# US 7,410,635 B2 · Aerosol formulations and aerosol delivery of scopolamine

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- Number: US 7,410,635 B2
- Document ID: US7410635B2
- Status: Granted
- Kind: B2
- Application number: 10/958,329
- Filed: 2004-10-06
- Published: 2005-04-14
- Granted: 2008-08-12
- Earliest claimed: 2003-10-07
- Assignees: Philip Morris USA Inc.
- Inventors: Frank E. Blondino; Justin Poklis; Matthew Baker
- Web page: https://patentgrep.com/patent/US7410635B2

## CPC

- A61K 9/007: {Pulmonary tract; Aromatherapy}
- A61K 31/4745: condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines (yohimbine derivatives, vinblastine A61K31/475; ergoline derivatives A61K31/48)
- A61K 31/485: Morphinan derivatives, e.g. morphine, codeine
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61M 11/041: {using heaters}
- A61M 11/042: {electrical}
- A61M 15/025: {Bubble jet droplet ejection devices}
- 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)
- 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)}

## Abstract

A liquid aerosol formulation comprising at least one thermally stable active ingredient selected from the group consisting of butalbital, lorazepam, ipratropium, baclofen, morphine, scopolamine, pharmaceutically acceptable salts and esters thereof and derivatives thereof. The liquid formulation can include an organic solvent such as propylene glycol and one or more optional excipients. The active ingredient can be present in an amount of 0.01 to 5 weight percent and the formulation can be heated to provide a vapor which forms an aerosol having a mass median aerodynamic diameter of less than 3 μm.

## Claims

### Claim 1

A method of generating an aerosol comprising: supplying a liquid aerosol formulation to a capillary-sized flow passage,
heating the liquid aerosol formulation in the capillary-sized flow passage so as to volatilize a liquid component thereof and form a vapor which exits from an outlet of the capillary-sized flow passage, and
contacting the vapor with a gaseous medium so as to form an aerosol,
wherein the liquid aerosol formulation includes at least one thermally stable active ingredient selected from the group consisting of scopolamine, pharmaceutically acceptable salts and esters thereof.

### Claim 2 (depends on 1)

The method of claim 1, wherein the gaseous medium comprises air, and the aerosol comprises propylene glycol-containing particles having an MMAD of less than 3 μm.

### Claim 3 (depends on 1)

The method of claim 1, wherein the aerosol comprises scopolamine particles having an MMAD of less than 3 μm.

### Claim 4 (depends on 1)

The method of claim 1, wherein the aerosol is formed in a mouthpiece of a handheld inhaler.

### Claim 5 (depends on 1)

The method of claim 1, wherein the aerosol includes particles of the thermally stable active ingredient having an MMAD of 0.1 to 2.5 μm.

### Claim 6 (depends on 1)

The method of claim 1, wherein the capillary-sized flow passage is heated by a resistance heater located in a handheld inhaler, the hand-held inhaler including a power supply and control electronics which controls supply of electrical power to the resistance heater as a function of a resistance target in a range of 0.5 to 1 ohm.

### Claim 7

An aerosol generator comprising:
a liquid supply providing a liquid aerosol formulation comprising at least one thermally stable active ingredient selected from the group consisting of scopolamine, pharmaceutically acceptable salts and esters thereof;
a capillary-sized flow passage in fluid communication with the liquid aerosol formulation from the liquid supply; and
a heater operable to heat the liquid aerosol formulation in at least a portion of the capillary-sized flow passage sufficiently to vaporize the liquid aerosol formulation and generate an aerosol containing the active ingredient.

### Claim 8 (depends on 7)

The aerosol generator of claim 7, wherein the aerosol generator is a hand-held inhaler having a mouthpiece, wherein the capillary-sized flow passage has an outlet in fluid communication with an interior of the mouthpiece.

### Claim 9 (depends on 7)

The aerosol generator of claim 7, wherein the heater is a resistance heater comprising a section of a metal capillary tube, and the capillary-sized flow passage comprises the interior of the metal capillary tube.

### Claim 10 (depends on 7)

The aerosol generator of claim 7, wherein the aerosol generator is a hand-held inhaler having a power supply and control electronics which controls supply of electrical power to the heater as a function of a control parameter selected to achieve boiling of the liquid aerosol formulation in the capillary-sized flow passage.

### Claim 11 (depends on 7)

The aerosol generator of claim 7, wherein the liquid supply comprises a reservoir containing the liquid aerosol formulation under a pressure of no greater than about atmospheric pressure.