- Hydrogels

Penetration Enhancing Agents

Penetration enhancing agents of an anti-depressant patch can include one or more of:

- Essential Oils (Chamomile, Clove, Eucalyptus, Melissa, Menthol, Orange, Peppermint, Rosemary, Tea Tree)
- Terpenes (Camphor, Limonene, Menthol, Menthone, Rose oxide, Thymol)
- Fatty Acids (Oleic, Linoleic, Palmitoleic, Palmitic, Stearic)
- Piperine (Tetrahydropiperine, Cosmoperine)

An example of an anti-depressant patch is below.

Anti-Depressant Patch

Permeation

Active Agent
Qty
Adhesive
Qty
Enhancer
Fabric
Qty
Liner

Selegiline
6 mg
Acrylic
89%
Menthol
Nylon/Spandex
80%/20%
Film

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.

EXAMPLES
Example 1

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:

- Alcohol (where indicated)
- Water (where indicated)
- Arnica Extract
- Boswellia Extract
- MSM
- Aloe Leaf Juice
- Calendula Extract
- White Curcumin
- Polysorbate 80
- Tocopheryl Acetate
- Lavender Oil
- Menthol (where indicated)
- Sodium Benzoate (where indicated)
- Potassium Sorbate (where indicated)
- Hemp Oil Extract (where indicated)

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

- 1. Mixing preparation and completion of the adhesive formula
- 2. Liner and Fabric are prepared for coating and lamination
- 3. Full width Liner and fabric are 58″ wide or greater

Transfer 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.

- 4. Lamination of the 4 way stretch fabric onto the coated liner while carefully controlling the web tension in the transverse direction.
- 5. Splicing and Slitting as needed.
- 6. Finished coated fabric is slit to 14″ wide rolls.
- 7. Wind up of the finished coated fabric.
- 8. Finished coated fabric is wrapped, sealed, and transported for conversion.
- 9. During the conversion process the coated fabric is placed on rewind/unwind machine for quality checks.
- 10. Qualified coated fabric is placed in the Mark Andy Die Cutting and Printing Press for printing on the release liner and Die Cutting.
  - a) Optionally, the liner is printed using a printing pattern.
- 11. Rotary Dies are used to perforate or kiss-cut the release liner. A Micro-perforation or kiss-cut is added down the center of the liner.
  - a) Optionally, horizontal, and vertical perforations are added between each strip.
- 12. Rotary Dies are used to kiss cut or die cut into the patch shapes.
  - a) Optionally, the product is slit into the appropriate length (10 strips or 5 patches).
- 13. The product is placed into a heat seal bag and sealed using a heat seal machine.
  - a) Optionally, the product is put on a tall, corrugated core with 1″ inside diameter.
  - b) Optionally, an adhesive tab is placed on the core and liner. The purpose of the tab is to keep the product in place while it is wound onto the core.
  - c) Optionally, the product is wound to the core and a final adhesive tab is placed on the end of the liner. The purpose of the tab is to ensure the roll doesn't unwind prior to final packaging. This tab is resealable and can be resealed by the end consumer as needed after use.
  - d) Optionally, shrink wrap is added to the finished roll. Shrink wrap has double vertical perforations for easy removal. Shrink wrap is placed in a heat or steam tunnel to shrink to size around finished roll.
- 14. Heat sealed bag containing the finished product is placed into a folding carton and closed.
  - a) Optionally, a finished roll is inserted into a HDPE bottle.