TRANSDERMAL PATCH PROVIDING IMPROVED PERMEABILITY AND COMPOSITION

Abstract

A transdermal patch contains a water-based solution containing electrolytes, vitamins, and at least one permeation enhancer. The water-based solution also acts as an adhesive matrix which binds the patch together. The solution is transferred to the body via an embossed release liner. In use, the permeation of electrolytes into the bloodstream improves the body's ability to manage hydration. The permeation enhancer increases the porosity of the skin in contact with the transdermal patch to make possible the permeation of the solution into the body. Critical proportions of solvent, solutes, and permeation enhancers are disclosed which have been found to make permeation of otherwise non-absorbable ingredients possible.

Claims

1. A transdermal patch, comprising: a gelatinous solution including an active ingredient, the active ingredient including a permeation enhancer; an outer layer configured to be resistant to the gelatinous solution; and an inner layer configured to control release of the gelatinous solution.

2. The transdermal patch of claim 1, wherein the inner layer and the gelatinous solution have an area smaller than an area of the outer layer.

3. The transdermal patch of claim 1, wherein the inner and outer layers are an inner and outer surface of a single membrane.

4. The transdermal patch of claim 1, wherein the inner and outer layers form a single piece in a customizable shape.

5. The transdermal patch of claim 1, wherein the outer layer is configured to provide a layer for printing graphics.

6. The transdermal patch of claim 5, wherein graphic is a logo or advertisement.

7. The transdermal patch of claim 1, wherein at least one of the inner and outer layers comprises an adhesive configured to bind the inner layer to the outer layer.

8. The transdermal patch of claim 1, wherein the gelatinous solution contains at least one of: water, electrolyte, vitamin, nutrient, analgesic, medication, cosmetic, anti-inflammatory, amino acid, and glycerin.

9. The transdermal patch of claim 1, wherein the gelatinous solution contains an adhesive agent.

10. The transdermal patch of claim 1, wherein the active ingredient comprises menthol.

11. The transdermal patch of claim 1, wherein the outer layer has a water-drop shape.

12. A method of manufacturing a transdermal patch, comprising: providing an inner layer configured to directly contact skin and control release of a gelatinous solution over time; creating a homologous solution of water, a permeation enhancer, and at least one solute; reducing the water of the homologous solution to be between ten percent and thirty percent to create the gelatinous solution; and binding an outer layer to the inner layer.

13. The method of claim 12, further comprising: providing the outer layer configured to be resistant to the gelatinous solution.

14. The method of claim 12, further comprising: providing the outer layer configured to provide a layer for printing graphics.

15. The method of claim 12, further comprising: providing the inner and outer layers into a single piece in a customizable shape.

16. The method of claim 12, further comprising: providing an adhesive configured to bind the inner layer to the outer layer.

17. The method of claim 12, wherein the at least one solute contains at least one of: electrolyte, vitamin, nutrient, analgesic, medication, cosmetic, anti-inflammatory, amino acid, and glycerin.

18. The method of claim 12, wherein the permeation enhancer comprises menthol.

19. The method of claim 12, wherein the outer layer is provided in a water-drop shape.

20. A transdermal patch, comprising: a gelatinous solution including an active ingredient, the active ingredient including a permeation enhancer; an outer layer configured to be resistant to the gelatinous solution; an inner layer configured to control release of the gelatinous solution; an adhesive configured to bind the inner layer to the outer layer; and wherein the outer layer is configured to provide a layer for printing graphics.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The figures which accompany the written portion of this specification illustrate embodiments and methods of use for the present disclosure, a transdermal patch having improved permeability and composition, constructed and operative according to the teachings of the present disclosure.

[0015] FIG. 1 is an exploded view of the transdermal patch illustrating the laminated construction of the patch according to an embodiment of the disclosure.

[0016] FIG. 2 is a perspective view of the transdermal patch of FIG. 1 in an in-use condition when applied to a user's forearm, according to an embodiment of the present disclosure.

[0017] FIG. 3 is a perspective view of the transdermal patch of FIG. 1 in an in-use condition when applied to a user's shoulder, according to an embodiment of the present disclosure.

[0018] FIG. 4 is a perspective view of the transdermal patch of FIG. 1 when applied to the floor of the mouth as a sublingual patch, according to an embodiment of the present disclosure.

[0019] The various embodiments of the present invention will hereinafter be described in conjunction with the appended drawings, wherein like designations denote like elements.

DETAILED DESCRIPTION

[0020] As discussed above, embodiments of the present disclosure relate to a medical device and more particularly to a transdermal patch having improved permeability and composition as used to improve the hydration of the body by conveying electrolytes to the body via transdermal permeation.

[0021] The present transdermal patch presents a new method of hydrating the body by enacting permeation of critical electrolytes and vitamins. Such a product is lacking in the prior art; so much so that NSF International (i.e. National Sanitation Foundation) currently lacks a testing procedure for such a product.

[0022] The transdermal patch implements a unique structure and formulation to provide electrolytes and nutrients to maintain hydration and prevent dehydration of the body. Dehydration is a widespread health factor that affects most people. Dehydration is also linked to stress. These undesirable factors may be eliminated by proper hydration through use of the patch. Use of the transdermal patch may further act to improve overall mental and physical performance by stabilizing hydration levels over time. As such, use of the patch may benefit the general populous, not only those working as first responders, military personnel, surgical staff, E-Sport gamers, and others engaged in demanding physical activity for extended time periods where proper hydration is made difficult by obvious time and focus demands of the job, but almost anyone engaged in physical activity. Other users who may benefit from this hydration aid include truck drivers, aircraft pilots, construction trades, factory workers, teachers, and office staff. In use, the patch acts to stabilize hydration levels between taking liquids. For individuals who must bear equipment during work, the weight of liquids carried can be reduced. Also, for those training or performing physically for prolonged periods, any number of physical performance related activities can be enhanced with proper hydration. Additionally, use of the transdermal patch to improve hydration can reduce waste caused by the disposal of excessive water containers (i.e. plastic bottles, aluminum cans, etc.) when users consume excessive water due to poor internal hydration management.

[0023] The delivery of electrolytes and nutrients using a patch offers advantages over traditional delivery methods. The patch reduces the amount of time spent drinking liquids and stopping to urinate. The delivery of electrolytes and nutrients does not require digestion and the resultant loss of nutrients and energy expended in the digestion process and the nutrients are released over a period of time. The delivery of hydration by transdermal patch also minimizes the psychological effect of feeling “heavy” or “full” as occurs drinking fluids traditionally. The patch consists of a transdermal patch with adhesive for applying on the skin, permeability enhancers and the nutrients. The outer surface of the patch provides area for branding, design or promotion.

[0024] Referring now more specifically to the drawings by numerals of reference, there is shown in FIGS. 1-4, various views of a transdermal patch 100.

[0025] FIG. 1 shows a transdermal patch during an ‘in-use’ condition, according to an embodiment of the present disclosure. Here, the transdermal patch may be beneficial for use by a user to improve the hydration of the body by delivering electrolytes to the body via transdermal permeation. As illustrated, the transdermal patch 100 may include backer 110, embossed release liner 120, and adhesive matrix 130. Adhesive matrix 130 binds backer 110 to embossed release liner 120. In use, embossed release liner 120 is placed in direct contact with the skin of the user, and adhesive matrix 130, as it begins to absorb through embossed release liner 120 into the skin, helps adhere embossed release liner 120 to the skin. Adhesive matrix 130 may contain water (as a solvent), electrolytes, vitamins, an adhesive agent, and a permeation enhancer. The permeation enhancer may increase the permeability of adhesive matrix 130 into the skin. The permeation enhancer may include menthol. In some embodiments, menthol may be supplemented by additional permeation enhancers, such as dimethyl sulfoxide (DMSO). The permeation enhancer may comprise peppermint oil. Adhesive agent 130 may include one or more of sodium polyacrylate, polyacrylic acid, carboxymethyl cellulose, and povidone. Polysorbate 80 may be contained within adhesive matrix 130, acting as a surfactant and emulsifier. In an exemplary embodiment, adhesive matrix 130 may contain between ten and thirty percent water. It has been found that this range of water content in the final product is sufficient to enable retention of the necessary solutes, but also low enough to maintain the structural integrity of the adhesive matrix 130 and bind the embossed release liner 120 to backer 110. During manufacture, the initial composition may contain as much as ninety percent water to absorb the solutes, before being dried and compressed into the final product that constitutes adhesive matrix 130. Since an initial composition of ten to thirty percent water would not be sufficient to absorb all solutes within the water, the drying process is necessary to initially create a homogenous solution before water content is decreased and the resulting adhesive matrix 130 is formed. As illustrated, transdermal patch 100 may have a perimeter in the form of a water-drop shape.

[0026] The active ingredient (i.e. active ingredient under FDA classification) of transdermal patch 100 is menthol. Menthol is the primary ingredient as an external analgesic which also increases permeability of the formula contained within adhesive matrix 130. Of the final weight of the patch, menthol may make up 0.01 to 16 percent. An exemplary proportion may be approximately 0.011 percent by weight. An ideal mass of menthol may be between 30 and 35 milligrams in an exemplary embodiment. The total mass of the final patch may range from 0.05 to 0.15 ounces. In use, transdermal patch 100 may convey contents to the bloodstream for approximately eight hours. The estimated shelf life of the product is two years.

[0027] In an exemplary embodiment, adhesive matrix 130 may further include an anti-inflammatory. While dimethyl sulfoxide and menthol may in and of themselves act as anti-inflammatories, additional ingredients acting as dedicated anti-inflammatories may be added. For the purposes of this specification, “anti-inflammatory” is used to mean any medication, compound, or ingredient recognized by the FDA as useful for anti-inflammatory purposes. Yet further, adhesive matrix 130 may include amino acids. Leucine is an exemplary amino acid which may be incorporated into the formula. Leucine may function in the patch to synthesize sterols, and may also act to regulate blood pressure, energy levels, and hormone secretion. Further, inclusion of leucine in the formula has been found experimentally to reduce appetite levels. While substitution or addition of other amino acids besides leucine may be suitable, it has been found that the use of leucine has resulted in superior results. Adhesive matrix 130 may further comprises glycerin. Glycerin may act as a plasticizer and humectant to preserve the flexibility and formulaic integrity of adhesive matrix 130, and may also provide additional benefits of relieving skin irritation and reducing interference with skin oils when transdermal patch 100 is placed in contact with skin.

[0028] Adhesive matrix 130 may also include an adhesive agent and one or more electrolytes. The adhesive agents may include one or more of sodium polyacrylate; polyacrylic acid; carboxymethylcellulose; and povidone. These are exemplary adhesive agents; others may be substituted or supplemented. Preferred electrolytes may include one or more of the following: potassium (as potassium gluconate); calcium (as calcium lactate); magnesium (as magnesium chloride); chloride (as magnesium chloride or sodium chloride); phosphorus (as monosodium phosphate monobasic); and sodium (via the sodium chloride or monosodium monobasic). Yet further, the adhesive matrix may further include acrylases copolymer, as a solvent-based adhesive.

[0029] Alternative embodiments may include a child-suitable version having lower doses of active and non-active ingredients. Some embodiments may implement waterproofed elements, versions which include higher levels of amino acids, trademarked versions with logos, etc.

[0030] FIG. 2 shows the transdermal patch of FIG. 1, according to an embodiment of the present disclosure. As shown, the transdermal patch 100 may be applied directly to the skin of user 40. Here, transdermal patch 100 is applied to the forearm.

[0031] FIG. 3 shows the transdermal patch of FIG. 1, according to an embodiment of the present disclosure. As shown, the transdermal patch 100 may be applied directly to the skin of user 40. Here, transdermal patch 100 is applied to the shoulder. The shoulder is envisioned as an optimal location for applying transdermal patch 100, as the shoulder is broad and flat enough to easily accommodate larger patches when desired by user 40, and usually lacks excessive body hair which may interfere with the permeation characteristics of transdermal patch 100.

[0032] FIG. 4 is a perspective view of the transdermal patch of FIG. 1 when applied to the floor of the mouth as a sublingual patch, according to an embodiment of the present disclosure. As illustrated, transdermal patch 100 may be applied directly to the floor of the mouth of user 40. In some applications, it may be envisioned that transdermal patch 100 may be alternatively applied to the gum, the inside of the cheek, or other locations as preferred by user 40. Like the skin, sublingual mucosa is an advantageous means of delivery of medical ingredients to the bloodstream, and provides similar advantages over traditional methods of ingredient intake (i.e. oral). The same disclosed transdermal patch taught for transdermal permeation may be applied for sublingual use. Some modifications may be envisioned for applications when sublingual use is desired. For example, patches intended for sublingual use may be smaller, and may be constructed of saliva-soluble components in order to dissolve in the mouth, reducing the need to remove the patch after use. Nonetheless, it is envisioned that the same elements and novelties taught herein may make the transdermal patch useful and desirable for sublingual applications as well.

[0033] The embodiments of the invention described herein are exemplary and numerous modifications, variations and rearrangements can be readily envisioned to achieve substantially equivalent results, all of which are intended to be embraced within the spirit and scope of the invention. Further, the purpose of the foregoing abstract is to enable the U.S. Patent and Trademark Office and the public generally, and especially the scientist, engineers and practitioners in the art who are not familiar with patent or legal terms or phraseology, to determine quickly from a cursory inspection the nature and essence of the technical disclosure of the application.