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Title:
DRY CBD DELIVERY FABRIC
Document Type and Number:
WIPO Patent Application WO/2022/090910
Kind Code:
A1
Abstract:
A skin care fabric for application to skin comprising a substrate, the substrate comprising non-woven hemp fibres and non-woven cotton fibres and / or non-woven lyocell fibres, the fabric further comprising CBD in dry form.

Inventors:
KIER REBECCA NYARUOT (CH)
SINGH VINITKUMAR (CH)
DENDAS CHRISTEL (CH)
SEVENICH MELISSA (CH)
Application Number:
PCT/IB2021/059861
Publication Date:
May 05, 2022
Filing Date:
October 26, 2021
Export Citation:
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Assignee:
JACOB HOLM & SONS AG (CH)
International Classes:
A61K8/02; A61K31/05; A61Q19/00; D04H1/425; D04H1/4258; D04H1/4266
Domestic Patent References:
WO2020007930A12020-01-09
WO2018179452A12018-10-04
WO2017027553A12017-02-16
WO2018179452A12018-10-04
WO2019162951A12019-08-29
Foreign References:
CN109820744A2019-05-31
US20190247453A12019-08-15
Attorney, Agent or Firm:
CHAS. HUDE A/S (DK)
Download PDF:
Claims:
CLAIMS

1. A skin care fabric for application to skin comprising a substrate, said substrate comprising non-woven hemp fibres and non-woven cotton fibres and I or non-woven lyocell fibres, the fabric further comprising CBD in dry form.

2. The fabric of claim 1 , wherein a combination of the hemp and cotton fibres constitute about 50% w/w of the fabric while the lyocell fibres constitute the remaining about 50% w/w.

3. The fabric of any of claims 1 or 2 comprising below 1 % w/w carrier solvent used to apply CBD to the fabric and below 1% w/w water.

4. A skin care fabric for application to skin comprising a CBD in a dry form in the range of 0.1-20 wt.% of the total fabric; and a substrate, said substrate comprising a non-woven hemp fibre(s) and, a non-woven cotton fibre(s) and / or a non-woven lyocell fibre(s), the fabric further comprising CBD in dry form; wherein

- said non-woven hemp fibre(s) is in the range of_20 wt.% to 80 wt.% of the total fabric,

- said non-woven cotton fibre(s) is in the range of_20 wt.% to 80 wt.% of the total fabric, and

- said non-woven lyocell fibre(s) is in the range of 10 wt.% to 60 wt.% of the total fabric.

5. A method of producing a skin care fabric comprising a substrate, said substrate comprising non-woven hemp fibres and non-woven cotton fibres and I or non-woven lyocell fibres, said method comprising the steps of: applying a composition comprising CBD oil and carrier solvent to the substrate by spraying or by rolling, and allowing the carrier solvent to evaporate.

6. The method of claim 5, wherein the carrier solvent is an alcohol, such as ethanol.

7. The method of either one of claims 5 or 6, wherein the substrate is coated with a composition comprising carrier solvent and between 0.1 % and 20% w/w CBD oil, preferably between 1 % and 10% w/w, such as between 2% and 5% w/w, such as 2%, 2.5% or 5% w/w CBD oil.

8. The method of any one of claims 5 to 7, wherein when the substrate is coated with the composition by rolling, and rotation speed of the roller is within a range from

10 rpm to 50 rpm, such as at 24 rpm or 32 rpm.

9. The method of any one of claims 5 to 8, wherein the fabric is further exposed to a temperature treatment of at least 60 °C.

10. The method of claim 9, wherein the temperature treatment is below 160 °C. 11. Use of a dry CBD-coated fabric of any of claims 1 to 4, wherein an outer surface of the fabric is wetted before being applied to the skin and wherein the CBD blends with oils present on the skin surface.

Description:
TITLE

Dry CBD Delivery Fabric

FIELD OF THE INVENTION

The invention relates to a skin care fabric comprising hemp fibres and CBD in dry form, a method of manufacture of the same, and a use where CBD is transferred from said skin care fabric to skin.

BACKGROUND OF THE INVENTION

CBD (cannabidiol) ’s natural properties make it a popular ingredient in many beauty products, as a natural, alternative skincare solution. The topical application of CBD through CBD-infused fabric or face masks is, thus, a practical solution for individuals whose target area for CBD is only an area of skin, e.g., on the face. CBD has been reported to exert beneficial beauty effects on human skin, such as anti-inflammatory effects, reduction of excessive oil production, antioxidant (anti-aging), and reducing itch and skin dryness. Further, CBD might also help enhance skin elasticity and hydration.

Traditional wet fabric or mask (aqueous) delivery systems are limited in terms of the amount of active ingredient they can contain due to limited solubility of hydrophobic compounds in water. Further, wet fabric or masks potentially accelerate the degradation rate of unstable ingredients or worse; promote the growth of bacteria. CBD is indeed very unstable when used with other highly water-soluble ingredients. Despite this, cannabinoids such as CBD are used as an emulsion in watercontaining lotions or creams. However, when CBD is suspended in lotion or cream form, the delivery potential is limited as only a small fraction of the CBD present on the mask will be delivered to the skin, thus taking it longer for the active compound to be absorbed into the skin and the effects being noticeable. CBD oil applied directly on the skin may provide faster effects because of its ability to directly interact with the skin. Mousses, gels, and creams, however, typically lead to the application of excessive product, resulting in waste. Single sheet fabric or masks, thus, provide a means for applying a controlled and effective amount of product.

International patent application WO2018/179452A describes a substrate based cosmetic product in wet form. US2019/0247453A1 describes a transdermal delivery device for the delivery of cannabidiol (CBD) and related moieties.

WO201 9/162951 uses CBD to enhance the drug delivery systems reconstituted in a solution in combination with PLGA nanoparticles.

These arrangements, nonetheless, call for a need to improve the delivery rate of CBD and related moieties in a controlled and efficient manner from a single sheet mask, such as a facial sheet mask.

SUMMARY OF THE INVENTION

It is a first object of the present invention to provide an alternative product for topical delivery of CBD and related moieties with improved delivery rate.

It is another object of the present invention to provide an alternative product for topical delivery of CBD and related moieties offering increased active compound stability.

One or both of the above mentioned objects is achieved in a first aspect of the present invention by a skin care fabric for application to skin comprising a substrate, said substrate comprising non-woven hemp fibres and non-woven cotton fibres and I or non-woven lyocell fibres, the fabric further comprising CBD in dry form.

By a fabric it is meant herein a thin piece of woven or non-woven fabric, cloth, felt, chiffon, netting, mesh, lattice, web, webbing, mat, mask, sheet, or patch with the purpose of contacting or providing a supporting substrate to a layer for contacting skin. Thus, the terms fabric, mask and substrate will be used interchangeably herein. It is to be understood that, generally, a dry coated CBD mask or fabric is a substrate coated with CBD oil.

By CBD it is meant herein (-)-cannabidiol, a phytocannabinoid known as one of 113 identified cannabinoids in cannabis plants. CBD can be abundant in cannabis extracts and may account for up to 40% of the plant's extract. CBD may be supplied and used within the context of the present invention as CBD oil, advantageously containing only CBD as the active ingredient (excluding tetrahydrocannabinol [THC] or terpenes). The term CBD is meant to encompass herein cannabidiol moieties and derivatives; naturally occurring phytocannabinoid derivatives such as other 5'- methyl-2'-(prop-1 -en-2-yl)-1 2', 3', 4'-tetrahydro-[ 1 , 1 '-biphenyl]-2,6-dioles retaining the trans-(1 R,6R) configuration, including cannabidiolic acid (CBDA), cannabidivarinic acid (CBDVA-C3), cannabidiorcol (CBD-C1 ), cannabidiol-C4; also named as nor-cannabidiol (CBD-C4), and cannabidivarin (CBDV) and cannabidiol monomethyl ether (CBDM), or synthetic CBD metabolites such as 7-COOH-CBD or 7-OH-CBD, CBD derivatives with a 1 1 '-dimethylheptyl (DMH) lipophilic alkyl chain, e.g., DMH-CBD, HU-320, DMH-CBDD, and 7-OH-DMH-CBD. Moreover, CBD with structural modifications on different pharmacophoric positions such as the lipophilic side chain, the phenolic hydroxyl groups or the C7-methyl, halogenated CBD derivatives and quinone derivatives of CBD are also included.

Hemp is to be understood herein as a variety of the Cannabis sativa plant species that is grown specifically for the industrial uses of its derived products. The term hemp fibres is to be understood as fibres that are spun from plant material containing low or undetectable concentrations of tetrahydrocannabinol (THC) but optionally detectable concentrations of cannabidiol (CBD) or its derivatives, which decreases or eliminates any possible psychoactive effects when contacted with a human being.

Hemp fibres generally excel at fibre length, durability, strength, absorbency and antimicrobial properties. Thus, by the skincare fabric comprising hemp fibres, the strength, durability, absorbency and anti-microbial properties may be delivered by the fabric. Absorbency and anti-microbial properties may contribute to enhancing the amount of active CBD present in the fabric and available for transfer at the time of application. Thus, facial sheet masks and beauty patches can offer increased CBD oil absorption and content to offer more potency and faster effect onset.

With relatively high strength, hemp fibres in the skincare fabric may contribute to increased durability and reduced elasticity. Durability may ensure that fabric and facial sheet masks maintain their intended shape despite the oil I active ingredient overlay, and reduced elasticity may ensure the conservation of shape of fabric and facial sheet masks when in use.

Furthermore, the inventors of the present invention have surprisingly established that the release rate and amount of CBD or related moieties released from a gauze comprising hemp fibres may be superior to that of a gauze not comprising hemp fibres.

By the CBD being present in dry form, it is to be understood herein that the fabric in ready-to-use form is free from water. For a fabric to be “dry” the difference between initial fabric weight (wt) and dried fabric weight (w) after drying in a circulating air oven for 30 minutes at 60 °C is not to exceed 10% according to: (wt - w) / wt ■ 100.

A dry fabric may contain other, oil-based substances in liquid form above 60 °C.

With a dry substrate, a support is provided that may promote stability of CBD or related moieties thereby extending the half-life and increasing the availability of active compound for release upon application to skin. Thus, delivery efficiency may result in less CBD or related moiety being needed and it may be advantageous to apply less active ingredient during manufacture to reduce production costs.

Further, hemp is a very fast-growing plant, which may further decrease production costs.

In one embodiment, the substrate of the present invention may further comprise cotton fibres and I or lyocell fibres. The three blended fibres give excellent results due to the advantages they offer. Each has their own beneficial properties which give better results than the use of just one fibre.

Hemp fibres are strong, absorbent, and durable. But using hemp fibre alone would give the substrate a rough feel. Cotton fibre, on the other hand, is softer but not transparent when used alone. With the inclusion of cotton fibres, the fabric, facial sheet mask and I or beauty patch may have a softer consistency to the touch, which may result in more comfort when in use.

Adding lyocell into the mix of hemp and cotton may improve the substrate fabric by giving it just the right combination it needs for ideal absorbance, transparency, strength and adhesion for skin applications.

These three fibres are three bio-sustainable fibres, the combined use of which may result in the production of a bio-sustainable and I or biodegradable substrate.

Other materials that may be used in combination with hemp include recycled or nonrecycled PET, PLA, wood pulp / PET blend, micro-fine fibres amongst others. With the inclusion of lyocell, the fabric may be more transparent, which may facilitate visually checking whether the fabric, facial sheet mask or beauty patch is satisfactorily adhered to skin when in use.

In one embodiment, the combination of the hemp and cotton fibres constitute about 50% w/w of the substrate while the lyocell fibres constitute the remaining about 50% w/w. This approximate distribution of components by weight may result in a combination that best balances the abovementioned qualities.

In one embodiment, the substrate further comprises non-woven fibres. In another embodiment, non-woven fibres are hemp and cotton and I or lyocell fibres and form a fabric. Non-woven fabric is a fabric-like material made from fibres bonded together by chemical, mechanical, heat or solvent treatment. Non-Woven materials are easier to produce because they do not involve any weaving. In producing the substrate, the fibres are made into a web and typically consolidated by spunlacing that hydraulically entangles fibres to produce the substrate. Since the weaving is eliminated, the material is created with short process flows, fast production, high yield and low cost. In addition, the absence of weaving may lead to improved softness and the fabric may be more easily moulded into a preferred shape. Thus, non-woven fabrics may also be easier to customise. Other advantages may include aeration, filtration, absorbance, insulation, light weight, and elastic recovery.

In a second aspect, the invention relates to a method of coating the substrate described herein above comprising the steps of: applying a composition comprising CBD oil and carrier solvent to the substrate by spraying or by rolling, and allowing the carrier solvent to evaporate, thereby obtaining a dry CBD-containing substrate, e.g. fabric, facial sheet mask or beauty patch.

By using a solvent, it is understood a carrier substance that advantageously enables the dissolution of oil, i.e., CBD oil, such that an even solution is formed. CBD oil may be obtained by resuspension of a CBD crystalline solid in oil or by direct CBD- dominant Cannabis oil extraction. In one embodiment, the solvent used is alcohol. Since alcohol is amphipathic, it is miscible with oils such as oils containing CBD and I or related moieties.

In another embodiment, the fabric is coated with solvent comprising between 0.1 % and 20% w/w CBD oil, preferably between 1 % and 10% w/w CBD oil, such as between 2% and 5% w/w CBD oil. These concentrations of CBD oil may enable an optimal transfer of CBD from the substrate to the user’s skin. In preferred embodiments, the fabric is coated with solvent comprising 2%, 2.5% or 5% w/w CBD oil.

In a further embodiment, the substrate is coated by rolling or spraying. Microgravure utilizes an engraved roller, such as an analux applicator roller, however the roller is significantly smaller than rollers used in other gravure methods. Kiss, squeeze & saturation roll coating utilizes a variety of smooth and rubber rollers to apply coatings through a kiss or dipping configuration. Reverse gravure also utilizes an engraved analux applicator roller. It is a gravure method which operates in reverse. Coat weight is controlled by cell volume but also by the speed of the applicator roller. Reverse gravure is extremely accurate and allows for the application of coatings with a very consistent and uniform profile. It is well suited for low viscosity coatings such as the solvent comprising CBD oil of the present invention. Reverse roll coating utilizes a smooth, chrome plated applicator roller. The coating deposition is determined by the gap between the applicator roller and the metering roller as well as the speed of the applicator roller.

In one embodiment, the substrate is coated by rolling and rotation speed of the roller is within a range from 10 rpm to 50 rpm. Rotation of the roller at a speed within this range may provide improved evaporation of the carrier solvent such that when exiting the roller I drier the substrate is free from solvent. In particular, ideal drying may be achieved at a rotation speed of either 24 rpm or 32 rpm.

In a further embodiment, the coated substrate is exposed to a temperature treatment of at least 60°C. At this temperature, improved evaporation of the carrier solvent may be achieved, such that when exiting the roller I drier substrate is free from solvent.

In a further embodiment, the coated substrate is exposed to a temperature treatment below 160 °C. At this temperature, CBD and I or CBD oil will not be affected since the boiling temperature of CBD is between 160 - 180 °C.

In a third aspect, the present invention relates to the use of any of the dry CBD- coated fabric described herein above, wherein an outer surface of the fabric is wetted before being applied to the skin. Wetting an outer surface of the fabric, facial sheet mask or beauty patch may improve adhesion to the skin.

In an embodiment, the CBD and I or the CBD oil of the fabric blends with oils present on the skin surface. This process may lead to the enhanced transfer of CBD to skin surface and enhanced transdermal CBD absorption. Without the desire to being bound to any particular theory, the hydrophobic nature of CBD and skin oils may favour their blending and consequently also favour rate and I or efficiency of CBD delivery from the fabric to the skin and I or transdermal CBD absorption rate and I or efficiency by skin.

In a particular suited embodiment, the invention relates to a skin care fabric for application to skin comprising a CBD in a dry form in the range of 0.1-20 wt.% of the total fabric; and a substrate, said substrate comprising a non-woven hemp fibre(s) and, a non-woven cotton fibre(s) and / or a non-woven lyocell fibre(s), the fabric further comprising CBD in dry form; wherein

- said non-woven hemp fibre(s) is in the range of_20 wt.% to 80 wt.% of the total fabric,

- said non-woven cotton fibre(s) is in the range of_20 wt.% to 80 wt.% of the total fabric, and

- said non-woven lyocell fibre(s) is in the range of 10 wt.% to 60 wt.% of the total fabric.

This combination is particularly suited for increased efficiency of CBD delivery from the fabric to the skin and reaching very high absorption rates.

BRIEF DESCRIPTION OF THE DRAWINGS

In the following, example embodiments are described according to the invention, where Fig.1 Is a schematic representation of a facial sheet mask according to the invention.

Fig.lA shows a facial sheet mask surface from above, Fig.1 B shows a cross-section of the same comprised of 3 layers of material while Fig.1 C shows a cross-section of the same comprised of a single layer.

Fig.2 shows a second arrangement of the facial sheet mask of the invention.

Fig.3 shows amounts of applied (infused) CBD oil at 2% and 5% w/w CBD oil before and after skin application as measured by HPLC.

Fig.4 is a bar chart plot of the results in Fig.3.

Fig.5 shows amounts of two CBD oil batches, “8620” and “8314” transferred to skin after application at 24 and 32 rpm roller speed.

Fig.6 is a bar chart plot of the results in Fig.5.

Fig.7 shows skin irritation classification of samples according to the obtained index.

DETAILED DESCRIPTION

The present invention relates to a self-adhesive facial sheet mask or fabric, for covering a portion of the anatomical surface of a living being, said patch being able to adhere to the skin or mucosa and will be described more fully hereinafter with reference to the accompanying drawings, in which preferred embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the claims to those skilled in the art. In the drawings, like numbers refer to like elements throughout the description of embodiments of the invention.

The facial sheet mask or fabric generally designated 1 throughout the accompanying drawings is a thin piece of fabric comprising non-woven hemp, cotton, and lyocell fibres.

In a preferred embodiment, the overall thickness of the facial sheet mask or fabric is approximately 20 mils (1/1000 of an inch; approximately 0.5 mm), and generally comprised within 10 mils to 45 mils (approximately 0.25 mm to 1.15 mm), such as within 12 mils to 37 mils (0.3 mm to 0.94 mm).

In a preferred embodiment, such components are blended as shown in blend 7 of Fig.1 C (bonded by chemical, mechanical, heat or solvent treatment) but said facial sheet mask or fabric 1 may also be composed of one or more separate hemp layer(s) 3, one or more cotton layer(s) 4, and one or more lyocell fibre layer(s) 5 as shown in Fig.l B, (also bonded together by any of the same methods) forming a fabric comprising three or more layers.

In another embodiment the order of layers 3, 4, 5 is different, such as (3, 5, 4), (4, 3, 5), (4, 5, 3), (5, 3, 4), or (5, 4, 3). Layers are further spunlaced to form a substantially unitary sheet structure i.e. the substrate or fabric.

The purpose of facial sheet mask or fabric is directly contacting skin or providing a supporting substrate to a CBD oil layer 6 for contacting skin.

In the embodiment shown in Fig.1 , the facial sheet mask or fabric comprises slits 2, placed strategically to accommodate the user’s anatomical features, such as nose, mouth and eyes. In another embodiment, slits accommodate other anatomical features such as fingers, toes or thumbs. With the inclusion of slits, the facial sheet mask or fabric may contact the user’s skin more effectively.

In another preferred embodiment, the composition ratio of the three materials is approximately 50% hemp and cotton, and 50% lyocell. This ratio provides the ideal combination of desired properties, but a different ratio may be deemed advantageous if either increased durability, strength, softness, transparency and I or adhesiveness to skin are desired. Such adhesiveness to skin may be desired for use in wetter or drier environmental conditions, or to counteract the effect of excessively dry or oily skin types.

In preferred embodiment, lyocell content is greatest, when present, but may vary between 0% w/w to 60% w/w. Hemp is present at between 20% w/w to 80% w/w and cotton between 20% w/w to 80% w/w.

Lyocell is a form of rayon that consists of cellulose fibre made from dissolving pulp (bleached wood pulp) using dry jet-wet spinning. Lyocell may, however, be replaced by another cellulose-based fibre with similar characteristics, such as ramie or viscose rayon.

Turning now to the facial sheet mask or fabric of Fig.2, slits 2 include slits to accommodate the user’s ears, thus creating ear loops 8. Ear loops 5 help tether face mask 1 to the user’s face and optimise contact with the user’s skin when wearing. With the use of other slits 2, contact with the user’s skin is further optimised.

In another aspect the invention is directed to a method of producing a skin care fabric comprising a substrate comprising non-woven hemp fibres and non-woven cotton fibres and I or non-woven lyocell fibres by applying a composition comprising CBD oil and a carrier solvent to the substrate by spraying or by rolling, and allowing the carrier solvent to evaporate, thereby obtaining a dry CBD-containing fabric for skin application.

Without the wish to be bound by any theory, the carrier solvent should fulfil the purpose of reducing the viscosity of the CBD oil or decreasing the quantity of CBD oil in a given volume (e.g., microscopic inspection). The solvent of the present invention may be an organic solvent. Suitable organic solvents include non-toxic, non-irritating compounds at low concentrations, such as C4-14 ethers and diethers, methyl and dimethyl ethers, polyols, glycols, alkoxylated glycols, C6-C16 glycol ethers, alkoxylated aromatic alcohols, aromatic alcohols, aliphatic linear or branched alcohols, alkoxylated aliphatic linear or branched alcohols, alkoxylated C1 -C5 alcohols, C8-C14 alkyl and cycloalkyl hydrocarbons and halohydrocarbons, and mixtures thereof. Preferably the organic solvents include alcohols, glycols, and glycol ethers, alternatively alcohols and glycols. The composition comprises from 80% to less than 100%, preferably from 90% to 99%, more preferably from 95% to 98%, or most preferably 95%, 97.5% or 98% by weight of the total composition of an organic solvent, preferably an alcohol, more preferably an ethanol, a polyalkyleneglycol, more preferably polypropyleneglycol, and mixtures thereof.

The function of allowing the carrier solvent to evaporate purges the carrier solvent off the coated substrate to ensure that as little residual solvent as possible is left remaining of the fabric. Thus, low boiling point solvent are preferred, and other solvents appropriate for such use will be known to the person skilled in the art. Use of a vacuum oven or dessicator and vacuum pump may assist in this process by increasing evaporation efficiency and effectiveness.

Rolling infusion methods are also known to the person skilled in the art, briefly, micro-gravure utilizes an engraved roller, such as an analux applicator roller, however the roller is significantly smaller than rollers used in other gravure methods. Typically, micro-gravure operates in a reverse kiss configuration without a backup roll. This method is well suited for low viscosity coatings at extremely low coat weights. It is also known by the person skilled in the art that other infusion methods may be used, such as dipping or spraying.

Turning now to the process of delivering CBD oil onto skin, Figs.3 and 4 indicate amounts of CBD present with coating of the facial sheet mask or fabric with 2% and 5% CBD oil before and after application to the skin. With 2% CBD oil coating, 90% of CBD is absorbed by the skin ((17.1 mg -1.7 mg) / 17.1 mg) and 77% of CBD is absorbed by the skin with 5% CBD oil infused on the substrate.

The hemp in the substrate allows for enhanced CBD and I or CBD oil delivery to the skin.

Figs.5 and 6 indicate amounts of CBD absorbed into the skin from CBD oil infused by micro-gravure at 24 and 32 rpm onto the substrate of the invention.

The substrate may be wetted, e.g., with water prior to application on to the skin. When the substrate is wet in water immediately before skin application, the active CBD is still intact on the substrate because CBD oil is insoluble in water and is not dissolved or diluted, thus, no CBD is lost. The CBD oil is only activated during transfer via skin contact. This is consistent with an oil to oil transfer mechanism. CBD active oil is pulled toward oils present on the skin from the substrate and enables skin penetration of the active ingredient. This testing confirmed the inventors’ unique mechanism of transdermal transfer versus the most popular passive transport for topical use products.

Examples

Example 1 :

CBD oil was dry coated on the nonwoven substrates using two different concentration levels. The initial trial was done by coating the substrate with 120 mg of CBD oil using a spray technique. Denatured alcohol was used as a carrier to expedite the drying process. After the substrate dried, it was confirmed that of 120 mg of the initial amount applied to the substrate, 54 mg remained per individual sample.

A subsequent trial was conducted, and the substrate was infused with 2.5% and 5% concentration of CBD oil using spray and dip techniques, and samples were sent to a third-party laboratory for CBD active analysis. The results came back showing the same content of CBD active was transferred into the skin, whether it was at 2.0 % or 5% percent concentration.

Example 2:

Substrates were infused with 5% concentration of CBD oil, using micro gravure technique. The substrate was treated at 80 degrees Celsius for 1 minute on the roll and 1 minute on dryer at line speeds of 16 rpms, 24 rpms and 32 rpm. Denatured alcohol was included with the CBD liquid Emulsion to accelerate the drying process during substrate coating. For each condition, one half of the sample was applied to the skin for 20 minutes and the other half was retained as a control for both 8620 and 8314 batches. 8620 CBD coated at 24 rpm showed more initial CBD active content of 6.5 mg I unit. After it was applied to the skin, the absorbed CBD into the skin was 6.3 mg / unit of CBD. 8314* with 0.5 mg / unit as the initial content, resulted in the CBD active absorbed into the skin being 0.49 mg I unit, which is 98% of initial CBD content.

HPLC Results:

□ 8620-24 RPM Control Fabric: Shows 6.5mg I unit.

□ 8620-24 RPM after applied to Skin: Shows 0.2mg I unit.

6.3 mg I unit ~ (96.9%) of CBD active was absorbed into the skin.

□ 8620-32 RPM Control Fabric: Shows 10.7mg I unit.

□ 8620-32 RPM after applied to Skin: Shows 0.3mg I unit.

10.4 mg I unit ~ (97%) of CBD active was absorbed into the skin.

Example 3:

Skin irritation study performed by taking measurements 30 minutes and 24 hours after the patch was applied and removed in a double-blind fashion. Both 8620 and 8314* were concluded to be non-irritating when used on the skin. Acute measurement index for 8620 was 0.00 and 0.10 for 8314*.

This invention finds support in that the CBD active ingredient, used in dry form, results in better active release to the skin and that the hemp substrate used in this invention was found to have better stabilizing effect on CBD active compound as well as on delivery rates compared to other substrates. Due to the unique transfer mechanism, it was found that the amount of CBD used in 0.5 mg/unit concentration yields different absorbance in terms of concentration. However, the content remains the same. It was discovered that using two different substrates or by changing the substrate base product for the control, the CBD active content delivered to the skin resulted in 96.7% and 97% for one control substrate, and yielded slightly higher for the CBD oil coated in hemp substrate. This is the interactive of CBD with hemp derivatives resulting in 98% as seen previously.