TOPICAL SKIN FORMULATIONS AND WOUND CARE PRODUCTS WITH INTEGRATED CBD DELIVERY MECHANISMS

Abstract

Cannabidiol (CBD) is one of the most abundant and physiologically active phytocannabinoids in Cannabis plants. The chemical has well-known mechanisms that have been the potential to treat and prevent numerous inflammatory, immunologic, anti-infectious, sun-damaged, age-related (wrinkling, drying, hair loss), and neurogenic-related (anti-pain, anti-itch) diseases as well as heal traumatized skin. The incorporation of CBD on or within topically applied formulations or within wound care dressings, biomaterials skin substitutes, or skin adhesives is a novel approach to alleviate, prevent and cure acute and chronic skin disease, and promote normal healing and recovery after injury.

Claims

1. An augmented topical medical system, the augmented topical medical system comprising: a topical wound care product configured to perform at least a first medical function ensuing from application of the topical product at a site of application; and a drug release mechanism in physical association with the topical product, the drug release mechanism being configured to deliver cannabidiol at the site of application; wherein the delivery of cannabidiol at the site of application is configured to augment the performance of the first medical function by the topical product.

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8. The augmented topical medical system of claim 2, wherein the topical wound care product comprises one or more of: honey, petrolatum, iodine, mineral oil, an occlusive bandage, a non-occlusive bandage, a synthetic gauze, a polyethylene gauze, a hydrocolloid dressing, a cyanoacrylate adhesive, a skin growth factor, a keratinocyte, collagen.

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Description

DETAILED DESCRIPTION

[0033] According to various embodiments of the present disclosure, augmented topical medical systems are are contemplated in which a topical product configured to perform at least a first medical function is augmented by the physical association therewith of a drug release mechanism configured to delivery cannabidiol (CBD) at the site of administration, thereby augmenting the performance of the first medical function. As described above, CBD delivery at the site of administration may be beneficial in treating or aiding in the treatment of a large number of conditions, through administration via a variety of biochemical pathways or combinations of biochemical pathways. Thus, it may be seen that the therapeutic application of CBD for augmentation of the performance of the first medical function of the topical product may be customized in a variety of ways particular to, among other things, the type of topical, the medical function of the topical product to be augmented, the condition or conditions being treated by the administration of the topical product, and the particular needs of the recipient of the topical product, which is primarily contemplated to be a human patient but may also be other organism which may benefit from administration of the presently contemplated augmented topical medical systems.

[0034] The following disclosure exemplifies a number of ways in which such contemplated augmented topical medical systems containing a drug release mechanism for the delivery of CBD at the site of administration may be customized, but it is to be understood that the ways in which such customization may occur is essentially infinite, and as such the foregoing discussed contemplated augmented topical medical systems are to be understood as exemplary and illustrative, and that the scope of the presently contemplated disclosure is not to be merely limited to the particular embodiments discussed herein, but rather as including the full scope of all varieties, combinations, and potential combinations of such customized augmented topical medical systems.

[0035] According to one exemplary embodiment of an augmented topical medical system having an topical product with a drug release mechanism being in physical association with the topical product and being configured to deliver cannabidiol at the site of application comprises an a cream, ointment, lotion, oil, emulsion, shampoo, or spray for application directly to the skin, with cannabidoil being directly emulsified or dissolved within the topical product. Following application of the topical product, the CBD may dissociate from or otherwise migrate from the applied topical product and to the site of application, which may occur via a number of processes, depending on the configuration of the topical product and the drug delivery mechanism. For example, it may be seen that in the case where the topical product is configured to be bioabsorbed by the skin, the CBD associated therewith may likewise be bioabsorbed along with or alongside the topical product. It may also be seen that in cases where the topical product is not configured to be bioabsorbed, but rather is to reside at the point of application and subsequently be removed from the point of application, the CBD may be configured remain with the patient and may be bioabsorbed.

[0036] It may also be seen that in other embodiments of an augmented topical medical system, the CBD may be confined within a distinct drug release mechanism that it's not itself embodied by formulation of the topical product, the CBD may be confined or otherwise configured to remain in place in physical association with the topical product via the drug release mechanism, with the CBD eluting or otherwise being administered from the drug release mechanism, such as in release or elution of CBD from a reservoir, depot, coating, a permeated material, or other method of confining CBD prior to delivery.

[0037] It may be seen that in the case that the drug release mechanism is a reservoir, depot, coating, permeated material, or other method of physical confining CBD prior to release or elution to the area of administration, the drug release mechanism may be any type of reservoir, depot, coating, permeated material known to be able to confine and subsequently allow release of small molecules such as CBD. As used in this disclosure, the term “reservoir” is to be understood as any method known or developed in the future that is capable of at least temporarily confining or containing small molecules such as with the CBD, and shall be inclusive of confinement techniques referred to under various names such as reservoirs, depots, permeated materials, permeated coatings, dissociative time release capsules, etc. In such reservoirs, the CBD may be contained by itself or in solution with or otherwise in association with other compounds, such as carrier oils or other carrier materials. Many drug reservoirs are known in the art which may serve to allow long-term sustained release of small molecules, or on-demand delivery. Some types of reservoirs may be configured deliver their supply passively over time, as in, for example, polymer formulations, liposomal formulations, micro-encapsulation formulations, ion exchange resins, hydrogels, or combinations of these. In other cases, reservoirs may be used in conjunction with microelectromechanical systems, such as microfluidic systems, in order to enable delivery from the reservoir in other ways (an actively driven reservoir). Other types of reservoirs may be configured to release CBD in response to external stimuli, such as heat, light, or the presence of other small molecules, such as, for example, exposure to blood, plasma, sweat, or any constituent components of skin, which may be seen to be useful in connection with a topical system. For example, it may be seen that a topical device such as a splint or bandage may contain associated therewith a reservoir of CBD which may be delivered following application of the splint or bandage. For example, in the case of the splint, the reservoir may be, for example, a coating on the surface of the splint meant to contact the patient's skin. To provide another example, in the case of the bandage, the reservoir may be a portion of the bandage or a pad or attachment to the bandage which may be at least partially permeated with CBD. These examples are to be understood as merely illustrative, as it may be seen that the combinations of possible systems is potentially limitless.

[0038] It may also be seen that reservoirs may be provided with an embedded fluid port or other mechanism to permit the reservoir to be refilled. Such reservoirs, rather than the drug delivery mechanism for delivery of CBD itself, may instead be for treatment of the first medical condition, with the drug delivery mechanism being associated with the reservoir. For example, a hemostatic dressing which contains a reservoir of a blood clotting agent may in addition contain a second reservoir (such as a coating) which may be configured to deliver CBD, or the reservoir of the blood clotting agent may also contain CBD. It may thus be seen that a first reservoir may itself deliver one medicament (the hemostatic agent, in the example of the hemostatic bandage) while CBD is also delivered via elution from an associated second reservoir (for example, a strip, liner, or second portion of the hemostatic bandage). These types of configurations may be useful where storage requirements for CBD and the medicament may differ in order to enhance efficacy or shelf life, such as where CBD is desired to be contained in solution with a carrier while the medicament is desired to remain a dry powdered material activated upon intermingling with a fluid, such as blood or plasma in the case of a hemostatic powder. In situations where it may not be necessary to deliver CBD and another agent from two reservoirs, the delivery action from a single reservoir may deliver both the medicament contained within the reservoir as well as CBD. For example, transdermal patches are known which may have separate drug layers, with some drugs contained within a liquid compartment or solution or suspension within the patch, while other drugs are contained within the adhesive layer of the patch. In this way, it may be seen that the delivery parameters of such as rate of delivery of the drugs contained in the different layers or compartments, or within the patch itself vs. within the adhesive component, may be controlled.

[0039] Further, it may also be seen that microfluidic devices in addition to an active or passive reservoir may be utilized as components within the present disclosures. For example, CBD may be used with an actively driven reservoir, a passive micropump, an electrostatic micropump, or an active micropump, or may otherwise be included within those components in a fashion configured to allow CBD to elute from the component following application at the site if application. Further, it may be seen that electrical components, which may or may not overlap with microfluidics devices may be utilized as well as either the topical device or to form the drug release mechanism.

[0040] It may be seen that in such cases where portions of or the entirety of a topical product of any type are configured to be bioabsorbed or to be otherwise internalized by the body, CBD may be bound up within the topical and be released at the site of administration as a consequence of such bioabsorption or internalization. It may also be seen that via modification of the way in which CBD is bound up or otherwise contained, the parameters of its release may be affected, as in a passive drug release mechanism such as a depot injection where CBD may be formulated as a component of a polymer formulation, a micro-encapsulation formulation, an ion-exchange resin formulation, a liposomal formulation, or combinations thereof.

[0041] According to other exemplary embodiments, the topical device may be other types of devices, such as a transdermal patches. Furthermore, it is contemplated that the CBD drug release mechanism may include aspects for active or passive control of delivery beyond mere time-release as a function of chemical properties of the formulation. For example, it may be seen that the drug release mechanism may be controlled by a microchip to release CBD as a function of a number of possible parameters, such as detecting a physiological condition or the receipt of a release command. For example, a system is contemplated in which a patient or doctor may, via transmission of a signal (electrical, radio, light, or otherwise), trigger the drug release mechanism to release CBD, or situations in which the system may detect (via, for example, a sensor) conditions such as elevated skin temperature or elevated heart rate, and release CBD upon detection of such conditions.

[0042] It may be seen that the delivery of CBD according to the presently described systems may aid in synergistically augmenting the performance of at least one of the medical functions of the topical product. For example, in the case of a topical product which serves an analgesic or pain-relieving function, the delivery of CBD at the site of application may synergistically aid in the analgesic function. Likewise, for a topical product for wound healing and/or prevention of scar formation, CBD delivery at the site of administration may synergistically aid in wound healing or scar formation. It is not critical that the CBD delivery at the site of the administration aids in the treatment of each and every one of the possible or actual medical functions of any given topical product, or even that CBD delivery aids in treatment of the primary medical function of a given topical product. Many topical products are recognized as delivering treatment in a number of aspects. For example, in the case of a hemostatic gauze applied for the primary purpose of stemming bleeding from a wound, the synergy flowing from the inclusion of the CBD drug delivery device may be the result of CBD's anti-anxiety effects, which may relieving anxiety in the patient caused from the wound. While application of the hemostatic gauze may be seen to directly relieve anxiety in the patient in the holistic sense (the patient is being relieved of anxiety caused by the presence of an untreated wound by receiving treatment for their wound), anxiety relief can almost never be said to the “primary” medical purpose of application of a hemostatic gauze to a wound. In this sense, it may be seen that the inclusion of the CBD drug release mechanism provides substantial synergy in treatment of a first medical function (anxiety relief) that is also performed by the application of the topical product, but that the first medical function is not necessarily the primary medical function for which the topical product has been applied. Rather, the first medical function can be a secondary medical effect of the topical product for which synergy is achieved via administration of CBD.

[0043] A similar paradigm may be seen in many other situations where the a patient may experience symptoms such as anxiety due to, for example, a condition resulting in an undesired physical appearance, such as in cases of rashes, hair loss, dandruff, sunburn, etc. In each of these cases and in others, even if administration of CBD may not itself substantially contribute to the direct mitigation of these conditions, the co-administration of CBD may serve to directly reduce anxiety, which will coordinate and synergize with the anxiety relief resulting from mitigation of those conditions. Similarly, other non-anxiety conditions relieved by CBD directly may be seen to be likewise not the “primary” purpose of the administration of the topical device, but may be a secondary or tertiary purpose or result, while still being a “first medical function” of the topical product augmented by delivery of CBD.

[0044] The above description is given by way of example, and not limitation. Given the above disclosure, one skilled in the art could devise variations that are within the scope and spirit of the invention disclosed herein, including various ways of physically associating the CBD drug release mechanism with the topical product, or of configuring the CBD drug release mechanism to release CBD. Further, the various features of the embodiments disclosed herein can be used alone, or in varying combinations with each other and are not intended to be limited to the specific combination described herein. Thus, the scope of the claims is not to be limited by the illustrated embodiments.