CA3053353A1 - Phonophoretic cannabidiol composition and transdermal delivery system - Google Patents

Phonophoretic cannabidiol composition and transdermal delivery system Download PDF

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CA3053353A1
CA3053353A1 CA3053353A CA3053353A CA3053353A1 CA 3053353 A1 CA3053353 A1 CA 3053353A1 CA 3053353 A CA3053353 A CA 3053353A CA 3053353 A CA3053353 A CA 3053353A CA 3053353 A1 CA3053353 A1 CA 3053353A1
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Shamaya Chah
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Essential Green Goodness LLC
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0002Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0009Galenical forms characterised by the drug release technique; Application systems commanded by energy involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/045Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/05Phenols
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/095Sulfur, selenium, or tellurium compounds, e.g. thiols
    • A61K31/10Sulfides; Sulfoxides; Sulfones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7008Compounds having an amino group directly attached to a carbon atom of the saccharide radical, e.g. D-galactosamine, ranimustine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/737Sulfated polysaccharides, e.g. chondroitin sulfate, dermatan sulfate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56Materials from animals other than mammals
    • A61K35/63Arthropods
    • A61K35/64Insects, e.g. bees, wasps or fleas
    • A61K35/644Beeswax; Propolis; Royal jelly; Honey
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/886Aloeaceae (Aloe family), e.g. aloe vera
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/46Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0014Skin, i.e. galenical aspects of topical compositions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00Ultrasound therapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00Ultrasound therapy
    • A61N2007/0004Applications of ultrasound therapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00Ultrasound therapy
    • A61N2007/0073Ultrasound therapy using multiple frequencies

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Abstract

A phonophoretic cannabidiol composition comprises an amount of cannabidiol, an amount of a glucose source, such as honey, an amount of aloe vera, and amounts of one or more of glucosamine, methylsulfonylmethane, and chondroitin. A transdermal delivery system for administration of a phonophoretic cannabidiol composition includes a phonophoretic cannabidiol composition, a laser generator comprising an emitter which generates and directs a laser beam to the treatment area, and an ultrasound generator comprising a transducer which generates and transmits a plurality of ultrasonic waves to the treatment area. A method for transdermal delivery of a phonophoretic cannabidiol composition includes selecting laser pretreatment parameters, directing a laser beam to the treatment area, applying an amount of a phonophoretic cannabidiol composition to a treatment area, selecting ultrasonic treatment parameters, and, transmitting a plurality of ultrasonic waves to the treatment area.

Description

\\011-DC001 Users$ \sar \Scans\ 2019-08-27 - Allowed Application (3) doc
2 SYSTEM
3
4 BACKGROUND OF THE INVENTION
Field of the Invention 6 The present invention is directed to a cannabidiol composition specifically formulated for 7 transdermal delivery to an affected area of a patient via phonophoresis.
In at least one embodiment, 8 the novel composition comprises amounts of cannabidiol, a glucose source, aloe vera, glucosamine, 9 methylsulfonylmethane, and chondroitin. A system for transdermal delivery of the novel phonophoretic cannabidiol composition comprises a laser generator and an ultrasound generator, and 11 the present invention further comprises a method for implementing transdermal delivery via the 12 present system.

Transdermal delivery of a variety of beneficial compounds is well known. Among the more 16 common applications are the nicotine containing "patches" which are intended to aid person's trying 17 to quit smoking cigarettes. Typically, transdermal delivery of a desired compound occurs via 18 migration of the compound across the dermal boundaries of a patient's skin into his or bloodstream 19 by further migration into the small blood vessels which are present close to the surface of a person's skin.
21 While known transdermal delivery systems are effective for the administration of many 22 beneficial compounds to a patient, as will be appreciated, transdermal delivery into the blood stream 23 of a patient is ineffective for the treatment of affected areas of a patient's body which receive little or \\OTTDC001 \Users$ \ear \Scans \2019-08-27 - Allowed Application (3) doc 1 no blood flow. One such example is cartilage. Cartilage is made up of specialized cells called 2 chondrocytes which produce large amounts of extracellular matrix composed of collagen fibers, 3 proteoglycan, and elastin fibers. There are no blood vessels in cartilage to supply the chondrocytes 4 with nutrients, rather, nutrients diffuse through connective tissue surrounding the cartilage, called the perichondrium, and into the core of the cartilage. Due to the lack of blood vessels, cartilage grows 6 and repairs more slowly than other tissues.
7 As such, it would be beneficial to provide a composition which is specifically formulated for 8 transdermal delivery to an affected area of patient which receives little to no blood flow. More in 9 particular, it would be beneficial to provide a cannabidiol composition which may be administered transdermally into the cartilage of patient via phonophoresis. A further benefit may be realized by 11 providing a system and method of transdermal delivery of a phonophoretic composition directly into 12 the cartilage of patient.

Cannabidiol compounds are known to impart beneficial therapeutic effects on various areas 16 of the human physiology. Among the tissues which may benefit from treatment with cannabidiol 17 compounds is damaged cartilage. As noted above, since cartilage contain no blood vessels, delivery 18 of beneficial compounds to the cartilage of a patient via standard transdermal mechanisms is 19 ineffective.
As such, the present invention comprises a cannabidiol composition specifically formulated 21 for transdermal delivery into cartilage via phonophoresis.
22 In accordance with one embodiment of the present invention, a phonophoretic cannabidiol 23 composition comprises an amount of cannabidiol, an amount of the glucose source, and an amount of \\OTTDC001 Users$ \sar \Scans \2019-08-27 - Allowed Application (3) doc 1 aloe vera. A phonophoretic cannabidiol composition in accordance with one further embodiment of 2 the present invention comprises an amount of cannabidiol in the range of about 1 to 5 percent by 3 weight, an amount of a glucose source in a range of about 10 to 20 percent by weight, and an amount 4 of aloe vera in a range of about 40 to 60 percent by weight. In one further embodiment of a phonophoretic cannabidiol composition in accordance with the present invention comprises one or 6 more of glucosamine, methylsulfonylmethane, and chondroitin in amounts in a range of about 5 to 15 7 percent by weight each.
8 In at least one embodiment, a phonophoretic cannabidiol composition in accordance with the 9 present invention comprises an amount of cannabidiol of about 2 percent by weight, an amount of a glucose source, such as honey, of about 14 percent by weight, an amount of aloe vera of about 54 11 .. percent by weight, an amount of glucosamine of about 10 percent by weight, an amount of 12 .. methylsulfonylmethane of about 10 percent by weight, and an amount of chondroitin of about 10 13 percent by weight.
14 The present invention further comprises a transdermal delivery system for administration of a phonophoretic cannabidiol composition. In at least one embodiment, a transdermal delivery system 16 .. comprises a phonophoretic composition including an amount of cannabidiol, an amount of a glucose 17 source, and an amount of aloe vera. In at least one further embodiment, a transdermal delivery 18 system comprises a phonophoretic composition including cannabidiol, a glucose source, aloe vera, 19 .. glucosamine, methylsulfonylmethane, and chondroitin. In accordance with at least one embodiment of the present invention, a transdermal delivery system comprises a laser generator comprising an 21 emitter which generates and directs a laser beam having a wavelength in a far infrared region to the 22 treatment area of the patient. One further embodiment of a transdermal delivery system in 23 accordance with the present invention also comprises an ultrasound generator comprising a \\01TDC001 Users$ \sar \Scans \2019-08-27 - Allowed Application (3) doc transducer which generates and transmits a plurality of ultrasonic waves having a frequency in an 2 .. ultrasonic range to the treatment area of the patient.
3 As stated above, the present invention also comprises a method for transdermal delivery of a phonophoretic cannabidiol composition. In at least one embodiment, the method includes selecting laser pretreatment parameters, directing a far infrared laser beam to the treatment area for a predetermined pretreatment period, applying an amount of a phonophoretic cannabidiol composition 7 to the treatment area of the patient, selecting ultrasonic treatment parameters, and, transmitting a plurality of ultrasonic waves to the treatment area of the patient for a predetermined treatment period.

These and other objects, features and advantages of the present invention will become clearer when the drawings as well as the detailed description are taken into consideration.

13 For a fuller understanding of the nature of the present invention, reference should be had to 14 the following detailed description taken in connection with the accompanying drawings in which:
Figure 1 is a diagrammatic representation of one illustrative embodiment of a phonophoretic 16 cannabidiol composition in accordance with the present invention.

Figure 2 is a schematic representation of one illustrative embodiment of a system for transdermal delivery of a phonophoretic cannabidiol composition to an affected area of a patient in 19 accordance with the present invention.
Figure 3 is a diagrammatic representation of one illustrative embodiment of a method for implementing transdermal delivery of a phonophoretic cannabidiol composition to a patient in 22 accordance with the present invention.

Figure 4 is a diagrammatic representation illustrat5ive of one alternative embodiment of a \\O11DC001 \Users$\sar\Scans)2019-08-27 - Allowed Application (3) doc 1 method for implementing transdermal delivery of a phonophoretic cannabidiol composition to a 2 patient in accordance with the present invention.
3 Like reference numerals refer to like parts throughout the several views of the drawings.

DETAILED DESCRIPTION
6 As stated above, the present invention is directed to a phonophoretic cannabidiol composition 7 10, such as is diagrammatically represented in the illustrative embodiment of Figure 1. A
8 phonophoretic cannabidiol composition 10 in accordance with the present invention includes at least 9 an amount of cannabidiol 12. In at least one embodiment, cannabidiol 12 is obtained from industrial hemp plants, which do not present regulatory restraints on cultivation due to the relatively low 11 amounts of the psychoactive component tetrahydrocannabinol, which is found in other strains of 12 plants of the genus cannabis.
13 Looking further to Figure 1, a phonophoretic cannabidiol composition 10 in in accordance 14 with at least one embodiment of the present invention also comprises an amount of a glucose source 13. As will be appreciated by those of skill in the art, a glucose source is required by living cells, and 16 incorporation of a glucose source 13 into the present phonophoretic cannabidiol composition 10 17 induces living cells to allow the present phonophoretic cannabidiol composition 10 to migrate across 18 cell walls.
19 Further, and as also disclosed above, in at least one embodiment a phonophoretic cannabidiol composition 10 comprises an amount of aloe vera 14. Aloe vera 14 is incorporated into the present 21 phonophoretic cannabidiol composition 10 in order to improve permeability of the composition 10 22 through the skin and the underlying subcutaneous tissue. Furthermore, the present of plant matter 23 will maximize the bioavailability of the composition 10.
5 \\OTTDC001 \Users$\sar \Scans \ 2019-08-27 - Allowed Application (3) doc 1 In at least one embodiment, a phonophoretic cannabidiol composition 10 in accordance with 2 the present invention includes an amount of one or more of glucosamine 16, methylsulfonylmethane 3 17, and chondroitin 18. In yet one further embodiment, a phonophoretic cannabidiol composition 10 4 in accordance with the present invention includes an amount of each of glucosamine 16, methylsulfonylmethane 17, and chondroitin 18. Both glucosamine 16 and chondroitin 18 are
6 components of cartilage, and are incorporated into a phonophoretic cannabidiol composition 10 in
7 accordance with the present invention to facilitate regeneration and elasticity of affected cartilage
8 being treated. Methylsulfonylmethane 17 is an anti-inflammatory and as such methylsulfonylmethane
9 17 is incorporated in at least one embodiment of a phonophoretic cannabidiol composition 10 in accordance with the present invention to help minimize inflammation in a treatment area of a patient, 11 as well as to provide usable sulfur thereto.
12 In accordance with at least one embodiment of the present invention, a phonophoretic cannabidiol composition 10 comprises an amount of cannabidiol 12 in a range of about 1 to 5 percent 14 by weight. In one further embodiment, a phonophoretic cannabidiol composition 10 includes an amount of cannabidiol 12 of about 2 percent by weight.

phonophoretic cannabidiol composition 10 in accordance with one embodiment of the present invention comprises an amount of a glucose source 13 in a range of about 10 to 20 percent by weight. In at least one embodiment, a phonophoretic cannabidiol composition 10 comprises an amount of a glucose source 13 of about 14 percent by weight. In one embodiment, a glucose source 13 in accordance with the present invention comprises honey. In yet one further embodiment, a 21 glucose source 13 in accordance with the present invention comprises organic honey.

With regard to aloe vera 14, a phonophoretic cannabidiol composition 10 in accordance with 23 at least one embodiment of the present invention comprises an amount of aloe vera 14 in a range of =
\\OTTDC001\Users$ \sar \Scans \ 2019-08-27 - Allowed Application (3) doc 1 about 40 to 60 percent by weight. In one further embodiment, a phonophoretic cannabidiol 2 composition 10 comprises an amount of aloe vera 16 of about 54 percent by weight.
3 One or more of glucosamine 16, methylsulfonylmethane 17, and chondroitin 18 are present in 4 an amount of about 5 to 15 percent by weight each in at least one embodiment of a phonophoretic cannabidiol composition 10 in accordance with the present invention. In yet one further embodiment, 6 each of glucosamine 16, methylsulfonylmethane 17, and chondroitin 18 are present in amounts of 7 about 5 to 15 percent by weight each in a phonophoretic cannabidiol composition 10 in accordance 8 with the present invention. In at least one embodiment, a phonophoretic cannabidiol composition 10 9 in accordance with the present invention comprises an amount of glucosamine 16 of about 10 percent by weight, an amount of methylsulfonylmethane 17 of about 10 percent by weight, and an amount of 11 chondroitin 18 of about 10 percent by weight.
12 In view of the foregoing, it follows that in at least one embodiment, a phonophoretic 13 cannabidiol composition 10 in accordance with the present invention comprises an amount of 14 cannabidiol 12 of about 2 percent by weight, an amount of a glucose source 13, such as honey or organic honey, of about 14 percent by weight, an amount of aloe vera 14 of about 54 percent by 16 weight, an amount of glucosamine 16 of about 10 percent by weight, an amount of 17 methylsulfonylmethane 17 of about 10 percent by weight, and an amount of chondroitin 18 of about 18 10 percent by weight.
19 As also disclosed above, the present invention comprises a transdermal delivery system 100 for a phonophoretic cannabidiol composition, as shown in the illustrative embodiment of Figure 2.
21 With reference to Figure 2, the present transdermal delivery system 100 comprises an amount of a 22 phonophoretic cannabidiol composition 110. As before, a phonophoretic cannabidiol composition 23 110 in accordance with at least one embodiment of the present invention comprises an amount of \\OTTDC001 \Users$ \sar \Scans \2019-08-27 - Allowed Application (3) doc 1 cannabidiol 120, an amount of a glucose source 130, and an amount of aloe vera 140. Also as before, 2 a phonophoretic cannabidiol composition in accordance with the present invention comprises an 3 amount of cannabidiol 120 in a range of about 1 to 5 percent by weight, an amount of a glucose 4 source 130 in a range of about 10 to 20 percent by weight, an amount of aloe vera 140 in a range of about 40 to 60 percent by weight, and one or more of glucosamine 160, methylsulfonylmethane 170, 6 and chondroitin 180 in an amount of about 5 to 15 percent by weight.
7 In at least one further embodiment, a phonophoretic cannabidiol composition 110 in 8 accordance with the present transdermal delivery system 100 comprises an amount of cannabidiol 9 120 of about 2 percent by weight, an amount of a glucose source 130, such as honey or organic honey, of about 14 percent by weight, an amount of aloe vera 140 of about 54 percent by weight, an 11 amount of glucosamine 160 of about 10 percent by weight, an amount of methylsulfonylmethane 170 12 of about 10 percent by weight, and an amount of chondroitin 180 of about
10 percent by weight.
13 With further reference to the illustrative embodiment of Figure 2, a transdermal delivery 14 system 100 for a phonophoretic cannabidiol composition comprises a laser generator, generally as shown as at 200. As shown in the illustrative embodiment of Figure 2, the laser generator 200 16 comprises an emitter 210 which generates a laser beam 220, such as may be directed towards a 17 treatment area ("TA") of a patient. A laser generator 200 in accordance with the present invention 18 has a defined power output 212 which, in at least one embodiment is in a range of about 2,000 19 milliwatts. In at least one embodiment, a laser generator 200 in accordance with the present invention comprises a gallium-aluminum-arsenide ("GaAlAs") infrared laser as a light source. hi one 21 further embodiment, a laser generator 200 in accordance with the present invention, generates a laser 22 beam 220 having a wavelength 222 in a range of about 810 nanometers. As will be appreciated by 23 those with skill in the art, a laser beam having a wavelength in a range of about 810 nanometers at =
\\OITDC001 Users$ \sar \Scans \ 2019-08-27 - Allowed Application (3) doe 1 least partially defines a laser beam in the far infrared region of the visible light spectrum.
2 In accordance with one embodiment of the present invention, a laser generator 200 comprises 3 a class 3B laser. More in particular, in one embodiment, a laser generator 200 comprises a plurality 4 of emitters 210, and in at least one embodiment, a laser generator 200 comprises four emitters 210.
Additional operating parameters of a laser generator 200 in accordance with at least one embodiment 6 of the present invention include a total power output 212 in a range of about 2,000 milliwatts, an 7 aperture of 9.5 and a beam divergence of 9*x38*. In one further embodiment, the polarization of the 8 laser beam 220 is linear.
9 In one embodiment, a laser generator 200 in accordance with the present invention is positioned such that the laser beam 220 presents a spot size in a range of about 0.5 to 1.0 square
11 centimeters at the treatment area of the patient. In at least one further embodiment, a laser generator
12 200 is positioned relative to the patient such that a laser beam 220 presents a spot size of about 0.7
13 square centimeters at the treatment area of the patient. In one further embodiment, a laser generator
14 200 generates a laser beam 220 which produces a power density 228 of about 0.5 to 1.0 watts per square centimeter at the treatment area of the patient. In at least one embodiment, a power density 16 228 is about 0.8 watts per square centimeter at the treatment area of the patient. As will be 17 appreciated by those with skill in the art a laser beam having a spot size of about 0.7 square 18 centimeters and a power density 228 of about 0.8 watts per square centimeter is capable of 19 generating an energy flux of at least about 50 joules per square centimeter at the treatment area of the patient.
21 Looking once again to the illustrative embodiment of Figure 2, the transdermal delivery 22 system 100 for a phonophoretic cannabidiol composition in accordance with the present invention 23 further comprises an ultrasound generator 300. In at least one embodiment, the ultrasound generator \\OTMC001 \Users$ \sar \Scans \ 2019-08-27 - Allowed Application (3) doc 1 300 comprises a transducer 310 which generates a plurality of ultrasonic waves 320, such as is 2 shown in Figure 2. As will be appreciated by those with skill in the art an ultrasonic wave 320 is 3 defined by a number of parameters, including at least a wave frequency 322. In at least one 4 embodiment, an ultrasound generator 300 generates a plurality of ultrasonic waves 320 having a frequency in a range of about 1 to 3 megahertz.
6 Turning next to the illustrative embodiment of Figure 3, the present invention further 7 comprises a method for transdermal delivery of a phonophoretic cannabidiol composition 1000 to a 8 treatment area of a patient.
9 As shown in the illustrative embodiment of Figure 3, the present method 1000 comprises selecting laser pretreatment parameters 1100. In at least one embodiment, selecting a plurality of 11 laser pretreatment parameters 1100 includes, by way of example only, selecting a power output 1110 12 of a laser generator, selecting a wavelength 1120 for a laser beam, selecting a spot size 1130 13 presented by a laser beam at a treatment area of a patient, and/or selecting a pretreatment time 1140 14 for exposure of a treatment area of a patient to a laser beam.
In at least one embodiment, the present method 1000 comprises selecting a power output 16 1110 in a range of about 2,000 milliwatts. In one further embodiment, the present method 1000 17 comprises selecting a wavelength 1120 of a laser beam in the far infrared range of the visible 18 spectrum. In still one further embodiment, the present method comprising selecting a spot size 1130 19 a laser beam presents at a treatment area of a patient in a range of about 0.5 to 1.0 square centimeters, and in one further embodiment, selecting a spot size 1130 of about 0.7 square centimeters.
21 The method 1000 in accordance with at least one embodiment of the present invention further 22 comprises directing an infrared laser beam to a treatment area of a patient 1200 for a preselected 23 pretreatment time. In at least one embodiment, the present method comprises selecting a =
\\ormcooi \Users$ \sar\Scans\2019-08-27 - Allowed Application (3) doc pretreatment time 1140 in a range of about one to five minutes. In at least one further embodiment, 2 the present method comprises selecting a pretreatment time 1140 of about two minutes.
3 As will be appreciated by those of skill in the art, directing a laser beam to a treatment area of 4 a patient 1300 will improve the receptiveness of the cells in the treatment area to the migration of a transdermal composition therethrough. In at least one embodiment, a laser beam is directed to a treatment area of a patient 1300 for a predetermined treatment time 1140 of between about one to 7 two minutes, as before. In one further embodiment, a laser beam is directed to a portion of a treatment area of a patient 1300 in a static application for between about 5 to 30 seconds before the laser is redirected to another portion of the treatment area, for a total pretreatment time of about one .. to two minutes.
11 The method 1000 in accordance with at least one embodiment of the present invention further comprises applying an amount of a phonophoretic cannabidiol composition 1300 to a treatment area 13 of a patient. In at least one embodiment, a phonophoretic composition includes an amount of cannabidiol, an amount of a glucose source, an amount of aloe vera, an amount of glucosamine, an amount of methylsulfonylmethane, and an amount of chondroitin. In one further embodiment, a phonophoretic cannabidiol composition comprises about 2 percent by weight of cannabidiol, about percent by weight of organic honey, about 54 percent by weight of aloe vera, about 10 percent by weight of glucosamine, about 10 percent by weight of methylsulfonylmethane, and about 10 percent 19 by weight of chondroitin. The amount of phonophoretic compound applied to a treatment area of a patient 1300 in accordance with at least one embodiment of the present invention is about one gram.

Looking once again to the illustrative embodiment of Figure 3, a method of transdermal delivery of a phonophoretic cannabidiol composition 1000 in accordance with at least one embodiment of the present invention further comprises selecting ultrasonic treatment parameters \\OTTDC001\Users$ \sar \Scans \ 2019-08-27 - Allowed Application (3) doc 1 1400. As before, in at least one embodiment, the present method 1000 comprises selecting a plurality 2 of ultrasonic treatment parameters 1400, such as, by way of example, selecting a frequency 1410 of a 3 plurality of ultrasonic waves. In at least one embodiment, the present method 1000 comprises 4 selecting a frequency 1410 in a range of about one to three megahertz. In one further embodiment, the present method 1000 comprises selecting a treatment time 1430 for exposure of a treatment area 6 of a patient to a plurality of ultrasonic waves.
7 The method 1000 in accordance with at least one embodiment of the present invention further 8 comprises directing a plurality of ultrasonic waves to a treatment area of a patient 1500 for a 9 preselected treatment time. In at least one embodiment, the present method comprises selecting a treatment time 1430 in a range of about five to forty minutes. In at least one further embodiment, the 11 present method comprises selecting a treatment time 1430 of about ten to twenty minutes.
12 As will be appreciated by those of skill in the art, transmitting a plurality of ultrasonic waves 13 to a treatment area of a patient 1500 will drive a phonophoretic composition through the dermal layer 14 and into a targeted tissue of the patient, such as, a section of cartilage.
Figure 4 is a diagrammatic representation illustrative of one alternative embodiment of a 16 method for transdermal delivery of a phonophoretic cannabidiol composition 2000 to a treatment 17 area of a patient. Notably, and unlike the method presented in accordance with the illustrative 18 embodiment of Figure 3, the method 2000 in accordance with Figure 4 does not include laser 19 pretreatment and associated steps.
To begin, the method 2000 in accordance with at the alternative embodiment of Figure 4 21 comprises applying an amount of a phonophoretic cannabidiol composition 2300 to a treatment area 22 of a patient. In at least one embodiment, a phonophoretic composition includes an amount of 23 cannabidiol, an amount of a glucose source, an amount of aloe vera, an amount of glucosamine, an \\O1TDC001\Users$ sar \Scans \ 2019-08-27 - Allowed Application (3) doc 1 .. amount of methylsulfonylmethane, and an amount of chondroitin. As before, in one further 2 embodiment, a phonophoretic cannabidiol composition comprises about 2 percent by weight of 3 cannabidiol, about 14 percent by weight of organic honey, about 54 percent by weight of aloe vera, 4 .. about 10 percent by weight of glucosamine, about 10 percent by weight of methylsulfonylmethane, and about 10 percent by weight of chondroitin. The amount of phonophoretic compound applied to a 6 treatment area of a patient 2300 in accordance with alternative embodiment of Figure 4 is about one 7 gram.
8 Looking further to the illustrative embodiment of Figure 4, the method of transdermal 9 .. delivery of a phonophoretic cannabidiol composition 2000 further comprises selecting ultrasonic .. treatment parameters 2400. As before, in at least one embodiment, selecting a plurality of ultrasonic 11 .. treatment parameters 2400 includes, by way of example, selecting a frequency 2410 of a plurality of 12 ultrasonic waves. In at least one embodiment, the present method 2000 comprises selecting a 13 frequency 2410 in a range of about one to three megahertz. In one further embodiment, the present 14 .. method 2000 comprises selecting a treatment time 2430 for exposure of a treatment area of a patient to a plurality of ultrasonic waves.
16 The method 2000 in accordance with at least one embodiment of the present invention further 17 comprises directing a plurality of ultrasonic waves to a treatment area of a patient 2500 for a 18 preselected treatment time. In at least one embodiment, the present method comprises selecting a 19 treatment time 2430 in a range of about five to forty minutes. In at least one further embodiment, the present method comprises selecting a treatment time 1430 of about ten to twenty minutes.
21 As will be appreciated by those of skill in the art, transmitting a plurality of ultrasonic waves 22 .. to a treatment area of a patient 2500 will drive a phonophoretic composition through the dermal layer 23 and into a targeted tissue of the patient, such as, a section of cartilage.

=
\\OTTDCOORUsers$ \sar \Scans \ 2019-08-27 - Allowed Application (3) doc 1 Since many modifications, variations and changes in detail can be made to the described 2 embodiments of the invention, it is intended that all matters in the foregoing description and shown 3 in the accompanying drawings be interpreted as illustrative and not in a limiting sense. Thus, the 4 scope of the invention should be determined by the appended claims and their legal equivalents.
Now that the invention has been described,

Claims (9)

What is claimed is:
1. A phonophoretic cannabidiol composition formulated for application to a patient's skin and transdermal delivery to a portion of the patient's cartilage in a treatment area, said composition comprising:
an amount of cannabidiol, an amount of a glucose source to induce living cells to allow said composition to migrate across the cells and for metabolization therein, an amount of aloe vera to improve permeability of said composition through the patient's skin and underlying subcutaneous tissue, and an amount of one or more of glucosamine and chondroitin to facilitate regeneration and elasticity of the portion of the patient's cartilage, and methylsulfonylmethane to reduce inflammation in the treatment area and to provide usable sulfur thereto.
2. The composition as recited in claim 1 wherein said amount of cannabidiol is about 1 to 5 percent by weight.
3. The composition as recited in claim 1 wherein said amount of said glucose source is about 10 to 20 percent by weight.
4. The composition as recited in claim 3 wherein said glucose source comprises organic honey.
5. The composition as recited in claim 1 wherein said amount of aloe vera is about 40 to 60 percent by weight.
6. The composition as recited in claim 1 wherein said amount of glucosamine is about 5 to 15 percent by weight.
7. The composition as recited in claim 1 wherein said amount of methylsulfonylmethane is about 5 to 15 percent by weight.
8. The composition as recited in claim 1 wherein said amount of chondroitin is about 5 to 15 percent by weight.
9. The composition as recited in claim 1 wherein said amount of cannabidiol is about 2 percent by weight, said amount of said glucose source is about 14 percent by weight, said amount of aloe vera is about 54 percent by weight, said amount of glucosamine is about 10 percent by weight, said amount of methylsulfonylmethane is about percent by weight, and said amount of chondroitin is about 10 percent by weight.
CA3053353A 2019-08-28 2019-08-28 Phonophoretic cannabidiol composition and transdermal delivery system Pending CA3053353A1 (en)

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