# US 11,298,477 B2 · Methods, devices and systems for pulmonary delivery of active agents

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- Number: US 11,298,477 B2
- Document ID: US11298477B2
- Status: Granted
- Kind: B2
- Application number: 16/030,967
- Filed: 2018-07-10
- Published: 2018-11-08
- Granted: 2022-04-12
- Earliest claimed: 2014-06-30
- Assignees: Syqe Medical Ltd.
- Applicants: Syqe Medical Ltd.
- Inventors: Perry Davidson; Shlomo Almog; Seth Kindler
- Web page: https://patentgrep.com/patent/US11298477B2

## CPC

- A61M 15/0028: {using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up}
- A61K 9/007: {Pulmonary tract; Aromatherapy}
- A61K 9/0073: {Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy; (nasal sprays A61K9/0043; inhalation of vapours of volatile or heated drugs, e.g. essential oils or nicotine, A61K9/007; devices A61M)}
- A61K 31/465: Nicotine; Derivatives thereof
- A61K 31/658: {o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol}
- A61K 36/185: Magnoliopsida (dicotyledons)
- A61K 36/3482: {Cannabis}
- A61K 36/742: {Coffea, e.g. coffee}
- A61K 36/81: Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
- A61M 11/041: {using heaters}
- A61M 11/042: {electrical}
- A61M 15/0001: {Details of inhalators; Constructional features thereof}
- A61M 15/0003: {with means for dispensing more than one drug}
- A61M 15/0013: {with inhalation check valves}
- A61M 15/0015: {located upstream of the dispenser, i.e. not traversed by the product}
- A61M 15/002: {with air flow regulating means}
- A61M 15/0045: {using multiple prepacked dosages on a same carrier, e.g. blisters}
- A61M 15/005: {the dosages being arranged on a cylindrical surface}
- A61M 15/0051: {the dosages being arranged on a tape, e.g. strips}
- A61M 15/0065: {Inhalators with dosage or measuring devices (A61M15/0028 takes precedence; dosage devices incorporated in aerosol cans B65D83/52)}
- A61M 15/0066: {with means for varying the dose size}
- A61M 15/06: Inhaling appliances shaped like cigars, cigarettes or pipes
- A61M 16/14: by mixing different fluids, one of them being in a liquid phase
- A61M 16/20: Valves specially adapted to medical respiratory devices
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 1/08: for nausea, cinetosis or vertigo; Antiemetics
- A61P 1/14: Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61P 9/12: Antihypertensives
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 11/06: Antiasthmatics
- A61P 13/10: of the bladder
- A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 17/04: Antipruritics
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 21/00: Drugs for disorders of the muscular or neuromuscular system
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/04: Centrally acting analgesics, e.g. opioids
- A61P 25/08: Antiepileptics; Anticonvulsants
- A61P 25/14: for treating abnormal movements, e.g. chorea, dyskinesia
- A61P 25/16: Anti-Parkinson drugs
- A61P 25/18: Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
- A61P 25/20: Hypnotics; Sedatives
- A61P 25/22: Anxiolytics
- A61P 25/24: Antidepressants
- A61P 25/30: for treating abuse or dependence
- A61P 25/32: Alcohol-abuse
- A61P 27/06: Antiglaucoma agents or miotics
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/04: Antibacterial agents
- A61P 31/14: for RNA viruses
- A61P 31/18: for HIV
- A61P 35/00: Antineoplastic agents
- A61P 35/02: specific for leukemia
- H05B 1/0227: {Applications}
- H05B 1/0244: {Heating of fluids (H05B1/0247 takes precedence)}
- H05B 1/025: {For medical applications}
- H05B 3/34: flexible, e.g. heating nets or webs
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/006: {Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays}
- A61M 11/02: operated by air {or other gas} pressure applied to the liquid {or other product} to be sprayed or atomised {(sprayers for horticulture A01G, A01H; killing insects A01M; air humidifying by nozzles F24F6/14, F24F6/18; cooling by spraying F28B, F28C)}
- A61M 15/0021: {Mouthpieces therefor}
- A61M 15/003: {using capsules, e.g. to be perforated or broken-up}
- A61M 15/0091: {mechanically breath-triggered}
- A61M 2016/0039: {in the inspiratory circuit}
- A61M 2016/0042: {in the expiratory circuit}
- A61M 2205/0216: Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
- A61M 2205/276: preventing unwanted use
- A61M 2205/3303: Using a biosensor
- A61M 2205/3313: used specific wavelengths
- A61M 2205/332: Force measuring means
- A61M 2205/3331: Pressure; Flow
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3368: Temperature
- A61M 2205/3375: Acoustical, e.g. ultrasonic, measuring means
- A61M 2205/3553: remote, e.g. between patient's home and doctor's office
- A61M 2205/3561: local, e.g. within room or hospital
- A61M 2205/3569: sublocal, e.g. between console and disposable
- A61M 2205/3592: using telemetric means, e.g. radio or optical transmission
- A61M 2205/36: related to heating or cooling
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/505: Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2205/70: with testing or calibration facilities
- A61M 2230/06: Heartbeat rate only
- A61M 2230/205: partial oxygen pressure (P-O2)
- A61M 2230/30: Blood pressure (A61M2230/04 takes precedence)
- A61M 2230/42: Rate
- A61M 2230/50: Temperature
- A61M 2230/60: Muscle strain, i.e. measured on the user
- A61M 2230/63: Motion, e.g. physical activity
- A61M 2230/65: Impedance, e.g. conductivity, capacity
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- H05B: ELECTRIC HEATING; ELECTRIC LIGHT SOURCES NOT OTHERWISE PROVIDED FOR; CIRCUIT ARRANGEMENTS FOR ELECTRIC LIGHT SOURCES, IN GENERAL

## Abstract

Provided herein is a method of pulmonary delivering to a subject at least one pharmacologically active agent being in a plant material, which is effected by pulmonary delivering the agent to the subject using a metered dose inhaler device that is configured to vaporize at least one pre-determined vaporized amount of the agent upon controllably heating the plant material, wherein the pre-determined vaporized amount is selected 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.

## Claims

### Claim 1

A method of delivering to a pulmonary tract of a subject suffering from at least one physiological symptom at least one pharmacologically active agent for treating the at least one physiological symptom, the method comprising:
providing the subject with an inhaler device associated with a controller which is preset with a personalized therapeutic window in which the at least one symptom for which the pharmacologically active agent was prescribed remains sufficiently alleviated, and at least one adverse effect induced by the pharmacologically active agent on the subject remains below a threshold; wherein the at least one adverse effect is not associated with the at least one physiological symptom being treated;
vaporizing, at the inhaler device, a first metered amount of at least one pharmacologically active agent;
delivering the first metered amount to the subject from the inhaler device; wherein the controller is preprogrammed with at least one predetermined effect to be induced in the subject by the at least one pharmacologically active agent; the at least one predetermined effect including the alleviation of at least one symptom that the subject is suffering from;
receiving at the controller monitoring data indicative of at least one effect induced in the subject by the first metered amount;
accessing data stored in a database, the stored data being other than the predetermined effect and other than the monitoring data; and
vaporizing and delivering from the inhaler device, within a treatment regimen including the delivering of the first metered amount, a second metered amount of at least one pharmacologically active agent, wherein a magnitude of the second metered amount is automatically controlled by the controller based at least partially on the monitoring data, the data stored in the database and on the at least one predetermined effect; wherein the controller is configured for selecting the magnitude of the second metered amount in order to maintain the subject within limits of the therapeutic window.

### Claim 2 (depends on 1)

The method of claim 1, wherein the stored data is derived from clinical experiment results, and monitoring of other patients, and research.

### Claim 3 (depends on 1)

The method of claim 1, wherein vaporizing the second metered amount is during the at least one effect induced in the subject by the first metered amount.

### Claim 4 (depends on 1)

The method of claim 1, wherein the first metered amount and the second metered amount are respectively vaporized from substances containing different compositions of pharmacologically active agent.

### Claim 5 (depends on 1)

The method of claim 1, wherein the at least one pharmacologically active agent vaporized in the first metered amount and the at least one pharmacologically active agent vaporized in the second metered amount together comprise a plurality of chemically different pharmacologically active agents; and wherein the first metered amount and the second metered amount comprise different compositions of the plurality of chemically different pharmacologically active agents.

### Claim 6 (depends on 1)

The method of claim 1, wherein vaporizing comprises heating of the at least one pharmacologically active agent.

### Claim 7 (depends on 6)

The method of claim 6, wherein controlling the magnitude of the first and/or second metered amounts by the controller comprises controlling the heating.

### Claim 8 (depends on 1)

The method of claim 1, wherein a magnitude of the first metered amount is controlled by the controller for exhibiting the at least one predetermined effect in the subject.

### Claim 9 (depends on 8)

The method of claim 8 wherein the magnitude of the second metered amount is controlled by the controller to induce an effect adjusting the at least one effect induced by the first metered amount, the at least one effect induced by the first metered amount differing from the predetermined effect, upon delivery of the second metered amount.

### Claim 10 (depends on 8)

The method of claim 8, wherein the magnitude of the second metered amount is selected to induce a pre-selected profile of the at least one predetermined effect, based on a difference between the at least one effect indicated by the monitoring data, and the pre-selected profile.

### Claim 11 (depends on 1)

The method of claim 1, wherein the at least one effect comprises at least a pharmacodynamic effect which is selected from the group consisting of a desired effect, an undesired effect, a therapeutic effect, an adverse effect and a level of a biomarker.

### Claim 12 (depends on 1)

The method of claim 1, wherein the at least one effect comprises at least a pharmacodynamic effect which is a psychotropic effect and/or a somatic effect.

### Claim 13 (depends on 1)

The method of claim 1, wherein a timing of the vaporizing of the second metered amount is controlled by the controller based on the monitoring data.

### Claim 14 (depends on 1)

The method of claim 1, wherein the at least one pharmacologically active agent is vaporized from a plant material.

### Claim 15 (depends on 1)

The method of claim 1, wherein at least one pharmacologically active agent is present in both of the first metered amount and the second metered amount.

### Claim 16 (depends on 1)

The method of claim 1, wherein the receiving, accessing, and vaporizing of the second metered amount are performed within 0-30 minutes from delivering of the first metered amount.

### Claim 17 (depends on 1)

The method of claim 1, comprising selecting a dose unit from a plurality of dose units contained in a magazine, the dose unit comprising source material, and wherein vaporizing comprises vaporizing the source material to release the at least one pharmacologically active agent.

### Claim 18 (depends on 1)

The method of claim 1, wherein the monitoring data comprises input from the subject pertaining to at least one of their psychoactive state and their treatment state.

### Claim 19 (depends on 1)

The method of claim 1, wherein the monitoring data comprises one or more of: data obtained by a sensor of the user interface device; data inserted by the subject into the user interface device; data automatically collected or deduced from an interaction of the subject with the user interface device.

### Claim 20 (depends on 1)

The method of claim 1, wherein the therapeutic window defines a range of amounts of the at least one pharmacologically active agent spanning from an amount that confers the predetermined effect and an amount that causes more than an acceptable or tolerable level of said at least one adverse effect.

### Claim 21 (depends on 1)

The method of claim 1, wherein the magnitude of the second metered amount is selected to reach the at least one predetermined effect if the at least one predetermined effect was not sufficiently obtained by the first metered amount.

### Claim 22 (depends on 1)

The method of claim 1, wherein the at least one symptom is associated with a disorder and/or disease which is therapeutically responsive to the at least one pharmacologically active agent.

### Claim 23 (depends on 1)

The method of claim 1, wherein the at least one physiological symptom is not caused by the at least one pharmacologically active agent.