Patent Application
20210000754
The following includes information that may be useful in understanding the present disclosure. It is not an admission that any of the information provided herein is prior art nor material to the presently described or claimed inventions, nor that any publication or document that is specifically or implicitly referenced is prior art.
The present invention relates generally to the field of medical devices of existing art and more specifically relates to a transdermal hydration patch.
Dehydration is a global health threat. Dehydration can reduce physical and mental performance, cause lack of focus, headaches, constipation, lethargy, and in extreme cases, death. While dehydration can be caused simply by lack of water intake, it can also be caused or exacerbated by poor water management when internal levels of vitamins and minerals prevent the body from properly managing water usage. Some commentators believe that up to 245 million Americans may suffer from dehydration.
It is known in the art to absorb ingredients into the human body by applying patches to the skin in order to transfer the ingredients directly to the bloodstream through skin permeation. Such devices are known in the art as transdermal patches. Advantages of such methods of intaking ingredients include ease of use, disposability of the carrying medium, and the avoidance of digestive side effects (i.e. nausea). It has been known in the art to use transdermal patches to intake substances such as nicotine and amino acids. While existing transdermal patches have been of use in certain applications (i.e. nicotine patches for reducing dependence on smoking, birth control patches, and Vitamin B patches), there are many potential health applications to which transdermal patches have not yet been applied. One such potential application is hydration.
A primary limitation of absorbing substances transdermally using such patches is that the human skin is relatively impermeable to many substances that would be desirable for such an application. For example, the skin may readily absorb lipids, but not water or electrolytes. This property of skin makes absorbing water-soluble substances through the skin impractical. While many non-proven health products on the market claim to allow permeation of vitamins, minerals, and other substances through the skin, it is perceived that the efficacy of these products are suboptimal lacking a novel permeation solution. A suitable solution is desired.
In the relevant art, U.S. Pat. No. 5,683,712 to Paolo Cavazza relates to a transdermal patch for the administration of homeopathic drugs. The described transdermal patch includes a medical device for the administration of active ingredients or drugs at very low doses, and particularly of homeopathic drugs, comprising a transdermal patch with a support membrane, a layer of porous adhesive, a microporous membrane and a gel containing the homeopathic drug to be administered. Cavazza attempts to overcome problems associated with alternative modes of drug administration (i.e. oral). Nonetheless, Cavazza's solution maintains the same aforementioned problems, and does not provide a suitable solution for transdermally conveying difficult-to-absorb solutes.
In view of the foregoing disadvantages inherent in the known transdermal patch art, the present disclosure provides a novel transdermal patch having improved permeability and a hydrating composition, and a combination over-the-counter external analgesic drug and cosmetic.
The disclosed transdermal patch having improved permeability and composition provides a novel solution to the transdermal permeation problem, being able to effectively enact permeation of vitamins, and electrolytes through the skin and enable the body to maintain improved hydration levels.
A primary objective of the disclosed transdermal patch is to enact effective hydration of a user by supplying the body with electrolytes and vitamins enabling the body to better self-regulate hydration. Another objective is to provide a patch with the disclosed applications which is also an over-the-counter medication. Yet another application is to provide a patch which is able to contain a “heavier” or denser composition in the patch and still be able to convey the contents to the body through the skin of the user.
The transdermal patch contains a water-based solution containing electrolytes, vitamins, and at least one permeation enhancer. The water-based solution further acts as a structural element of the patch, being an adhesive matrix which binds the patch together. In use, the solution is transferred to the body via an embossed release liner placed in contact with the skin. 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 passage 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.
In one embodiment of the transdermal patch, the embossed release liner and the adhesive matrix may be of a smaller area coverage than the liner. The excess liner space that does not overlap with the release liner may circumscribe the release liner, and may be coated with a solvent-based adhesive which adheres to the skin around the release liner to adhere the transdermal patch to the skin of the user. The liner may include a water-proof liner layer, preferably composed of a polymer. The polymer may be flexible and suitable for printing graphics on the liner. The adhesive may be an occlusive compound activatable by body heat and skin moisture. The adhesive may not melt or disperse when wetted. In this format, the adhesive matrix may be divided between forty-percent of active formula and sixty-percent adhesive.
For purposes of summarizing the invention, certain aspects, advantages, and novel features of the invention have been described herein. It is to be understood that not necessarily all such advantages may be achieved in accordance with any one particular embodiment of the invention. Thus, the invention may be embodied or carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein. The features of the invention which are believed to be novel are particularly pointed out and distinctly claimed in the concluding portion of the specification. These and other features, aspects, and advantages of the present invention will become better understood with reference to the following drawings and detailed description.
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.
The various embodiments of the present invention will hereinafter be described in conjunction with the appended drawings, wherein like designations denote like elements.
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.
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.
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.
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.
Referring now more specifically to the drawings by numerals of reference, there is shown in
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.
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.
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 phgosphate monobasic); and sodium (via the sodium chloride or monosodium monobasic). Yet further, the adhesive matrix may further i8nclude acrylases copolymer, as a solvent-based adhesive.
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.
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.
The present application is related to and claims priority to U.S. Provisional Patent Application No. 62/869,944 filed Jul. 2, 2019, which is incorporated by reference herein in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 62869944 | Jul 2019 | US |
