WO2020165769A1

WO2020165769A1 - Delivery methods to optimize cannabis bioavailability

Info

Publication number: WO2020165769A1
Application number: PCT/IB2020/051090
Authority: WO
Inventors: Michael CABIGON; Steven Splinter; Denis TASCHUK
Original assignee: Radient Technologies Innovations Inc
Current assignee: Radient Technologies Innovations Inc
Priority date: 2019-02-11
Filing date: 2020-02-11
Publication date: 2020-08-20
Anticipated expiration: 2021-08-11

Abstract

Systems and methods of optimizing bioavailability of cannabinoids (e.g., of THC or CBD) in accordance with specifications and preferences are provided. Various processing, extraction, and form factors may be evaluated to identify requirements and parameters. The extractor may be capable of delivering a product with the optimal THC or CBD bioavailability. The customer may select a route of administration and a preferred bioavailability through a user interface in the extractor network, and the main module may report back to the product manufacturer device the most adequate form factor of the THC or CBD extract for the desired product, as well as report back to the extractor network the optimal conditions and parameters under which the THC or CBD extraction process should operate. The extractor can tailor their manufacturing processes, and product forms and compositions to the needs of the customers' delivery methods in terms of bioavailability.

Description

DELIVERY METHODS TO OPTIMIZE CANNABIS BIOAVAILABILITY

CROSS-REFERENCED TO RELATED APPLICATIONS

[00011 The present patent application claims the priority benefit of U.S. provisional patent number 62/804,025 filed February 11, 2019, the disclosure of which is incorporated by reference herein.

BACKGROUND OF THE INVENTION

1. Field of the Disclosure

[0002] The present disclosure is generally related to providing the cannabis extract form and composition selected to fulfill bioavailability requirements for specific types of products required for desired routes of administration.

2. Description of the Related Art

[0003] The bioavailability of cannabinoids such as THC and CBD is the measure of the degree and rate at which the substance of interest is released by a cannabis-based product into the bloodstream for absorption. THC and CBD bioavailability varies based on the consumption method, the concentration of THC and CBD in the product, and the form and composition of the product, including any and all additional compounds present (e.g., additives and excipients used to manufacture a particular formulation). It is important for product manufacturers to understand the different delivery methods for THC and CBD, types of products, form factors, and compositions for those products.

[0004] The physicochemical characteristics of cannabinoids, like many other lipophilic agents, present major challenges to drug delivery scientists. When formulating compositions with cannabinoids, the intestinal absorption and metabolism of, for example, THC remains a challenge, and therefore, the search for a non-parenteral delivery system for THC continues. Much research has been done to deliver THC through various routes (e.g., nasal, inhalation, sublingual, buccal, rectal, etc.) by means of different product forms and compositions.

[0005] Entities that extract cannabinoids from plant matter may be referred to as "extractors." Entities that combine cannabis extracts into a cannabinoid-containing product, formulation or product form that is consumed by persons may be referred to as "product manufacturers." In some instances, extractors and product manufacturers may be the same entity. Extractors are high in the supply chain, so that they are not aware of the correlations between different delivery methods, product forms and product compositions that may influence bioavailability of cannabinoids in the final products that reach the consumer. In certain cases, the customer may be a manufacturer of cannabis products requiring specific cannabinoid extracts, concentrates, distillates, isolates or formulated ingredients containing cannabinoids in order to manufacture specific cannabis product forms for consumers.

BRIEF DESCRIPTIONS OF THE DRAWINGS

[0006] FIG. 1 illustrates an exemplary network environment in which a delivery system for optimizing bioavailability may be implemented.

[0007] FIG. 2 is a flowchart illustrating an exemplary method of optimizing bioavailability.

[0008] FIG. 3 is a flowchart illustrating an exemplary method of delivery choice for bioavailability optimization.

[0009] FIG. 4 illustrates an exemplary choice database.

[0010] FIG. 5 is a flowchart illustrating an exemplary method of delivery design for bioavailability optimization.

[0011] FIG. 6 illustrates an exemplary capability database.

[0012] FIG. 7 is a flowchart illustrating an exemplary method of reporting bioavailability optimization.

[0013] FIG. 8 is a flowchart illustrating an exemplary method of extraction design for bioavailability optimization.

DETAILED DESCRIPTION

[0014] Systems and methods of optimizing bioavailability of cannabinoids (e.g., of THC or CBD) in accordance with specifications and preferences are provided. As used herein, optimization refers to adjustments in accordance with specified requirements or parameters. Various extraction, processing, compositions, and form factors may be evaluated to identify correlations to requirements and parameters. Such correlations may further be used to adjust operations at different points in order to provide a final product with bioavailability that meets or aligns as closely as possible to the specified requirements or parameters. The extractor may be capable of delivering a product with the optimal THC or CBD bioavailability. The customer may select a route of administration and a preferred bioavailability through a user interface associated with the extractor network server, and the main module may report back to the product manufacturer device 102 the most adequate form factor of the THC or CBD extract for the desired product, as well as report back to the extractor network server the operational conditions and parameters under which the THC or CBD extraction process should operate. The extractor can tailor their manufacturing processes, and product forms and compositions to the needs of the customers' delivery methods in terms of bioavailability.

[0015] FIG. 1 illustrates an exemplary network environment in which a delivery system for optimizing bioavailability may be implemented. The network environment includes a product manufacturer device 102 that manages information regarding production of a cannabis-based product. The product manufacturer device 102 may be associated with any large or small product manufacturer (e.g., edible or beverage company) that is creating cannabis-infused products. A research network server 104 is a server system for managing cannabis research information, which may be obtained from any research institution or company that publicly discloses information regarding bioavailability and other parameters for different delivery methods or routes of administration, forms of intake, and form factors. Among other information, the research network server 104 can include summaries of reports providing recommendations to physicians, studies of time of onset, and studies of duration of onset. [0016] An extractor network server 106 is a server system that represents extractors. For the purposes of this invention, "extractor" means any entity that extracts cannabinoids and other compounds from cannabis to produce cannabinoid extracts, resins, concentrates, distillates. isolates or uses these forms to produce formulated ingredients containing cannabinoids. The product manufacturer device 102 and the extractor may be the same entity. Various methods can be used to extract cannabis, including microwave extraction, supercritical C02 extraction, ethanol extraction, and hydrocarbon extraction. The extractor network server 106 can store operations data and can allow a product manufacturer device 102 to access the data when needed.

[00171 A user interface 108 is inclusive of any type of device or device component that may accept inputs from users and/or provide outputs to the users. In one example, a user can interact with the one or more user interfaces 108 using one or more user-interactive objects and devices. The user-interactive objects and devices may comprise user input buttons, switches, knobs, levers, keys, trackballs, touchpads, cameras, microphones, motion sensors, heat sensors, inertial sensors, touch sensors, or a combination of the above. Further, the user interface 108 may either be implemented as a command line interface (CLI), a graphical user interface (GUI), a voice interface, or a web-based user-interface. An application programming interface (API) 110 allows the extractor network server 106 to communicate and exchange information with the research network server 104.

[0018] A main module 112 is software that records manufacturer choices, accesses choice database 116 and extractor data, reports on capability of the extractor to produce the THC and/or CBD extract in the right form factor, and estimates the extraction parameters to achieve the right form factor and design parameters (i.e., extraction processing parameters). A delivery choice module 114 is software that, by means of a user interface 108, collects the preferred route of administration from the product manufacturer device 102. A choice database 116 stores bioavailability and other parameters for different delivery methods or routes of administration, forms of intake, and form factors. A design delivery module 118 is software that selects based on customer-desired route of administration and bioavailability, the optimal form factor. A capability database 120 is a historical database of the extractor operation. The capability database 120 is maintained by the extractor. The capability database 120 stores extractor historical data regarding form factors, extraction methods, extract types, extract concentrations, processing parameters, and formulation specifics (e.g., recipe). A reporting module 122 is software that decides whether the selected form factor or concentration or formulation specifics may be produced by the extractor. A processing module 124 is software that provides the extractor with the processing parameters closest to the form factor or extract concentration or formulation specifics desired by the product manufacturer.

[0019] FIG. 2 is a flowchart illustrating an exemplary method of optimizing bioavailability. Functioning of the main module 112 will now be explained with reference to FIG.2. One skilled in the art will appreciate that, for this and other processes and methods disclosed herein, the functions performed in the processes and methods may be implemented in differing order. Furthermore, the outlined steps and operations are only provided as examples, and some of the steps and operations may be optional, combined into fewer steps and operations, or expanded into additional steps and operations without detracting from the essence of the disclosed embodiments.

[0020] The process begins at step 200 with the main module 112 continuously updating the choice database 116 and the capability database 120 by means of an API 110 that connects to the extractor network server 106 and to the research network server 104 and integrates capability database information with extractor information for storage at the extractor network server 106.

[0021] At step 202, the main module 112 executes the delivery choice module 114. At step 204, the delivery choice module 114 receives from the customer the route of administration selection and the bioavailability requested and then transfers the route of administration selection and the bioavailability requested to the main module 112. The main module 112 executes the design delivery module 118 at step 206. The design delivery module estimates the optimal form factor for the selected route of administration and bioavailability requested and sends the resulting design parameters to the main module 112 at step 208. The main module 112 executes the reporting module 122 at step 210. The reporting module 122 evaluates the capability of the extractor to deliver the design requested, as well as the processing parameters needed to deliver such design and extract concentration at step 212. If the result is yes, the extractor is capable of delivering the design requested, the main module 112 continues with the execution of the processing module at step 214. If the result is no, the extractor is not capable of delivering the design requested, the main module 112 goes back to step 200 since the main module 112 runs continuously. At step 214, the main module 112 executes the processing module 124. The processing module 124 estimates the processing parameters to obtain the selected design and the right extract concentration at step 216.

[0022] FIG. 3 is a flowchart illustrating an exemplary method of delivery choice for bioavailability optimization. Functioning of the delivery choice module 114 will now be explained with reference to FIG.3.

[0023] At step 300, the delivery choice module 114 is continuously polling the main module

112. At step 302, the delivery choice module 114 initiates when a user makes a selection through the user interface 108 for a preferred route of administration and preferred bioavailability. As an example, the product manufacturer may be interested in a formulated ingredient suitable for production of a CBD cream (i.e., topical route of administration) having high bioavailability. The delivery choice module 114 sends the product manufacturer selection back to the main module

112 at step 304.

[0024] FIG. 4 illustrates an exemplary choice database. Functioning of the choice database 116 will now be explained with reference to FIG. 4. FIG. 4 illustrates the data content of the choice database 116 that stores routes of administration or delivery methods, product types, form factors(e.g., solid, powder, edible, liquid, oil, capsule, gel, patch, smoke, vapor, spray, etc.), and bioavailability that are available through the research network server 104. The choice database 116 is continuously updated with publicly available data by means of the main module 112. The choice database 116 may include other parameters such as dose accuracy, time to onset, duration of effect quality and/or consistency of effect, so that extractor and product manufacturer device 102 can design the extract or delivery method and form factor that optimizes at least one of these parameters of interest. In one example, for medium

bioavailability and high dose accuracy a topical gel may be optimal. In another example, for high bioavailability and low dose accuracy vapor or smoke through inhalation may be optimal. [0025] FIG. 5 is a flowchart illustrating an exemplary method of delivery design for bioavailability optimization. Functioning of the design delivery module 118 will now be explained with reference to FIG.5. The method begins at step 500 with the main module 112 receiving the product manufacturer's 102 route of administration and desired bioavailability selections. In one example, the product manufacturer device 102 is interested in manufacturing a CBD cream (i.e., topical route of administration) having high bioavailability. The design delivery module 118 opens the choice database 116 and selects form factor choices for the selected route of administration and desired bioavailability at step 502. In one example, the form factor choices for topical with high bioavailability would be a formulated CBD cream ingredient. The design delivery module 118 selects the optimal form factor and design parameters at step 504. In one example, the optimal form factor for a CBD cream product would be a formulated CBD cream ingredient with the desired CBD extract concentration in liquid form. The design delivery module 118 sends the form factor and design parameters (i.e., concentration and type of extract) to the main module 112 at step 506.

[0026] FIG. 6 illustrates an exemplary capability database. Functioning of the capability database 120 will now be explained with reference to FIG. 6. FIG. 6 displays the data content of the capability database 120. The capability database 120 stores and updates continuously with the information from the extractor and is maintained by the extractor. The information in the capability database 120 includes for example, form factors (e.g., liquid, vaping liquid, oil, tincture, powder, gel, cream, spray, balsam, ointment, etc.), extraction method used (e.g., microwave, C02, ethanol, hydrocarbon, etc.), extraction parameters employed, extract type produced (e.g., CBD distillate, resin, isolate, concentrate, etc.), processing parameters (e.g., extraction time, temperature, distillation conditions, isolation method), whether additives are needed, extract concentration (e.g., 0.37% w/v/ THC), and formulation ID (e.g., CBD topicals liquid 032).

[0027] FIG. 7 is a flowchart illustrating an exemplary method of reporting bioavailability optimization. Functioning of the reporting module 122 will now be explained with reference to FIG. 7. FIG. 7 displays the object content of the reporting module 122. The process begins at step 700 with the main module 112 feeding form factor and design parameter information to the reporting module 122. In an example, the optimal form factor for a CBD cream product was a formulated CBD liquid with the desired CBD concentration (e.g., 65% w/v CBD). The reporting module 122 opens the capability database 120 that contains extractor historical data and decides whether the extractor has the capability to manufacture the form factor and to achieve the necessary processing parameters at step 702. In one example, the form factor would be a formulated liquid extract with a concentration of 65% w/v CBD. At step 704, the reporting module sends the confirmation or refusal to the main module 112.

[0028] FIG. 8 is a flowchart illustrating an exemplary method of extraction design for bioavailability optimization. Functioning of the processing module 124 will now be explained with reference to FIG. 8. The process begins at step 800 with the processing module 124 receiving information from the main module 112 about the extract form factor and design parameters. The processing module 124 opens the capability database 120 at step 802. The processing module 124 compares the current required extraction conditions and extracts form factors to the historical conditions and form factors saved in the capability database 120 at step 804. The processing module 124 retrieves the closest operational conditions and/or parameters to the current ones at step 806. In one example, the extract is in gel or liquid form with an extract concentration of 0.37% w/v THC. The processing module 124 sends the retrieved information (i.e., operational conditions such as solvent used, residence time, additive use, etc.) to the main module 112 so the extractor can initiate production at step 808.

[0029] The present invention may be implemented in an application that may be operable using a variety of devices. Non-transitory computer-readable storage media refer to any medium or media that participate in providing instructions to a central processing unit (CPU) for execution. Such media can take many forms, including, but not limited to, non-volatile and volatile media such as optical or magnetic disks and dynamic memory, respectively. Common forms of non-transitory computer-readable media include, for example, a floppy disk, a flexible disk, a hard disk, magnetic tape, any other magnetic medium, a CD-ROM disk, digital video disk (DVD), any other optical medium, RAM, PROM, EPROM, a FLASHEPROM, and any other memory chip or cartridge. [0030] Various forms of transmission media may be involved in carrying one or more sequences of one or more instructions to a CPU for execution. A bus carries the data to system

RAM, from which a CPU retrieves and executes the instructions. The instructions received by system RAM can optionally be stored on a fixed disk either before or after execution by a CPU. Various forms of storage may likewise be implemented as well as the necessary network interfaces and network topologies to implement the same.

[0031] The foregoing detailed description of the technology has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the technology to the precise form disclosed. Many modifications and variations are possible in light of the above teaching. The described embodiments were chosen in order to best explain the principles of the technology, its practical application, and to enable others skilled in the art to utilize the technology in various embodiments and with various modifications as are suited to the particular use contemplated. It is intended that the scope of the technology be defined by the claim.

Claims

CLAIMS WHAT IS CLAIMED IS:

1. A system for optimizing bioavailability, the system comprising:

one or more databases that store information regarding a plurality of cannabis-based product form factors each associated with a route of administration and a level of

bioavailability;

one or more communications interfaces that communicate over a communication network, wherein the interfaces receive one or more specifications regarding a route of administration and a level of bioavailability, and

a processor that executes instructions stored in memory, wherein execution of the instructions by the processor:

identifies a set of one or more of the stored form factors associated with the specified route of administration,

selects a form factor from the set based on the associated level of bioavailability corresponding to the specified level of bioavailability, and

determines one or more operational parameters associated with the selected form factor, wherein the determined operational parameters are provided to an extractor device that prepares a cannabis-based product having the selected form factor in accordance with the determined operational parameters.

2. The system of claim 1, further comprising at least one database of a research network server, the at least one database storing information regarding the one or more operational parameters.

3. The system of claim 1, wherein at least one of the databases is a choice database.

4. The system of claim 3, wherein the processor selects the form factor by querying the choice database.

5. The system of claim 4, further comprising a capability database that stores historical data regarding a plurality of operational parameters, and further stores one or more updates regarding the prepared cannabis-based product.

6. The system of claim 5, wherein the historical data associates a plurality of processing parameters with one or more form factors.

7. The system of claim 6, wherein the processor determines the one or more operational parameters by querying the capability database.

8. The system of claim 6, wherein the processor determines the one or more operational parameters by comparing the selected form factor to historical data in the capability database regarding the form factors.

9. The system of claim 6, wherein the processor determines the one or more operational parameters by retrieving one or more form factors from the capability database.

10. A method for optimizing bioavailability, the method comprising:

storing information regarding a plurality of cannabis-based product form factors each associated with a route of administration and a level of bioavailability;

communicating over a communication network to receive one or more specifications regarding a route of administration and a level of bioavailability;

identifying a set of one or more of the stored form factors associated with the specified route of administration;

selecting a form factor from the set based on the associated level of bioavailability corresponding to the specified level of bioavailability; and

determining one or more operational parameters associated with the selected form factor, wherein the determined operational parameters are provided to an extractor device that prepares a cannabis-based product having the selected form factor in accordance with the determined operational parameters.

11. The method of claim 10, wherein selecting the form factor includes querying a choice database.

12. The method of claim 12, further comprising populating the choice database by querying a database of a research network server.

13. The method of claim 10, wherein determining the one or more operational parameters includes querying a capability database that stores historical data regarding a plurality of operational parameters.

14. The method of claim 13, further comprising updating the capability database regarding the prepared cannabis-based product.

15. The method of daim 13, wherein the historical data associates a plurality of processing parameters with one or more form factors.

16. The method of claim 13, wherein determining the one or more operational parameters includes comparing the selected form factor to historical data in the capability database regarding the form factors.

17. The method of claim 13, wherein determining the one or more operational parameters includes retrieving one or more form factors from the capability database.

18. A non-transitory computer-readable storage medium, having embodied thereon a program executable by a processor to perform a method for optimizing bioavailability, the method comprising: