Method of forming an aerosol for inhalation delivery

• US 9,439,907 B2
• Filed: 11/11/2013
• Issued: 09/13/2016
• Est. Priority Date: 06/05/2001
• Status: Expired due to Term

• Current Assignee: Alexza Pharmaceuticals Inc. (Grupo Ferrer Internacional SA)
• Original Assignee: Alexza Pharmaceuticals Inc. (Grupo Ferrer Internacional SA)
• Inventors: Hale, Ron L., Hodges, Craig C., Lloyd, Peter M., Mufson, Daniel, Rogers, Daniel D., Song, Soonho, Wensley, Martin J., Myers, Daniel J., McKinney, Jeffrey A., Quintana, Reynaldo J., Rabinowitz, Joshua D.
• Primary Examiner(s): DOUGLAS, STEVEN O
• Application Number:
  US14/077,015
• Publication Number:
  US 20140066618A1
• Time in Patent Office: 1,037 Days
• Field of Search: 128/200.16, 128/200.14, 128/200.19, 128/200.18, 128/203.25, 128/203.26, 128/204.14, 128/204.15, 128/204.16, 128/203.16, 128/203.17, 128/203.18, 424/45, 424/46
• US Class Current: 1/1
• CPC Class Codes: A61K 31/235 having an aromatic ring attached to a carboxyl group
• CPC Class Codes: A61K 31/4468 having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 31/519 ortho- or peri-condensed with heterocyclic rings
• CPC Class Codes: A61K 9/007 Pulmonary tract; Aromatherapy
• CPC Class Codes: A61K 9/0073 Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy; nasal sprays A61K9/0043; inhalation of vapours of volatile or heated drugs, e.g. essential oils or nicotine, A61K9/007; devices A61M
• CPC Class Codes: A61M 11/001 Particle size control
• CPC Class Codes: A61M 11/02 operated by air or other gas pressure applied to the liquid or other product to be sprayed or atomised sprayers for horticulture A01G, A01H; killing insects A01M; air humidifying by nozzles F24F6/14, F24F6/18; cooling by spraying F28B, F28C
• CPC Class Codes: A61M 11/044 with electrodes immersed in the liquid
• CPC Class Codes: A61M 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04
• CPC Class Codes: A61M 15/0028 using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
• CPC Class Codes: A61M 16/109 the humidifying liquid or the beneficial agent
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2205/3606 cooled
• CPC Class Codes: A61M 2205/3653 by Joule effect, i.e. electric resistance
• CPC Class Codes: A61M 2205/368 by electromagnetic radiation, e.g. IR waves
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61P 23/00 Anaesthetics
• CPC Class Codes: B05B 17/04 operating with special methods
• CPC Class Codes: B05B 7/1686 involving vaporisation of the material to be sprayed or of an atomising-fluid-generating product

Abstract

The present application relates to the inhalation delivery of aerosols containing small particles. Specifically, it relates to a method of forming an aerosol for use in inhalation therapy. The method involves: (a) heating a substrate coated with a composition of a drug to form a vapor, wherein the coated composition is in the form of a film less than 10μ thick; and, (b) allowing the vapor to cool, thereby forming an aerosol, which is used in inhalation therapy. In another aspect, a method of forming an aerosol for use in inhalation therapy is provided, wherein the method involves: (a) heating a substrate coated with a composition of a drug to form a vapor in less than 100 milliseconds, wherein the vapor has a mass greater than 0.1 mg; and, (b) allowing the vapor to cool, thereby forming an aerosol, which is used in inhalation therapy.

Claims

1. A method of forming an aerosol comprising loxapine, said method comprising:

(a) heating a substrate coated with a composition comprising loxapine for a period of time by a heater system, thereby forming a vapor, wherein the period of time is less than 500 milliseconds and wherein an increase in temperature of the substrate over the period of time is greater than 1000°

C./s; and

(b) allowing the vapor to cool, thereby forming an aerosol comprising loxapine.

2. An apparatus, comprising:

a housing defining an airway extending between an inlet of the housing and an outlet of the housing, a first portion of the airway having a first cross-sectional area, a second portion of the airway having a second cross-sectional area less than the first cross-sectional area, the second portion of the airway; and

a substrate, at least a portion of the substrate having a surface in communication with the second portion of the airway, the portion of the substrate configured to be heated by a heater system such that a composition comprising loxapine coated on the surface of the substrate is engaged by air passing through the airway upon inhalation by a patient, the heater system configured to heat the composition to a vaporization temperature to begin vaporization of the composition and forming a vaporized composition, the second portion of the airway configured to increase a speed of the air passing over the surface of the composition to remove vapors resulting from vaporization of the composition from the heated portion of the substrate, the second portion of the airway configured to cool the removed vapors below the vaporization temperature without significant decomposition of the vaporized composition.