# US 2021/0330901 A1 · Systems and Methods to Administer Pharmaceuticals

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- Number: US 2021/0330901 A1
- Document ID: US20210330901A1
- Status: Published application
- Kind: A1
- Application number: 17/278,305
- Filed: 2019-09-23
- Published: 2021-10-28
- Earliest claimed: 2018-09-23
- Inventors: Douglas G. Metcalf
- Web page: https://patentgrep.com/patent/US20210330901A1

## CPC

- A61M 11/042: {electrical}
- A23D 7/0053: {Compositions other than spreads}
- A23L 2/52: Adding ingredients (adding preservatives A23B70/10)
- A23L 33/105: Plant extracts, their artificial duplicates or their derivatives
- A61K 9/0095: {Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches (A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006)}
- A61K 31/658: {o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol}
- A61M 15/0028: {using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up}
- G05B 19/4155: characterised by program execution, i.e. part program or machine function execution, e.g. selection of a program
- G06F 21/32: using biometric data, e.g. fingerprints, iris scans or voiceprints
- G16H 20/10: relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H 40/63: for local operation
- H05B 1/025: {For medical applications}
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- A24F 40/42: Cartridges or containers for inhalable precursors
- A61C 19/063: {Medicament applicators for teeth or gums, e.g. treatment with fluorides}
- A61M 2202/0468: non-physiological
- A61M 2205/0233: Conductive materials, e.g. antistatic coatings for spark prevention
- A61M 2205/276: preventing unwanted use
- A61M 2205/50: with microprocessors or computers
- A61M 2205/6018: providing set-up signals for the apparatus configuration
- A61M 2205/6054: Magnetic identification systems
- A61M 2205/609: Biometric patient identification means
- A61M 2205/8206: battery-operated
- G05B 2219/50333: Temperature
- 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)}
- A23D: EDIBLE OILS OR FATS, e.g. MARGARINES, SHORTENINGS OR COOKING OILS (preservation thereof A23B20/00; production, refinement or preservation of animal or vegetable fats or oils C11B, C11C)
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- 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)
- G05B: CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS (systems for controlling or regulating non-electric variables G05D; systems for regulating electric or magnetic variables G05F; control devices or systems insofar as characterised by mechanical features only G05G)
- G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- H05B: ELECTRIC HEATING; ELECTRIC LIGHT SOURCES NOT OTHERWISE PROVIDED FOR; CIRCUIT ARRANGEMENTS FOR ELECTRIC LIGHT SOURCES, IN GENERAL
- A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A24F: SMOKERS' REQUISITES; MATCH BOXES; SIMULATED SMOKING DEVICES (inhaling appliances for medical purposes, shaped like cigars, cigarettes or pipes A61M15/06)
- A61C: DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE (non-driven toothbrushes A46B; {tongue scrapers A61B17/24;} preparations for dentistry A61K6/00; preparations for cleaning the teeth or mouth A61K8/00, A61Q11/00)

## Abstract

Various aspects of this disclosure relate to containers, devices, and methods to administer single doses of pharmaceutical agents.

## Claims

### Claim 1

A container, comprising (i) a hermetically-sealed chamber, (ii) a composition contained within the hermetically-sealed chamber, and (iii) a thermally-conductive surface in thermal communication with the composition, wherein:
the composition comprises 0.01 to 500 micromoles of a pharmaceutical agent;
the pharmaceutical agent has a boiling point between 26 and 260 degrees Celsius; and
the thermally-conductive surface has a thermal conductivity greater than 2 watts per meter-Kelvin (W·m−1·K−1).

### Claim 2 (depends on 1)

The container of claim 1, wherein the hermetically-sealed chamber contains less than 0.1 milligrams of molecular oxygen (O2).

### Claim 3 (depends on 1)

The container of claim 1, wherein the thermally-conductive surface has a surface area of less than 0.01 meters squared.

### Claim 4 (depends on 1)

The container of claim 1, comprising metal, wherein the thermally-conductive surface comprises the metal, and the metal has a thermal conductivity of at least 2 watts per meter-Kelvin.

### Claim 5 (depends on 1)

The container of claim 1, comprising an exit path, wherein the container is configured to inhibit the flow of the composition through the exit path until after the pharmaceutical agent is heated to a temperature above the boiling point of the pharmaceutical agent.

### Claim 6 (depends on 1)

The container of claim 1, wherein the hermetically-sealed chamber is configured such that the composition can exist in either a liquid phase or a gas phase within the hermetically-sealed chamber; the hermetically-sealed chamber has an initial volume when the composition is in the liquid phase; the hermetically-sealed chamber has an inflated volume when the composition is in the gas phase; and the inflated volume is at least 900% greater than the initial volume.

### Claim 7 (depends on 6)

The container of claim 6, wherein the initial volume is 0.01 to 100 microliters, and the inflated volume is 0.01 to 100 milliliters.

### Claim 8 (depends on 1)

The container of claim 1, wherein: the composition comprises 1 to 1000 micromoles of a vehicle; the vehicle consists of one or more molecules that each have a boiling point between 40 and 260 degrees Celsius; and each molecule of the vehicle has a different molecular formula than the pharmaceutical agent.

### Claim 9 (depends on 8)

The container of claim 8, wherein the vehicle comprises one or both of water and ethanol.

### Claim 10 (depends on 1)

The container of claim 1, wherein the composition has a volume of 0.5 to 50 microliters.

### Claim 11 (depends on 1)

The container of claim 1, wherein: the hermetically-sealed chamber comprises a first surface and a second surface; the composition is in physical communication with both the first surface and the second surface such that the composition separates at least a portion of the first surface from at least a portion of the second surface; and the average distance between the portion of the first surface and the portion of the second surface that are separated by the composition is 20 nanometers to 2 millimeters.

### Claim 12 (depends on 1)

The container of claim 1, wherein: the composition is a gas phase composition; the gas phase composition has a total pressure; the pharmaceutical agent has a first partial pressure in the gas phase composition; the vehicle has a second partial pressure in the gas phase composition; the first partial pressure is 0.1% to 50% of the total pressure; and the second partial pressure is 50% to 99.9% of the total pressure.

### Claim 13

A device, comprising a heating compartment and a heating element, wherein:
the heating compartment is configured to receive a container that comprises (i) a hermetically-sealed chamber, (ii) a composition that is contained within the hermetically-sealed chamber and that comprises a pharmaceutical agent, and (iii) a thermally-conductive surface in thermal communication with the composition; and
the heating element is configured to be in thermal communication with the thermally-conductive surface after the heating compartment receives the container such that the heating element is operable to (i) heat the thermally-conductive surface and (ii) heat the composition to (i) vaporize at least a portion of the pharmaceutical agent and (ii) produce a vaporized pharmaceutical agent.

### Claim 14 (depends on 13)

The device of claim 13, comprising a controller in directive communication with the heating element, wherein:
the controller is configured to receive one or more inputs;
the controller is configured to run an authorization program comprising one or more boolean functions that determine whether the controller is authorized to run a heating program based on the one or more inputs;
the controller is configured to run the heating program when the controller is authorized to run the heating program; and
running the heating program causes the heating element to heat the thermally-conductive surface of a container contained in the heating compartment of the device.

### Claim 15 (depends on 14)

The device of claim 14, wherein the one or more inputs comprise variable data and authorization data; the variable data comprises one or more of (i) the present date, (ii) the present time, (iii) the present location of the device, (iv) the present velocity of the device, (v) an identifier associated with a person who is operating the device that identifies the person; and the authorization data comprises one or more of (i) a date, a plurality of dates, or a range of dates during which the device may administer the pharmaceutical agent of the composition of the container contained within the heating compartment of the device; (ii) a time, a plurality of times, or a range of times during which the device may administer the pharmaceutical agent; (iii) a location, a plurality of locations, or a range of locations at which the device may administer the pharmaceutical agent; (iv) a velocity, a plurality of velocities, or a range of velocities at which the device may administer the pharmaceutical agent; and (v) an identifier that is associated with an authorized person who is authorized to either operate the device, administer the pharmaceutical agent, or both operate the device and administer the pharmaceutical agent.

### Claim 16 (depends on 15)

The device of claim 15, wherein either (i) the identifier associated with the person who is operating the device is a password, an electromagnetic signal, or biometric data, or (ii) the identifier is either directly related to or dependent upon a password, an electromagnetic signal, or biometric data.

### Claim 17

A method to prepare a vaporized pharmaceutical agent, comprising:
providing a container that comprises (i) a hermetically-sealed chamber, (ii) a composition that is contained within the hermetically-sealed chamber and that comprises a pharmaceutical agent, and (iii) a thermally-conductive surface in thermal communication with the composition;
heating the thermally-conductive surface to heat the composition and to vaporize at least a portion of the pharmaceutical agent to produce a gas phase composition comprising a vaporized pharmaceutical agent;
connecting the hermetically-sealed chamber of the container to an administration path to convert the hermetically-sealed chamber into an unsealed chamber such that the gas phase composition is in fluid communication with the administration path; and
directing the gas phase composition out of the unsealed chamber and into the administration path.

### Claim 18 (depends on 17)

The method of claim 17, wherein producing the gas phase composition inflates the hermetically-sealed chamber from an initial volume to an inflated volume; and the inflated volume is at least 500% greater than the initial volume.

### Claim 19 (depends on 17)

The method of claim 17, wherein the initial volume is 0.01 to 250 microliters and the inflated volume is greater than 0.5 milliliters.

### Claim 20 (depends on 17)

The method of claim 17, comprising deflating the unsealed chamber from the inflated volume to a deflated volume, wherein the inflated volume is at least 1000% greater than the deflated volume, and deflating the unsealed chamber directs the gas phase composition out of the unsealed chamber and into the administration path.
