# US 12,214,119 B2 · Electrical condensation aerosol device

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- Number: US 12,214,119 B2
- Document ID: US12214119B2
- Status: Granted
- Kind: B2
- Application number: 17/076,808
- Filed: 2020-10-22
- Published: 2021-04-15
- Granted: 2025-02-04
- Earliest claimed: 2018-02-02
- Assignees: Alexza Pharmaceuticals, Inc.
- Applicants: Alexza Pharmaceuticals, Inc.
- Inventors: David Koji Hasegawa; Mingzu Lei; Gilbert T. Tong
- Web page: https://patentgrep.com/patent/US12214119B2

## CPC

- A61M 11/042: {electrical}
- A61P 11/00: Drugs for disorders of the respiratory system
- A61M 11/001: {Particle size control}
- A24F 40/20: Devices using solid inhalable precursors
- A24F 40/50: Control or monitoring
- A61M 15/0028: {using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up}
- A61M 15/0081: {Locking means}
- A61M 15/0083: {Timers}
- A61M 15/06: Inhaling appliances shaped like cigars, cigarettes or pipes
- A61M 2016/0015: {inhalation detectors}
- A61M 2202/06: Solids
- A61M 2205/0233: Conductive materials, e.g. antistatic coatings for spark prevention
- A61M 2205/0238: the material being a coating or protective layer
- A61M 2205/3331: Pressure; Flow
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3368: Temperature
- A61M 2205/3653: by Joule effect, i.e. electric resistance
- A61M 2205/60: with identification means
- A61M 2205/6054: Magnetic identification systems
- A61M 2205/6072: Bar codes
- A61M 2205/8206: battery-operated
- 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)}
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A24F: SMOKERS' REQUISITES; MATCH BOXES; SIMULATED SMOKING DEVICES (inhaling appliances for medical purposes, shaped like cigars, cigarettes or pipes A61M15/06)

## Abstract

The present invention provides a method for producing condensation aerosols for the treatment of disease and/or chronic, intermittent or acute conditions. These condensation aerosols are produced from drugs including temperature sensitive drugs and small molecule drugs that are coated onto a foil substrate which is heated via electrical resistance heating at precisely controlled temperature profiles with controllable ramp-up and heating rates to vaporize the coated drug which subsequently condenses to form aerosol particles. These condensation aerosols have little or no degradation products. Kits comprising a drug and a device for producing a condensation aerosol are also provided. Also disclosed, are methods for using these aerosols and kits and methods of making the aerosols.

## Claims

### Claim 1

A drug device for producing an alprazolam condensation aerosol by thermal vaporization of alprazolam comprising:
a disposable cartridge (200); and
a handheld medical device (100), comprising:
a) one or more air inlets (107);
b) one or more air outlets (103);
c) one or more batteries (105) to provide electric current;
d) one or more connectors to electrically connect the device (100) to the disposable cartridge (200) comprising an alprazolam composition (210) coated on a foil substrate (209); and
e) one or more electrical current delivery devices (106) to control the release of electric current to the disposable cartridge (200);
said air inlets (107) and air outlets (103) defining an airway;
at least one of the air outlets (103) being configured as a housing to attach said disposable cartridge (200);
said electrical current delivery devices (106) being configured to drive a precise electrical current profile to the foil substrate (209) of the disposable cartridge (200) to affect electrical resistive heating at a rate that achieves a precise temperature profile with a controllable ramp-up to a target temperature and heating rate; and
the temperature profile is suitable to vaporize a therapeutically effective amount of alprazolam composition (210) coated on the foil substrate (209) of the cartridge (200) within a period of 3 seconds or less followed by condensation inside the cartridge of the resulting vapor to form alprazolam aerosol particles wherein the one or more connectors and the foil substrate (209) are electrically connected through a printed circuit board (211) or a flex circuit (207).

### Claim 2 (depends on 1)

The device of claim 1, wherein said ramp-up target temperature is between 15° and 550° C.

### Claim 3 (depends on 1)

The device of claim 1, wherein said ramp-up target temperature is between 20° and 500° C.

### Claim 4 (depends on 1)

The device of claim 1, wherein said ramp-up target temperature is between 25° and 450° C.

### Claim 5 (depends on 1)

The device of any of claim 1, wherein the ramp-up time is between 50 and 200 ms.

### Claim 6 (depends on 1)

The device of claim 1, wherein the ramp-up time is between 50 and 115 ms.

### Claim 7 (depends on 1)

The device of claim 1, wherein the foil substrate (209) is heated at 3 to 10° C./ms in the ramp-up time.

### Claim 8 (depends on 1)

The device of claim 1, wherein said heating rate is selected from one of plateau heating, tampered cooling or progressive heating, or a combination thereof.

### Claim 9 (depends on 1)

The device of claim 1, wherein the batteries (105) are able to provide a peak electric current higher than 30 A and a voltage of 8-13 V.

### Claim 10 (depends on 1)

The device of claim 1, wherein the batteries (105) are able to provide a peak electric current higher than 100 A and a voltage of 9-12 V.

### Claim 11 (depends on 1)

The device of claim 1, wherein the batteries (105) are lithium polymer batteries.

### Claim 12 (depends on 1)

The device of claim 1, which further comprises a device enclosure (108).

### Claim 13 (depends on 1)

The device of claim 1, which further comprises means for verifying the correct attachment (103A) of the disposable cartridge (200) into the housing of the device (103).

### Claim 14 (depends on 13)

The device of claim 13, wherein the means for verifying the correct attachment (103A) of the disposable cartridge (200) into the housing of the device (103) comprise verification of electrical contact.

### Claim 15 (depends on 13)

The device of claim 13, wherein the means for verifying the correct attachment (103A) of the disposable cartridge (200) into the housing of the device (103) comprise a proximity sensor.

### Claim 16 (depends on 13)

The device of claim 13, wherein the means for verifying the correct attachment (103A) of the disposable cartridge (200) into the housing of the device (103) comprise a mechanical or optical switch.

### Claim 17 (depends on 1)

The device of claim 1, which further comprises means for uniquely recognizing the disposable cartridge (200).

### Claim 18 (depends on 17)

The device of claim 17, wherein the means for uniquely recognizing the disposable cartridge (200) are selected from RFID tag, bar code, QR code, read/write chip or combinations thereof.

### Claim 19 (depends on 1)

The device of claim 1, which further comprises means for controlling the temperature of the foil substrate (209) in the disposable cartridge (200) by sensing the temperature of the foil substrate (209) and feeding the foil substrate temperature information to the electrical current delivery device (106) to modify the electric current delivery in order to achieve the required temperature.

### Claim 20 (depends on 19)

The device of claim 19, wherein the means for controlling the temperature of the foil substrate (209) in the disposable cartridge (200) comprise the measurement of electrical resistance across the foil substrate.

### Claim 21 (depends on 19)

The device of claim 19, wherein the means for controlling the temperature of the foil substrate (209) in the disposable cartridge (200) comprise optical measurement.

### Claim 22 (depends on 19)

The device of claim 19, wherein the means for controlling the temperature of the foil substrate (209) in the disposable cartridge (200) comprise direct contact measurement with a thermocouple.

### Claim 23 (depends on 1)

The device of claim 1, which further comprises a pneumatic sealing interface between the air outlet (103) of the device (100) and the air inlet (220) of the cartridge (200).

### Claim 24 (depends on 1)

The device of claim 1, wherein the foil substrate (209) is rectangular with two opposing edges of the foil substrate electrically connected along the full length of each edge to the printed circuit board (211) or to the flex circuit (207) and the electrically connected edges run parallel to the main direction of air flow in the airway.

### Claim 25 (depends on 1)

The device of claim 1, wherein the foil substrate (209) and the printed circuit board (211) or the flex circuit (207) are made of different metals.

### Claim 26 (depends on 25)

The device of claim 25, wherein the foil substrate (209) and the printed circuit board (211) or the flex circuit (207) are laser welded.