WO2021194911A1

WO2021194911A1 - Systems and methods to administer pharmaceuticals

Info

Publication number: WO2021194911A1
Application number: PCT/US2021/023369
Authority: WO
Inventors: Douglas G. Metcalf
Original assignee: Metcalf Douglas G
Priority date: 2020-03-22
Filing date: 2021-03-21
Publication date: 2021-09-30

Abstract

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

Description

Systems and Methods to Administer Pharmaceuticals

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent Application No. 62/993,024, filed March 22, 2020, which is incorporated by reference in its entirety.

BACKGROUND

Numerous hydrophobic pharmaceutical agents fail pre-clinical and clinical trials due to limited bioavailability. Vaporization presents a widely-unexplored alternative to administer pharmaceuticals that lack robust bioavailability by other routes of administration. Vaporization is technically challenging because accurate dosing is difficult to achieve and because vaporization may result in the thermal degradation of a pharmaceutical agent. Excipients also often cause undesirable side effects when heated, and a number of deaths have been recently linked to vape oil products. Improved methods and devices to vaporize pharmaceuticals could result in the further development of multitudes of abandoned drug candidates.

SUMMARY

Some aspects of the disclosure relate to 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, in which the thermally-conductive surface has a thermal conductivity of 5 to 10,000 watts per meter-Kelvin; the composition comprises 0.1 to 20 micromoles of a pharmaceutical agent; the hermetically-sealed chamber has an initial volume of 0.01 to 50 microliters when the composition is not in a gas phase; and the hermetically-sealed chamber has an inflated volume of 0.05 to 5 milliliters when the composition is in a gas phase. In some embodiments, a composition comprises a pharmaceutical agent selected from one, two, three, four, five, six, seven, or each of cannabidiol, cannabidiolic acid, cannabivarin, cannabivarin carboxylic acid, tetrahydrocannabinol, tetrahydrocannabinolic acid, tetrahydrocannabivarin, and tetrahydrocannabivarin carboxylic acid. In some specific embodiments, a composition comprises (i) a pharmaceutical agent selected from one, two, three, four, five, six, seven, or each of cannabidiol, cannabidiolic acid, cannabivarin, cannabivarin carboxylic acid, tetrahydrocannabinol, tetrahydrocannabinolic acid, tetrahydrocannabivarin, tetrahydrocannabivarin carboxylic acid; and (ii) a vehicle selected from one or more of alpha-bisabolol, alpha-pinene, beta-caryophyllene, beta-pinene, humulene, limonene, linalool, myrcene, nerolidol, terpineol, terpinolene, water, and ethanol. In some very specific embodiments, a composition comprises a pharmaceutical agent selected from one or both of cannabidiol and tetrahydrocannabinol; and a vehicle selected from one or both of water and ethanol.

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1 A is a diagram of a container comprising (i) a hermetically-sealed chamber 1, (ii) a composition comprising a pharmaceutical agent 2 contained within the hermetically-sealed chamber 1, and (iii) a thermally-conductive surface 3 in thermal communication with the composition, in which the pharmaceutical agent 2 is not in a gas phase.

Fig. IB is a diagram of a container comprising (i) a hermetically-sealed chamber 1, (ii) a composition comprising a pharmaceutical agent 2 contained within the hermetically-sealed chamber 1, and (iii) a thermally-conductive surface 3 in thermal communication with the composition, in which the pharmaceutical agent 2 is in a gas phase.

Fig. 2A is a diagram of a container comprising (i) a hermetically-sealed chamber 1, (ii) a composition comprising both a pharmaceutical agent 2 and a vehicle 4 contained within the hermetically-sealed chamber 1, and (iii) a thermally-conductive surface 3 in thermal communication with the composition, in which neither the pharmaceutical agent 2 nor the vehicle 4 are in a gas phase.

Fig. 2B is a diagram of a container comprising (i) a hermetically-sealed chamber 1, (ii) a composition comprising both a pharmaceutical agent 2 and a vehicle 4 contained within the hermetically-sealed chamber 1, and (iii) a thermally-conductive surface 3 in thermal communication with the composition, in which the pharmaceutical agent 2 and the vehicle 4 are in a gas phase.

Fig. 3 A is a diagram of a device comprising a heating compartment 5 and a heating element 6, in which the heating compartment 5 is in receipt of a container. The container comprises (i) a hermetically-sealed chamber 1, (ii) a composition comprising a pharmaceutical agent 2 contained within the hermetically-sealed chamber 1, and (iii) a thermally-conductive surface 3 in thermal communication with the composition, in which the pharmaceutical agent 2 is not in a gas phase.

The heating element 6 is in thermal communication with the thermally-conductive surface 3 such that the heating element 6 is operable to both heat the thermally-conductive surface 3 and heat the composition to vaporize at least a portion of the pharmaceutical agent 2. Fig. 3B is a diagram of a device comprising a heating compartment 5 and a heating element 6, in which the heating compartment 5 is in receipt of a container. The container comprises (i) a hermetically-sealed chamber 1, (ii) a composition comprising a vaporized pharmaceutical agent 2 contained within the hermetically-sealed chamber 1, and (iii) a thermally-conductive surface 3 in thermal communication with the composition. The heating element 6 is in thermal communication with the thermally-conductive surface 3, and the heating element 6 has heated the thermally- conductive surface 3 and the composition to produce the vaporized pharmaceutical agent 2.

Fig. 3C is a diagram of a device comprising a heating compartment 5 and a heating element 6, in which the heating compartment 5 is in receipt of a container. The container comprises an unsealed chamber 1 and a thermally-conductive surface 3. The heating element 6 is in thermal communication with the thermally-conductive surface 3, and the heating element 6 has heated the thermally-conductive surface 3 and a composition previously contained within the unsealed chamber 1 to produce a vaporized pharmaceutical agent 2.

Fig. 4A is a diagram of a device comprising a heating compartment 5, a heating element 6, an administration path 7 in fluid communication with the heating compartment 5, and an actuator 8 in mechanical communication with the heating compartment 5, in which the heating compartment 5 is in receipt of a container. The container comprises (i) a hermetically-sealed chamber 1, (ii) a composition comprising a pharmaceutical agent 2 contained within the hermetically-sealed chamber 1, and (iii) a thermally-conductive surface 3 in thermal communication with the composition, in which the pharmaceutical agent 2 is not in a gas phase. The heating element 6 is in thermal communication with the thermally-conductive surface 3 such that the heating element 6 is operable to both heat the thermally-conductive surface 3 and heat the composition to vaporize at least a portion of the pharmaceutical agent 2.

Fig. 4B is a diagram of a device comprising a heating compartment 5, a heating element 6, an administration path 7 in fluid communication with the heating compartment 5, and an actuator 8 in mechanical communication with the heating compartment 5, in which the heating compartment 5 is in receipt of a container. The container comprises (i) a hermetically-sealed chamber 1, (ii) a composition comprising a vaporized pharmaceutical agent 2 contained within the hermetically-sealed chamber 1, and (iii) a thermally-conductive surface 3 in thermal communication with the composition. The heating element 6 is in thermal communication with the thermally-conductive surface 3, and the heating element 6 has heated the thermally-conductive surface 3 and the composition to produce the vaporized pharmaceutical agent 2. Fig. 4C is a diagram of a device comprising a heating compartment 5, a heating element 6, an administration path 7 in fluid communication with the heating compartment 5, and an actuator 8 in mechanical communication with the heating compartment 5, in which the heating compartment 5 is in receipt of a container. The container comprises an unsealed chamber 1 and a thermally- conductive surface 3. The heating element 6 is in thermal communication with the thermally- conductive surface 3, and the heating element 6 has heated the thermally-conductive surface 3 and a composition previously contained within the unsealed chamber 1 to produce a vaporized pharmaceutical agent 2. The unsealed chamber 1 is connected to the administration path 7, and the actuator 8 has propelled the vaporized pharmaceutical agent 2 from the unsealed chamber 1 and into the administration path 7.

Fig. 5A is a diagram of a device comprising a heating compartment 5, a heating element 6, and a controller 9, in which the heating compartment 5 is in receipt of a container. The container comprises (i) a hermetically-sealed chamber 1, (ii) a composition comprising a pharmaceutical agent 2 contained within the hermetically-sealed chamber 1, and (iii) a thermally-conductive surface 3 in thermal communication with the composition, in which the pharmaceutical agent 2 is not in a gas phase. The controller 9 is in directive communication with the heating element 6 such that the controller 9 is operable to run a heating program that causes the heating element 6 to heat. The heating element 6 is in thermal communication with the thermally-conductive surface 3 such that the heating element 6 is operable to both heat the thermally-conductive surface 3 and heat the composition to vaporize at least a portion of the pharmaceutical agent 2.

Fig. 5B is a diagram of a device comprising a heating compartment 5, a heating element 6, and a controller 9, in which the heating compartment 5 is in receipt of a container. The container comprises (i) a hermetically-sealed chamber 1, (ii) a composition comprising a vaporized pharmaceutical agent 2 contained within the hermetically-sealed chamber 1, and (iii) a thermally- conductive surface 3 in thermal communication with the composition. The controller 9 is in directive communication with the heating element 6, and the controller 9 has run a heating program that caused the heating element 6 to heat. The heating element 6 is in thermal communication with the thermally-conductive surface 3, and the heating element 6 has heated the thermally-conductive surface 3 and the composition to produce the vaporized pharmaceutical agent 2.

Fig. 5C is a diagram of a device comprising a heating compartment 5, a heating element 6, and a controller 9, in which the heating compartment 5 is in receipt of a container. The container comprises an unsealed chamber 1 and a thermally-conductive surface 3. The controller 9 is in directive communication with the heating element 6, and the controller 9 has run a heating program that caused the heating element 6 to heat. The heating element 6 is in thermal communication with the thermally-conductive surface 3, and the heating element 6 has heated the thermally-conductive surface 3 and a composition previously contained within the unsealed chamber 1 to produce a vaporized pharmaceutical agent 2.

Fig. 6A is a diagram of a device comprising a heating compartment 5, a heating element 6, an administration path 7 in fluid communication with the heating compartment 5, an actuator 8 in mechanical communication with the heating compartment 5, and a controller 9, in which the heating compartment 5 is in receipt of a container. The container comprises (i) a hermetically- sealed chamber 1, (ii) a composition comprising a pharmaceutical agent 2 contained within the hermetically-sealed chamber 1, and (iii) a thermally-conductive surface 3 in thermal communication with the composition, in which the pharmaceutical agent 2 is not in a gas phase. The controller 9 is in directive communication with the heating element 6 such that the controller 9 is operable to run a heating program that causes the heating element 6 to heat. The heating element 6 is in thermal communication with the thermally-conductive surface 3 such that the heating element 6 is operable to both heat the thermally-conductive surface 3 and heat the composition to vaporize at least a portion of the pharmaceutical agent 2.

Fig. 6B is a diagram of a device comprising a heating compartment 5, a heating element 6, an administration path 7 in fluid communication with the heating compartment 5, an actuator 8 in mechanical communication with the heating compartment 5, and a controller 9, in which the heating compartment 5 is in receipt of a container. The container comprises (i) a hermetically- sealed chamber 1, (ii) a composition comprising a vaporized pharmaceutical agent 2 contained within the hermetically-sealed chamber 1, and (iii) a thermally-conductive surface 3 in thermal communication with the composition. The controller 9 is in directive communication with the heating element 6, and the controller 9 has run a heating program that caused the heating element 6 to heat. The heating element 6 is in thermal communication with the thermally-conductive surface 3, and the heating element 6 has heated the thermally-conductive surface 3 and the composition to produce the vaporized pharmaceutical agent 2.

Fig. 6C is a diagram of a device comprising a heating compartment 5, a heating element 6, an administration path 7 in fluid communication with the heating compartment 5, an actuator 8 in mechanical communication with the heating compartment 5, and a controller 9, in which the heat- ing compartment 5 is in receipt of a container. The container comprises an unsealed chamber 1 and a thermally-conductive surface 3. The controller 9 is in directive communication with the heating element 6, and the controller 9 has run a heating program that caused the heating element 6 to heat. The heating element 6 is in thermal communication with the thermally-conductive surface 3, and the heating element 6 has heated the thermally-conductive surface 3 and a composition previously contained within the unsealed chamber 1 to produce a vaporized pharmaceutical agent 2. The unsealed chamber 1 is connected to the administration path 7, and the actuator 8 has propelled the vaporized pharmaceutical agent 2 from the unsealed chamber 1 and into the administration path 7.

Fig. 7A is a diagram of a device comprising a heating compartment 5, a heating element 6, an administration path 7 in fluid communication with the heating compartment 5, an actuator 8 in mechanical communication with the heating compartment 5, a controller 9, a battery 10, and an interface 11, in which the heating compartment 5 is in receipt of a container. The container comprises (i) a hermetically-sealed chamber 1, (ii) a composition comprising a pharmaceutical agent 2 contained within the hermetically-sealed chamber 1, and (iii) a thermally-conductive surface 3 in thermal communication with the composition, in which the pharmaceutical agent 2 is not in a gas phase. The controller 9 is in electronic communication with the interface 11 such that the controller 9 is operable to receive at least one input from the interface 11 to run an authorization program to determine whether the controller 9 is authorized to run a heating program based on one or more inputs that include the at least one input. The controller 9 is in directive communication with the heating element 6 such that the controller 9 is operable to run a heating program that causes the heating element 6 to heat. The heating element 6 is in electrical communication with the battery 10, such that the battery 10 is operable to power the heating element 6. The heating element 6 is in thermal communication with the thermally-conductive surface 3 such that the heating element 6 is operable to both heat the thermally-conductive surface 3 and heat the composition to vaporize at least a portion of the pharmaceutical agent 2.

Fig. 7B is a diagram of a device comprising a heating compartment 5, a heating element 6, an administration path 7 in fluid communication with the heating compartment 5, an actuator 8 in mechanical communication with the heating compartment 5, a controller 9, a battery 10, and an interface 11, in which the heating compartment 5 is in receipt of a container. The container comprises (i) a hermetically-sealed chamber 1, (ii) a composition comprising a vaporized pharmaceutical agent 2 contained within the hermetically-sealed chamber 1, and (iii) a thermally-conductive surface 3 in thermal communication with the composition. The controller 9 is in electronic communication with the interface 11 such that the controller 9 is operable to receive at least one input from the interface 11 to run an authorization program to determine whether the controller 9 is authorized to run a heating program based on one or more inputs that include the at least one input. The controller 9 is in directive communication with the heating element 6, and the controller 9 has run a heating program that caused the heating element 6 to heat. The heating element 6 is in electrical communication with the battery 10, such that the battery 10 is operable to power the heating element 6. The heating element 6 is in thermal communication with the thermally-conductive surface 3, and the heating element 6 has heated the thermally-conductive surface 3 and the composition to produce the vaporized pharmaceutical agent 2.

Fig. 7C is a diagram of a device comprising a heating compartment 5, a heating element 6, an administration path 7 in fluid communication with the heating compartment 5, an actuator 8 in mechanical communication with the heating compartment 5, a controller 9, a battery 10, and an interface 11, in which the heating compartment 5 is in receipt of a container. The container comprises an unsealed chamber 1 and a thermally-conductive surface 3. The controller 9 is in electronic communication with the interface 11 such that the controller 9 is operable to receive at least one input from the interface 11 to run an authorization program to determine whether the controller 9 is authorized to run a heating program based on one or more inputs that include the at least one input. The controller 9 is in directive communication with the heating element 6, and the controller 9 has run a heating program that caused the heating element 6 to heat. The heating element 6 is in electrical communication with the battery 10, such that the battery 10 is operable to power the heating element 6. The heating element 6 is in thermal communication with the thermally-conductive surface 3, and the heating element 6 has heated the thermally-conductive surface 3 and a composition previously contained within the unsealed chamber 1 to produce a vaporized pharmaceutical agent 2. The unsealed chamber 1 is connected to the administration path 7, and the actuator 8 has propelled the vaporized pharmaceutical agent 2 from the unsealed chamber 1 and into the administration path 7.

DETAILED DESCRIPTION

Various aspects of the disclosure relate to a container. Some of the containers of the disclosure are designed to contain a single dose of a pharmaceutical agent to be administered by inhalation after the single dose of the pharmaceutical agent is vaporized. In some embodiments, a container comprises (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.

In some embodiments, a composition comprises 0.01 to 500 micromoles of a pharmaceutical agent. In some specific embodiments, a composition comprises 0.01 to 10, 0.1 to 20, 0.5 to 5, or 10 to 500 micromoles of a pharmaceutical agent. In some very specific embodiments, a composition comprises 0.1 to 20 micromoles of a pharmaceutical agent selected from one or more of cannabidiol, cannabidiolic acid, cannabivarin, cannabivarin carboxylic acid, tetrahydrocannabinol, tetrahydrocannabinolic acid, tetrahydrocannabivarin, and tetrahydrocannabivarin carboxylic acid.

In some embodiments, a pharmaceutical agent has a boiling point between 26 and 260 degrees Celsius. The term “boiling point” refers to boiling points at atmospheric pressure. In some specific embodiments, a pharmaceutical agent is selected from one or more of cannabidiol, cannabidiolic acid, cannabivarin, cannabivarin carboxylic acid, tetrahydrocannabinol, tetrahydrocannabinolic acid, tetrahydrocannabivarin, and tetrahydrocannabivarin carboxylic acid.

In some embodiments, a thermally-conductive surface has a thermal conductivity greater than 2 watts per meter-Kelvin (W-rrf'T ¹) The term “thermal conductivity” refers to thermal conductivity at atmospheric pressure and 20 degrees Celsius. In some specific embodiments, a thermally-conductive surface has a thermal conductivity of 7 to 1000 watts per meter-Kelvin. In some very specific embodiments, a thermally-conductive surface has a thermal conductivity of 50 to 500 watts per meter-Kelvin.

In some embodiments, a container comprises a metal, and the metal has a thermal conductivity of at least 2 watts per meter-Kelvin. In some specific embodiments, a container comprises a metal, and the metal has a thermal conductivity of 7 to 1000 watts per meter-Kelvin.

In some embodiments, a hermetically-sealed chamber contains less than 1 milligram of molecular oxygen (0₂). In some specific embodiments, a hermetically-sealed chamber contains less than 0.1 milligrams of molecular oxygen. In some very specific embodiments, a hermetically-sealed chamber contains less than 0.01 milligrams of molecular oxygen.

In some embodiments, a thermally-conductive surface has a surface area of less than 0.01 meters squared. In some specific embodiments, a thermally-conductive surface has a surface area of 0.00001 to 0.01 meters squared.

In some embodiments, 0.000001 to 0.01 meters squared of a thermally-conductive surface is in physical communication with 0.000001 to 0.01 meters squared of a composition. In some specific embodiments, 0.00001 to 0.01 meters squared of a thermally-conductive surface is in physical communication with 0.00001 to 0.01 meters squared of a composition.

In some embodiments, a hermetically-sealed chamber comprises a hermetic layer. A hermetic layer inhibits the diffusion of gases. In some specific embodiments, a thermally-conducive surface is permeable to gases, and a hermetic layer covers the thermally-conductive surface to inhibit the diffusion of gases into or out of a hermetically-sealed chamber. In some specific embodiments, a hermetic layer comprises a polymer. In some specific embodiments, a hermetic layer is 1 to 500 micrometers thick.

In some embodiments, a container comprises an exit path, in which the container is configured to inhibit the flow of a composition through the exit path until after a pharmaceutical agent of the composition is heated to a temperature above the boiling point of the pharmaceutical agent.

In some embodiments, a container lacks a heating element. In some embodiments, a container lacks a battery. In some specific embodiments, a container lacks both a heating element and a battery.

In some embodiments, a composition comprises 0.01 to 10 micromoles of a second pharmaceutical agent; the second pharmaceutical agent has a different molecular formula than the pharmaceutical agent; the pharmaceutical agent is neither a thermal decomposition product nor an oxidation product of the second pharmaceutical agent; the second pharmaceutical agent is neither a thermal decomposition product nor an oxidation product of the pharmaceutical agent; and the second pharmaceutical agent has a boiling point between 26 and 260 degrees Celsius. In some embodiments, a pharmaceutical agent is tetrahydrocannabinol, and a second pharmaceutical agent is cannabidiol. In some embodiments, a pharmaceutical agent is cannabidiol, and a second pharmaceutical agent is tetrahydrocannabinol. In some embodiments, a pharmaceutical agent is tetrahydrocannabinol, and a second pharmaceutical agent is tetrahydrocannabivarin.

In some embodiments, a hermetically-sealed chamber is configured such that a composition contained within the hermetically-sealed container 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.

In some embodiments, a composition is not a gas. In some specific embodiments, a composition is a liquid. In some embodiments, a composition is a gas. In some embodiments, a composition comprises a vehicle. A vehicle consists of molecules that vaporize by heating to increase the volume of a composition comprising a vaporized pharmaceutical agent. A composition comprising a pharmaceutical agent and a vehicle typically comprises the vehicle at a greater amount by mole than the pharmaceutical agent.

In some embodiments, a composition comprises a pharmaceutical agent and a vehicle, and each molecule of the vehicle has a different molecular formula than the pharmaceutical agent.

In some embodiments, a composition comprises 1 to 10,000 micromoles of a vehicle. In some specific embodiments, a composition comprises 1 to 1,000 micromoles of a vehicle. In some very specific embodiments, a composition comprises 1 to 100 micromoles of a vehicle.

In some embodiments, a vehicle consists of one or more molecules that each have a boiling point between 40 and 260 degrees Celsius. In some specific embodiments, a vehicle comprises one or both of water and ethanol. In some specific embodiments, a vehicle comprises one or more terpenes. In some very specific embodiments, a vehicle comprises one or more terpenes selected from alpha-bisabolol, alpha-pinene, beta-caryophyllene, beta-pinene, humulene, limonene, linalool, myrcene, nerolidol, terpineol, and terpinolene.

In some embodiments, a composition is a gas phase composition comprising a pharmaceutical agent and a vehicle; the gas phase composition has a total pressure; the pharmaceutical agent has a first partial pressure; the vehicle has a second partial pressure; 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. In some specific embodiments, a composition is a gas phase composition comprising a pharmaceutical agent and a vehicle; the gas phase composition has a total pressure; the pharmaceutical agent has a first partial pressure; the vehicle has a second partial pressure; the first partial pressure is 1% to 40% of the total pressure; and the second partial pressure is 60% to 99% of the total pressure.

In some embodiments, a hermetically-sealed chamber has a volume of 5 nanoliters to 5 milliliters. In some embodiments, a composition has a volume of 5 nanoliters to 5 milliliters. In some specific embodiments, a hermetically-sealed chamber has a volume of 0.005 to 100 microliters. In some specific embodiments, a composition has a volume of 0.005 to 100 microliters. In some specific embodiments, a hermetically-sealed chamber has a volume of 0.01 to 100 microliters. In some specific embodiments, a composition has a volume of 0.01 to 100 microliters. In some very specific embodiments, a hermetically-sealed chamber has a volume of either 0.2 to 10 microliters. In some very specific embodiments, a composition has a volume of 0.2 to 10 microliters. In some very specific embodiments, a hermetically-sealed chamber has a volume of 0.5 to 50 microliters. In some very specific embodiments, a composition has a volume of 0.5 to 50 microliters.

In some embodiments, a hermetically-sealed chamber has an initial volume of 0.01 to 100 microliters and an inflated volume of 0.01 to 100 milliliters. In some embodiments, a hermetically-sealed chamber has an initial volume of 0.005 to 100 microliters and an inflated volume of 1 to 10,000 microliters. In some specific embodiments, a hermetically-sealed chamber has an initial volume of 1 to 100 microliters and an inflated volume of 0.2 to 10 milliliters.

In some embodiments, a container comprises (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, in which the thermally-conductive surface has a thermal conductivity of 2-50,000 watts per meter-Kelvin; the composition comprises 0.01-500 micromoles of a pharmaceutical agent; the hermetically-sealed chamber has an initial volume of 5-100,000 nanoliters when the composition is not in a gas phase; and the hermetically-sealed chamber has an inflated volume of 1-10,000 microliters when the composition is in a gas phase. In some specific embodiments, a container comprises (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, in which the thermally-conductive surface has a thermal conductivity of 5-10,000 watts per meter-Kelvin; the composition comprises 0.1-20 micromoles of a pharmaceutical agent; the hermetically-sealed chamber has an initial volume of 10-100,000 nanoliters when the composition is not in a gas phase; and the hermetically-sealed chamber has an inflated volume of 2-10,000 microliters when the composition is in a gas phase. In some very specific embodiments, a container comprises (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, in which the thermally-conductive surface has a thermal conductivity of 5 to 10,000 watts per meter-Kelvin; the composition comprises 0.1 to 20 micromoles of a pharmaceutical agent; the hermetically-sealed chamber has an initial volume of 0.01 to 50 microliters when the composition is not in a gas phase; and the hermetically-sealed chamber has an inflated volume of 0.05 to 5 milliliters when the composition is in a gas phase.

In some embodiments, a hermetically-sealed chamber comprises a first surface and a second surface; a 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. In some specific embodiments, the average distance between a portion of a first surface and a portion of a second surface that are separated by a composition is 0.1 to 1000 micrometers, and, in some very specific embodiments, the average distance is 0.5 to 500 micrometers.

In some embodiments, a container comprises a hermetically-sealed chamber and 25 to 1001 milliliters of a composition contained within the hermetically-sealed chamber.

Various aspects of the disclosure relate to a device. Some of the devices of the disclosure are configured to (i) receive a container comprising a single dose of a pharmaceutical agent and (ii) vaporize the single does of the pharmaceutical agent to produce a vaporized pharmaceutical agent to be administered by inhalation.

In some embodiments, a device comprises a heating compartment and a heating element, in which: the heating compartment is configured to receive a container described anywhere in this patent document; and the heating element is configured to be in thermal communication with a thermally-conductive surface of the container after the heating compartment receives the container such that the heating element is operable to (i) heat a thermally-conductive surface of the container and (ii) heat a composition contained in a hermetically-sealed chamber of the container to (i) vaporize at least a portion of a pharmaceutical agent of the composition and (ii) produce a vaporized pharmaceutical agent.

In some embodiments, a device comprises a heating compartment and a heating element, in which: 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.

In some embodiments, a heating compartment of a device contains a container described anywhere in this patent document.

In some embodiments, a device comprises (i) a storage compartment configured to store a plurality of containers described anywhere in this patent document and (ii) an insulating surface configured to inhibit thermal communication between a heating element of the device and a thermally-conductive surface of any container stored in the storage compartment, in which the thermal conductivity of the insulating surface is less than 0.5 watts per meter-Kelvin.

In some embodiments, a heating element is configured to heat a composition to a temperature greater than 150 degrees Celsius. In some specific embodiments, a heating element is configured to heat a composition to a temperature in the range of 150 to 260 degrees Celsius.

In some embodiments, a device comprises a heating element and a battery, in which the battery is in electrical communication with the heating element and operable to heat the heating element to a temperature greater than 150 degrees Celsius. In some specific embodiments, a device comprises a heating element and a battery, in which the battery is in electrical communication with the heating element and operable to heat the heating element to a temperature in the range of 150 to 260 degrees Celsius.

In some embodiments, a device comprises a heating compartment, a heating element, an administration path, and an actuator, in which (a) the administration path is in fluid communication with the heating compartment such that the device is operable to direct a vaporized pharmaceutical agent through the administration path after the heating element (i) heats a thermally-conductive surface of a container that is received in the heating compartment and (ii) heats a composition contained in a hermetically-sealed chamber of the container to (i) vaporize at least a portion of a pharmaceutical agent of the composition and (ii) produce the vaporized pharmaceutical agent; and (b) the actuator is in mechanical communication with the heating compartment such that the actuator is operable to propel the vaporized pharmaceutical agent from the hermetically-sealed chamber and into the administration path after the hermetically-sealed chamber is both converted into an unsealed chamber and connected to the administration path.

In some embodiments, a device comprises a heating compartment, a heating element, and a controller, in which the controller is in directive communication with the heating element; 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 a thermally-conductive surface of a container contained in the heating compartment of the device. In some specific embodiments, a device comprises a heating compartment, a heating element, and a controller, in which the controller is in directive communication with the heating element; 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; running the heating program causes the heating element to heat a thermally-conductive surface of a container contained in the heating compartment of the device; 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 a pharmaceutical agent of a 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. In some specific embodiments, an identifier associated with a person who is operating a device is a password, an electromagnetic signal, or biometric data. In some specific embodiments, an identifier associated with a person who is operating a device is either directly related to or dependent upon a password, an electromagnetic signal, or biometric data.

Various aspects of the disclosure relate to a method to administer a pharmaceutical agent.

In some embodiments, a method is performed using one or both of a container and a device described anywhere in this patent document.

In some embodiments, a method comprises (a) receiving a container, in which a heating compartment of a device receives the container, and the container comprises (i) a hermetically-sealed chamber, (ii) a composition comprising a pharmaceutical agent contained within the hermetically-sealed chamber, and (iii) a thermally-conductive surface in thermal communication with the composition; (b) receiving one or more inputs, in which a controller of the device receives the one or more inputs; (c) running an authorization program, in which the controller runs the authorization program, and the authorization program comprises one or more boolean functions that determine whether the controller is authorized to run a heating program based on the one or more inputs; and (d) running the heating program, in which the controller runs the heating program, and the heating program causes a heating element of the device to heat the thermally-conductive surface of the container to heat the composition and vaporize at least a portion of the pharmaceutical agent.

In some embodiments, one or more inputs comprise variable data and authorization data; and a method comprises one or more of (i) identifying the present time, in which the variable data comprises the present time, and one or more boolean functions compare the present time with authorization data comprising either a time, a plurality of times, or a range of times during which a device may administer a pharmaceutical agent; (ii) identifying the present date, in which the variable data comprises the present date, and the one or more boolean functions compare the present date with authorization data comprising either a date, a plurality of dates, or a range of dates during which the device may administer the pharmaceutical agent; (iii) identifying the location of the device, in which the variable data comprises the location of the device, and the one or more boolean functions compare the location of the device with authorization data comprising either a location, a plurality of locations, or a range of locations at which the device may administer the pharmaceutical agent; (iv) identifying the velocity of the device, in which the variable data comprises the velocity of the device, and the one or more boolean functions compare the velocity of the device with authorization data comprising either a velocity, a plurality of velocities, or a range of velocities at which the device may administer the pharmaceutical agent; (v) obtaining an identifier associated with a person who is operating the device that identifies the person, in which the variable data comprises the identifier associated with the person who is operating the device, and the one or more boolean functions compare the identifier associated with the person who is operating the device with authorization data comprising 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.

In some embodiments, a method comprises providing the container described anywhere in this patent document; heating a thermally-conductive surface of the container to heat a composition of the container and to vaporize at least a portion of a pharmaceutical agent of the composition to produce a gas phase composition comprising a vaporized pharmaceutical agent; connecting a 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.

In some embodiments, a method comprises 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.

In some embodiments, producing a gas phase composition inflates a hermetically-sealed chamber from an initial volume to an inflated volume, in which the inflated volume is at least 500% greater than the initial volume. In some specific embodiments, an inflated volume is at least 900% greater than an initial volume. In some embodiments, an initial volume is 0.01 to 250 microliters, and an inflated volume is greater than 0.5 milliliters. In some specific embodiments, an initial volume is 0.01 to 250 microliters, and an inflated volume is 0.5 to 10 milliliters.

In some embodiments, a method comprises deflating an unsealed chamber of a container from an inflated volume to a deflated volume, in which the inflated volume is at least 1000% greater than the deflated volume, and deflating the unsealed chamber directs a gas phase composition out of the unsealed chamber and into an administration path.

In some embodiments, a method comprises converting at least 50% of a pharmaceutical agent into a vaporized pharmaceutical agent. In some specific embodiments, a method comprises converting at least 75% of a pharmaceutical agent into a vaporized pharmaceutical agent. In some very specific embodiments, a method comprises converting at least 90% of a pharmaceutical agent into a vaporized pharmaceutical agent.

Claims

What is claimed is:

1. A container, comprising a thermally-conductive surface, a hermetically-sealed chamber, and a composition comprising 10 nanomoles to 500 micromoles of a pharmaceutical agent, wherein: the composition is disposed within the hermetically-sealed chamber; the composition is in thermal communication with the thermally-conductive surface; the pharmaceutical agent has a boiling point between 26 and 260 degrees Celsius; and the thermal conductivity of the thermally-conductive surface is at least 2 watts per meter-Kelvin (W-rrf'T ¹)

2. The container of claim 1, wherein the hermetically-sealed chamber lacks molecular oxygen (0₂) at an amount greater than 1 mg.

3. The container of claim 1 or 2, wherein the thermally-conductive surface has a surface area of 10⁶ to 10² square meters.

4. The container of any one of the preceding claims, wherein 10⁶ to 10² square meters of the thermally-conductive surface is in physical communication with 10⁶ to 10² square meters of the composition.

5. The container of any one of the preceding claims, further comprising metal, wherein: the metal has a thermal conductivity of at least 2 watts per meter-Kelvin (W-rrf'TC ¹); and the thermally-conductive surface is metal.

6. The container of any one of the preceding claims, wherein the thermally-conducive surface is permeable to gases.

7. The container of any one of claims, further comprising a hermetic layer, wherein the hermetic layer covers the thermally-conductive surface.

8. The container of claim 7, further comprising a polymer, wherein: the hermetic layer comprises the polymer; the polymer is impermeable to gases; and the polymer melts or decomposes at a temperature between 26 and 260 degrees Celsius.

9. The container of any one of the preceding claims, wherein the container lacks a heating element.

10. The container of any one of the preceding claims, wherein: the composition comprises 10 nanomoles to 10 micromoles of a second pharmaceutical agent; the second pharmaceutical agent has a different molecular formula than the pharmaceutical agent; the pharmaceutical agent is not a thermal decomposition product of the second pharmaceutical agent; the second pharmaceutical agent is not a thermal decomposition product of the pharmaceutical agent; and the second pharmaceutical agent has a boiling point between 26 and 260 degrees Celsius.

11. The container of any one of the preceding claims, wherein: the chamber has a volume; and the volume of the chamber is 500 nanoliters to 50 microliters.

12. The container of any one of the preceding claims, wherein: the composition can exist in a liquid phase or a gas phase; the chamber has an initial volume when the composition is in the liquid phase; the chamber has an inflated volume when the composition is in the gas phase; the inflated volume is at least 10 times greater than the initial volume; the initial volume is 5 nanoliter to 100 microliter; and the inflated volume is 1 microliter to 10 milliliters.

13. The container of any one of the preceding claims, wherein the composition is a liquid.

14. The container of claim 13, wherein: the chamber comprises a top surface and a bottom surface, which define opposite sides of the chamber; the composition is in physical communication with both the top surface and the bottom surface; and the average internal distance between the top surface and the bottom surface is 20 nanometers to 2 millimeters.

15. The container of any one of the preceding claims, wherein: the composition comprises 1 micromole to 100 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.

16. The container of claim 15, wherein the vehicle consists of one or more of water, ethanol, and one or more terpenes.

17. The container of claim 15 or 16, 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 percent of the total pressure; and the second partial pressure is 50 to 99.9 percent of the total pressure.

18. The container of claim 17, wherein gas phase composition lacks molecular oxygen (0₂) at a partial pressure greater than 2 percent.

19. A device, comprising a heating compartment a heating element, wherein: the heating compartment is adapted to receive a container of any one of the preceding claims; the heating element is configured to be in thermal communication with the thermally-conductive surface of the container when the container is in the heating compartment; the heating element is configured to heat the thermally-conductive surface; and the heating element is configured to heat the composition disposed within the hermetically-sealed chamber of the container by heating the thermally-conductive surface.

20. The device of claim 19, further comprising the container disposed within the heating compartment.

21. The device of claim 19 or 20, further comprising a storage compartment, wherein the storage compartment is adapted to receive a second container of any one of claims 1 to 16.

22. The device of claim 21, further comprising the second container within the storage compartment.

23. The device of claim 21 or 22, wherein the storage compartment is adapted to receive a plurality of containers of any one of claims 1 to 16, and the plurality of containers comprises the second container.

24. The device of claim 23, further comprising a third container within the storage compartment, wherein the plurality of containers comprises the third container.

25. The device of any one of claims 21 to 24, further comprising an insulating surface disposed between the heating element and the second container, wherein: the insulating surface is configured to inhibit thermal communication between the heating element and the thermally-conductive surface of the container; and the thermal conductivity of the insulating surface is less than 0.5 watts per meter-Kelvin (W-m^-K ¹).

26. The device of claim 25, wherein the device comprises the insulating surface.

27. The device of claim 25, wherein the container comprises the insulating surface.

28. The device of any one of claims 25 to 27, further comprising an insulating material, wherein: the insulating surface comprises the insulating material; the insulating material is a polymer or inorganic molecule; and the thermal conductivity of the insulating material is less than 0.5 watts per meter-Kelvin (W-rrf'T ¹).

29. The device of claim 28, wherein: the insulating material has a melting temperature greater than 260 degrees Celsius; and the insulating material has a decomposition temperature greater than 260 degrees Celsius.

30. The device of any one of claims 19 to 29, wherein the heating element is configured to heat the composition to a temperature from 150 to 250 degrees Celsius.

31. The device of any one of claims 19 to 30, further comprising a battery in electrical communication with the heating element.

32. The device of any one of claims 19 to 31, further comprising an actuator and an administration path, wherein: the actuator is configured to be in mechanical communication with the chamber of the container; the administration path is configured to be in fluid communication with the chamber; and the actuator is configured to mechanically compress the chamber to direct the composition out of the chamber and into the administration path when the composition is a gas phase composition.

33. The device of any one of claims 19 to 32, further comprising a controller in electrical communication with the heating element, wherein: the controller is configured to run an authorization program; the controller is configured to receive one or more inputs for the authorization program; the controller is configured to run a heating program when the controller receives the one or more inputs, the controller runs the authorization program using the one or more inputs, and running the authorization program using the one or more inputs indicates that the controller can run the heating program based on the one or more inputs; and running the heating program causes the heating element to heat.

34. The device of claim 33, wherein the one or more inputs includes the present date and time.

35. The device of claim 33 or 34, wherein the one or more inputs includes the present location of the device.

36. The device of any one of claims 33 to 35, wherein the one or more inputs includes the present velocity of the device.

37. The device of any one of claims 33 to 36, wherein the one or more inputs includes an identifier for a person.

38. The device of any one of claims 33 to 37, wherein the one or more inputs comprise authorization data, and the authorization data comprises one or more of: a date or plurality of dates on which the pharmaceutical agent of the composition of the chamber of the container may be vaporized; a time or plurality of times at which the pharmaceutical agent of the composition of the chamber of the container may be vaporized; a location or plurality of locations at which the pharmaceutical agent of the composition of the chamber of the container may be vaporized; a velocity or plurality of velocities at which the pharmaceutical agent of the composition of the chamber of the container may be vaporized; and an identifier for a person who may operate the device to vaporize the pharmaceutical agent of the composition of the chamber of the container.

39. The device of any one of claims 19 to 38, further comprising a controller, wherein: the controller is configured to transmit use data after heating the composition disposed within the chamber of the container; and the use data comprises one or more of: the identity of the container; the identify of the composition; a temperature within the device during the heating; the time of the heating; the duration of the heating; the date on which the heating occurred; the location of the device during the heating; the velocity of the device during the heating; and an identifier associated with a person who operated the device during the heating.

40. The device of any one of claims 37 to 39, wherein the identifier comprises a password, an electromagnetic signal, or biometric data.

41. A system to provide multiple doses of a pharmaceutical agent, comprising: a plurality of containers according to the container of any one of claims 1 to 18; and computer storage media comprising a plurality of unique data sets, wherein: each container of the plurality of containers is associated with a unique data set of the plurality of unique data sets; each unique data set is unique because each unique data set is associated with a different container; each container of the plurality of containers comprises a unique identifier; each unique data set comprises identifier data that identifies the unique identifier of a specific container that is associated with the unique data set; each unique data set comprises pharmaceutical agent data that identifies a specific pharmaceutical agent of a specific composition of a specific chamber of a specific container that comprises the specific unique identifier that is associated with the unique data set; the specific pharmaceutical agent is present in a specific amount within the specific composition of the specific chamber of the specific container; and each unique data set comprises dose data that identifies the specific amount.

42. The system of claim 41, wherein, for each unique data set of the plurality of unique data sets, either: the computer storage media is configured to add use data to the unique data set after vaporizing a specific pharmaceutical agent of a specific composition of a specific chamber of a specific container that comprises a specific unique identifier that is associated with the unique data set; or the specific pharmaceutical agent has been vaporized, and the unique data set comprises the use data; and the use data comprises one or more of: a temperature within the device during the vaporizing; the time of the vaporizing; the duration of the vaporizing; the date on which the vaporizing occurred; the location of the device during the vaporizing; the velocity of the device during the vaporizing; and an identifier associated with a person who operated the device during the vaporizing.

43. The system of claim 41 or 42, wherein: each container is adapted for insertion into a device comprising a heating compartment and a heating element; the heating compartment is adapted to receive an individual container of the plurality of containers; the heating element is configured to be in thermal communication with the thermally-conductive surface of the individual container when the individual container is in the heating compartment; the heating element is configured to heat the thermally-conductive surface; and the heating element is configured to heat the composition disposed within the hermetically-sealed chamber of the container by heating the thermally-conductive surface.

44. The system of claim 43, further comprising the device.

45. The system of claim 43 or 44, wherein the device further comprises a controller in electrical communication with the heating element, wherein: the controller is configured to run an authorization program; each unique data set comprises authorization data; the controller is configured to receive one or more inputs for the authorization program; the one or more inputs comprise the authorization data of a unique data set; the controller is configured to run a heating program when the controller receives the one or more inputs, the controller runs the authorization program using the one or more inputs, and running the authorization program using the one or more inputs indicates that the controller can run the heating program based on the one or more inputs; and running the heating program causes the heating element to heat.

46. The system of any one of claims 41 to 45, wherein each unique data set comprises authorization data comprising one or more of: a date or plurality of dates on which a specific pharmaceutical agent of a specific composition of a specific chamber of a specific container that comprises a specific unique identifier that is associated with the unique data set may be vaporized; a time or plurality of times at which the specific pharmaceutical agent of the specific container may be vaporized; a location or plurality of locations at which the specific pharmaceutical agent of the specific container may be vaporized; a velocity or plurality of velocities at which the specific pharmaceutical agent of the specific container may be vaporized; and an identifier for a person, a plurality of identifiers for a person, or a plurality of identifiers for a plurality of people who may operate a device to vaporize the specific pharmaceutical agent of the specific container.

47. A method to prepare a vaporized pharmaceutical agent, comprising: providing the container of any one of claims 1 to 18, wherein the composition is a volatile composition, and the pharmaceutical agent is a volatile pharmaceutical agent; heating the volatile composition; vaporizing a vaporized portion of the volatile pharmaceutical agent to produce a vaporized pharmaceutical agent; producing a gas phase composition comprising the vaporized pharmaceutical agent; directing the gas phase composition out of the container; and directing the gas phase composition into an administration path in fluid communication with the container.

48. A method to prepare a vaporized pharmaceutical agent, comprising: providing a container comprising a volatile composition comprising a volatile pharmaceutical agent; heating the volatile composition; vaporizing a vaporized portion of the volatile pharmaceutical agent to produce a vaporized pharmaceutical agent; producing a gas phase composition comprising the vaporized pharmaceutical agent; directing the gas phase composition out of the container; and directing the gas phase composition into an administration path in fluid communication with the container.

49. The method of claim 47 or 48, further comprising inflating a chamber from an initial volume to an inflated volume, wherein: the container comprises the chamber; the chamber comprises the volatile pharmaceutical agent; the inflated volume is at least 500 percent greater than the initial volume; and the inflated volume is less than 10 milliliters.

50. The method of claim 49, wherein: the initial volume is greater than 10 nanoliters and less than 500 microliters; and the inflated volume is greater than 1000 microliters.

51. The method of claim 49 or 50, further comprising deflating the chamber from the inflated volume to a deflated volume, wherein the inflated volume is at least 1000 percent greater than the deflated volume.

52. The method of claim 51, further comprising compressing the chamber to deflate the chamber, wherein an actuator is in mechanical communication with the chamber; and the actuator compresses the chamber.

53. The method of claim 52, further comprising transmitting a signal to compress the chamber; and receiving the signal to compress the chamber, wherein the actuator is in electrical communication with a circuit; the circuit transmits the signal to compress the chamber; and the actuator receives the signal to compress the chamber.

54. The method of any one of claims 47 to 53, wherein the volatile composition is a liquid; the container comprises at least 10 nanoliters and less than 1000 microliters of the volatile composition.

55. The method of any one of claims 47 to 54, wherein the volatile composition has a surface-area-to-volume ratio greater than 2000 per meter.

56. The method of any one of claims 47 to 55, further comprising converting at least 25 percent of the volatile pharmaceutical agent of the volatile composition into vaporized pharmaceutical agent by vaporizing the vaporized portion of the volatile pharmaceutical agent.

57. The method of any one of claims 47 to 56, wherein the volatile composition comprises 10 micrograms to 10 milligrams of the volatile pharmaceutical agent; and the gas phase composition comprises 10 micrograms to 10 milligrams of the vaporized pharmaceutical agent.

58. The method of claim 57, wherein the container comprises 10 micrograms to 10 milligrams of the volatile pharmaceutical agent; and the container comprises less than 5 micrograms of molecular oxygen (0₂).

59. The method of any one of claims 47 to 58, wherein: the gas phase composition has a total pressure; the vaporized pharmaceutical agent has a partial pressure in the gas phase composition; and the partial pressure of the vaporized pharmaceutical agent in the gas phase composition is at least 1 percent of the total pressure of the gas phase composition.

60. The method of any one of claims 47 to 59, further comprising: heating a volatile vehicle; and vaporizing a vaporized portion of the volatile vehicle to produce a vaporized vehicle; wherein: the volatile composition comprises the volatile vehicle; and the gas phase composition comprises the vaporized vehicle.

61. The method of claim 60, wherein the volatile vehicle is water, ethanol, a terpene, or a combination of two or more of the foregoing.

62. The method of claim 60 or 61, wherein: the gas phase composition has a total pressure; the vaporized pharmaceutical agent has a first partial pressure in the gas phase composition; the vaporized vehicle has a second partial pressure in the gas phase composition; the first partial pressure is 0.1 to 50 percent of the total pressure; and the second partial pressure is 50 to 99.9 percent of the total pressure.

63. The method of any one of claims 60 to 62, wherein the gas phase composition consists essentially of the vaporized pharmaceutical agent and the vaporized vehicle.

64. The method of any one of claims 47 to 63, wherein: the gas phase composition has a total pressure; and the partial pressure of molecular oxygen (0₂) in the gas phase composition is less than 5 percent of the total pressure.

65. The method of any one of claims 47 to 64, further comprising unsealing the container before directing the gas phase composition out of the container, wherein providing a container comprises providing a hermetically-sealed container.

66. The method of any one of claims 47 to 65, further comprising: inserting the container into a device comprising the administration path, a heating surface, a heating element, and a battery, wherein the battery is in electrical communication with the heating element, and the heating element is in thermal communication with the heating surface; positioning a thermally-conductive surface of the container in thermal communication with the heating surface; positioning the administration path in fluid communication with the container; directing electricity from the battery to the heating element to heat the heating element; conductively heating the heating surface by heating the heating element; conductively heating the thermally-conductive surface by heating the heating surface; and conductively heating the volatile composition by heating the thermally-conductive surface.

67. The method of any one of claims 47 to 66, further comprising: directing electricity from a battery to a heating element to heat the heating element; conductively heating a thermally-conductive surface of the container by heating the heating element, wherein the thermally-conductive surface is metal; and conductively heating the volatile composition by heating the thermally-conductive surface.

68. The method of any one of claims 47 to 67, wherein heating the volatile composition comprises heating the volatile composition to a temperature from 150 to 250 degrees Celsius.

69. The method of any one of claims 47 to 68, further comprising holding the gas phase composition in the respiratory system for a period of time; and exhaling the gas phase composition.

70. The method of any one of claims 47 to 69, wherein the heating comprises conductive heating, convective heating, and/or radiative heating.

71. The method of any one of claims 47 to 70, further comprising: positioning a respiratory system of a user in fluid communication with the administration path; and directing the gas phase composition into the respiratory system.

72. A method of regulating the use of a pharmaceutical agent, comprising: transferring a unique container comprising a pharmaceutical agent to a person, thereby creating an association between the unique container and the person; recording the association of the unique container and the person; inserting the unique container into a device; verifying the identity of the person; verifying the association between the unique container and the person; and vaporizing the pharmaceutical agent.

73. A method of regulating the use of a pharmaceutical agent, comprising: transferring a unique container according to any one of claims 1 to 18 to a person, thereby creating an association between the unique container and the person; recording the association of the unique container and the person; inserting the unique container into a device according to any one of claims 19 to 40; verifying the identity of the person; verifying the association between the unique container and the person; and vaporizing the pharmaceutical agent.

74. The method of claim 72 or 73, further comprising identifying the present time.

75. The method of any one of claims 72 to 74, further comprising identifying the date.

76. The method of any one of claims 72 to 75, further comprising identifying the location of the device.

77. The method of any one of claims 72 to 76, further comprising identifying the velocity of the device.