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WO2016001922A1 - Procédés, dispositifs et systèmes utilisables en vue de l'administration pulmonaire d'agents actifs - Google Patents

Procédés, dispositifs et systèmes utilisables en vue de l'administration pulmonaire d'agents actifs Download PDF

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Publication number
WO2016001922A1
WO2016001922A1 PCT/IL2015/050674 IL2015050674W WO2016001922A1 WO 2016001922 A1 WO2016001922 A1 WO 2016001922A1 IL 2015050674 W IL2015050674 W IL 2015050674W WO 2016001922 A1 WO2016001922 A1 WO 2016001922A1
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WO
WIPO (PCT)
Prior art keywords
effect
agent
determined
pharmacodynamic
subject
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/IL2015/050674
Other languages
English (en)
Inventor
Perry Davidson
Shlomo ALMOG
Seth Kindler
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Syqe Medical Ltd
Original Assignee
Syqe Medical Ltd
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
Priority to PCT/IL2015/050674 priority Critical patent/WO2016001922A1/fr
Priority to AU2015283590A priority patent/AU2015283590B2/en
Priority to IL273507A priority patent/IL273507B2/en
Application filed by Syqe Medical Ltd filed Critical Syqe Medical Ltd
Publication of WO2016001922A1 publication Critical patent/WO2016001922A1/fr
Priority to US15/375,098 priority patent/US10118006B2/en
Priority to US15/386,182 priority patent/US9839241B2/en
Priority to IL249837A priority patent/IL249837B/en
Anticipated expiration legal-status Critical
Priority to US16/030,967 priority patent/US11298477B2/en
Priority to IL260852A priority patent/IL260852B/en
Priority to AU2020205271A priority patent/AU2020205271A1/en
Priority to US17/694,764 priority patent/US12194230B2/en
Priority to AU2022211900A priority patent/AU2022211900B2/en
Priority to US19/014,337 priority patent/US20250144328A1/en
Priority to AU2025200462A priority patent/AU2025200462A1/en
Ceased legal-status Critical Current

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Definitions

  • monitoring a PK effect and/or a PD effect includes receiving data indicative of at least one PD effect in the subject from at least one sensor being in communication with a controller associated with the inhaler device.
  • the pre-determined vaporized amount of the first agent affects a level of the PD effect induced by the second agent.
  • the method further includes pulmonary delivering at least two pre-determined vaporized amounts of at least one of the first agent and the second agent according to a pre-defined regimen.
  • the adjusting is effected in real-time.
  • the psychotropic effect corresponds to a symptom
  • the symptom includes paranoia, anxiety, panic attack, euphoria, pseudo- hallucinatory, ataxia, sedation, conscious perception variation, joviality, metacognition and introspection, an enhanced recollection (episodic memory), amnesia, a sensuality variation, a variation in awareness of sensation and a variation in libido, dizziness, ataxia, euphoria, perceptual alterations, temporal distortion, intensification of ordinary sensory experiences, short term memory, and attention, impaired reaction, skilled activity, verbal fluency, dependence and depression.
  • the user interface device includes a smartphone device.
  • the pharmacologically active agent includes A9-tetrahydrocannabinol (THC), cannabidiol (CBD), cannabigerols (CBG), cannabichromenes (CBC), cannabinol (CBN), cannabinodiol (CBDL), cannabicyclol (CBL), cannabielsoin (CBE), cannabidivarin (CBDV), tetrahydrocannabivarin (THCV) and cannabitriol (CBT).
  • THC A9-tetrahydrocannabinol
  • CBD cannabidiol
  • CBD cannabigerols
  • CBC cannabichromenes
  • CBD cannabinol
  • CBN cannabinodiol
  • CBDL cannabicyclol
  • CBE cannabielsoin
  • CBDV cannabidivarin
  • THCV cannabitriol
  • a method of pulmonary delivering to a subject at least one pharmacologically active agent being in a plant material includes:
  • determining at least one pharmacokinetic effect in the subject at predetermined time intervals before during and/or after the pulmonary delivering optionally, determining at least one pharmacodynamic effect in the subject at predetermined time intervals before during and/or after the pulmonary delivering;
  • a method of pulmonary delivering at least one pharmacologically active agent to a patient comprising pulmonary delivering the agent to the patient from a metered dose inhaler device configured to release at least one pre-determined vaporized amount of the agent upon controllably heating a solid form of a substance comprising the agent, wherein the at least one pre-determined vaporized amount of the agent is selected so as to exhibit at least one pre-selected pharmacokinetic profile and/or at least one pre-selected pharmacodynamic profile of the agent in the patient.
  • each of the pharmacokinetic parameter and/or the pharmacokinetic variable and/or the pharmacodynamic parameter is determined for an individual patient, such that the predetermined vaporized amount is determined personally for the patient.
  • determining at least one personal pharmacodynamic and/or at least one personal pharmacokinetic parameter in an individual patient so as to determine if pulmonary delivering the at least one pre-determined vaporized amount of the agent exhibits the pre-selected pharmacodynamic and/or the pre-selected pharmacokinetic profile in said individual patient;
  • the adjusted vaporized amount is the pre- determined vaporized amount.
  • the personally perceived therapeutic effect corresponds to a symptom, the symptom being selected from the group consisting of pain, migraine, depression, cognitive function deficit, attention deficit, hyperactivity, anxiety disorders, diarrhea, nausea, vomiting, insomnia, delirium, appetite variations, sexual dysfunction, spasticity, increased intra ocular pressure, bladder dysfunction, tics, Tourette symptoms, post traumatic stress disorder (PTSD) symptoms, inflammatory bowel disease (IBD) symptoms, irritable bowel syndrome (IBS) symptoms, hyper tension, hemorrhagic symptoms, septic and cardiogenic shock, drug addiction and craving, withdrawal symptoms, tremors and other movement disorders.
  • the personally perceived adverse effect is a psychotropic adverse effect and/or a somatic adverse effect.
  • the somatic adverse effect corresponds to a symptom, the symptom being selected from the group consisting of nausea, muscle twitches, muscle relaxation cramps, spasms, sweating, ataxia, a motor activity variation, dry mouth and a sensation of cold or hot hands and feet, increased heart rate, increased cerebral blood flow, dilation of bronchial passages, dilation of blood vessels, eye redness and pupil dilation, dry mouth, thirst, hunger or food craving.
  • the pulmonary delivering further comprises:
  • the device is configured to deliver the pre-determined vaporized amount such that a deviation of an actual vaporized amount of the agent, from the pre-determined vaporized amount of the agent, is less than 20 % of the pre-determined vaporized amount. According to some of any of the embodiments described herein, a deviation of an actual pharmacokinetic profile from the pre-selected pharmacokinetic profile is less than 40 % of the pre-selected pharmacokinetic profile.
  • the pharmacodynamic profile ranges within a minimal level of the therapeutic effect to a maximal level of the therapeutic effect in which an adverse effect is not exhibited or perceived (within a therapeutic window).
  • a deviation of the perceived pharmacodynamic profile from the pre-selected pharmacodynamic profile at at least one time point is less than 25 % below the pre-selected pharmacodynamic profile.
  • the pulmonary delivering, the agent, the pre-determined vaporized amount, the pre-selected pharmacokinetic profile and/or the pre-selected pharmacodynamic profile of the agent in the patient, the at least one pharmacokinetic parameter and/or at least one pharmacokinetic variable and/or at least one pharmacodynamic parameter, the re- selected pharmacodynamic profile, the adjusted vaporized amount and the determining of any of the foregoing, are as described in any one of the respective embodiments.
  • the personally perceived therapeutic effect is a reduction in a level of a symptom and the personally perceived adverse effect is a psychotropic effect and/or a somatic adverse effect.
  • FIG. 8 presents a representative example of a pulmonary delivering of three predetermined vaporized amounts (the calculated dosing) over a time period of 3-hours, as determined for Patient X;
  • FIG. 10 is a flowchart of a method for prescribing a personalized regimen to a patient, according to some embodiments of the present disclosure
  • FIG. 14 is a flowchart of a method for obtaining one or more biomarkers using a personal portable device and/or using the inhaler device, and optionally modifying the dose and/or regimen accordingly, according to some embodiments of the present disclosure
  • FIGs. 15 A, 15B and 15C are print screens of a patient interface comprising various applications for obtaining biomarkers and/or for assisting a patient in determining a perceived therapeutic and/or adverse effect, according to some embodiments of the present disclosure
  • FIGs. 17A-D are a schematic diagrams of a configuration of an inhaler device (FIG. 17A), and a cartridge, also referred to herein interchangeably as “dose unit” or “dose cartridge”, of an inhaler device optionally comprising discrete doses (FIG. 17B), and other optional features thereof (FIG. 17C-D), according to some embodiments of the present disclosure;
  • FIG. 18 is a flowchart of a method of treating an individual patient using a system according to figure 9, while maintaining the patient within a personalized therapeutic window, according to some embodiments of the present disclosure
  • FIG. 19 presents a flowchart of a procedure for determining and administering a personal dosing and/or regimen for treating neurological pain in a human subject
  • FIG. 20 is a graphical representation of a regimen for the treatment of pain and sleeplessness by pulmonary delivering of an active agent, wherein the red line represents pain level, and the green line represent blood level of the active agent, wherein the active agent is pain reliving as well as sedative;
  • FIG. 21 is a graphical representation of a regimen for the treatment of pain by pulmonary delivering of a combination of two active agents, THC and CBD, wherein the dashed line represents the level of the adverse (psychotropic) effect, and the solid line represent the pain level, and wherein THC is inhaled by using a dose unit of 0.5 mg (empty triangle), 1.2 mg (grey triangle) and 2.4 mg (black triangle), and CBD is inhaled by using a dose unit of 25 mg (empty diamond).
  • THC is inhaled by using a dose unit of 0.5 mg (empty triangle), 1.2 mg (grey triangle) and 2.4 mg (black triangle)
  • CBD is inhaled by using a dose unit of 25 mg (empty diamond).
  • the present invention in some embodiments thereof, relates to pharmacology and, more particularly, but not exclusively, to methods, devices and systems for controlled pulmonary delivery of active agents.
  • Standard pharmacological regulations dictate that a treatment of a medical condition using a pharmaceutically active agent must be based on a therapeutically effective dose, which is administered according to a therapeutically effective regimen, while making all efforts to maintain a balance between the therapeutic effects and the adverse effects.
  • results of the study open the way to pulmonary delivering a wide range of natural plant materials, under widely accepted pharmaceutical practices and regulations, while using that precise MDI device.
  • Such pulmonary deliveries may be used in the treatment of a wide range of medical conditions in which vaporizable agents in said natural plant materials are beneficial for treating the medical condition and/or ameliorating a symptom of the condition.
  • the terms “therapeutic window” and “pharmaceutical window” are interchangeable and refer to the range of pharmacodynamic effects induced by a range of doses of one or more pharmaceutically active agents, providing a balance between one or more desired (positive) effect(s) and one or more adverse (negative) effect(s).
  • the pharmaceutical/therapeutic window is referred to as a pharmacodynamic profile.
  • the window may relate to a given point in time or may span a period of time of any length, including for example minutes, hours, days or longer, shorter or to any intermediate period of time.
  • the desirability and undesirability of an effect can be defined based on a variety of criteria, and include without limitation, medical practices, rules and regulations, cultural and demographic norms, genetic factors and personal preferences and tolerances.
  • the desirability and undesirability of an effect can be defined based on the purpose of treatment and based on generally acceptable values and optionally may take into account other parameters such as patient preference, capacity and activity. It is noted that a given effect may be regarded as desired in some cases, but be regarded as undesired in other cases, and vice versa.
  • the methods, devices and systems provided herein are capable of vaporizing a pre-determined vaporized amount of an active agent that induced one or more pre-determined pharmacodynamic effects in a given subject or a population of subjects, wherein the pre-determined pharmacodynamic effect pertains to a pre-determined pharmacodynamic profile that may range between a minimal level of a desired effect and any level of an undesired effect.
  • patient is used interchangeably with the terms “subject”, “user” and “a person in need thereof to refer to the entity that uses any of the devices and systems provided herein and being the subject of any of the methods provided herein.
  • a therapeutic window can be correlated, via a pharmacokinetic profile, to a range of amounts of one or more pharmaceutically active agents.
  • a therapeutic window may be defined as a range of amounts of one or more pharmaceutically active agent spanning from an amount that confers a desired effect (a therapeutic effect, in which case the amount is a therapeutically effective amount or therapeutic dose) and an amount that causes more than an acceptable or tolerable level of undesired effects (e.g., adverse effects).
  • a pharmaceutically active agent having a narrow therapeutic window should be administered with great care and control so as to stay between the therapeutically effective amount and the amount that causes an adverse effect.
  • a method of pulmonary delivering at least one pharmacologically active agent to a patient which is carried out by pulmonary delivering the agent to the patient using a metered dose inhaler device, wherein the device is configured to release at least one pre-determined vaporized amount of the agent upon controllably heating a substance that contains the agent, wherein the amount is set so as to achieve at least one predetermined effect in a subject, such as a pre-determined pharmacodynamic effect.
  • a method of vaporizing at least one pharmacologically active agent being in a plant material and being suitable for pulmonary delivery to a patient which is carried out by using a metered dose inhaler device, wherein the device is configured to release at least one pre-determined vaporized amount of the agent upon controllably heating the plant material, wherein the amount is set so as to achieve at least one pre-determined pharmacokinetic effect and/or at least one pre-determined pharmacodynamic effect induced by said agent in the subject upon pulmonary delivering the agent to the patient.
  • the pharmaceutically active agent can be in a solid or a liquid form, and further noted that the agent is contained in a solid form of a substance described herein. According to some embodiments of the present disclosure, the pharmaceutically active agent is vaporizable by heat, thereby can be released from the substance by being heat-induced vaporization.
  • the substance that contains at least one vaporizable active agent is, for example, a plant material.
  • the active agent is a naturally occurring agent, namely the agent occurs (produced) naturally in the plant.
  • the substance is an organic material which contains, or consists of, for example, one or more natural plant materials, or a synthetic material which may comprise at least one vaporizable active agent.
  • the solid form of a substance comprises a plurality of vaporizable active agents derived or extracted from natural or organic sources, such as plants, fungi, bacteria and the likes.
  • the substance is a natural plant matter.
  • the plant matter is processed without damaging the vaporizable active agent in the plant matter.
  • the plant matter retains a macroscopic plant structure.
  • the amount of the substance used in the MDI device may be determined based on the contents of the vaporizable agent contained therein, and on the pre-determined vaporized amount required to be released therefrom.
  • the amount of the substance used in the MDI device may range from 20 to 500 mg, 10 to 200 mg, 9 to 150 mg, 8 to 100 mg, 7 to 50 mg, 5 to 20 mg, 1 to 10 mg, 10 to 70 mg, 10 to 60 mg, 12 to 50 mg, 12 to 40 mg, 15 to 40 mg, 12 to 30 mg or 12 to 25 mg.
  • pharmaceutically active agent refers to a compound, a polymer, a conjugate or a complex, or any combination thereof, which exerts a physiological or psychological effect when administered to a subject.
  • the pharmaceutically active agent or biologically active substance exerts a desired physiological or psychological effect upon pulmonary delivering thereof via a systemic pathway (e.g., blood, lymph) to a target organ.
  • the agent may be of natural origin or synthetic.
  • active agents include CNS active agents, chemotherapeutic agents, sedative or analgesic agents and a psychotropic agent.
  • the method is carried out using an MDI which is capable of delivering reproducibly and accurately an amount of at least one vaporizable agent by heating a solid form of a substance.
  • an MDI which is capable of delivering reproducibly and accurately an amount of at least one vaporizable agent by heating a solid form of a substance.
  • the MDI device is a device as described in WO 2012/085919, including any one of the embodiments described therein, and any combination thereof.
  • the method is performed such that the predetermined vaporized amount is selected/controlled so as to exhibit a pre- selected (also referred to herein as pre-determined) pharmacokinetic profile and/or a pre-selected or pre-determined pharmacodynamic profile of the agent in the patient.
  • pre-determined also referred to herein as pre-determined
  • a pre-selected pharmacokinetic and/or pharmacodynamic profile by exhibiting a pre-selected pharmacokinetic and/or pharmacodynamic profile, it is meant that the vaporized amount of the agent has been pre-determined based on pharmacokinetic/pharmacodynamic (PK/PD) studies conducted in at least one subject by pulmonary delivering the agent using an MDI device which is configured to release a consistent and accurate vaporized amount of the agent upon heating a solid substance comprising the same.
  • PK/PD pharmacokinetic/pharmacodynamic
  • a desired pharmacokinetic profile and/or a desired pharmacodynamic profile is typically afforded by conducting PK/PD studies for a particular pharmaceutically active agent in a particular subject or a group thereof.
  • the ability to conduct standard and widely accepted PK/PD studies in a particular subject or a group thereof for a pharmaceutically active agent, which is delivered by inhalation (pulmonary delivery) upon controllably and reproducibly releasing a vaporized amount of the agent by heating a solid sample of a substance is made possible (enabled) by, for example, an MDI device such as disclosed in WO 2012/085919, which can use a plant material as a source of the active agent(s).
  • pre-determined vaporized amount is also used herein to describe the amount of the agent that is determined based on pharmacokinetic/pharmacodynamic (PK/PD) data, namely a vaporized amount that has been determined by determining PK/PD effects (parameters) for the agent in one or more patients.
  • PK/PD pharmacokinetic/pharmacodynamic
  • pharmacokinetic profile refers to a bodily concentration of a pharmaceutically active agent, or a metabolite thereof (e.g., an active metabolite), namely, a concentration of the agent or a metabolite thereof in a physiological system of an organism (whole body, blood, plasma, lymph, tissue, organ and the likes) to which the compound has been administered, as a function of time.
  • a pharmacokinetic (PK) profile is considered from a time point of administration of the compound to a time point at which the compound is no longer detectable in the organism or to any intermediate period of time between administration of the compound and a time at which it is no longer detectable in the organism (e.g.
  • a regimen is a plurality of predetermined plurality pre-determined vaporized amounts given at pre-determined time intervals.
  • Tmax which is the time passed between administration and arriving at C max ;
  • Ciast which is the last observed quantifiable concentration
  • Pharmacokinetic variable refers to a property of a subject that is not necessarily dependent on a pharmaceutically active agent or a method of delivery a pharmaceutically active agent to a subject, and provide information pertaining to factors that affect the pharmacokinetic and pharmacodynamic profiles of an active agent in the subject.
  • Pharmacokinetic variables typically include, without limitation, body weight, body height, body mass index (BMI), waist-to-hip ratio, lean body mass (LBM), age and gender, race, background illnesses, patient history (e.g. previous exposure to the agent or other agents) and concurrent medication.
  • a PK profile of a given pharmaceutically active agent is a result of the dose and/or regimen by which an agent is administered to a patient, or, alternatively, according to some embodiments, the PK profile is a mean to afford a particular, a pre-selected or otherwise desired pharmacodynamic profile of the agent in the patient.
  • the term "pharmacodynamic profile” refers to the effect of a pharmaceutically active agent in a subject as a function of time. Accordingly, the term “pharmacodynamic profile” refers to a sum of all biological expressions and responses of an organism as a function of time, upon administration of a pharmaceutically active agent. A pharmacodynamic profile is typically a direct or indirect result of pharmacokinetic effect(s) at any given time point, or a pharmacokinetic profile of the agent in the patient, over any given time period.
  • Pharmacodynamic parameters can typically be determined by, without limitation, a therapeutic (desirable) effect (e.g., personally perceived therapeutic effect), an adverse (undesirable) effect (e.g., a personally perceived adverse effect), and by means of determining a level of a biomarker (which is indicative of a therapeutic and/or an adverse effect), as these terms are described hereinbelow.
  • a pharmacodynamic profile which can be a pre-selected (desired) pharmacodynamic profile is defined by the therapeutic window of a given agent in a given subject, as this term is defined herein.
  • a vital sign selected from the group consisting of a heart rate, an oxygenation level (Sp02), a blood pressure, a respiratory rate and a body temperature;
  • a hematological marker selected from the group consisting of a hemoglobin level, a hematocrit ratio, a red blood cell count, a white blood cell count, a white blood cell differential and a platelet count;
  • biomarker level determination technologies such as automatic facial expression recognition systems for estimation of pain level [Ashraf, A.B. et ah, Image and Vision Computing, 2009, 27(12), p. 1788-1796; Hu, Y. et ah, Conference: IEEE International Conference on Automatic Face and Gesture Recognition - FGR, 2008, p. 1-6] and ultraminiature cordless EMG measurement systems [Yamaguchi, T. et al., Oral Surg Oral Med Oral Pathol Oral Radiol Endod., 2007 104(5), p. e22-7], for estimation of pain and other biomarkers, can be integrated into the methods presented herein via interfaces and systems as presented hereinbelow.
  • Invasively-detected biomarkers include any indicator that requires a sensor to be placed inside the body of the patient, including skin penetration, or requires a sample taken from within the body of the patient in order to quantify the indicator.
  • a sensor for example, blood extraction from a vein of the patient using a needle, or via skin pricking, in order to measure the concentration of any indicator or factor (biomarker), is regarded as an invasive measurement, and thus these biomarkers are regarded as invasively- detected biomarkers.
  • an inhalation of a second agent is performed at such timing that a first active agent inhaled previously still induces at least one PD effect in the subject.
  • co-administration of more than one active agent by delivery thereof in rapid succession means that the inhaled agents have essentially the same effect as they would have had if inhaled in a single inhalation.
  • a metered dose inhaler device for vaporizing at least a first pharmacologically active agent and a second pharmacologically active agent, at least one of which being in at least one plant material and being suitable for pulmonary delivery to a patient
  • the device is configured to vaporize at least a first predetermined vaporized amount of the first agent and at least a second pre-determined vaporized amount of the second agent upon controllably heating the plant material, and wherein upon pulmonary delivering the agents to the subject, the heating is effected such that the first pre-determined vaporized amount is delivered to the subject successively, concomitantly and/or at least partially overlapping with the second predetermined vaporized amount, and wherein upon pulmonary delivering the agents to the subject, each of the pre-determined vaporized amounts of each of the agents induces in the subject independently at least one pharmacokinetic effect and/or at least one pharmacodynamic effect.
  • the device further comprises a controller configured to synchronize the application of heat with the movement of a cartridge and/or with airflow rate effected by inhalation.
  • a size of particles ranges from about 100 ⁇ to about 700 ⁇ .
  • a plurality of cartridges is organized as a roll of tape, a daisy or a magazine.
  • Some plants which can be used in the context of the present disclosure include, without limitation, Cannabis sativa, Cannabis indica, Cannabis ruderalis, Acacia spp, Amanita muscaria, Yage, Atropa belladonna, Areca catechu, Brugmansia spp., Brunfelsia latifolia, Desmanthus illinoensis, Banisteriopsis caapi, Trichocereus spp., Theobroma cacao, Capsicum spp., Cestrum spp., Erythroxylum coca, Solenostemon scutellarioides, Arundo donax, Coffea arabica, Datura spp., Desfontainia spp., Diplopterys cabrerana, Ephedra sinica, Claviceps purpurea, Paullinia cupana, Argyreia nervosa, Hyoscyamus niger, Tabernanthe
  • the active agent is a terpenoid, alkaloid or cannabinoid.
  • the active agent is a diterpenoid such as, but not limited to salvinorin A from salvia.
  • the active agent is an alkaloid such as, but not limited to, benzoylmethylecgonine from the coca plant, or the active agent is a tryptamine such as psylocibin from mushrooms.
  • the active substance is dimethyltryptamine (DMT) from a variety of plants.
  • the active substance is nicotine from tobacco.
  • the active substance is a terpenoid, e.g., limonene, a-pinene, ⁇ - myrcene, linalool, ⁇ -caryophyllene, caryophyllene, nerolidol or phytol, present in various plant forms.
  • a terpenoid e.g., limonene, a-pinene, ⁇ - myrcene, linalool, ⁇ -caryophyllene, caryophyllene, nerolidol or phytol
  • Cannabis is a natural source for vaporizable cannabinoids, which constitute a class of diverse chemical compounds that act on cannabinoid receptors found in cells of humans and other animals.
  • Cannabinoids which include endocannabinoids (produced in animals), phytocannabinoids (found in cannabis and some other plants) and synthetic cannabinoids (manufactured chemically), are known to bind to naturally receptor proteins, and repress neurotransmitter release in the brain.
  • the primary psychoactive compound of cannabis is the phytocannabinoid A9-tetrahydrocannabinol (THC).
  • Cannabidiol is another major constituent of the plant, representing up to 40 % in extracts of the plant resin.
  • CBD cannabigerols
  • CBC cannabichromenes
  • CBN cannabinol
  • CBDL cannabinodiol
  • CBL cannabicyclol
  • CBE cannabielsoin
  • CBT Cannabidivarin
  • THCV Tetrahydrocannabivarin
  • the present inventors have demonstrated a PK/PD profile of A 9 -THC similar to that previously reported in the art using purified and thus quantified A 9 -THC.
  • the inhalation method employed by the present inventors has successfully obtained pulmonary delivery of THC that was characterized by rapid absorption, followed by bi-phasic decline in plasma concentration over time: a phase of rapid decline corresponding to the distribution of THC to tissues and extensive storage, followed by a phase of prolonged release from adipose tissue to the blood and elimination.
  • the present inventors compared the peak plasma concentration (C max ) of ⁇ 9 - THC obtained by smokeless inhalation in accordance with the method described herein to C max levels known in the art for various delivery routes of cannabis.
  • the inhalation method described herein yielded the highest increase of C max per mg of THC available in the cannabinoid material used - mean of 12.3 ng/ml/mg THC compared to 6.1-9.0 for Volcano vaporizer and 0.6-4.6 for regular smoking cigarettes.
  • the inter-individual variability in peak THC concentrations obtained by the method described herein was considerably lower compared to inter-individual variability obtained in the art: 25.3 % versus 47-85 % for vaporizer, 32-115 % for smoking cigarettes, 42-115 % for oral administration and 59-67 % for oromucosal route of delivery.
  • PK/PD protocols are developed for vaporized cannabinoids, based on clinical data, accumulated individually for each patient as well on a cohort of patients, which account for the dose and regimen administered, based on individual and population parameters, as described hereinabove. These protocols accurately simulate the PK profile of a patient after delivering a pre-determined dose, or pre-determined regimen, and in parallel predict the PD profile which is composed of symptom relief (therapeutic effect) and psychoactive levels (adverse effect). Once a sub therapeutic level, and the adverse psychoactive level are correlated with PK and patient parameters, a relatively narrow therapeutic window is derived, in which the MDI device can precisely maintain in the patient, by automating specific pre-selected vaporized amounts (doses and/or regimen). By inputting patient data, the protocol calculates the recommended dose and regimen for that specific patient in order to stay within the therapeutic window for a specific duration.
  • the method and device presented herein are highly suitable for personalization, self-titration, mechanization and automatization of an otherwise complex and challenging mode of administration and treatment of a variety of medical conditions; while any personalized treatment protocol presents challenges, a treatment based on pulmonary delivery of active agents vaporized by heat from natural substances is a task which has not been achieved hitherto.
  • the present inventors have conceived an integrated system that can control the device using input collected from a variety of sources so as to provide a highly personalized and effective treatment for any given patient, also in real-time.
  • a system that includes:
  • a metered dose inhaler device for pulmonary delivering to a subject at least one pre-determined vaporized amount of at least one pharmacologically active agent being in a plant material by controllably heating the plant material so as to vaporize a predetermined vaporized amount of the agent from the plant; and a controller associated with the inhaler device, and configured to control the predetermined vaporized amount.
  • a controller configured to select the at least one pre-determined vaporized amount of the agent so as to achieve at least one pre-determined pharmacokinetic effect and/or at least one pre-determined pharmacodynamic effect induced by the agent in the subject.
  • a metered dose inhaler device configured independently deliver the agents to the subject by heating the at least one plant material to vaporize at least a first predetermined vaporized amount of the first agent and at least a second pre-determined vaporized amount of the second agent;
  • a metered dose inhaler device for pulmonary delivering to a subject at least one pre-determined vaporized amount of at least one pharmacologically active agent being in a plant material by controllably heating the plant material so as to vaporize a predetermined vaporized amount of the agent from the plant;
  • a system that includes, without limitation:
  • At least one sensor for monitoring at least one pharmacodynamic effect in the subject induced by the agent and/or a user interface device for inputting data obtained from at least one sensor for monitoring at least one pharmacodynamic effect in the subject induced by the agent;
  • the controller used in the system described herein is configured to control the pre-determined vaporized amount by controlling the heating of the substance (e.g., plant material).
  • Controllably heating the plant material is effected, for example, by controlling at least one of a heating temperature, a heating pattern (which part of the plant material to heat), a heating rate (how many times the plant material is exposed to heat), a heating duration (how long the plant material is exposed to heat in any given heating event), and any combination thereof.
  • the controller is used to carry out more complex treatment plans, such as a regimen, a delivery of more than one active agent, each having a different dose and/or regimen, and/or other dose and timing related adjustments.
  • a controller can be configured for adjusting the regimen so as to achieve a pre-determined pharmacokinetic effect and/or a pre-determined pharmacodynamic effect based on the pharmacodynamic effect.
  • the controller is configured for effecting a pre-defined regimen that comprises delivering at least two pre-determined vaporized amounts.
  • the controller is configured for real-time adjustment of various operational settings of the inhaler device and parameters of the pulmonary delivery.
  • the system further includes or may be in communication with a user interface device, which can be used to input information and data into the controller, and/or to display, transmit or otherwise output data and information from the controller.
  • the user interface comprises an output device for providing information to at least one of the following: the subject, a practitioner, a memory unit and a remote device (a server, a display, a remote monitoring system/device and the like).
  • the user interface device includes a smartphone device.
  • a smartphone may include a touchscreen, a microphone, a speaker, a GPS receiver, an accelerometer, a thermometer, a light detector and the like.
  • MDI device 901 is configured to communicate with a physician interface 903 and/or with a patient interface 905. In some embodiments, MDI device 901 is configured to receive input from one or both of the interfaces 903 and/or 905. Additionally or alternatively, MDI device 901 is configured to send output to one or both of the interfaces 903 and/or 907.
  • communication between the system components is performed via one or more data transfer means such as a USB connection, a cable connection, a wireless connection, and/or any suitable wired and/or wireless communication protocol.
  • data transfer means such as a USB connection, a cable connection, a wireless connection, and/or any suitable wired and/or wireless communication protocol.
  • MDI device 901 comprises a controller 913, configured, for example, to activate heating of the substance to thereby vaporize the active agent, control the heating profile and/or activation of heat, control a cartridge feed mechanism of the MDI device, read data from a memory 919 of MDI device 901, control power usage, and/or other functions.
  • controller 913 communicates with a memory 919.
  • memory 919 is configured to store prescription data, personal usage data, patient details, personal PD effects obtained from the patient, dose and/or regimen modifications, parameters obtained from the patient in response to a change in a dose and/or regimen, and/or other values or information.
  • controller 913 activates pulmonary delivery of the active agent according to dose and/or regimen data stored in memory 919.
  • memory 919 is configured to store usage data and/or feedback data from the patient with respect to a specific dose and/or regimen and/or with respect to a pre-selected (desired) PD profile of the active agent in the patient.
  • patient interface 905 comprising, for example, one or more of a controller 917, a memory 923 and/or a communication module 911, is configured on a personal computer (tablet computer, laptop computer, desktop computer, or others), a mobile device such as a smartphone, and/or on MDI device 901 itself.
  • a personal computer tablet computer, laptop computer, desktop computer, or others
  • a mobile device such as a smartphone
  • MDI device 901 itself.
  • patient interface 905 receives an input 929.
  • the input may be received from one or more of the patient, the physician interface, the database server, the MDI device.
  • Examples of various types of inputs may include a dose and/or regimen defined by the physician and received on the physician interface, a current personal PD effect of the patient, inserted by the patient and/or obtained from the patient, personal usage statistics recorded for example on the database server and/or on the memory of the MDI device, an indication of inhalation duration and/or inhalation volume sensed by the MDI device, and/or other types of input.
  • the notice is provided automatically based on a scheduled regimen stored in the memory. Additionally or alternatively, the notice is set by the patient. Additionally or alternatively, the notice is issued by the physician.
  • a patient using MDI device 901 may wish to schedule their dose and/or regimen in a way in which possible adverse effects least interfere with the patient's daily activities. While certain adverse effects are tolerable in a home setting or at certain time of day, and are an acceptable trade off for symptom relief, these adverse effects may be undesirable when the patient is engaged in activities such as driving, attending a meeting, and/or other activities.
  • the patient schedules a dose and/or regimen in a manner that least interferes with their planned activities.
  • Fig. 10 is a flowchart of a method for prescribing a regimen to a patient using an MDI device for delivery of at least one active agent, according to some embodiments of the invention.
  • a physician may decide to treat a patient by effecting a pulmonary delivery of one or more active agents by an MDI device (1001).
  • patient data such as one or more of, for example, PK variables (e.g., age, gender, BMI etc.), pathophysiological status, pharmocogenetic and/or pharmacogenomic variables and/or other parameters are inserted to the system (1003), for example by the physician and/or other clinical personnel.
  • PK variables e.g., age, gender, BMI etc.
  • pathophysiological status e.g., pathophysiological status
  • pharmocogenetic and/or pharmacogenomic variables and/or other parameters are inserted to the system (1003), for example by the physician and/or other clinical personnel.
  • the patient's parameters and personal variables are inserted using the physician interface.
  • the physician receives one or more indications such as indications relating to the patient's general usage of the device, indications relating to dose and/or regimen administered to the patient, substance consumed by the patient, one or more personal PD effects of the patient, for example relating to the presence of adverse effects, such as the psychoactive level and/ or indications relating to the symptom intensity such as the pain level, and/or a level of one or more biomarkers and/or other indications (1013).
  • one or more indications are provided in real-time.
  • the indications are provided at the end of a pulmonary delivery of the agent.
  • the indications are provided on demand of the physician. Additionally or alternatively, the patient decides when to send indications to the physician.
  • the dose and/or regimen is adjusted or otherwise modified (1015).
  • modification is performed in real-time.
  • a specific dose and/or regimen is modified, optionally in real-time.
  • the dose and/or regimen is modified while taking into account upper and lower PD effect limits defined individually per the patient.
  • An upper limit may allow dose and/or regimen above which substantial adverse effects are present.
  • a lower limit may allow dose and/or regimen below which a symptom, which was intended to be treated by delivery of the active agent, is not sufficiently alleviated.
  • Figs. 11A, 11B, l lC and 11D are a schematic diagram (Fig. 11A) and print screens (Figs. 11B, 11C and 11D) of a physician interface for selecting and prescribing a dose and/or regimen to a patient, according to some embodiments of the invention.
  • the dose and/or regimen is selected so as to have the expected and/or pre-selected PK/PD profiles fit within a range of the therapeutic window 1117.
  • a physician may perform one or more of raising and/or lowering of limit 1119 and/or limit 1121, raising and/or lowering the peaks of profile 1113 and/or of profile 1111, extending and/or shortening a treatment duration along the time axis, and/or other modifications.
  • the graphic representation is shown herein as an example, and that various graphic representations such as a bar graph may be used.
  • the profile 1111 and/or profile 1113 may be presented in a non- continuous manner, for example as a set of points.
  • Fig. 11B illustrates a simulation of an expected pharmacokinetic profile of a patient using a pre-determined vaporized amount delivered according to a predetermined regimen, according to some embodiments.
  • a physician may fill in patient data 1101 (such as gender, weight, height, administered drug, patient ID and/or other data), and obtain a pharmacokinetic profile extrapolation of the individual patient, as shown for example by graph 1103, simulating the plasma concentration of an active agent in the patient over time.
  • patient data 1101 such as gender, weight, height, administered drug, patient ID and/or other data
  • Fig. 11C illustrates an expected pharmacodynamic profile extrapolation 1105 of the individual patient, showing an adverse effect level in the patient over time.
  • Fig. 11D shows a physician interface print screen, according to some embodiments of the invention.
  • a simulated pharmacokinetic profile is represented by graph 1103 and a simulated pharmacodynamic profile is represented by graph 1105, which are displayed on a time series axis 1115, in this example representing an 8-hour period.
  • a pharmacodynamic parameter scale of the patient is visually divided into sections indicating, for example, an "in pain" state (below a therapeutic effect level), indicating "optimum” state (within the therapeutic window) and indicating, for example, "psychoactive" state (above an adverse effect level) as defined per the individual patient, and the simulated PK/PD profiles as graphs are shown with respect to these sections.
  • a first dose is provided at 8:00, resulting in a change of both the pharmacodynamic and pharmacokinetic parameters, going up from the "in pain” section into the “optimum” section.
  • a second dose is shown to maintain the patient within "optimum” (the therapeutic window).
  • the PD effect relates to an adverse effect such as a psychoactive level, a therapeutic effect such as a pain level, and/or a change in any of those levels thereof.
  • the PD effect may include an absolute quantification of the level, and/or a relative quantification of the level, assessed, for example, with respect to a level measured before a delivery of single dose and/or before a delivery of dosing and/or regimen.
  • the PD effect may be obtained before, during and/or after a delivery of single dose and/or before, during and/or after a delivery of dosing and/or regimen and/or before, during and/or after a general time period over which treatment is provided to the patient.
  • the PD effect is provided directly by the patient, for example using the patient interface.
  • the patient can manually adjust a visual representation of the PD effect, based on a personal determination of the level of the PD effect.
  • the patient may raise or lower a bar on a graph indicating a pain level, for example on a touch screen of a cellular phone and/or any other personal device on which the patient interface is configured.
  • patients who are unable to articulate levels of the PD effect may utilize an interactive set of tools to assist them in determining their current level of the PD effect, for example as further described herein.
  • a personal PD effect such as a biomarker is obtained by the patient interface and/or by the system, for example using a sensor.
  • a sensor In some embodiments, one or more standard components of a cellular phone and/or personal computer on which the patient interface is configured as acts as a sensor for obtaining the parameter.
  • the MDI device is configured to obtain personal feedback data.
  • the MDI device comprises a flow sensor and/or a pressure sensor.
  • a breathing related indication of the patient is obtained using the flow and/or pressure sensor.
  • the sensor is adapted to detect a volume of inhalation. Since a correlation may exist between inhalation volume and a PD effect, such as a pain level, in some embodiments, a flow and/or pressure measurement is initiated to determine a PD effect in the patient.
  • the dose and/or regimen may be modified accordingly (1203).
  • the dose and/or regimen is modified, on one hand, to improve or otherwise change a condition of the patient based on the provided indication, and, on the other hand, to achieve a pre- selected pharmacodynamic profile, such as maintaining the patient within the therapeutic window - between a lower limit of a therapeutic effect that provides symptom relief, and a higher limit of an adverse effect in which the adverse effect level is still tolerable.
  • the MDI device can be configured such that when below a minimal therapeutic effect, input by the patient may increase the dose and/or adjust the regimen in frequency and/or in quantity.
  • the dose and/or regimen is modified to obtain a level above a minimal therapeutic effect. Additionally or alternatively, the dose and/or regimen is modified as much as the maximal level of an adverse effect permits.
  • Fig. 13B presents an example for a calculated 3-hours regimen for a certain patient (Patient X, 35 years old and has a BMI of 22).
  • Patient X is required to be subjected to pulmonary delivery of an active agent using a metered-dose MDI device according to some embodiments of the present disclosure, at the following times and doses: 00 minutes - 1.2 mg; 10 minutes - 1.0 mg; 60 minutes - 0.5 mg.
  • the blue curve represents an example for a calculated PD profile at the indicated doses.
  • the calculated regimen maintains Patient X within limit levels, namely below the adverse effect level and above the therapeutic effect level, namely at a therapeutic window 1303 ranging between 2.5 to 7.5 on the adverse psychoactivity effect scale.
  • Patient X indicates a wish to alter the adverse effect limit, for example by raising a psychoactivity level bar 1301 on the patient interface screen. By raising the bar, the patient may indicate he is willing to increase the tolerable level of an adverse psychoactive effect.
  • the therapeutic window as shown in Fig. 13D, is then redefined based on the patient's input - for example, the window is narrowed to a range of 2.5 to 5 on the psychoactivity scale. The currently administered dose and/or regimen may then be modified accordingly.
  • a pre-determined vaporized amount that is planned for pulmonary delivering at, for example, 60 minutes from the initial pulmonary delivering is reduced from 0.5 mg to 0.3 mg, in attempt to lower the level of an adverse effect (psychoactive effect) the patient is experiencing.
  • the sensitivity of a patient to the therapeutic and/or an adverse effect may vary throughout the day for a patient, e.g., demonstrating higher pain sensitivity in the evening, diminished cognitive abilities in the morning, thus less susceptive to a therapeutic effect in the evening, or more susceptive to an adverse effect in the morning.
  • the patient may drag the slider to reflect their perceived PD profile. For example, if the patient experiences a complete therapeutic effect (e.g., patient is no longer in pain), the patient may move the slider to an "optimal" state (e.g., to a "psychoactive" state).
  • a complete therapeutic effect e.g., patient is no longer in pain
  • the patient may move the slider to an "optimal" state (e.g., to a "psychoactive" state).
  • the input from the patient and/or the modified settings are automatically transferred to the physician interface.
  • the physician may decide to manually change the newly defined dose and/or regimen settings.
  • Fig. 14 is a flowchart of a method for measuring one or more biomarkers using a personal portable device and/or using the MDI device, and modifying the dose and/or regimen accordingly, according to some embodiments of the invention.
  • biomarkers such as CNS biomarkers
  • CNS biomarkers are obtained from the patient, using, for example, one or more sensors in the system, and/or one or one more sensors configured in the patient interface device, such as cellular phone sensors for example as described hereinabove.
  • Non-invasive biomarker assessment methods may include one or more of saccadic eye movement assessment (such as saccadic movement), memory testing, adaptive tracking, finger tapping assessment, body sway assessment, visual analog scale match, and/or other assessment methods.
  • the biomarker measures are communicated to the physician (1403).
  • the PD effect measures are stored in a memory of the MDI device and/or a memory of the patient interface. Additionally or alternatively, the PD effect measures are uploaded to a database.
  • the PD effect measures are compared to PD effect measures stored in the database, including, for example, previous PD effect measures of the individual patient, PD effect measures of other patients, PD effect measures from literature, etc.
  • the dose and/or regimen is modified according to the PD effect measures (1405).
  • Figs. 15 A, 15B and 15C are print screens of a patient interface comprising various applications for obtaining PD effect data and/or for assisting a patient in determining a vaporized amount of the agent (dose and/or regimen), according to some embodiments of the invention.
  • a patient interactively performs one or more tasks, which may be incorporated as a part of a game or the like, based on a personal PD effect which can be assessed based on the task.
  • an adverse effect level such as a psychoactive level of the patient, is automatically deduced by the application. Additionally or alternatively, the application assists the patient in articulating their perceived therapeutic and/or adverse effect, which can then be provided as an input to the system.
  • the tasks shown herein for example include tracking a target with a finger (Fig. 15A), visually tracking a target (Fig. 15B), aligning a target (Fig. 15C).
  • Other applications may include various personal PD effect measurements using activities and methods known in the art, such as simulated driving, card sorting, arithmetic skill testing, time estimation, symbol copying, adaptive tracking, reaction time, picture and/or wording skills, and/or other applications, for example as described hereinabove.
  • device 1601 comprises substance dispenser 1603, e.g., a dispenser for the substance that contains the pharmaceutically active agent and allows the pharmaceutically active agent to be vaporized therefrom.
  • the substance dispenser comprises, or is in communication with, a source of at least one substance from which the active agent originates, and a mechanism for processing the substance to obtain a deliverable active agent, for example as described hereinabove.
  • the substance may comprise various forms, such as, for example, a solid bulk, solid particles or a powder.
  • the substance is contained within a cartridge, a capsule, and/or other containers.
  • the processing mechanism includes one or more of, for example, heating (e.g., for vaporizing), turning to aerosol, causing a chemical reaction, for example by mixing with other materials, releasing substance from a container such as by breaking open a capsule, pressure propellant, mobilizing and/or other types of processing.
  • the active agent is already in a ready to use form and does not require any processing before delivering to the user by heating the substance.
  • MDI device 1601 comprises input module 1605.
  • input module 1605 is configured to receive data pertaining to a dose and/or a regimen according to which the active agent will be delivered to the patient. Additionally or alternatively, input module 1605 is configured to receive one or more indications from a sensor (not shown in this figure), comprised within device 1601 and/or configured externally to device 1601.
  • components of device 1601 such as the substance dispenser and/or the controller and/or other components are contained within a housing 1611.
  • the housing is shaped and sized to be used as a handheld device.
  • MDI device 1601 comprises a flow control mechanism.
  • Fig. 17 A is a schematic diagram of a configuration of an MDI device 1701, according to some embodiments of the invention.
  • the heating element is configured to provide localized heating, for example by conduction, convection and/or radiation.
  • a substance is heated sufficiently quickly to a temperature suitable for forming vapors of a vaporizable pharmaceutically active agent contained therein.
  • the substance is organized as a moving element, which can be selectively and/or locally activated.
  • the substance is organized into compacted shapes.
  • each shape represents a pre-determined vaporized amount.
  • the vapors released from the substance collect within a vapor chamber 1711, from which they travel to the patient through an outflow tract.
  • a valve 1713 is positioned along the tract to control the rate of flow.
  • device 1701 comprises a mouthpiece 1715 from which the vapors are delivered to the patient in response to inhalation.
  • mouthpiece 1715 can be attached to other elements, for example, to a mask and/or nasal cannula, optionally with supplemental oxygen, for example, to deliver therapy to debilitated patients.
  • mouthpiece is in fluid communication with valve 1713.
  • device 1701 comprises a power source 1717, for example a battery, a manually wound spring, and/or a wall socket plug.
  • a power source 1717 for example a battery, a manually wound spring, and/or a wall socket plug.
  • device 1701 comprises a controller 1719, for example as described hereinabove, configured to control one or more of valve 1713, power source 1717, and/or the substance dispenser 1703 as a whole and/or separately control the components of the substance dispenser.
  • controller 1719 verifies that a substance cartridge is authorized for use.
  • Fig. 17B shows a cartridge 1723, comprising a plurality of discrete substance cartridges 1725.
  • Each cartridge 1725 contains one or more substances 1727 intended for vaporization (e.g. plant material), enclosed within a heating element 1729 which functions as the housing of the cartridge.
  • heating element 1729 is shaped as cage-like a net of wires which encases the substance.
  • electrical current is passed through heating element 1729, heating the substance contained within the specific individual cartridge.
  • the system provided herein includes at least one dose unit that includes plant material that contains the active agent.
  • the system comprises a plurality of dose units, and the controller is configured to use at least one of the dose units for vaporizing the active agent from the dose unit.
  • the system comprises a plurality of dose units, each of which comprises a plant material having a different composition of at least one pharmacologically active agent.
  • a subset of the dose units have the essentially the same active agent(s) composition.
  • a plurality of does units have the same agents but at different amount ratios.
  • the controller of the system is configured to select at least one of the dose units based on its active agent composition. For example, the controller can be used to select a dose unit having a plant material that includes one active, and then select another dose unit to vaporize a different active agent.
  • FIGs. 17C-D present schematic illustrations of a dose unit (dosing substance vaporization cartridge, or cartridge), according to some embodiments, showing dose unit 2300 having substance 2304 containing one or more active agents and fitting into aperture 2303 in frame 2308 which forms a part of housing 2301 (FIG. 17C), and a resistive heating element 2306 in thermal contact with and extending across two opposite surfaces of substance 2304 (FIG. 17D).
  • resistive heating element 2306 extends across only one surface of substance 2304, while in other embodiments it extends over more than two opposite surfaces thereof.
  • dose unit 2300 comprises:
  • means for heating (vaporizing) substance 2304 for example, a resistive heating element 2306, for example a mesh.
  • At least a portion of dose unit 2300 comprising at least a portion of substance 2304 (or at least all heated portions of substance 2304), is permeable to the passage of air, such that air may pass through the substance when heating and carry with it the heat-vaporized agent.
  • the dose unit is disposable.
  • Potential advantages of a disposable dose unit include: containment of active agent residue for disposal; close integration of dosage support and transport for reliable dosage transport within a dosing apparatus; and/or reduced need to maintain and/or monitor portions of the dosing system (such as a vaporizing heating element) which are subject to conditions that could degrade performance over time.
  • the dose unit is for use in a single inhalation. Potential advantages of a single-use dose unit include improving the precision and/or reliability in controlling the vaporized amount of the bioactive agent under inhaler settings. For example, the concentration and/or dispersal of an active agent in the substance 2304 may be controlled during manufacture at some degree of precision.
  • substance 2304 dimensions are, for example, about 6x10 mm across the exposed surface area, and about 1 mm thick.
  • the thickness of substance 2304 is in the range of about 0.1-1.0 mm, or a greater, lesser, or intermediate thickness.
  • the face area of substance 2304 is in the range of about 20-100 mm 2 ; for example 20 mm 2 , 40 mm 2 , 50 mm 2 , 60 mm 2 , 80 mm 2 , or another greater, lesser, or intermediate face area.
  • Substance 2304 is optionally formed into a square or substantially square shape (for example, about 8x8x1 mm); optionally substance 2304 is oblong with a side ratio of, for example, 1:2, 1:3, 1:4, 1: 10, or another larger, smaller, or intermediate ration of side lengths.
  • substance 2304 is, for example, about 30x2x0.5 mm in dimension.
  • Corresponding substance 2304 by weight is about 15 mg in some embodiments. In some embodiments, substance 2304 weight is selected from within a range of about 1-100 mg, or another range having the same, larger, smaller, and/or intermediate bounds. It is a potential advantage to surround substance 2304 with a framing housing 2301 for greater mechanical stability.
  • vaporization of an active agent comprises heating by resistive heating element 2306 or other form of resistive heating element.
  • the resistive mesh optionally comprises a material which displays substantial resistive heating; for example, nichrome (typical resistivity of about 1-1.5 ⁇ -m), FeCrAl (typical resistivity of about 1.45 ⁇ -m), stainless steel (typical resistivity of about 10-100 ⁇ -m), and/or cupronickel (typical resistivity of about 19-50 ⁇ -m).
  • parameters such as heating element length and width, thickness, aperture size and/or aperture pattern are adjusted to comprise a total resistance across the resistive heating element which is, for example, in the range from about 0.05-1 ⁇ , 0.5-2 ⁇ , 0.1-3 ⁇ , 2-4 ⁇ , or within another range having the same, higher, lower, and/or intermediate bounds.
  • resistive heating element 2306 is attached to housing 2301, in a position overlying substance 2304 on one or more sides.
  • the resistive heating element 2306 has a U shape that extends both sides of frame 2308 from dorsal surface 2309A to fold around housing end 2311, and extend back along ventral surface 2309B.
  • resistive heating element 2306 extends around chamber 2303 such that substance 2304 contained within chamber 2303 is enclosed by the heating element 2306.
  • resistive heating element 2306 (e.g. mesh) comprises a plurality of separate panels, for example, a panel on each side of the cartridge.
  • the panels are electrically connected, one to the other.
  • resistive heating element 2306 comprises a ratio of open (aperture) to closed (mesh material) surface area of between about 1: 1 (50 %) and 1:3 (33 %).
  • the ratio is in the range of about 10-20 %, about 20-40 %, about 30-50 %, about 40-70 %, about 60-80 %, about 70-90 %, or another range of ratios having the same, larger, smaller, and/or intermediate bounds.
  • the apertures of the mesh are in the range of about 10 ⁇ , about 25 ⁇ , 32 ⁇ , 50 ⁇ , 75 ⁇ , 100 ⁇ , 200 ⁇ , 300-750 ⁇ , 700-1200 ⁇ , or another larger, smaller, or intermediate range.
  • resistive heating element 2306 comprises an etched resistive foil (for example a foil etched into a continuous ribbon or other shape, and backed by a polymer such as polyimide and/or silicone rubber).
  • a backed resistive foil is perforated through the backing to allow airflow during volatilization of the dosing substance.
  • a fuse is added to the resistive foil, for example as an added component, and/or as a region of ribbon manufactured deliberately thin, so as to provide a method of destroying the heating element after use (by sending an appropriately high current through the heating element for a sufficient period of time).
  • a potential advantage of LCP and/or PEEK is good resistance to temperature higher than a temperature needed to vaporize a substance held in the cartridge.
  • bonding of mesh and housing occurs at a temperature of about 280 °C (or another temperature high enough to melt and/or soften LCP or PEEK).
  • LCP and PEEK provide the potential advantage of good thermal stability at lower temperatures, for example, at a vaporization temperature of about 230 °C.
  • dose unit 2300 comprises a locking member for use in cartridge transport.
  • the locking member comprises, for example, latch mandible 2302.
  • the locking allows engagement by one or more matching members of a dosing system transport mechanism, for securing and/or movement of the cartridge.
  • Cartridge movement and/or securing against unwanted movement may occur during the cartridge life cycle, for example: when the cartridge is placed into a queue of cartridges comprising a plurality of cartridges arranged for use, when the cartridge is advanced in the queue, when a cartridge is selected for use, when a cartridge is moved into position for use, when a cartridge is actually used, and/or when a cartridge is discarded, or, alternatively, moved to a "used" position in the cartridge queue.
  • the produced vapors are optionally collected in a vapor chamber and delivered to the patient.
  • Fig. 18 a flowchart of a method of treating an individual patient using a system according to Fig. 9, while maintaining the patient within a therapeutic window, according to some embodiments of the invention.
  • the MDI device is programmed with a pre-determined vaporized amount (dose and/or regimen) (1801).
  • dose and/or regimen is set in the inhaler device by the physician, manually (such as by activating buttons on the device itself) and/or using the physician interface. Additionally or alternatively, the dose and/or regimen is set in the MDI device according to instructions sent from the patient interface.
  • the MDI device is optionally configured for selecting at least one pre-determined vaporized amount for an inhalation session, which can include a plurality of inhalations, based on the dose unit's contents, and controlling at least one of heating and airflow in the device to control the pre-determined vaporized amount of an active agent provided to the user.
  • the MDI device is activated to deliver the active agent to the patient (1803).
  • direct and/or indirect feedback data from the patient is obtained in real-time (1805).
  • feedback data is obtained during a pulmonary delivering (an inhalation session).
  • a treatment may typically start with a pulmonary delivery, and end between 5-20 minutes thereafter, for example when the pre-selected pharmacodynamic profile has fully manifested for the active agent and/or at a later time.
  • feedback data is obtained over a series of pulmonary deliveries, for example over a time period of 1 hour, 3 hours, 5 hours, 9 hours, 12 hours or intermediate, longer or shorter time periods.
  • a protocol may include 5-10 pulmonary deliveries per day, in time intervals ranging between 15-180 minutes between successive pulmonary deliveries.
  • the feedback data which is obtained from the patient includes personal PD effects such as therapeutic effects, for example symptom intensity, and/or adverse effects, for example a psychoactive state of the patient.
  • the patient interface interacts with the patient to obtain the feedback data.
  • questions to the patient relating their current state are displayed on a screen, and the patient answers the questions.
  • Such a question may be presented, for example, in the form of a bar indicating a pain level, for example, which the patient raises and/or lowers.
  • feedback data is obtained by one or more applications, such as games, which the patient interacts with.
  • non-invasive biomarkers levels are estimated by analyzing the patient's input when interacting with the user interface.
  • feedback data from the patient is obtained by measuring various biomarkers using one or more sensors, for example by utilizing components of a smartphone, a handheld device, a wearable device, a wrist device or an integrated eyewear device, to act as non-invasive biomarker sensors.
  • the personal PD effects are obtained periodically, for example semi-daily, daily, weekly, monthly, per demand such as before a dose and/or a series of doses, before and/or after alterations in dosing and/or regimen, or others.
  • a dose and/or regimen in response to the PD effects, is modified (1809).
  • the dose and/or regimen is modified to achieve a desired effect, for example reduce pain level of the patient, while maintaining the patient within a therapeutic window.
  • the dose and/or regimen is iteratively modified by the patient interface. Modifications may take place a plurality of times, for example during, between or after one or more pulmonary deliveries, and/or over a total treatment time period (days, weeks, months, years) over which the patient is treated. The modification is limited by safety cutoffs, such as doses which may put the patient at risk.
  • usage data of the patient is recorded and stored in the MDI device memory and/or in the patient interface memory.
  • the delivery of the active agent is modified, potentially in real-time, according to usage data.
  • the dose and/or regimen may be automatically modified to set a delivery of, for example, an increased amount of active agent in the following one or more pulmonary deliveries.
  • compositions, method or microcapsules may include additional ingredients, steps and/or parts, but only if the additional ingredients, steps and/or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.
  • VAS visual analog scale
  • Negative pregnancy test (defined by ⁇ human chorionic gonadotropin pregnancy test), when applicable.
  • the PK/PD study was carried out based on a single-dose open-label design protocol. The medical history of all patients was evaluated, and they were physically examined by the study physician. Routine medications were continued throughout the trial. Patients were required to abstain from using cannabis for 12 hours prior to the trial.
  • Pain intensity reduction was assessed as a therapeutic effect by asking participants to indicate the intensity of their current pain on a 100 mm visual analog scale (VAS) between 0 (no pain) and 100 (worst possible pain) at baseline (prior to the inhalation) and at 20 and 90 minutes following the pulmonary delivery of the pharmaceutically active agent from cannabis.
  • VAS visual analog scale
  • Adverse effects in the form of psychotropic symptoms, were recorded at 5, 15, 30, 60 and 120 minutes post pulmonary delivery, along with those spontaneously reported by the participants. Adverse effects were evaluated according to standardized criteria in terms of severity, frequency, duration and relationship to the study's active agent. Adverse effects were graded using the NIH Division of AIDS table for scoring severity of adult adverse experiences. Blood pressure and pulse rate were also recorded before, during and after the pulmonary delivery.
  • the crude substance employed was pharmaceutical-grade cannabis flos (Bedrocan BV, Veendam, The Netherlands) containing 19.9 % dronabinol (A 9 -THC), 0.1 % cannabidiol (CBD) and 0.2 % cannabinol (CBN).
  • the crude substance was free of pesticides and heavy metal (less than 0.2 ppm lead, less than 0.02 ppm mercury and less than 0.02 ppm cadmium). Foreign materials (stalks, insects and other vermin) were removed from the crude substance. Microbiological purity was confirmed (total aerobic microbial count of less than 10 CFU/gram, total yeast and moulds count of less than 10 CFU/gram and absence of P. aeruginosa, S. aureus and bile-tolerant gram negative bacteria).
  • the cannabis flos substance was gently grounded while retaining all compounds in raw form, resulting in a physically modified substance containing 20.4 % of the active A9-THC.
  • the grounded cannabis was provided in preloaded cartridges containing 15.1 + 0.1 mg each.
  • the study's MDI device was a battery operated palm sized hand held metered dose MDI (Syqe MDITM), designed to vaporize multiple doses of pharmaceutically active agent(s), resulting in pulmonary delivery of vaporizable active agent(s) (see, Background Art Fig. 1 and WO/2012/085919).
  • the MDI consisted of a multi-cartridge daisy, cartridge counter, indication light and power switch. Each cartridge was preloaded with pre- weighed 15.1 + 0.1 mg of the substance (cannabis flos) prepared as described above, each containing about 3.08 + 0.02 mg A 9 -THC based on substance analysis.
  • the vaporization and pulmonary delivery process was instantaneously triggered by the inhalation force of the patient and lasted about 3 seconds. The transition to the next pulmonary delivery was performed by sliding the dose indicator.
  • Each cartridge was heated to about 190 °C in about 470 ms, and was precisely sustained for 2,530 ms.
  • the efficiency of the THC vaporization process was 52.7 + 2.7 % (data not shown), indicating a low variability between pulmonary delivered doses.
  • the device allowed for inhalation ranges between 1 to 30 L/minute, engaging real-time flow control and an automated anatomic dead space elimination mechanism, assuring all vapors pass the trachea post inhalation.
  • the device required minimal user training.
  • the device electronically controlled and logged the entire pulmonary delivery process, allowing for storing and uploading of treatment data logs.
  • the MDI device further allowed for "single dose" resolution, instantaneous administration, and required no preprocessing or any user intervention other than the inhalation.
  • Results are reported herein as mean values + 1 standard deviation (+ SD).
  • VAS pain intensity, systolic and diastolic blood pressure, heart rate and satisfaction score the mean and 95 % confidence interval (CI) at different time points was plotted. Differences between VAS pain intensity values and satisfaction scores, before and after inhalation, were tested by two-tailed paired Student t-test. Blood pressure and heart rate values were compared among different time points by one-way ANOVA. P-values ⁇ 0.05 were accepted as significant. All statistical analyses were performed using Minitab Statistical Software, version 16. Eight patients participated in the study. Patients' demographic and baseline characteristics data are presented in Table 1.
  • Table 2 presents pharmacokinetics data obtain for A 9 -THC following a single dose inhalation of 15.1 + 0.1 mg cannabis flos, containing 3.08 + 0.02 mg A 9 -THC, self- administered by 8 adult patients as described herein (see, Table 1 hereinabove).
  • Table 1 hereinabove
  • the inter-individual variability in plasma cannabinoids levels upon the single dose inhalation is presented in Fig. 2 and Table 2 below.
  • BP mean systolic blood pressure
  • providing patient data (1901) includes treatment instructions and/or treatment preferences.
  • Some examples for treatment instructions or preferences may include no dose during a given temporal window; allowing more drowsiness generally (e.g., for bedridden patients) or at a given time (e.g., initial treatment and/or during the night and/or when dealing with extreme symptoms); requiring alertness in given timeframe (e.g., when a patient expects to need alertness), and the like.
  • Such instructions may be given a weighted value; for example, a patient may be less adamant on some instructions then others, for example the patient may prefer having more drowsiness in the evening, but may indicate that he must be alert for a test at 10 AM.
  • sensing airflow properties in the device may be used as an indication of the user's status, wherein such air flow properties may include one or more of flow rate and/or the rate of increase in flow rate and or a degree and/or rate of variation in flow during an inhalation event.
  • air flow properties may include one or more of flow rate and/or the rate of increase in flow rate and or a degree and/or rate of variation in flow during an inhalation event.
  • baseline values which may indicate for example an improvement or a decline in wellbeing (e.g. as manifested by strength and/or pain that may affect the inhalation properties/patterns for the user) and/or concentration or attention.
  • One or more treated symptoms is not sufficiently alleviated
  • the therapeutic/adverse effect balance is below a given threshold
  • a given activity of an agent may be regarded as a desired effect or an undesired effect inter alia in different circumstances and for different subjects.
  • an active agent that is analgesic, sedative and/or hallucinogenic it may be that the analgesic property is a therapeutic effect and the hallucinogenic property is an adverse effect.
  • this might be a desired effect of treatment while in others it may be undesired.
  • the dosing and/or regimen includes a second active agent (or more than two agents) that is coadministered in order to reduce an undesired side effect of the drug.
  • pulmonary delivering a pre-determined vaporized amounts over a day from wakefulness at about 6:30 am to sleep after 22:30, wherein the patient is, for instance, a 35 years old male exhibiting a BMI of 22.
  • the patient suffers from chronic neuropathic pain, occasional breakthrough pain (BTH) episodes (once in the presented day) and sleeplessness due to pain, particularly difficulty in falling asleep.
  • BTH breakthrough pain
  • PK/PD profiles are predicted and an initial regimen is proposed, in order to maintain the effect of the active agent (such as THC) within the therapeutic window for at least 12 hours.
  • the regimen includes a first dose of, for example, 1.2 mg taken at 7 AM in view of pain increase through the night, when no treatment was administered, followed by 0.5 mg every 1.5 hours.
  • Fig. 20 also shows that this regimen reduced pain (red line) from a high value before 7 am to a value that is maintained within the allowed window until about 14:30 when the patient experienced a BTH of severe pain.
  • the therapeutic window is adjusted.
  • the high threshold of the dose increases in this example, because in view of the severe pain, some excess psychoactive effect becomes tolerable and even desired. Additionally, the bottom range of the window moved up because the required dose needed to alleviate the pain became higher.
  • the dosing is adjusted. This is because the PD effect of drowsiness changed from an adverse effect to a therapeutic effect.
  • the patient administers a dose of 2.4 mg about 30 minutes prior to intended sleep time. Before awaking, the dose may be adjusted gradually or abruptly so that any late night inhalation would not be likely to have an excessive effect in the morning.
  • An MDI device for example as described herein in Fig. 16 and/or Fig. 17, is loaded with a plurality of pre-weighted cartridges, each containing a substance that comprises one or more vaporizable pharmaceutically active agent(s).
  • the MDI is pre- calibrated and preset to release a pre-determined vaporized amount of the pharmaceutically active agent according to PK/PD data obtained for a population and/or PK effects of a particular patient, as described hereinabove.
  • monitoring comprises determining personal PD effects.
  • Various parameters may be voluntarily provided by the patient via, e.g., a patient interface, while others may be independently collected by the system, via sensors and/or a practitioner interface.
  • Personally perceived parameters such as a perceived therapeutic effect (for example a pain level) and a perceived adverse effect (for example a psychoactive level) are inserted to the system, for example by the patient interacting with a patient interface display.
  • An application for obtaining personally perceived parameters may, for example, visually present a graph to the patient, such as a bar graph, which the patient can modify based on his perceived notion of the effects.
  • Other personal PD effects may include presence and/or levels of biomarkers.
  • presence and/or level of biomarkers is determined using one or more sensors.
  • the sensors are common components of a mobile personal device, such as a smartphone, a handheld device, a wearable device, a wrist device or an integrated eyewear device, which are utilized to collect indications based on which biomarkers can be deduced.
  • biomarkers are detected and measured via external elements paired to the mobile personal device.
  • Biomarker assessment methods may include one or more of saccadic eye movement assessment (such as saccadic movement), memory testing, adaptive tracking, finger tapping assessment, body sway assessment, visual analog scale match, and/or other assessment methods.
  • the applications are designed to test the patient using various known in the art cognitive tasks, including, for example, reaction time, attention, visuospatial span, spatial-temporal reasoning, name recall, narrative recall, face recall, name -face association, construction, verbal fluency, object naming, implicit memory, logical reasoning and/or other cognitive tasks.
  • the collected parameters are stored in a memory of the patient interface, for example as described in Fig 9.
  • the collected parameters are transferred to the physician's interface, for example as described in Fig. 9.
  • the parameters are transferred in real-time, during use of the MDI device.
  • the dose and/or the regimen may be modified.
  • the patient initiates a dose/regimen modulation by entering personally perceived PD effects via the patient interface.
  • the systems may perform a series of data collection pertaining to other PD effects, objective and subjective, analyze the data in correlation to the personally perceived PD effects entered by the patient and to safety cutoff values, and either alerts the patient to the allowed, recommended and/or prescribed dose/regimen comparatively.
  • the system may alert the patient/practitioner to a non-safe dose/regimen or to an ineffective dose/regimen, and/or alert the patient/practitioner to a different dose/regimen according to the prescribed dose/regimen or past experiences logged in the database of the system, and/or notify the patient to ramifications of any given dose/regimen per time of day, activity and location ("too early in the day", “too far from home", "in a moving vehicle” and the likes).
  • the PD-based personalization of the dose/regimen is monitored and recorded for future reference, and may be translated to a re-determined initial vaporized amount and regimen.
  • the patient interface automatically modifies the dose and/or regimen, while restricting the modulation by the safety thresholds and/or other thresholds, such as thresholds initially defined by the physician.
  • the physician upon receipt of the personal PD effects, modifies the dose and/or regimen, for example using the patient interface, and instructions are transferred to the patient interface and/or to the MDI device.
  • the physician re-selects a personal PD profile for the patient and/or re-selects a personal dosing/regimen to suit a therapeutic window of the patient.
  • the patient and/or physician operate the MDI device manually (for example by activating buttons or switches on the device), to set the desired dosing and/or regimen.
  • the potential benefits of a combination treatment which is effected, according to some embodiments, for example, by use of the presently described device, include, without limitation, precise dosing for each of the plurality of active agents and for each inhalation event and precise proportion between active agents and/or inhalation events.
  • a simultaneous delivery of two (or more) active agents may include the use of: a.
  • a plant e.g. cannabis
  • plant variety may be chosen to provide a desired active agent ratio
  • a co-administration regimen can be delivered, according to some embodiments of the present disclosure, by providing different dose units comprising different active agents within the device and controlling the relative vaporization timing thereof so as to allow selective vaporization of the different active agents or active agents composition, each for different inhalation events (e.g., by selecting a dose unit having a desired composition and/or by matching a plurality of dose units to provide a desired amount/combination of active agents).
  • Table 3 below presents dosing regimen useful in treating disorders and diseases responsive to co-administration of THC and CBD using the device and methods presented herein.
  • the regimens represent Peri-Disorder/event, episodic and chronic (12 hour treatment period) treatment for average patient
  • Pain is to be maintained below a given threshold, at least as long as the patient is awake.
  • the patient is provided with a dose unit containing a 25 mg dose of CBD about 20 minutes before each dose of THC, beginning when the patient wakes up in the morning.
  • the first dose unit contains 1.2 mg THC. This is more than the usual dose because it is required to remove residual pain buildup that occurred during the night.
  • This is followed by using a dose unit containing 25 mg CBD plus 0.5 mg THC paired doses about once every two hours.
  • the pain level decreases and remains constant while psychoactivity is kept at a low level.
  • the last dose is a high 1.2 mg THC dose taken alone without a CBD precursor.
  • the user interface can provide feedback from the user, indicative of one or more of:
  • the perceived or measured therapeutic or adverse effects may include one or more of treatment related effects (pain/nausea/PD level) and/or side effects (PD), and may be provided in different classes of indications:
  • the user may be interrogated periodically (e.g., once a day or every several hours or upon preparation for inhalation or as a requirement before inhalation) and may be limited to only a part of the period of treatment.
  • interrogation may cover the initial 6, 12 or 24 hours in order to determine a regimen and then repeated periodically (e.g. once a day or once a week or once a month or upon desire) in order to confirm the regimen and/or readjust it in view of progress.
  • the user may interact with the interface at will.
  • a user semi-controlled indication is exemplified by a user who participates in measuring his own status. In such cases some user compliance is required for these indications, but the user has little or no control on the consequences as these are expressed in the device's output and response, such as the determination of the predetermined vaporized amount.
  • Examples include:
  • a user subjecting himself to a sensor e.g., eye redness or heart rate sensor
  • a user performing a test such as playing a game, or instructing the user to perform a task, such as for example, following a mark on a screen with his eyes while having his pupils monitored, dragging a mark on a screen through a pattern without touching walls
  • completing mental tasks such as solving mathematical equations or answering verbose questions; playing memory and/or concentration games; etc.
  • a user uncontrolled indication includes a user interface which is associated with sensing one or more user properties for providing an indication of the user's status and use that information to control the determination of the pre-determined vaporized amount, the dose and/or the regimen, thereby controlling one or more therapeutic/adverse effects in the user.
  • Examples include:
  • Sensing airflow properties in the device as induced by the user may include one or more of flow rate and/or the rate of increase in flow rate and or a degree and/or rate of variation in flow during an inhalation event. For example considering changes from one or more baseline values, which may indicate for example an improvement or a decline in wellbeing (e.g. as manifested by strength and/or pain that may affect the inhalation properties/patterns for the user).
  • the user may provide instructions/requests via the user interface to the device in advance and/or during the inhalation session.
  • Examples include:
  • one psychoactive state may be defined by the user as a desired "default” condition while another may be defined as “sufficiently pain free” and yet another as "good for performance of specific tasks (e.g., driving).
  • Such designations may be subject to constraints imposed by the device based for example on a physician's input or a maximal allowed dosage for a period of time and the like.
  • the user may be prompted to indicate how well this desired effect was met, in order to improve the dosing regimen on an ongoing basis;
  • General regimen requests e.g. sleep times where drowsiness becomes a desired affect and no longer an undesired side effect; times where special awareness is needed, such as work or study or driving sessions);
  • a dose request or a regimen request or a dosing regimen proposed by the user is sent to a physician for approval before being implemented by the device.
  • the request is sent only when the device cannot execute the request without exceeding pre-entered constraints.
  • some constraints are made rigid and cannot be exceeded regardless of a physician approval (e.g., lethal dosage);
  • the user interface may allow a user to chart/plan his psychoactive state throughout the day manually (e.g., on a touch screen or an image that is captured by the device, etc.), and have the device adapt the regimen accordingly.
  • a user may draw the levels of psychoactivity on a time based chart representing a desired psychoactivity throughout the day.
  • the user defines the psychoactivity state and treatment state, namely the user is involved in determining the therapeutic window, and the device calculates an adequate regimen that is known or expected to achieve the desired PKPD balance, as long as it also falls within any optional pre-imposed constraints;
  • Unplanned changes e.g., unexpected need to perform a task that requires a heightened awareness or other schedule change or sudden medical requirement like breakthrough pain
  • Snoozing the device or missing a session the device imposes a limitation on the amount of time allowed for snoozing;
  • the device provides temporal and location dependent treatment, which is based on sensors in communication with the device and patient's personal treatment information.
  • the sensors provide time and location data (based on GPS/WiFi or the like) and/or location data is provided via a user interface and boundaries are determined in which a particular therapeutic window is in effect, thereby selecting a time/location-dependent dose and/or regimen, as well as specific time/location-dependent set of alerts.
  • a default degree of freedom is prescribed by a physician when providing the device.
  • One or more other degrees of freedom may be set in advance or calculated upon request. These degrees of freedom may be manifested as boundaries in a treatment (therapeutic window).
  • the treatment window may be location dependent.
  • a user's workplace may be designated as area which will not allow the user to reach a certain psychoactive state, while a user's home address, and optionally during late evening and nighttime, be considered as a free psychoactivity area (other types of places are contemplated for any sort of default pre- setting).
  • the alerts provided by a user interface are location sensitive, such that for example sound or volume may be restricted in a workplace; and
  • a user's interface equipped with a database for storing, analyzing and using information regarding the user's preferences, dated activities and locations and the like.
  • User interface output may include automated text messages provided for example by email or text messages to the user, a care giver of physician, or a medical treatment center.
  • the output may be available generally or individually to individual users.
  • Outputs and/or alerts provided for the patient, a caregiver or any pre-designated individual or system, designed to assist and/or protect a user when in a relatively high psychoactive state.
  • the following may be performed when an adverse effect is perceived, and/or anticipated and/or upon request by the user, such as alerts to designated recipients (e.g., relatives or neighbors) when certain psychoactive levels are reached;
  • an adverse effect (psychoactive) level-dependent message such as "do not disturb" on the user's personal smartphone and other devices.
  • an adverse effect level-dependent message such as "do not disturb"
  • calls from pre-selected callers are blocked and/or responded automatically with a text message to indicate that the user is not available, thus potentially reducing anxiety during the treatment session;
  • an 'anticipating alert may be given.
  • the interface may guide the user to a safe environment, offer the possibility of communicating the situation to pre-selected recipient, suggest to have food/beverage ready in order to mitigate the adverse effect, prepare an antidote dose from the device as an emergency precaution, and/or provide a notification to a care giver and/or physician;
  • Visual real-time representation of the adverse effect level of a user may be provided, for example as a graph, chart, number, bar, line or any other visual representation.
  • this representation may be viewed by a user and/or a physician and/or a care giver at all times.
  • the visual representation may include data derived from one or more of the inhaler regarding a dose taken, and PK/PD algorithms which simulate the psychoactive PD, the user's history for inhaler use and its effect and sensed information.
  • the physician interface may include, for example, the regimen as provided by the physician. This regimen may be imposed on the user or subject to the user's acceptance.
  • the regimen includes a degree of freedom that allows the user and/or the device to modify a regimen without physician intervention or approval. In such cases the physician may be notified before and/or after the treatment session.
  • the physician may be able to approve/reject/modify dosing regimens selected or requested by the user.
  • a user/physician interface for obtaining input in any category can include any interface that allows the above examples (including user control or lack thereof and visual schematics, sound, text etc.).
  • Sensors can be integrated in the inhaler device or otherwise be associated or in communication therewith.
  • the sensors can be dedicated sensors or advantage may be taken from a device for other use (e.g., communication with a pacemaker for cardiac related properties).
  • Environmental sensors can provide information on user activity as an indication for the user's PD and/or wellbeing. Examples include heart-rate sensors, pace/motion/velocity sensors, and GPS location.
  • Table 4 lists dosing and/or regimen according to syndromes (symptoms, events, disorders and diseases), which are treatable and/or therapeutically responsive to THC.
  • a dose, individual or part of a regimen corresponds to a single pre-determined vaporized amount of THC.
  • Different treatments may include prophylactic treatment (pre-disorder/event treatment), namely pulmonary delivery of THC via the device presented herein when an event is expected, based on time and/or circumstance wherein a pre-event dose may be prescribed; acute or episodic treatment, namely pulmonary delivery of THC via the device presented herein when an episode occurs and the duration of the symptom(s) (the time period until symptom(s) subside); semi-chronic or chronic treatment, namely pulmonary delivery of THC via the device presented herein regardless of perception of an acute symptom or when an event/symptom(s) may last for an extended period of time.
  • prophylactic treatment pre-disorder/event treatment
  • acute or episodic treatment namely pulmonary delivery of THC via the device presented herein when an episode occurs and the duration of the symptom(s) (the time period until symptom(s) subside)
  • semi-chronic or chronic treatment namely pulmonary delivery of THC via the device presented herein regardless of perception of an acute symptom or when an event/
  • Psychoactive agents affect the central nervous system in various ways by influencing the release of neurotransmitters (chemical messengers within the nervous system, such as acetylcholine, serotonin, dopamine, norepinephrine), or mimicking their actions.
  • Psychoactive agents can be classified based on their effects, such as, without limitation, sedative agents, stimulating agents, excitants and enhancers of mental alertness and physical activity; agents that reduce fatigue, appetite enhancers/suppressants, hallucinogenic agents, perception- altering agents, mood- altering agents, depressants and stimulants.

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Abstract

La présente invention concerne un procédé d'administration pulmonaire à un sujet d'au moins un premier agent pharmacologiquement actif et d'un second agent pharmacologiquement actif, dont au moins l'un est présent dans au moins une matière végétale. Le procédé est mis en œuvre en administrant indépendamment ces agents au sujet à l'aide d'un dispositif inhalateur-doseur qui est conçu pour vaporiser au moins une première quantité prédéterminée du premier agent et au moins une seconde quantité prédéterminée du second agent suite au chauffage régulé de la matière végétale, ledit chauffage étant mis en œuvre de telle sorte que la première quantité vaporisée prédéterminée est administrée au sujet à la suite de, de manière concomitante avec et/ou au moins partiellement en même temps que la seconde quantité vaporisée prédéterminée, et chacune des quantités vaporisées prédéterminées de chacun des agents induisant, indépendamment, chez le sujet au moins un effet pharmacocinétique et/ou au moins un effet pharmacodynamique.
PCT/IL2015/050674 2014-06-30 2015-06-30 Procédés, dispositifs et systèmes utilisables en vue de l'administration pulmonaire d'agents actifs Ceased WO2016001922A1 (fr)

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PCT/IL2015/050674 WO2016001922A1 (fr) 2014-06-30 2015-06-30 Procédés, dispositifs et systèmes utilisables en vue de l'administration pulmonaire d'agents actifs
AU2015283590A AU2015283590B2 (en) 2014-06-30 2015-06-30 Methods, devices and systems for pulmonary delivery of active agents
IL273507A IL273507B2 (en) 2014-06-30 2015-06-30 Methods, devices and systems for administering active substances through the lungs
US15/375,098 US10118006B2 (en) 2014-06-30 2016-12-11 Methods, devices and systems for pulmonary delivery of active agents
US15/386,182 US9839241B2 (en) 2014-06-30 2016-12-21 Methods, devices and systems for pulmonary delivery of active agents
IL249837A IL249837B (en) 2014-06-30 2016-12-28 Inhaler for pulmonary delivery of active agents
US16/030,967 US11298477B2 (en) 2014-06-30 2018-07-10 Methods, devices and systems for pulmonary delivery of active agents
IL260852A IL260852B (en) 2014-06-30 2018-07-30 Methods, devices and systems for administering active substances through the lungs
AU2020205271A AU2020205271A1 (en) 2014-06-30 2020-07-15 Methods, Devices And Systems For Pulmonary Delivery Of Active Agents
US17/694,764 US12194230B2 (en) 2014-06-30 2022-03-15 Methods, devices and systems for pulmonary delivery of active agents
AU2022211900A AU2022211900B2 (en) 2014-06-30 2022-08-05 Methods, Devices And Systems For Pulmonary Delivery Of Active Agents
US19/014,337 US20250144328A1 (en) 2014-06-30 2025-01-09 Methods, devices and systems for pulmonary delivery of active agents
AU2025200462A AU2025200462A1 (en) 2014-06-30 2025-01-23 Methods, Devices And Systems For Pulmonary Delivery Of Active Agents

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US201462035588P 2014-08-11 2014-08-11
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US201462085772P 2014-12-01 2014-12-01
US62/085,772 2014-12-01
US201462086208P 2014-12-02 2014-12-02
US62/086,208 2014-12-02
US201562164710P 2015-05-21 2015-05-21
US62/164,710 2015-05-21
PCT/IL2015/050674 WO2016001922A1 (fr) 2014-06-30 2015-06-30 Procédés, dispositifs et systèmes utilisables en vue de l'administration pulmonaire d'agents actifs

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