WO2020251642A1 - Systems for dispensing film for oral transmucosal delivery with user specific composition - Google Patents

Systems for dispensing film for oral transmucosal delivery with user specific composition Download PDF

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Publication number
WO2020251642A1
WO2020251642A1 PCT/US2020/022256 US2020022256W WO2020251642A1 WO 2020251642 A1 WO2020251642 A1 WO 2020251642A1 US 2020022256 W US2020022256 W US 2020022256W WO 2020251642 A1 WO2020251642 A1 WO 2020251642A1
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WO
WIPO (PCT)
Prior art keywords
user
tab
dispenser
substrate
active ingredient
Prior art date
Application number
PCT/US2020/022256
Other languages
French (fr)
Inventor
Eliahu Amir HASIDIM
Sharon Fima
Omri SCHANIN
Original Assignee
Cannova Medical Ltd.
The IP Law Firm of Guy Levi, LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cannova Medical Ltd., The IP Law Firm of Guy Levi, LLC filed Critical Cannova Medical Ltd.
Publication of WO2020251642A1 publication Critical patent/WO2020251642A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A61J3/078Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of wafers or cachets
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/13ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered from dispensers
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/17ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems

Definitions

  • the disclosure is directed to systems for a personalized dispenser of controlled, orally dissolving film tabs. More specifically, the disclosure is directed to a device for dispensing a film tab comprising cannabinoids and additional compounds at user-defined ratios.
  • cannabinoids are safe, versatile and potent ingredients that were proved to possess unique biological, medical and chemical properties as drugs and food supplement.
  • Cannabinoids were reported as being beneficial to treat patients suffering from a wide range of symptoms experienced in connection with various, often very serious, medical conditions.
  • cannabinoids has been used to alleviate symptoms associated with cancer, anorexia, AIDS, chronic pain, spasticity, glaucoma, arthritis, migraine and many other illnesses.
  • Dosing of pharmaceuticals and food supplements is a process that needs to be personalized to the user’s needs and tolerances. Moreover, the ratio between the various pharmaceuticals and the various food supplements may prove to change over time, to answer the changing needs and symptoms. For example, 2.5 mg CBD combined with a small amount of THC was found to have a therapeutic effect, while micro dosing intake with as little as 2.5 mg of THC were likewise found to have therapeutic effect.
  • CBD:THC ratios such as 2: 1 or 3: 1, may be an ideal ratio for combating autoimmune disorders, gastrointestinal issues such as Crohn’s and colitis, arthritis, and psoriasis with little to no psychoactivity.
  • equal portions of CBD:THC were found to be effective in use in compositions used for the treatment of pain relief, anxiety, spasticity, fibromyalgia, insomnia, nausea and appetite stimulation, as well as relieving symptoms associated with Multiple Sclerosis and Amyotrophic Fateral Sclerosis (AFS).
  • AFS Amyotrophic Fateral Sclerosis
  • a computerized device (referring to an apparatus comprising one or more processors operable or operating according to one or more programs) for forming a user-specific oral tab, the computerized device comprising a housing with a door; a cartridge comprising a tab forming substrate, wherein the substrate is in a solid form, a first dispenser with a first active ingredient; a conveyor belt sized and configured to deliver the tab-forming substrate from the cartridge to the first dispenser; a user interface module; and a central processing module (CPM) in communication with the cartridge, the first dispenser, the conveyor belt, the user interface module, the CPM comprising a processor, and a non-volatile memory storage device comprising a processor- readable media, having thereon a set of executable instruction configured, when executed, to cause the CPM to: using the user interface, receive a plurality of user-specific parameters associated with the user; compute at least one of dosage, strength, and number of tabs; based on the at least one of the dosage, strength
  • a computerized method of forming a personalized, orally-dispersible thin film tab comprising at least one of THC and CBD at a predetermined concentration (w/w), the method comprising: providing a computerized system comprising a housing with a door, a cartridge comprising a substrate for forming an orally-dispersible film (ODF) tab in a solid form, a first dispenser with a first active ingredient, a conveyor belt sized and configured to deliver the ODF tab-forming substrate from the cartridge to the first dispenser, a user interface, and a central processing module (CPM) in communication with the cartridge, the first dispenser, the conveyor belt, the user interface module, the CPM comprising a processor, and a non volatile memory storage device comprising a processor-readable medial having thereon a set of executable instruction configured, when executed, to cause the CPM to: using the user interface, receive a plurality of user-specific parameters associated with the user; compute at least one of dosage, strength, and number
  • ODF orally-dispersible film
  • FIG. 1 shows a schematic illustration of the device.
  • inventions of systems for a personalized dispenser of controlled orally dissolving film tabs More specifically, provided herein are embodiments of devices for dispensing a film tab comprising THC and CBD at pre-defined doses and ratio based on user-specific parameters.
  • Mouth dissolving films, or orodispersible films can consist of a very thin strip of a given size with a known payload of an agent (the“Tab”), which is placed in an embodiment on the tongue, or in another embodiment, under the tongue of a user in need thereof, or any oral mucosal tissue, then, wet by saliva, leading to rapid disintegration and release of the entrapped ingredient for oromucosal absorption or with formula modifications, will maintain the quick-dissolving aspects allow for absorption to be achieved.
  • the“Tab” an agent
  • the tab can be thin (in other words, less than 4 mm) film with an area of 5- 20 cm 2 containing at least one active ingredient.
  • the dissolution in one embodiment, or disintegration, breakdown, fragmentation, degeneration, deagglomeration or any other process leading to immediate, controlled, extended or sustained release or delivery of payload agent, in water or saliva respectively, is reached through a special matrix fabricated from polymers that are at least partially water-soluble.
  • Active ingredients’ composition can be incorporated up to any single dose that, due to the particular agent will not adversely affect the integrity of the tab and its ability to be physically manipulated by a user, nor affect the physico-chemical properties of the payload agent or the carrier matrix.
  • payload agent concentration of between about 100 mg at a loading range of between about 0.1% to about 50% (w/w) of the carrier (matrix).
  • the physico-chemical properties can be, for example, at least one of:
  • SI Swelling index
  • Tensile strength (the ratio between the maximum force applied to a standard film (e.g., 4 cm 2 ) to break, and the initial cross sectional area of the film (e.g., 4 cm 2 )).
  • Poisson Ratio the ratio between length and width of a standard film (e.g., 4 cm 2 ) along a unidirectional stretching (at the printer dispensing rate).
  • a user-specific oral tab comprising housing 100 with door 101; cartridge 103 comprising tab forming substrate 200, wherein substrate 200 is in solid form.
  • CPM 110 central processing module
  • CPM 110 comprises processor, and non-volatile memory with processor-readable media, having thereon set of executable instruction configured, when executed, to cause CPM 110 to: using user interface 150, receive plurality of user-specific parameters associated with the user consuming the tab; compute at least one of dosage, strength, and number of tabs; based on at least one of dosage, strength and number of tabs, deliver tab forming substrate 200, and dispense active material (or payload agent) onto tab forming substrate 200.
  • CPM 110 central processing module
  • UI user interface
  • the term“user interface” means one or more graphical areas including any number of UI controls which may receive user input (e.g., via a mouse- click, through a ouch screen, etc.).
  • the one or more graphical areas may also include other UI elements (e.g., work areas, menus, graphics, etc.) to facilitate interaction with a user.
  • the one or more graphical areas of UI need not be presented simultaneously.
  • module denotes, but is not limited to, a software component, a hardware component, or a combination of a software component and a hardware component, which performs certain tasks.
  • a module may advantageously be configured to reside on the addressable storage medium/media and configured to execute on one or more processors.
  • a module may include, by way of example, components, such as software components, application specific software component, object-oriented software components, class components and task components, processes, functions, operations, execution threads, attributes, procedures, subroutines, segments of program code, drivers, firmware, microcode, circuitry, data, databases, data structures, tables, arrays, and variables.
  • a module may be combined into fewer components or modules or may be further separated into additional components or modules. Further, the components or modules can operate at least one processor (e.g. central processing unit (CPU)) provided in a device.
  • processor e.g. central processing unit (CPU)
  • a hardware component include an application specific integrated circuit (ASIC) and Field Programmable Gate Array (FPGA).
  • ASIC application specific integrated circuit
  • FPGA Field Programmable Gate Array
  • a module can also denote a combination of a software component(s) and a hardware component(s).
  • the term“module” may refer to sub-systems or systems configured and adapted to perform various tasks.
  • the dissolving (or dispersing, disintegrating etc.,) film tab forming substrate 200 present in cartridge 103 is in the form of a rolled strip defining a longitudinal axis.
  • the film forming substrate can be fabricated by various methods. For example, using at least one of: solvent casting, semisolid casting, hot melt extrusion, solid dispersion extrusion, and rolling.
  • solvent casting water soluble polymers are dissolved in a solvent (e.g., water) along with other additives is dissolved in suitable solvent, then both the polymer and the other additives solutions are mixed and stirred and finally casted into the desired shape, then the solvent is removed by, for example heat and/or vacuum.
  • solid polymer is mixed with additives’ composition entrapped in solid form are mixed to homogeneous mixture, then deposited for example in an extruder hopper. Then the extruder having combination of heaters and pressure melts the mixture. Finally the melt is shaped in to films by the dies.
  • the final tab 250 may also be in the form of a rolled strip, and conveyor belt may further be equipped with at least one roller 170, sized and configured to roll the strip following deposition of the active ingredient(s) or any payload agent.
  • User specific parameters that can be used by the device CPM in order to determine the most beneficial payload can be at least one of the final user of the tab age, gender, weight, underlying pathology, disorder, condition, symptoms, counter indications with other medication of the patient at the time of forming the user-specific formulation, and the severity of such disorders, conditions, pathologies as assessed or otherwise determined by the user (patient), and/or a physician.
  • the device may further be in communication with a remote database and a machine-learning module, and the user-specific parameters input as part of the operation of the device can be a parameter associated with the efficiency and effectiveness of any previously formed tabs.
  • the device can be configured to take into consideration any previously provided tabs and their efficiency (duration of effect, lag time before effect is perceived) and effectiveness (how well was the remediation of the underlying symptoms, elimination of adverse side effects, etc.).
  • the device can provide a user-specific payload that is consistently improving.
  • loading anonymized parameters and final payload parameters to a backend management server, and device, acting as a network node, can be provided an initial payload configuration as an initial“suggestion”.
  • External formulation considerations e.g., plasticizers (molecules soluble in the substrate, operable to increase the interstitial free volume of the substrate to above the volume of the substrate’s molecule critical chain length), crosslinking agents, etc.
  • plasticizers molecules soluble in the substrate, operable to increase the interstitial free volume of the substrate to above the volume of the substrate’s molecule critical chain length
  • crosslinking agents etc.
  • mechanical properties of the films such as, for example, shifting the glass transition temperature (T g ) of the matrix forming substrate 200 to a temperature below the mouth (or room) temperature, flow modifiers, surfactants and the like that will affect the mechanical, chemical and biological properties of the strip and the resulting tabs, as well as their adhesive properties for receiving the dispensed ingredients.
  • Other additives can be added to improve adsorption and/or adherence of the active ingredient(s) (in other words, the payload agents), onto (or partially into) the tab forming substrate 200.
  • Cartridge 103 in communication with CPM 110, can be configured to provide for example, a film strip of the substrate, requiring a cutting means 120 such as guillotine, or a cross knife, or fluid jet (with the proper configuration of the conveyor belt), or a bladed drum, and the like.
  • a cutting means 120 such as guillotine, or a cross knife, or fluid jet (with the proper configuration of the conveyor belt), or a bladed drum, and the like.
  • the location of cutting means 120 can be fixed or movable along longitudinal axis XL of conveyor belt 102, depending on the type and configuration of cutting means 120.
  • cartridge 103 can be sized and configured (operable) to provide the tab (referring to the substrate and the payload agent and any other additive that are together operable to deliver the active ingredient) substrates in their final shape (in other words, pre formed), for example a rectangle, having a thickness of about 1 mm to about 3 mm and a length of between about 2.5 cm and about 5 cm, with width between about 2 cm, and about 4 cm.
  • the CPM can be configured to size the tab (in other words, the substrate forming the orally-dissolving film tab), for optimal loading configured to deliver the active ingredient(s) in the most efficient manner as a function of the surface properties of the substrate forming the orally-dissolving film tab, and the liquids containing the active ingredients.
  • the terms“sized and configured” and“operable”, means the system and/or the device is fully functional and calibrated, comprises elements for, and meets applicable operability requirements to perform a recited function when activated.
  • the substrate forming the orally-dissolving film tab may be dispensed as a strip that is wider than a single tab, and the cutting means, such as a bladed roll, may be configured to have both axial and transversal (to the axial direction) blades, that will form a plurality of tabs 200, such that a single dispensing of the active ingredient, will form an array of tabs.
  • the bladed roll 120 may trim the substrate strip 200 forming the orally-dissolving film tab, to, for example, ensure uniform coverage of the substrate strip forming the orally-dissolving film with the active ingredient(s) (or payload agent) before forming the final tabs 250.
  • Conveyor 102 maneuvering substrate 200 to the dispensing means 104 and when available, 105 used in the methods described and implementable in the systems described can be configured to move at a velocity of between about 5 mm/sec and about lOOOmm/sec.
  • the velocity of the substrate can depend, for example, on at least one of: the form of the tab forming substrate (strip or final sized tab), the desired throughput, the number of dispensing means used in the process, the physico-chemical properties of the dispensed ingredient(s), any post deposition processing, the evaporation rate of solvents in the dispensed ingredient(s), the distance between the dispensing heads, and the like or a combination of factors comprising one or more of the foregoing.
  • device 10 may further comprise second dispenser 105, with a second active ingredient.
  • dispenser refers in an embodiment, to any pump, tube, or container suitable for dispensing the active ingredient(s) regardless of their physical state, without altering that state.
  • the dispenser can be, for example, pneumatic, piezo electric, positive displacement, reciprocal or centrifugal pumps, an auger (if in solid form), or through gravitational dispensing.
  • the term“dispensing means” is broadly meant to include devices or systems for providing, distributing, releasing, injecting, conveying, and/or dosing the active ingredient(s) into a solution to create the dispensed active ingredients in a liquid form.
  • the dispenser can be a module, comprising the hardware, circuitry and component change the phase of the active ingredient, whether chemically or physically, for example, from oil, to an emulsion, or from solid to a solution, emulsion or suspension, as well as, if necessary, the proper openings, dyes, atomizers and the like to provide the proper coverage on the substrate forming the orally-dissolving film tab.
  • the dispensing means is a Piezoelectric pump, configured to deliver between about 25 picoliter (pL), and about 80 pL of the active ingredient(s) per drop, in a temperature of between about 22 °C and about 70 °C.
  • the waveform (in other words, an electrical firing signal waveform measured for example using an oscilloscope, that is adjusted to affect the velocity and/or mass of ejected material) to expel a single droplet can be between about 10V to about 70 V pulse, or between about 16V and about 20V, and can be expelled at frequencies between about 2 kHz and about 500 kHz.
  • Other dispensing means can be needle valve, diaphragm valve, pneumatic solenoid, and the like.
  • the active ingredient used in the first or second dispenser can be at least one of CBD and THC.
  • each dispenser can either have a single active ingredient (only CBD, or only THC e.g.,), or a combination of CBD and THC where each active ingredient is substantially dominant (e.g., having a ratio of between 25: 1 and about 10: 1 major ingredient to minor ingredient.
  • the active ingredients can be in the form of an oily solution, glycerin solution (for both carboxylated and decarboxylated d-THC), acetone extraction (THC-a, crystalline and/or melted), polyethylene glycol, ethanol solution.
  • CBD can be provided as an emulsion in water, etheric oils, acetone and the like.
  • the active ingredients can be sprayed, dripped, or drizzled on the substrate forming the orally-dissolving film tab.
  • the amount used can be controlled and the dispenser (first and/or second) controlled to deliver the desired amount within the operational limits, which will depend on the substrate polymer forming the orally-dissolving film tab, its size and the phase (chemical and physical of the active ingredient(s).
  • the phase of the active ingredient can be the same or different between the dispensers.
  • the first dispenser can have CBD as an active ingredient, in the form of an oil (CBD oil)-in-water (O/W) emulsion, a suspension, a solution, a duplex emulsion, a micelle, a lyposome, or a liquid form comprising one or more of the foregoing, while the second dispenser can have THC in a solid form, as acetone extracted crystals.
  • the first dispenser can be, for example, a pump
  • the second dispenser can be an auger, sized and configured (in other words, operable) to uniformly drizzle the crystalline THC onto the substrate forming the orally-dissolving film tab.
  • both active ingredients can be in the form of an oil, and the dispensers (first and second) can be the same, for example a pneumatic pump.
  • the CBD portion can be at least one of: CBD (cannabidiol), CBDA (cannabidiolic acid), CBN (cannabinol), CBG (cannabigerol), CBC (cannabichromene), and CBL (cannabicyclol).
  • the THC can be at least one of: THC (tetrahydrocannabinol), and THC A (tetrahydrocannabinolic acid), and a composition comprising one or more of the forgoing CBD and/or THC components.
  • the substrate forming the orally-dissolving thin film tab can be formed of, for example, natural polymers, or synthetic polymers.
  • the suitable polymers can be water-soluble or water- swellable polymers, for example at least one of: starch and starch derivatives, dextran; cellulose derivatives, such as carboxymethyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl ethyl cellulose, sodium carboxymethyl cellulose, ethyl cellulose or propyl cellulose; polyacrylic acid, polyacrylates, polyvinyl pyrrolidone, polyethylene oxide polymers, polyacrylamide, polyethylene glycol, gelatin, collagen, alginate, pectin, pullulan, tragacanth, chitosan, alginic acid, arabinogalactan, galactomannan, agar-agar, agarose, carrageenan, and natural gums.
  • the substrate forming the orally-dissolving film tab can further comprise other components, ingredients and/or agents.
  • flavourings, odorous or coloring substances and aromatics either alone or in combination. It is, for example, possible to improve the impression of the taste by adding, for example, flavourings and aromatics such as menthol, eucalyptol, limonene, phenyl ethanol, camphene, pinene, seasoning aromatics such as n-butyl phthalide or cineol, as well as eucalyptus oil and thyme oil, methyl salicylate, turpentine oil, chamomile oil, ethyl vanillin, 6-methyl coumarin, citronellol, and acetic acid n-butyl ester.
  • Additional components can be, for example, plasticizers, to improve the mechanical properties of film such as tensile strength and elongation to the film as well as improving the flow and increasing the polymer’s Young’s modulus.
  • plasticizers can be glycerol, propylene glycol, polyethylene glycol, dimethyl, dibutyl, diethyl phthalate, tributyl, triethyl, actyl citrate, triacetin and castor oil.
  • saliva-promoting agents can also be used. These can be, for example, used alone or in combination in the range of 2-6%. Commonly used saliva stimulating agents are citric acid, malic acid, lactic acid, ascorbic acid, tartaric acid.
  • Various surfactants can also be used, for example to promote wetting and adhesion of the dispensed ingredient(s) onto the substrate forming the orally-dissolving film tab.
  • These can be, for example at least one of: sodium lauryl sulphate; poloxamer 407, benzalkonium chloride, benzethonium chloride, tweens, spans, and the like.
  • the device can also comprise a third dispenser or more, the third dispenser being sized adapted and configured to deposit the substrate forming the orally-dissolving film tab in a liquid form.
  • the language“in a liquid form” refers in an embodiment to a physicochemical form that allows the even deposition of the substrate forming the orally-dissolving film tab as a sealant layer, providing an apical layer above the dispensed active ingredients.
  • other functional modules may be added to the device, such as, at least one of: a heating element 300, an exhaust fan 400 and a vacuum pump 130, in liquid communication with housing 100.
  • the third dispenser can also be an extruder, having solidified substrate forming the orally-dissolving thin film, which is melted by at least one of adding a plasticizer, heating, and pressurizing, such that the extruded strip will adhere to the substrate strip forming the orally-dissolving film coated with the active ingredient(s), then, using the cutting means, cut to the final tabs 250.
  • Other functional modules can also be incorporated in device 10. These include imaging modules, recycling modules for dispensed active ingredient(s), collection troughs, sensor arrays (e.g., temperature, humidity and the like).
  • the term“conveyor belt system” means the same as “conveyor system” or“conveyor belt.”
  • the conveyor belt may further be comprised of links enabling the collection of the active material and be comprised of several segments that are not necessarily in the same direction.
  • the terms“central processing module” (CPM),“module”, “processing circuit”, and/or“processing unit” may be a single processing device or a plurality of processing devices.
  • a processing device may be a microprocessor, micro-controller, digital signal processor, microcomputer, central processing unit, field programmable gate array, programmable logic device, state machine, logic circuitry, analog circuitry, digital circuitry, and/or any device that manipulates signals (analog and/or digital) based on hard coding of the circuitry and/or operational instructions (in other words, firmware).
  • the processor, processing circuit, and/or processing unit may have an associated memory and/or an integrated memory element, which may be a single memory device, a plurality of memory devices, and/or embedded circuitry of the processing module, module, processing circuit, and/or processing unit.
  • a memory device may be a read only memory, random access memory, transient memory, non-transient memory, static memory, dynamic memory, flash memory, cache memory, and/or any device that stores digital information.
  • processor is defined as including, but not necessarily being limited to, an instruction execution system such as a computer/processor based system, an Application Specific Integrated Circuit (ASIC), a computing device, or a hardware and/or software system that can fetch or obtain the logic from a non-transitory storage medium or a non-transitory computer- readable storage medium and execute the instructions contained therein.
  • ASIC Application Specific Integrated Circuit
  • processor can also include any controller, state-machine, microprocessor, cloud-based utility, service or feature, or any other analogue, digital and/or mechanical implementation thereof.
  • the computer program (software and/or firmware), can comprise program code means for carrying out the steps of the methods described herein, as well as a computer program product comprising program code means stored on a medium that can be read by a computer, such as a hard disk, SATA CD-ROM, DVD, USB memory stick, or a storage medium that can be accessed via a data network, such as the Internet or Intranet, when the computer program product is loaded in the main memory of a computer and is carried out by the computer.
  • a data network such as the Internet or Intranet
  • Non-transitory storage medium and non-transitory computer-readable storage medium may include any one of many physical media such as, for example, electronic, magnetic, optical, electromagnetic, or semiconductor media. More specific examples of suitable non-transitory storage medium and non-transitory computer- readable storage medium include, but are not limited to, a magnetic computer diskette such as floppy diskettes or hard drives, magnetic tape, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM), a flash drive, a compact disc (CD), or a digital video disk (DVD).
  • a magnetic computer diskette such as floppy diskettes or hard drives
  • RAM random access memory
  • ROM read-only memory
  • EPROM erasable programmable read-only memory
  • flash drive a compact disc (CD), or a digital video disk (DVD).
  • CD compact disc
  • DVD digital video disk
  • the term “about” means that amounts, sizes, formulations, parameters, and other quantities and characteristics are not and need not be exact, but may be approximate and/or larger or smaller, as desired, reflecting tolerances, conversion factors, rounding off, measurement error and the like, and other factors known to those of skill in the art. In general, an amount, size, formulation, parameter or other quantity or characteristic is “about” or “approximate” whether or not expressly stated to be such.
  • a computerized device for forming a user-specific oral tab comprising a housing with a door (referring to any housing that at least partially encloses the treatment segment.
  • the housing can be only partially closed); a cartridge (referring to a removable container operable to deliver the tab forming substrate, whether solid, or liquid) comprising a tab forming substrate, wherein the substrate is in a solid form a first dispenser with a first active ingredient; a conveyor belt sized and configured to deliver the tab forming substrate from the cartridge to the first dispenser; a user interface module; and a central processing module (CPM) in communication with the cartridge, the first dispenser, the conveyor belt, the user interface module, the CPM comprising at least one processor, and a non-volatile memory storage device comprising a processor-readable media, having thereon a set of executable instruction configured, when executed, to cause the CPM to: using the user interface, receive a plurality of user- specific parameters associated with the user;
  • CPM central processing module

Abstract

The disclosure relates to systems for a personalized dispenser of controlled orally dissolving film tabs. More specifically, the disclosure relates to a computerized device for dispensing a film tab comprising cannabinoids at user-specific doses and ratio.

Description

SYSTEMS FOR DISPENSING FIFM FOR ORAF TRANSMUCOSAF DEFIVERY WITH USER
SPECIFIC COMPOSITION
BACKGROUND
[0001] The disclosure is directed to systems for a personalized dispenser of controlled, orally dissolving film tabs. More specifically, the disclosure is directed to a device for dispensing a film tab comprising cannabinoids and additional compounds at user-defined ratios.
[0002] Evidence suggests that cannabinoids are safe, versatile and potent ingredients that were proved to possess unique biological, medical and chemical properties as drugs and food supplement. Cannabinoids were reported as being beneficial to treat patients suffering from a wide range of symptoms experienced in connection with various, often very serious, medical conditions. For example, cannabinoids has been used to alleviate symptoms associated with cancer, anorexia, AIDS, chronic pain, spasticity, glaucoma, arthritis, migraine and many other illnesses.
[0003] Dosing of pharmaceuticals and food supplements is a process that needs to be personalized to the user’s needs and tolerances. Moreover, the ratio between the various pharmaceuticals and the various food supplements may prove to change over time, to answer the changing needs and symptoms. For example, 2.5 mg CBD combined with a small amount of THC was found to have a therapeutic effect, while micro dosing intake with as little as 2.5 mg of THC were likewise found to have therapeutic effect.
[0004] Change in the ratio between pharmaceuticals and/or food supplements can result in different medical effects. For example, CBD:THC ratios such as 2: 1 or 3: 1, may be an ideal ratio for combating autoimmune disorders, gastrointestinal issues such as Crohn’s and colitis, arthritis, and psoriasis with little to no psychoactivity. On the other hand, equal portions of CBD:THC were found to be effective in use in compositions used for the treatment of pain relief, anxiety, spasticity, fibromyalgia, insomnia, nausea and appetite stimulation, as well as relieving symptoms associated with Multiple Sclerosis and Amyotrophic Fateral Sclerosis (AFS).
[0005] Accordingly, users, which may be very diverse in their personal needs, very seldom have a single symptom and there is a need to provide a personalized dosing, both in terms of total ingredients’ amount and their ratio in a dosage form that is personalized for their underlying condition and more effective in delivering the pharmaceutical payload. SUMMARY
[0006] Disclosed, in various embodiments, are systems and methods providing a personalized, user-specific dispenser of controlled orally dissolving transmucosal film tabs. More specifically, the disclosure is directed to a device for dispensing a tab comprising THC and/or CBD at defined ratio and concentrations based on user-specific parameters and methods for forming the tabs.
[0007] In an embodiment provided herein is a computerized device (referring to an apparatus comprising one or more processors operable or operating according to one or more programs) for forming a user-specific oral tab, the computerized device comprising a housing with a door; a cartridge comprising a tab forming substrate, wherein the substrate is in a solid form, a first dispenser with a first active ingredient; a conveyor belt sized and configured to deliver the tab-forming substrate from the cartridge to the first dispenser; a user interface module; and a central processing module (CPM) in communication with the cartridge, the first dispenser, the conveyor belt, the user interface module, the CPM comprising a processor, and a non-volatile memory storage device comprising a processor- readable media, having thereon a set of executable instruction configured, when executed, to cause the CPM to: using the user interface, receive a plurality of user-specific parameters associated with the user; compute at least one of dosage, strength, and number of tabs; based on the at least one of the dosage, strength and number of tabs, deliver the tab forming substrate, and dispense the active material onto the tab forming substrate.
[0008] In another embodiment, provided herein is a computerized method of forming a personalized, orally-dispersible thin film tab, comprising at least one of THC and CBD at a predetermined concentration (w/w), the method comprising: providing a computerized system comprising a housing with a door, a cartridge comprising a substrate for forming an orally-dispersible film (ODF) tab in a solid form, a first dispenser with a first active ingredient, a conveyor belt sized and configured to deliver the ODF tab-forming substrate from the cartridge to the first dispenser, a user interface, and a central processing module (CPM) in communication with the cartridge, the first dispenser, the conveyor belt, the user interface module, the CPM comprising a processor, and a non volatile memory storage device comprising a processor-readable medial having thereon a set of executable instruction configured, when executed, to cause the CPM to: using the user interface, receive a plurality of user-specific parameters associated with the user; compute at least one of dosage, strength, and number of tabs; based on the at least one of the dosage, strength and number of tabs, deliver the tab forming substrate, and dispense the active material onto the tab forming substrate; using the user interface, inputting the plurality of user-specific parameters; based on the input plurality of the user-specific parameters, defining the desired amount of the first active ingredient; providing the substrate forming the orally-dispersible film (ODF) tab; and using the first dispenser, depositing the first ingredient onto the substrate.
[0009] These and other features of the systems and methods for a personalized dispenser of controlled orally dissolving film tabs comprising THC and/or CBD at pre-defined doses and ratio based on user-specific parameters, will become apparent from the following detailed description when read in conjunction with the figures and examples, which are exemplary, not limiting.
BRIEF DESCRIPTION OF THE FIGURES
[00010] For a better understanding of the device for dispensing a film tab comprising user selected components at pre-defined doses and ratios based on user-specific parameters, with regard to the embodiments thereof, reference is made to the accompanying examples and figures, in which:
[00011] FIG. 1 shows a schematic illustration of the device.
DETAILED DESCRIPTION
[00012] Provided herein are embodiments of systems for a personalized dispenser of controlled orally dissolving film tabs. More specifically, provided herein are embodiments of devices for dispensing a film tab comprising THC and CBD at pre-defined doses and ratio based on user-specific parameters.
[00013] Mouth dissolving films, or orodispersible films (ODF), can consist of a very thin strip of a given size with a known payload of an agent (the“Tab”), which is placed in an embodiment on the tongue, or in another embodiment, under the tongue of a user in need thereof, or any oral mucosal tissue, then, wet by saliva, leading to rapid disintegration and release of the entrapped ingredient for oromucosal absorption or with formula modifications, will maintain the quick-dissolving aspects allow for absorption to be achieved.
[00014] For example, the tab can be thin (in other words, less than 4 mm) film with an area of 5- 20 cm2 containing at least one active ingredient. The dissolution in one embodiment, or disintegration, breakdown, fragmentation, degeneration, deagglomeration or any other process leading to immediate, controlled, extended or sustained release or delivery of payload agent, in water or saliva respectively, is reached through a special matrix fabricated from polymers that are at least partially water-soluble. Active ingredients’ composition can be incorporated up to any single dose that, due to the particular agent will not adversely affect the integrity of the tab and its ability to be physically manipulated by a user, nor affect the physico-chemical properties of the payload agent or the carrier matrix. For example payload agent concentration of between about 100 mg at a loading range of between about 0.1% to about 50% (w/w) of the carrier (matrix).
[00015] The physico-chemical properties can be, for example, at least one of:
• Physical appearance (color, flexibility, homogeneity and smoothness, uniformity of weight and film thickness).
• In Vitro disintegration (the time for disintegration, breakdown, fragmentation, degeneration, deagglomeration or any other process leading to immediate, controlled, extended or sustained release or delivery of payload agent).
• Swelling index (SI) the rate of weight gain of a standard film (e.g., 4 cm2) in simulated saliva.
• Resiliency (number of folds in the same location to break).
• Tensile strength (the ratio between the maximum force applied to a standard film (e.g., 4 cm2) to break, and the initial cross sectional area of the film (e.g., 4 cm2)).
• Poisson Ratio (the ratio between length and width of a standard film (e.g., 4 cm2) along a unidirectional stretching (at the printer dispensing rate).
• Surface pH (of the film loaded with the active ingredients)
• Drug Yield (percent of active ingredients ending on the film relative to the dispensed amount)
• Release Rate (the amount of drug sampled at a fixed time interval under simulated saliva conditions)
The methods for measuring the physico-chemical parameters disclosed is known to the skilled artisan and can be found, for example, in Prabhakara Prabhu et ak,“ Formulation and evaluation of fast dissolving films of lisinopri Egyptian Pharmaceutical Journal, 14:56-64 (2015)
[00016] Accordingly, and in an embodiment illustrated in FIG. 1, provided herein is computerized device 10 for forming a user-specific oral tab comprising housing 100 with door 101; cartridge 103 comprising tab forming substrate 200, wherein substrate 200 is in solid form. The first dispenser 104 with first active ingredient, or, in other words, payload agent (referring to the portion of a greater whole which is distinct from the oral tab required to deliver it), dispenser 104 adapted to deliver the payload agent onto conveyor belt 102, sized and configured to deliver tab-forming substrate 200 from cartridge 103 to first dispenser 104. Also shown is user interface module 150; and central processing module (CPM) 110 in communication with cartridge 103, first dispenser 104, conveyor belt 102, further wherein CPM 110 comprises processor, and non-volatile memory with processor-readable media, having thereon set of executable instruction configured, when executed, to cause CPM 110 to: using user interface 150, receive plurality of user-specific parameters associated with the user consuming the tab; compute at least one of dosage, strength, and number of tabs; based on at least one of dosage, strength and number of tabs, deliver tab forming substrate 200, and dispense active material (or payload agent) onto tab forming substrate 200.
[00017] In the context of the disclosure, the term“user interface” (UI) means one or more graphical areas including any number of UI controls which may receive user input (e.g., via a mouse- click, through a ouch screen, etc.). The one or more graphical areas may also include other UI elements (e.g., work areas, menus, graphics, etc.) to facilitate interaction with a user. Moreover, the one or more graphical areas of UI need not be presented simultaneously.
[00018] The term“module”, as used herein, denotes, but is not limited to, a software component, a hardware component, or a combination of a software component and a hardware component, which performs certain tasks. A module may advantageously be configured to reside on the addressable storage medium/media and configured to execute on one or more processors. Thus, a module may include, by way of example, components, such as software components, application specific software component, object-oriented software components, class components and task components, processes, functions, operations, execution threads, attributes, procedures, subroutines, segments of program code, drivers, firmware, microcode, circuitry, data, databases, data structures, tables, arrays, and variables. The functionality provided for in the components or module, may be combined into fewer components or modules or may be further separated into additional components or modules. Further, the components or modules can operate at least one processor (e.g. central processing unit (CPU)) provided in a device. In addition, examples of a hardware component include an application specific integrated circuit (ASIC) and Field Programmable Gate Array (FPGA). As indicated above, a module can also denote a combination of a software component(s) and a hardware component(s). Furthermore, the term“module” may refer to sub-systems or systems configured and adapted to perform various tasks. [00019] In an embodiment, the dissolving (or dispersing, disintegrating etc.,) film tab forming substrate 200 present in cartridge 103 is in the form of a rolled strip defining a longitudinal axis. Initially, before being stored in cartridge, the film forming substrate can be fabricated by various methods. For example, using at least one of: solvent casting, semisolid casting, hot melt extrusion, solid dispersion extrusion, and rolling. For example, in solvent casting, water soluble polymers are dissolved in a solvent (e.g., water) along with other additives is dissolved in suitable solvent, then both the polymer and the other additives solutions are mixed and stirred and finally casted into the desired shape, then the solvent is removed by, for example heat and/or vacuum. Likewise, in hot melt extrusion, solid polymer is mixed with additives’ composition entrapped in solid form are mixed to homogeneous mixture, then deposited for example in an extruder hopper. Then the extruder having combination of heaters and pressure melts the mixture. Finally the melt is shaped in to films by the dies. It is noted, that the final tab 250 may also be in the form of a rolled strip, and conveyor belt may further be equipped with at least one roller 170, sized and configured to roll the strip following deposition of the active ingredient(s) or any payload agent.
[00020] User specific parameters that can be used by the device CPM in order to determine the most beneficial payload (dose and combination) can be at least one of the final user of the tab age, gender, weight, underlying pathology, disorder, condition, symptoms, counter indications with other medication of the patient at the time of forming the user-specific formulation, and the severity of such disorders, conditions, pathologies as assessed or otherwise determined by the user (patient), and/or a physician. Furthermore, the device may further be in communication with a remote database and a machine-learning module, and the user-specific parameters input as part of the operation of the device can be a parameter associated with the efficiency and effectiveness of any previously formed tabs. In other words, the device can be configured to take into consideration any previously provided tabs and their efficiency (duration of effect, lag time before effect is perceived) and effectiveness (how well was the remediation of the underlying symptoms, elimination of adverse side effects, etc.). By learning the user (e.g., patient in need thereof), the device can provide a user-specific payload that is consistently improving. Moreover, loading anonymized parameters and final payload parameters to a backend management server, and device, acting as a network node, can be provided an initial payload configuration as an initial“suggestion”.
[00021] External formulation considerations (e.g., plasticizers (molecules soluble in the substrate, operable to increase the interstitial free volume of the substrate to above the volume of the substrate’s molecule critical chain length), crosslinking agents, etc.) can be made to affect mechanical properties of the films, such as, for example, shifting the glass transition temperature (Tg) of the matrix forming substrate 200 to a temperature below the mouth (or room) temperature, flow modifiers, surfactants and the like that will affect the mechanical, chemical and biological properties of the strip and the resulting tabs, as well as their adhesive properties for receiving the dispensed ingredients. Other additives can be added to improve adsorption and/or adherence of the active ingredient(s) (in other words, the payload agents), onto (or partially into) the tab forming substrate 200.
[00022] Cartridge 103, in communication with CPM 110, can be configured to provide for example, a film strip of the substrate, requiring a cutting means 120 such as guillotine, or a cross knife, or fluid jet (with the proper configuration of the conveyor belt), or a bladed drum, and the like. As illustrated in FIG. 1, the location of cutting means 120, can be fixed or movable along longitudinal axis XL of conveyor belt 102, depending on the type and configuration of cutting means 120. Alternatively, cartridge 103 can be sized and configured (operable) to provide the tab (referring to the substrate and the payload agent and any other additive that are together operable to deliver the active ingredient) substrates in their final shape (in other words, pre formed), for example a rectangle, having a thickness of about 1 mm to about 3 mm and a length of between about 2.5 cm and about 5 cm, with width between about 2 cm, and about 4 cm. In an embodiment, the CPM can be configured to size the tab (in other words, the substrate forming the orally-dissolving film tab), for optimal loading configured to deliver the active ingredient(s) in the most efficient manner as a function of the surface properties of the substrate forming the orally-dissolving film tab, and the liquids containing the active ingredients. In the context of the disclosure, the terms“sized and configured” and“operable”, means the system and/or the device is fully functional and calibrated, comprises elements for, and meets applicable operability requirements to perform a recited function when activated.
[00023] The substrate forming the orally-dissolving film tab may be dispensed as a strip that is wider than a single tab, and the cutting means, such as a bladed roll, may be configured to have both axial and transversal (to the axial direction) blades, that will form a plurality of tabs 200, such that a single dispensing of the active ingredient, will form an array of tabs. Moreover, the bladed roll 120 may trim the substrate strip 200 forming the orally-dissolving film tab, to, for example, ensure uniform coverage of the substrate strip forming the orally-dissolving film with the active ingredient(s) (or payload agent) before forming the final tabs 250. [00024] Conveyor 102 maneuvering substrate 200 to the dispensing means 104 and when available, 105 used in the methods described and implementable in the systems described can be configured to move at a velocity of between about 5 mm/sec and about lOOOmm/sec. The velocity of the substrate can depend, for example, on at least one of: the form of the tab forming substrate (strip or final sized tab), the desired throughput, the number of dispensing means used in the process, the physico-chemical properties of the dispensed ingredient(s), any post deposition processing, the evaporation rate of solvents in the dispensed ingredient(s), the distance between the dispensing heads, and the like or a combination of factors comprising one or more of the foregoing.
[00025] In certain embodiments, device 10 may further comprise second dispenser 105, with a second active ingredient. The term“dispenser” as used herein, refers in an embodiment, to any pump, tube, or container suitable for dispensing the active ingredient(s) regardless of their physical state, without altering that state. The dispenser can be, for example, pneumatic, piezo electric, positive displacement, reciprocal or centrifugal pumps, an auger (if in solid form), or through gravitational dispensing. In another embodiment, the term“dispensing means” is broadly meant to include devices or systems for providing, distributing, releasing, injecting, conveying, and/or dosing the active ingredient(s) into a solution to create the dispensed active ingredients in a liquid form.
The dispenser can be a module, comprising the hardware, circuitry and component change the phase of the active ingredient, whether chemically or physically, for example, from oil, to an emulsion, or from solid to a solution, emulsion or suspension, as well as, if necessary, the proper openings, dyes, atomizers and the like to provide the proper coverage on the substrate forming the orally-dissolving film tab. In an embodiment, the dispensing means is a Piezoelectric pump, configured to deliver between about 25 picoliter (pL), and about 80 pL of the active ingredient(s) per drop, in a temperature of between about 22 °C and about 70 °C. Likewise, the waveform (in other words, an electrical firing signal waveform measured for example using an oscilloscope, that is adjusted to affect the velocity and/or mass of ejected material) to expel a single droplet can be between about 10V to about 70 V pulse, or between about 16V and about 20V, and can be expelled at frequencies between about 2 kHz and about 500 kHz. Other dispensing means can be needle valve, diaphragm valve, pneumatic solenoid, and the like.
[00026] As indicated, the active ingredient used in the first or second dispenser, can be at least one of CBD and THC. For example, each dispenser can either have a single active ingredient (only CBD, or only THC e.g.,), or a combination of CBD and THC where each active ingredient is substantially dominant (e.g., having a ratio of between 25: 1 and about 10: 1 major ingredient to minor ingredient. The active ingredients can be in the form of an oily solution, glycerin solution (for both carboxylated and decarboxylated d-THC), acetone extraction (THC-a, crystalline and/or melted), polyethylene glycol, ethanol solution. Likewise CBD can be provided as an emulsion in water, etheric oils, acetone and the like. The active ingredients can be sprayed, dripped, or drizzled on the substrate forming the orally-dissolving film tab. Using the CPM, the amount used can be controlled and the dispenser (first and/or second) controlled to deliver the desired amount within the operational limits, which will depend on the substrate polymer forming the orally-dissolving film tab, its size and the phase (chemical and physical of the active ingredient(s). The phase of the active ingredient can be the same or different between the dispensers. For example, the first dispenser can have CBD as an active ingredient, in the form of an oil (CBD oil)-in-water (O/W) emulsion, a suspension, a solution, a duplex emulsion, a micelle, a lyposome, or a liquid form comprising one or more of the foregoing, while the second dispenser can have THC in a solid form, as acetone extracted crystals. Accordingly, the first dispenser can be, for example, a pump, while the second dispenser can be an auger, sized and configured (in other words, operable) to uniformly drizzle the crystalline THC onto the substrate forming the orally-dissolving film tab. Alternatively, both active ingredients can be in the form of an oil, and the dispensers (first and second) can be the same, for example a pneumatic pump.
[00027] The CBD portion can be at least one of: CBD (cannabidiol), CBDA (cannabidiolic acid), CBN (cannabinol), CBG (cannabigerol), CBC (cannabichromene), and CBL (cannabicyclol). Likewise, the THC can be at least one of: THC (tetrahydrocannabinol), and THC A (tetrahydrocannabinolic acid), and a composition comprising one or more of the forgoing CBD and/or THC components.
[00028] The substrate forming the orally-dissolving thin film tab can be formed of, for example, natural polymers, or synthetic polymers. The suitable polymers can be water-soluble or water- swellable polymers, for example at least one of: starch and starch derivatives, dextran; cellulose derivatives, such as carboxymethyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl ethyl cellulose, sodium carboxymethyl cellulose, ethyl cellulose or propyl cellulose; polyacrylic acid, polyacrylates, polyvinyl pyrrolidone, polyethylene oxide polymers, polyacrylamide, polyethylene glycol, gelatin, collagen, alginate, pectin, pullulan, tragacanth, chitosan, alginic acid, arabinogalactan, galactomannan, agar-agar, agarose, carrageenan, and natural gums. [00029] The substrate forming the orally-dissolving film tab can further comprise other components, ingredients and/or agents. For example, flavourings, odorous or coloring substances and aromatics, either alone or in combination. It is, for example, possible to improve the impression of the taste by adding, for example, flavourings and aromatics such as menthol, eucalyptol, limonene, phenyl ethanol, camphene, pinene, seasoning aromatics such as n-butyl phthalide or cineol, as well as eucalyptus oil and thyme oil, methyl salicylate, turpentine oil, chamomile oil, ethyl vanillin, 6-methyl coumarin, citronellol, and acetic acid n-butyl ester.
[00030] Additional components can be, for example, plasticizers, to improve the mechanical properties of film such as tensile strength and elongation to the film as well as improving the flow and increasing the polymer’s Young’s modulus. Examples of the used plasticizers can be glycerol, propylene glycol, polyethylene glycol, dimethyl, dibutyl, diethyl phthalate, tributyl, triethyl, actyl citrate, triacetin and castor oil. Likewise, saliva-promoting agents can also be used. These can be, for example, used alone or in combination in the range of 2-6%. Commonly used saliva stimulating agents are citric acid, malic acid, lactic acid, ascorbic acid, tartaric acid.
[00031] Various surfactants can also be used, for example to promote wetting and adhesion of the dispensed ingredient(s) onto the substrate forming the orally-dissolving film tab. These can be, for example at least one of: sodium lauryl sulphate; poloxamer 407, benzalkonium chloride, benzethonium chloride, tweens, spans, and the like.
[00032] The device can also comprise a third dispenser or more, the third dispenser being sized adapted and configured to deposit the substrate forming the orally-dissolving film tab in a liquid form. As used herein, the language“in a liquid form” refers in an embodiment to a physicochemical form that allows the even deposition of the substrate forming the orally-dissolving film tab as a sealant layer, providing an apical layer above the dispensed active ingredients. Under these circumstances, other functional modules may be added to the device, such as, at least one of: a heating element 300, an exhaust fan 400 and a vacuum pump 130, in liquid communication with housing 100. The third dispenser can also be an extruder, having solidified substrate forming the orally-dissolving thin film, which is melted by at least one of adding a plasticizer, heating, and pressurizing, such that the extruded strip will adhere to the substrate strip forming the orally-dissolving film coated with the active ingredient(s), then, using the cutting means, cut to the final tabs 250.
[00033] Other functional modules can also be incorporated in device 10. These include imaging modules, recycling modules for dispensed active ingredient(s), collection troughs, sensor arrays (e.g., temperature, humidity and the like). Likewise, the term“conveyor belt system” means the same as “conveyor system” or“conveyor belt.” In other words, the conveyor belt may further be comprised of links enabling the collection of the active material and be comprised of several segments that are not necessarily in the same direction.
[00034] As may also be used herein, the terms“central processing module” (CPM),“module”, “processing circuit”, and/or“processing unit” may be a single processing device or a plurality of processing devices. Such a processing device may be a microprocessor, micro-controller, digital signal processor, microcomputer, central processing unit, field programmable gate array, programmable logic device, state machine, logic circuitry, analog circuitry, digital circuitry, and/or any device that manipulates signals (analog and/or digital) based on hard coding of the circuitry and/or operational instructions (in other words, firmware). The processor, processing circuit, and/or processing unit may have an associated memory and/or an integrated memory element, which may be a single memory device, a plurality of memory devices, and/or embedded circuitry of the processing module, module, processing circuit, and/or processing unit. Such a memory device may be a read only memory, random access memory, transient memory, non-transient memory, static memory, dynamic memory, flash memory, cache memory, and/or any device that stores digital information.
[00035] As used herein, the term“processor” is defined as including, but not necessarily being limited to, an instruction execution system such as a computer/processor based system, an Application Specific Integrated Circuit (ASIC), a computing device, or a hardware and/or software system that can fetch or obtain the logic from a non-transitory storage medium or a non-transitory computer- readable storage medium and execute the instructions contained therein.“Processor” can also include any controller, state-machine, microprocessor, cloud-based utility, service or feature, or any other analogue, digital and/or mechanical implementation thereof. In addition, the computer program (software and/or firmware), can comprise program code means for carrying out the steps of the methods described herein, as well as a computer program product comprising program code means stored on a medium that can be read by a computer, such as a hard disk, SATA CD-ROM, DVD, USB memory stick, or a storage medium that can be accessed via a data network, such as the Internet or Intranet, when the computer program product is loaded in the main memory of a computer and is carried out by the computer. Thus, the terms“non-transitory storage medium” and non-transitory computer-readable storage medium” are defined as including, but not necessarily being limited to, any media that can contain, store, or maintain programs, information, and data. Non-transitory storage medium and non-transitory computer-readable storage medium may include any one of many physical media such as, for example, electronic, magnetic, optical, electromagnetic, or semiconductor media. More specific examples of suitable non-transitory storage medium and non-transitory computer- readable storage medium include, but are not limited to, a magnetic computer diskette such as floppy diskettes or hard drives, magnetic tape, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM), a flash drive, a compact disc (CD), or a digital video disk (DVD).
[00036] The term "comprising" and its derivatives, as used herein, are intended to be open ended terms that specify the presence of the stated features, elements, components, groups, integers, and/or steps, but do not exclude the presence of other unstated features, elements, components, groups, integers and/or steps. The foregoing also applies to words having similar meanings such as the terms, "including", "having" and their derivatives. Additionally and unless specifically stated otherwise, as apparent from the discussions, it is appreciated that throughout the specification discussions utilizing terms such as“processing,”“providing,”“in communication,”“forming”“generating”,“transmitting”, “receiving” or the like, refer to the action and/or processes of a computer or computing system, or similar electronic computing device, that manipulate and/or transform data represented as physical, such as a transceiver architecture into other data similarly represented as physical and structural layers
[00037] All ranges disclosed herein are inclusive of the endpoints, and the endpoints are independently combinable with each other.“Combination” is inclusive of blends, mixtures, alloys, reaction products, and the like. The terms“a”,“an” and“the” herein do not denote a limitation of quantity and are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The suffix“(s)” as used herein is intended to include both the singular and the plural of the term that it modifies, thereby including one or more of that term (e.g., the particle(s) includes one or more particles). Reference throughout the specification to “one embodiment”,“another embodiment”,“an embodiment”, and so forth, when present, means that a particular element (e.g., feature, structure, and/or characteristic) described in connection with the embodiment is included in at least one embodiment described herein, and may or may not be present in other embodiments. In addition, it is to be understood that the described elements may be combined in any suitable manner in the various embodiments.
[00038] All ranges disclosed herein are inclusive of the endpoints, and the endpoints are independently combinable with each other. Furthermore, the terms“first,”“second,” and the like, herein do not denote any order, quantity, or importance, but rather are used to denote one element from another.
[00039] Likewise, the term "about" means that amounts, sizes, formulations, parameters, and other quantities and characteristics are not and need not be exact, but may be approximate and/or larger or smaller, as desired, reflecting tolerances, conversion factors, rounding off, measurement error and the like, and other factors known to those of skill in the art. In general, an amount, size, formulation, parameter or other quantity or characteristic is "about" or "approximate" whether or not expressly stated to be such.
[00040] Accordingly and in an exemplary implementation, disclosed herein is a computerized device for forming a user-specific oral tab comprising a housing with a door (referring to any housing that at least partially encloses the treatment segment. In particular, the housing can be only partially closed); a cartridge (referring to a removable container operable to deliver the tab forming substrate, whether solid, or liquid) comprising a tab forming substrate, wherein the substrate is in a solid form a first dispenser with a first active ingredient; a conveyor belt sized and configured to deliver the tab forming substrate from the cartridge to the first dispenser; a user interface module; and a central processing module (CPM) in communication with the cartridge, the first dispenser, the conveyor belt, the user interface module, the CPM comprising at least one processor, and a non-volatile memory storage device comprising a processor-readable media, having thereon a set of executable instruction configured, when executed, to cause the CPM to: using the user interface, receive a plurality of user- specific parameters associated with the user; compute at least one of dosage, strength, and number of tabs; based on the at least one of the dosage, strength and number of tabs, deliver the tab forming substrate, and dispense the active material onto the tab forming substrate, wherein (i) the tab-forming substrate is in the form of a rolled strip defining a longitudinal axis, (ii) the device further comprises a cutting means, configured, when actuated, to cut the strip to a predetermined size, wherein (iii) the tab forming substrate is pre-formed, wherein (iv) the first active ingredient is at least one of a Tetrahydrocannabinol (THC) and a Cannabidiol (CBD), the device (v) further comprising a second dispenser with a second active ingredient, (vi) the second active ingredient is at least one of a Tetrahydrocannabinol (THC) and a Cannabidiol (CBD), that is different than, or having a different ratio than the first dispenser, wherein (vii) the substrate is a composition comprising hydrocolloid comprising an alginate, xanthan gum, carrageenan gum, poly(vinylpirrolidone), poly(maltotriose), or a composition comprising one or more of the foregoing, wherein (viii) the first active ingredient is in the form of an emulsion, a suspension, a solution, a duplex emulsion, a micelle, a lyposome, or a liquid form comprising one or more of the foregoing, wherein (ix) the user interface is configured to provide, upon execution by the user, a selectable ratio between the first active ingredient and the second active ingredient, the device further comprising (x) comprising a third dispenser with the substrate or a portion thereof in a liquid form, as well as (xi) at least one of: a heating element, a vacuum pump in liquid communication with the housing, and a fan, and (xii) a bladed roll, configured to cut the substrate strip forming the orally-dispersible thin film in an axial direction and in transverse direction, and wherein (xiii) the plurality of user-specific parameters comprise: user age, user weight, user gender, at least one of the disorder, pathology, symptom, and condition of the user for which the tab is sought, and the severity of the at least one of the: disorder, pathology, symptom, and condition of the user for which the tab is sought.
[00041] While particular embodiments have been described, alternatives, modifications, variations, improvements, and substantial equivalents that are or may be presently unforeseen may arise to applicants or others skilled in the art. Accordingly, the appended claims as filed and as they may be amended, are intended to embrace all such alternatives, modifications variations, improvements, and substantial equivalents.

Claims

What is claimed:
1. A computerized device for forming a user-specific oral tab comprising
a. a housing with a door;
b. a cartridge comprising a tab forming substrate, wherein the substrate is in a solid form. c. a first dispenser with a first active ingredient;
d. a conveyor belt sized and configured to deliver the tab-forming substrate from the cartridge to the first dispenser;
e. a user interface module; and
f. a central processing module (CPM) in communication with the cartridge, the first dispenser, the conveyor belt, the user interface module, the CPM comprising at least one processor, and a non-volatile memory storage device comprising a processor-readable media, having thereon a set of executable instruction configured, when executed, to cause the CPM to:
i. using the user interface, receive a plurality of user-specific parameters associated with the user;
ii. compute at least one of dosage, strength, and number of tabs;
iii. based on the at least one of the dosage, strength and number of tabs, deliver the tab forming substrate, and dispense the active material onto the tab forming substrate.
2. The device of claim 1, wherein the tab-forming substrate is in the form of a rolled strip defining a longitudinal axis.
3. The device of claim 2, wherein the device further comprises a cutting means, operable to cut the strip to a predetermined size.
4. The device of claim 1, wherein the tab forming substrate is pre-formed.
5. The device of claim 2, or 4, wherein the first active ingredient is at least one of a
Tetrahydrocannabinol (THC) and a Cannabidiol (CBD).
6. The device of claim 5, further comprising a second dispenser with a second active ingredient.
7. The device of claim 6, wherein the second active ingredient is at least one of a
Tetrahydrocannabinol (THC) and a Cannabidiol (CBD), that is different than, or having a different ratio than the first dispenser.
8. The device of claim 1, wherein the substrate is a composition comprising hydrocolloid comprising an alginate, xanthan gum, carrageenan gum, poly(vinylpirrolidone), poly(maltotriose), or a composition comprising one or more of the foregoing.
9. The device of claim 1, or 7, wherein the first active ingredient is in the form of an emulsion, a suspension, a solution, a duplex emulsion, a micelle, a lyposome, or a liquid form comprising one or more of the foregoing.
10. The device of claim 7, wherein the user interface is configured to provide, upon execution by the user, a selectable ratio between the first active ingredient and the second active ingredient.
11. The device of claim 8, further comprising a third dispenser with the substrate or a portion thereof in a liquid form.
12. The device of claim 11, further comprising at least one of: a heating element, a vacuum pump in liquid communication with the housing, and a fan.
13. The device of claim 12, further comprising a bladed roll, configured to cut the substrate strip forming the orally-dispersible thin film in an axial direction and in transverse direction.
14. The device of claim 1, wherein the plurality of user-specific parameters comprise: user age, user weight, user gender, at least one of the disorder, pathology, symptom, and condition of the user for which the tab is sought, and the severity of the at least one of the: disorder, pathology, symptom, and condition of the user for which the tab is sought.
PCT/US2020/022256 2019-02-06 2020-03-12 Systems for dispensing film for oral transmucosal delivery with user specific composition WO2020251642A1 (en)

Applications Claiming Priority (2)

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US201962802173P 2019-02-06 2019-02-06
US62/802,173 2019-02-06

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020187248A1 (en) * 2001-06-07 2002-12-12 Childers Winthrop D. Pharmaceutical dispensing apparatus and method
US20040172169A1 (en) * 2001-03-02 2004-09-02 Curtis Wright Method and apparatus for compouding individualized dosege forms
US20130253946A1 (en) * 2008-09-03 2013-09-26 Ebroselow, Llc Computerized method of determining medical treatment values
US20160038376A1 (en) * 2010-12-23 2016-02-11 Tailorpill Technologies, Llc Ingredient cartridge for pharmacy compounding system
US20180369066A1 (en) * 2017-06-27 2018-12-27 Resolve Digital Health Inc. Film Dispensing Device

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040172169A1 (en) * 2001-03-02 2004-09-02 Curtis Wright Method and apparatus for compouding individualized dosege forms
US20020187248A1 (en) * 2001-06-07 2002-12-12 Childers Winthrop D. Pharmaceutical dispensing apparatus and method
US20130253946A1 (en) * 2008-09-03 2013-09-26 Ebroselow, Llc Computerized method of determining medical treatment values
US20160038376A1 (en) * 2010-12-23 2016-02-11 Tailorpill Technologies, Llc Ingredient cartridge for pharmacy compounding system
US20180369066A1 (en) * 2017-06-27 2018-12-27 Resolve Digital Health Inc. Film Dispensing Device

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