WEARABLE LIPOSOMAL CANNABIDIOL TRANSDERMAL PATCH

Abstract

A wearable patch for the transdermal delivery of cannabidiol (CBD). Cannabidiol is delivered in in the form of a CBD mixture which comprises CBD oil loaded into liposomes. The CBD mixture can be delivered without the use of dermal enhancers. A transdermal patch is preloaded with the CBD mixture and placed upon the skin to penetrate the dermis layer, where the CBD mixture will diffuse into the interstitial body fluid. The patch comprises microneedles and the CBD mixture which is preloaded into or on the needles depending on the type of microneedles used.

Claims

1. A method of using a transdermal patch to treat a patient with cannabidiol (CBD) comprising the steps of: loading the patch with a CBD mixture, wherein the CBD mixture comprises CBD oil and liposomes; applying the patch to the skin; and allowing the CBD mixture to penetrate the skin.

2. The method of using a transdermal patch to treat a patient with CBD of claim 1, further comprising the steps of: removing a release liner from the patch before applying the patch to the skin.

3. The method of using a transdermal patch to treat a patient with CBD of claim 1, wherein the step of allowing the CBD mixture to penetrate the skin does not utilize dermal penetration enhancers.

4. The method of using a transdermal patch to treat a patient with CBD of claim 1, wherein the step of allowing the CBD mixture to penetrate the skin comprises the step of releasing the CBD mixture into the interstitial body fluid.

5. The method of using a transdermal patch to treat a patient with CBD of claim 1, wherein the step of allowing the CBD mixture to penetrate the skin releases CBD mixture at a rate greater than 0.2 μl of CBD mixture per hour.

6. The method of using a transdermal patch to treat a patient with CBD of claim 1, wherein the step of applying the patch to the skin comprises the step of using an at least one microneedle on the patch to puncture the stratum corneum, the viable epidermis, and the dermis, so that when the patch is positioned upon the skin, a tip of the at least one microneedle is positioned within the dermis.

7. The method of using a transdermal patch to treat a patient with CBD of claim 1, wherein the step of allowing the CBD mixture to penetrate the skin is pressure driven.

8. A microneedle device, comprising: a membrane having an adhesive thereon; a microneedle substrate adhered to the membrane using the adhesive; a release layer positioned upon the microneedle device to protect the microneedle substrate; wherein the microneedle substrate has a plurality of microneedles coupled thereto; and a CBD mixture comprising CBD oil within liposomes is loaded onto or into the microneedle device.

9. The microneedle device of claim 8, wherein the microneedles are solid and coated with the CBD mixture

10. The microneedle device of claim 8, wherein the microneedles are hollow.

11. The microneedle device of claim 10, wherein the microneedles are connected to a pressure mechanism configured to force CBD mixture out of the needles.

12. The microneedle device of claim 8, wherein the plurality of microneedles comprises microneedle tips configured to dissolve in interstitial body fluid.

13. The microneedle device of claim 8, forming part of a system, the system further comprising a drug container having wells defined therein, the wells configured to hold CBD mixture.

14. The device of claim 8, wherein the plurality of microneedles is at least partially coated with the CBD mixture.

15. A method of using a microneedle device for delivery of CBD, comprising the steps of: placing a microneedle device of the present disclosure upon the skin of a wearer so to cause at least part of a plurality of microneedles of the microneedle device to enter a dermis of the skin; and removing the microneedle device from the skin after a CBD mixture enters the interstitial body fluid from the plurality of microneedles, the CBD mixture comprising CBD oil mixed with liposomes.

16. The method of using a microneedle device for delivery of CBD as in claim 15 further comprising the step of removing the microneedle device from a drug container, wherein the drug container comprises wells filled with CBD mixture.

17. The method of using a microneedle device for delivery of CBD as in claim 15, further comprising the step of introducing the CBD mixture into the interstitial body fluid via diffusion from the plurality of microneedles.

18. The method of using a microneedle device for delivery of CBD as in claim 15, wherein the CBD mixture enters the interstitial body fluid from the plurality of microneedles without the use of dermal penetrant enhancers.

19. The method of using a microneedle device for delivery of CBD as in claim 15, further comprising the step of introducing the CBD mixture into the interstitial body fluid at a rate of greater than 0.2 μl per hour.

20. The method of using a microneedle device for delivery of CBD as in claim 15, wherein the CBD mixture comprises liposomes carrying CBD oil; and the method further comprises the step of allowing the liposome carrying the CBD oil to fuse with bilayers within the patient to deliver the CBD oil.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0055] The disclosed embodiments and other features, advantages, and disclosures contained herein, and the matter of attaining them, will become apparent and the present disclosure will be better understood by reference to the following description of various exemplary embodiments of the present disclosure taken in conjunction with the accompanying drawings, wherein:

[0056] FIG. 1 shows a delivery device used to deliver CBD mixture, according to an exemplary embodiment of the present disclosure;

[0057] FIG. 2 shows a microneedle device having a plurality of hollow needles, used to deliver CBD mixture, according to an exemplary embodiment of the present disclosure;

[0058] FIG. 3 shows a microneedle device applied to the skin, according to an exemplary embodiment of the present disclosure;

[0059] FIG. 4 microneedle device and release liner according to an exemplary embodiment of the present disclosure; and

[0060] FIG. 5 shows a Drug container according to an exemplary embodiment of the present disclosure.

[0061] As such, an overview of the features, functions and/or configurations of the components depicted in the various figures will now be presented. It should be appreciated that not all of the features of the components of the figures are necessarily described and some of these non discussed features (as well as discussed features) are inherent from the figures themselves. Other non-discussed features may be inherent in component geometry and/or configuration.

[0062] Furthermore, wherever feasible and convenient, like reference numerals are used in the figures and the description to refer to the same or like parts or steps. The figures are in a simplified form and not to precise scale.

DETAILED DESCRIPTION

[0063] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of this disclosure is thereby intended.

[0064] In an embodiment of the invention a transdermal patch 100 as shown in FIG. 1 is utilized to dispense drugs. In this embodiment, the drug dispensed is CBD oil, specifically a CBD mixture 116 comprising CBD oil mixed with liposomes. The patch 100 provides for the release of a sufficient amount of drug at reasonable residence time such that the desired symptom effectively treated.

[0065] An exemplary patch/microneedle device 100 (also referred to herein as a transdermal patch) of the present disclosure is shown in FIG. 1. As shown therein, patch 100 comprises a membrane 102, and an adhesive layer 106 present upon membrane 102 (an adhesive being applied to membrane 102), whereby adhesive 106 facilitates adhesion of microneedle substrate 110 to membrane 102 and adhesion of patch 100 to a wearer's skin 402 shown in FIG. 3.

[0066] An exemplary adhesive layer 106 of the present disclosure can comprise any number of suitable adhesives, such as bio adhesives (Duro-TAK 387-2510/87-2510 from Henkel, for example) or other materials which is/are mixed with sodium carboxymethyl cellulose (NaCMC) or other materials, resulting in a total adhesive layer 106 thickness of 100 to 150 μm, or thicker or thinner.

[0067] Membranes 102 of the present disclosure essentially exist as a backing film on an opposite side of adhesive layer 106 used to adhere to the skin of a wearer. The total thickness of the membrane 102 can be 200 to 300 μm, or thicker or thinner.

[0068] The patch 100 comprises an adhesive layer 106 on top of a membrane 102 such that adhesive 106 is present between membrane 102 and a microneedle substrate 110 to adhere microneedle substrate 110 to membrane 102. Preferably, the adhesive layer 106 covers the entire membrane 102. Microneedles 112 can be arranged upon microneedle substrate 110 in microneedle groups 114 as desired, whereby each microneedle group 114 comprises a plurality of microneedles 112. Preferably, the microneedle substrate 110 will have a smaller area than the adhesive layer such that a border 120 is formed around the microneedle substrate that comprises only the adhesive layer 106 and the membrane 102.

[0069] In an embodiment of a system for dosing CBD mixture, the system also comprises a drug container. Said groups 114 of microneedles 112 can be arranged about microneedle substrate 110 so to correspond with locations of wells 1202 defined within a corresponding drug container 1200, whereby CBD mixture 116 is present within said wells 1202 of drug container 1200, as in FIG. 5. The microneedles can take up CBD mixture from the wells of the drug container.

[0070] In an embodiment, the drug delivered is CBD oil or more specifically, CBD oil mixed with liposome creating a CBD mixture 116.

[0071] The microneedles may be of any type, solid, hollow or polymeric. As represented in FIG. 1, the drug, CBD mixture 116, is preloaded onto or into the microneedles. Solid MNs puncture skin thereby introducing the pre-coated CBD mixture 116 into the body. As shown in FIG. 2, hollow bore microneedles allow diffusion or pressure-driven flow of drugs through a central lumen 118. They may be attached to a pressure mechanism 122 allowing them to force out CBD mixture, as in FIG. 3. The polymeric MNs are either of dissolved type or hydrogel-forming. The dissolved MNs release their CBD mixture payload as they dissolve in the skin layers and are generally a biocompatible polymer. The skin insertion of the array is followed by dissolution of the MNs tips upon contact with skin interstitial fluid. The CBD mixture is then released over time. The hydrogelforming MNs releases CBD mixture to interstitial body fluids (IBF) through diffusion.

[0072] To protect and maintain sterility of microneedle device 100, a release liner 108 can be used to cover the side of microneedle device 100 having the plurality of microneedles, such as shown in FIG. 4. When release layer is removed, a plurality of microneedles 112 is revealed, such as shown in FIG. 1.

[0073] Like the other embodiments, the patch may also comprise a release liner 108. A release liner may cover the patch during storage and prior to use, so to avoid potential contamination. Release liner 108 is removed before use to expose microneedles. Release liners 108 can have a thickness between 50 to 70 μm, or larger or smaller.

[0074] Microneedle devices 100 of the present disclosure ideally include the fewest number of microneedles 112 necessary in order to deliver a dosage of CBD mixture effective to treat pain of the wearer of microneedle device 100. For example, and as shown in FIG. 1, each group 114 of microneedles 112 contains three microneedles 112, and with six groups 114 (an exemplary number of groups), that would be eighteen microneedles 112 in total. Other microneedle devices 100 may include any desired number of groups 114 of microneedles 112, with any desired number of microneedles 112 per group 114, such as a) six groups 114 of three microneedles 112 each (so eighteen total microneedles 112), b) six groups 114 of six microneedles 112 each (so thirty-six total microneedles 112), c) four groups 114 of four microneedles 112 each (so sixteen total microneedles 112), d) six groups 114 of twelve microneedles 112 each (so seventy-two total microneedles 112), etc.

[0075] In some embodiments of microneedle devices 100 of the present disclosure, microneedle devices 100 comprises a microneedle substrate 110 which is formed as part of an overall unit with microneedles 112, or which is coupled to microneedles 112 to help complete an embodiment of the microneedle device 100 that can withstand the desired uses as referenced herein. Substrate 1106, as referenced herein, can be relatively flexible so to accommodate the irregular topography of the surface of the skin 402 due to macroscopic curvature of different body regions to prevent breakage of microneedles 112 during insertion. As shown in FIG. 1, microneedle substrate 110 can be adhered to membrane 102 on one side and microneedle substrate 110 on another, using adhesive 106, as may be desired.

[0076] FIG. 3 shows several layers of skin 402, including the stratum corneum 1300, viable epidermis 1302, and dermis 1304 containing interstitial body layer (IBL), from the outside moving inward. When microneedle device 100 is positioned upon the skin 402 (first the stratum corneum 1300), microneedle device 100 can then be pressed in the direction of skin 402 to cause microneedles 112 to puncture the stratum corneum 1300, the viable epidermis 1302, and the dermis 1304, in that order, so that when completely positioned upon the skin 402, microneedle device 100 contacts the skin 402, and the relative tips of microneedles 112 are positioned within the dermis 1304. This allows the CBD mixture to be introduced into the interstitial body layer.

Method of Use for Transdermal CBD Patch

[0077] An exemplary embodiment of using a CBD patch comprises the steps of: 1) preloading the device with CBD mixture; 2) removing a release liner, 3) applying the patch to the skin; and 4) allowing the CBD mixture to penetrate the skin to the dermis layer. The patch may be removed after use.

[0078] The step of preloading the device with CBD mixture, can comprise the step of coating CBD mixture on the needles, or loading CBD mixture into the needles. This step may be performed using the drug container having wells filled with CBD mixture. The microneedles will align with the wells and the two elements can be mated to coat the needles with the CBD mixture.

[0079] The step of applying the patch to the skin comprises the step of piercing the skin with the microneedles attached to the patch. The patch is secured in place with the adhesive. Preferably, the tips of the microneedles are located in the dermis layer of the skin after piercing.

[0080] The step of allowing the CBD mixture to penetrate the skin to the dermis layer may comprise the step of leaving the patch on the skin of the wearer for a reasonable residence time.

[0081] The step of allowing the CBD mixture to penetrate the dermis layer, may comprise the step of allowing the CBD mixture to diffuse into the dermis or/and through dissolving the microneedles.

[0082] Ultimately, the type of microneedles used will determine the exact mechanism of drug introduction. For example, where the microneedles are solid, the CBD mixture may directly enter the interstitial body fluid. Hollow needles may use a pressure mechanism to drive the CBD mixture from a reservoir out of the needles and into the interstitial body fluid. In some embodiments, diffusion may allow CBD mixture within the path to flow out of the hollow needles. In another embodiment, the microneedles may dissolve releasing the CBD mixture. Alternatively, the microneedles may swell, and CBD mixture may flow from the microneedles into the interstitial body fluid.

[0083] The patch can be used to treat pain, chronic or acute, inflammation, or any other malady treatable with CBD.

[0084] While various embodiments of devices for dosing CBD transdermally and methods for the same have been described in considerable detail herein, the embodiments are merely offered as non-limiting examples of the disclosure described herein. It will therefore be understood that various changes and modifications may be made, and equivalents may be substituted for elements thereof, without departing from the scope of the present disclosure. The present disclosure is not intended to be exhaustive or limiting with respect to the content thereof.

[0085] Further, in describing representative embodiments, the present disclosure may have presented a method and/or a process as a particular sequence of steps. However, to the extent that the method or process does not rely on the particular order of steps set forth therein, the method or process should not be limited to the particular sequence of steps described, as other sequences of steps may be possible. Therefore, the particular order of the steps disclosed herein should not be construed as limitations of the present disclosure. In addition, disclosure directed to a method and/or process should not be limited to the performance of their steps in the order written. Such sequences may be varied and still remain within the scope of the present disclosure.

REFERENCES

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