PROCESS FOR CREATING A CANNABINOID PICO-EMULSION WITH ANTIBIOTIC PROPERTIES AND THE RESULTING PICO-EMULSION

20240415854 ยท 2024-12-19

    Inventors

    Cpc classification

    International classification

    Abstract

    A novel process of creating a cannabinoid pico-emulsion resulting in a sterile and injectable cannabinoid emulsion with increased bioavailability and antibiotic characteristics, and the resulting novel cannabinoid pico-emulsion, for the purpose of treating a wide variety of medical condition in both human and animals.

    Claims

    1. A process of making a cannabinoid pico-emulsion, said process comprising the steps of: (a) mixing deionized water, a cannabinoid isolate, and a surfactant to form a pre-sonicated mixture; (b) mechanically agitating and heating said pre-sonicated mixture to the optimal sonication temperature to promote homogenization; (c) subjecting said pre-sonicated mixture to sonic energy to produce a cannabis pico-emulsion comprising micelles ranging in size from about 850 to about 4900 picometers; (d) passing cannabis pico-emulsion through a about 0.1 micrometer mechanical filter for sterility.

    2. The process of claim 1, wherein said surfactant is a surfactant with an hydrophilic-lipophilic balance (HLB) number of about 15.

    3. The process of claim 1, wherein the quantity of surfactant is calculated by calculating the total surface area of the quantity of cannabinoid isolate intended to be emulsified if said quantity of cannabinoid isolate was divided into spheres equal in size to the desire emulsified droplet size, then calculating the quantity of surfactant necessary to cover said total surface area, then increasing said quantity of surfactant by about 5%.

    4. The process of claim 1 wherein, said surfactant is Polysorbate 80.

    5. The process of claim 1 wherein, the optimal sonication temperature is between about 140 and about 200 degrees fahrenheit.

    6. The process of claim 1 wherein, the optimal sonication temperature is about 10 degrees below the boiling point of pre-sonication mixture.

    7. The process of claim 1 wherein the optimal frequency of said sonic energy is sonic energy of a frequency greater or equal to about 60 Hertz.

    8. The process of claim 1 wherein the optimal frequency of said sonic energy is sonic energy of a frequency between about 60 Hertz and about 80 hertz.

    9. A cannabinoid pico-emulsion of claim 1 wherein said cannabinoid isolate is a about 99 percent pure isolate of one or more cannabinoids selected from a group consisting of: Cannabichromene (CBC), Cannabichromenic acid (CBCA), Cannabichromevarin (CBCV), Cannabichromevarinic acid (CBCVA), Cannabicyclol (CBL), Cannabicyclolic acid (CBLA), Cannabicyclovarin (CBLV), Cannabidiol (CBD), Cannabidiol monomethylether (CBDM), Cannabidiolic acid (CBDA), Cannabidiorcol (CBD-C1), Cannabidivarin (CBDV), Cannabidivarinic acid (CBDVA), Cannabielsoic acid B (CBEA-B), Cannabielsoin (CBE), Cannabielsoin acid A (CBEA-A), Cannabigerol (CBG), Cannabigerol monomethylether (CBGM), Cannabigerolic acid (CBGA), Cannabigerolic acid monomethylether (CBGAM), Cannabigerovarin (CBGV), Cannabigerovarinic acid (CBGVA), Cannabinodiol (CBND), Cannabinodivarin (CBVD), Cannabinol (CBN), Cannabinol methylether (CBNM), Cannabinol-C2 (CBN-C2), Cannabinol-C4 (CBN-C4), Cannabinolic acid (CBNA), Cannabiorcool (CBN-C1), Cannabivarin (CBV), 10-Ethoxy-9-hydroxy-delta-6a-tetrahydrocannabinol, 8,9-Dihydroxy-delta-6a-tetrahydrocannabinol, Cannabitriol (CBT), Cannabitriolvarin (CBTV), Delta-8-tetrahydrocannabinol (8-THC), Delta-8-tetrahydrocannabinolic acid (8-THCA), Delta-9-tetrahydrocannabinol (THC), Delta-9-tetrahydrocannabinol-C4 (THC-C4), Delta-9-tetrahydrocannabinolic acid A (THCA-A), Delta-9-tetrahydrocannabinolic acid B (THCA-B), Delta-9-tetrahydrocannabinolic acid-C4 (THCA-C4), Delta-9-tetrahydrocannabiorcol (THC-C1), Delta-9-tetrahydrocannabiorcolic acid (THCA-C1), Delta-9-tetrahydrocannabivarin (THCV), Delta-9-tetrahydrocannabivarinic acid (THCVA), 10-Oxo-delta-6a-tetrahydrocannabinol (OTHC), Cannabichromanon (CBCF), Cannabifuran (CBF), Cannabiglendol, Cannabiripsol (CBR), Cannbicitran (CBT), Dehydrocannabifuran (DCBF), Delta-9-cis-tetrahydrocannabinol (cis-THC), Tryhydroxy-delta-9-tetrahydrocannabinol (triOH-THC), and OH-iso-HHCV.

    10. A cannabinoid pico-emulsion formed by the process of claim 1.

    11. A cannabinoid pico-emulsion formed by the process of claim 2.

    12. A cannabinoid pico-emulsion formed by the process of claim 3.

    13. A cannabinoid pico-emulsion formed by the process of claim 4.

    14. A cannabinoid pico-emulsion formed by the process of claim 5.

    15. A cannabinoid pico-emulsion formed by the process of claim 6.

    16. A cannabinoid pico-emulsion formed by the process of claim 7.

    17. A cannabinoid pico-emulsion formed by the process of claim 8.

    18. A cannabinoid pico-emulsion formed by the process of claim 9.

    19. A method of treating a gram-negative infection into a human or animal by introducing the cannabinoid pico-emulsion of claim 10 into the said human or animal's bloodstream.

    20. A method of treating a gram-negative infection into a human or animal by introducing the cannabinoid pico-emulsion of claim 11 into the said human or animal's bloodstream.

    21. A method of treating a gram-negative infection into a human or animal by introducing the cannabinoid pico-emulsion of claim 12 into the said human or animal's bloodstream.

    22. A method of treating a gram-negative infection into a human or animal by introducing the cannabinoid pico-emulsion of claim 13 into the said human or animal's bloodstream.

    23. A method of treating a gram-negative infection into a human or animal by introducing the cannabinoid pico-emulsion of claim 14 into the said human or animal's bloodstream.

    24. A method of treating a gram-negative infection into a human or animal by introducing the cannabinoid pico-emulsion of claim 15 into the said human or animal's bloodstream.

    25. A method of treating a gram-negative infection into a human or animal by introducing the cannabinoid pico-emulsion of claim 16 into the said human or animal's bloodstream.

    26. A method of treating a gram-negative infection into a human or animal by introducing the cannabinoid pico-emulsion of claim 17 into the said human or animal's bloodstream.

    27. A method of treating a gram-negative infection into a human or animal by introducing the cannabinoid pico-emulsion of claim 18 into the said human or animal's bloodstream.

    28. A cannabinoid pico-emulsion comprising: a cannabinoid isolate dispersed component; a surfactant component; an aqueous continuous phase; wherein said surfactant has a hydrophilic-lipophilic balance (HLB) number of about 15; where said surfactant and said cannabinoid form micelles between about 850 picometers and about 4900 picometers in size.

    29. A cannabinoid pico-emulsion described in claim 28 wherein said surfactant is polysorbate 80.

    30. A cannabinoid pico-emulsion described in claim 28 wherein said cannabinoid isolate dispersed component is a about 99 percent pure isolate of one or more cannabinoids selected from a group consisting of: Cannabichromene (CBC), Cannabichromenic acid (CBCA), Cannabichromevarin (CBCV), Cannabichromevarinic acid (CBCVA), Cannabicyclol (CBL), Cannabicyclolic acid (CBLA), Cannabicyclovarin (CBLV), Cannabidiol (CBD), Cannabidiol monomethylether (CBDM), Cannabidiolic acid (CBDA), Cannabidiorcol (CBD-C1), Cannabidivarin (CBDV), Cannabidivarinic acid (CBDVA), Cannabielsoic acid B (CBEA-B), Cannabielsoin (CBE), Cannabielsoin acid A (CBEA-A), Cannabigerol (CBG), Cannabigerol monomethylether (CBGM), Cannabigerolic acid (CBGA), Cannabigerolic acid monomethylether (CBGAM), Cannabigerovarin (CBGV), Cannabigerovarinic acid (CBGVA), Cannabinodiol (CBND), Cannabinodivarin (CBVD), Cannabinol (CBN), Cannabinol methylether (CBNM), Cannabinol-C2 (CBN-C2), Cannabinol-C4 (CBN-C4), Cannabinolic acid (CBNA), Cannabiorcool (CBN-C1), Cannabivarin (CBV), 10-Ethoxy-9-hydroxy-delta-6a-tetrahydrocannabinol, 8,9-Dihydroxy-delta-6a-tetrahydrocannabinol, Cannabitriol (CBT), Cannabitriolvarin (CBTV), Delta-8-tetrahydrocannabinol (8-THC), Delta-8-tetrahydrocannabinolic acid (8-THCA), Delta-9-tetrahydrocannabinol (THC), Delta-9-tetrahydrocannabinol-C4 (THC-C4), Delta-9-tetrahydrocannabinolic acid A (THCA-A), Delta-9-tetrahydrocannabinolic acid B (THCA-B), Delta-9-tetrahydrocannabinolic acid-C4 (THCA-C4), Delta-9-tetrahydrocannabiorcol (THC-C1), Delta-9-tetrahydrocannabiorcolic acid (THCA-C1), Delta-9-tetrahydrocannabivarin (THCV), Delta-9-tetrahydrocannabivarinic acid (THCVA), 10-Oxo-delta-6a-tetrahydrocannabinol (OTHC), Cannabichromanon (CBCF), Cannabifuran (CBF), Cannabiglendol, Cannabiripsol (CBR), Cannbicitran (CBT), Dehydrocannabifuran (DCBF), Delta-9-cis-tetrahydrocannabinol (cis-THC), Tryhydroxy-delta-9-tetrahydrocannabinol (triOH-THC), and OH-iso-HHCV.

    Description

    BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

    [0060] The accompanying drawings illustrate various exemplary implementations and are part of the specification. The illustrated implementations are proffered for purposes of example not for purposes of limitation. Illustrated elements will be designated by numbers.

    [0061] Once designated, an element will be identified by the identical number throughout. Illustrated in the accompanying drawing(s) is at least one of the best mode embodiments of the present disclosure. In such drawing(s):

    [0062] FIG. 1 is a flowchart describing a process for creating a sterile and injectable cannabinoid pico-emulsion featuring increased bioavailability and antibiotic characteristics.

    [0063] FIG. 2 is a conceptual diagram illustrating an micelle in a cannabis pico-emulsion featuring a droplet of cannabinoid oil sequestered by the hydrophobic tails of a plurality of amphiphilic surfactant molecules while the hydrophilic heads of such molecules are in contact with the surrounding continuous phase.

    [0064] FIG. 3 is a conceptual diagram illustrating the thermodynamically-driven phenomena called Oswalt ripening in which several smaller micelles in an emulsion combine to form a single larger, more energetically favorable micelle.

    [0065] FIG. 4 is an exploded cutaway view of a conceptual diagram of a gram-negative bacterium featuring it's characteristic cell wall, which consists of a thin peptidoglycan layer between an inner and an outer cytoplasmic membrane.

    [0066] FIG. 5 is a conceptual cutaway diagram of the characteristic cell wall of a gram-negative bacterium, including a porin site which is a feature in the outer cytoplasmic membrane through which gram-negative bacterium mediate diffusion of small hydrophilic molecules.

    [0067] FIG. 6 is a comparative culture of the gram-negative bacteria, Pseudomonas aeruginosa, with and without exposure to the presently disclosed cannabinoid pico-emulsion.

    [0068] FIG. 7 is a comparative array of the gram-negative bacteria, Pseudomonas aeruginosa, of various growth density exposed to various concentrations of the presently disclosure cannabinoid pico-emulsion.

    DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

    [0069] The above described drawing illustrate multiple exemplary embodiments of the presently disclosed process and its many features in at least one of its preferred, best mode embodiments, which is further defined in detail in the following description. Those having ordinary skill in the art may be able to make alterations and modifications to what is described herein without departing from its spirit and scope of the disclosure. Therefore, it must be understood that what is illustrated is set forth only for the purposes of example and that it should not be taken as a limitation in the scope of the present process or its many features.

    [0070] Described now in detail is a novel process for creating a sterile and injectable cannabinoid pico-emulsion featuring increased bioavailability and antibiotic characteristics for the use of treating a wide variety of medical conditions.

    [0071] FIG. 1 illustrates an exemplary embodiment of a flowchart setting forth the basic the steps in the presently disclosed process 100. It begins with combining one or more cannabinoid isolates with a carefully calculated amount of surfactant. The surfactant should have a hydrophilic-lipophilic balance (HLB) number of about 15, preferably polysorbate 80, and deionized water 110. In another embodiment, the HLB is about 14.9 to about 15.1. An HLB number of about 15 indicates a strong hydrophilic character making it very well suited for an oil-in-water emulsion (as opposed to water-in-oil emulsion). Then the pre-sonicated mixture is stirred or otherwise mechanically agitated and heated to between 140 to 200 degrees fahrenheit 120. Once the pre-sonicated mixture is brought up to temperature and thoroughly blended, the pre-sonicated mixture is bombarded with sonic energy of a frequency 60 and 80 Hz. The bombardment should continue until such time as the dispersed phase has formed micelles in the range 4900 to 850 picometers in diameter 130, and finally, the resulting pico-emulsion is passed through a 0.1 micron mechanical filter to sterilize the emulsion and remove any large impurities 140.

    [0072] FIG. 2 is a conceptual drawing 200 of a droplet of the dispersed phase (the cannabinoid isolate) 210 sequestered by a plurality of surfactant molecules 220 featuring a hydrophilic head 240 and a lipophilic tail 230. The lipophilic tails 230 each bond to the cannabinoid isolate 210 and the hydrophilic heads 240 each bond to the continuous phase (the deionized water); thereby decreasing the interfacial tension between the dispersed and continuous phases.

    [0073] FIG. 3 is a conceptual illustration of the Oswalting effect whereby the smallest sized droplets (perhaps picometer sized) 200 of a dispersed phase tend to combine with and contribute to the growing size of slightly larger sized droplet 250, which again tend to combine with even larger droplets 260, and even larger droplets 270. This phenomena is driven by thermodynamic forces of surface tension and the fact that larger droplet are a lower energy state. In order to create a stable pico-emulsion this tendency has to be prevented, which highlights the proper selection of the appropriate surfactant and the use of a sufficient amount of such surfactant.

    [0074] FIG. 4 is perspective conceptual drawing an exemplar gram-negative bacterium 300 with an exploded cutaway section 310 illustrating the complex multi-layer cell wall comprised of a peptidoglycan cell wall 330 between two an inner and outer cytoplasmic membrane 320, 340. It is this complex structural barrier that enables gram-negative bacteria 300 to be resistant to many traditional antibiotic and makes infections of gram-negative bacteria 300 particularly problematic.

    [0075] FIG. 5 is perspective conceptual drawing of cross-section of the cell wall of a gram-negative bacterium 400. The diagram illustrated the peptidoglycan layer 330 flanked by both an outer cytoplasmic membrane 320 and an inner cytoplasmic membrane 320 comprised of phospholipids 410, and, most importantly for the present disclosure, the porin site 420 through which gram-negative bacteria regulate molecule uptake. It is through the porin site 420 that a picometer sized cannabinoid micelle 200 can gain entry passed the protective outer layers and potentially cause the demise of the bacterium. In the drawing, the picometer sized cannabinoid micelles 200 are depicted as spherical. It is important to note that when cannabinoid micelles 200 reach such a diminutive sizes there shape is dictated by the various bonding forces of the surfactant which causes the micelles to assume an elongated shape.

    [0076] FIG. 6 is a comparative culture of the gram-negative bacteria, Pseudomonas aeruginosa. The upper two images are photographs of the bottom of the petri dishes 500 identifying the starting conditions while the bottom two photographs show the resultant bacterial growth. The petri dish 500 on the left was exposed to the presently disclosed cannabinoid pico-emulsion while the petri dish 500 on the right was not. It is visually apparent that the bacterial growth 510 was significantly inhibited by the cannabinoid pico-emulsion.

    [0077] FIG. 7 is a comparative array of the gram-negative bacteria, Pseudomonas aeruginosa, of various growth density exposed to various concentrations of the presently disclosure cannabinoid pico-emulsion. In the array, the concentration of cannabinoid pico-emulsion is increased along the x-axis and the density of bacteria is increased along the y axis. The presence of the bacteria is indicated by a bright pink color and the absence of bacteria is indicated by a dark purple color. It is visually apparent that as the density of cannabinoid pico-emulsion is increased the bacteria survival decreases.

    [0078] The embodiments described in detail above are considered novel over the prior art The words used in this specification to describe the instant embodiments are to be understood not only in the sense of their commonly defined meanings, but to include by special definition in this specification: structure, material, or acts beyond the scope of the commonly defined meanings. Thus, if an element can be understood in the context of this specification as including more than one meaning, then its use must be understood as being generic to all possible meanings supported by the specification and by the word(s) describing the element.

    [0079] The definitions of the words or drawing elements described herein are meant to include not only the combination of elements which are literally set forth, but all similar structures, materials or acts for performing substantially the same function in substantially the same way to obtain substantially the same result. In this sense it is therefore contemplated that an equivalent substitution of two or more elements may be made for any one of the elements described and its various embodiments or that a single element may be substituted for two or more elements in a claim.

    [0080] Changes from the claimed subject matter as viewed by a person with ordinary skill in the art, now known or later devised, are expressly contemplated as being equivalents within the scope intended and its various embodiments. Therefore, substitutions, now or later known to one with ordinary skill in the art, are defined to be within the scope of the defined elements. This disclosure is thus meant to be understood to include what is specifically illustrated and described above, what is conceptually equivalent, what can be obviously substituted, and also what incorporates the essential ideas.

    [0081] The scope of this description is to be interpreted only in conjunction with the appended claims and it is made clear, here, that each named inventor believes that the claimed subject matter is what is intended to be patented.