Method of forming an aerosol for inhalation delivery

• US 8,074,644 B2
• Filed: 05/22/2009
• Issued: 12/13/2011
• Est. Priority Date: 06/05/2001
• Status: Expired due to Fees

• 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:
  US12/471,070
• Publication Number:
  US 20090229600A1
• Time in Patent Office: 935 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, 424/25, 424/46
• US Class Current: 128/203.16
• 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 invention 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. In a method aspect of the present invention, a method of forming an aerosol for use in inhalation therapy is provided. The method involves the following steps: (a) heating a substrate coated with a composition comprising a drug at a rate greater than 1000° C./s, thereby forming an vapor; and, (b) allowing the vapor to cool, thereby forming an aerosol, which is used in inhalation therapy. In another method aspect of the present invention, a method of forming an aerosol for use in inhalation therapy is provided. The method involves the following steps: (a) heating a substrate coated with a composition comprising 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 method aspect of the present invention, a method of forming an aerosol for use in inhalation therapy is provided. The method involves the following steps: (a) heating a substrate coated with a composition comprising 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 for use in inhalation therapy comprising:

(a) heating a substrate coated with a composition comprising a drug, thereby forming a vapor;

(b) establishing an airflow over the surface of the coated composition during said heating; and

(c) allowing the vapors to cool in the air flow thereby forming an aerosol comprising the drug,

wherein a dose of the drug is vaporized in less than 1 second.

2. The method according to claim 1, wherein a dose of the drug is vaporized in less than 500 milliseconds.

3. The method according to claim 2, wherein a dose of the drug is vaporized in less than 100 milliseconds.

4. The method according to claim 3, wherein the formed aerosol is greater than 80 percent by weight of the drug.

5. The method according to claim 3, wherein the formed aerosol contains less than 5 percent by weight of drug decomposition products.

6. The method according to claim 3, wherein the formed aerosol is stable over 1 second.

7. The method according to claim 3, wherein the formed aerosol has an MMAD in the 10 nm to 100 nm range.

8. The method according to claim 3, wherein the formed aerosol has an MMAD in the 1 μ

m to 3 μ

m range.

9. The method according to claim 3, wherein the geometric standard deviation of the form aerosol is other than 1.

10. The method according to claim 3, wherein the film is less than 10 μ

m thick.

11. The method according to claim 10, wherein the film is less than 5 μ

m thick.

12. The method according to claim 10, wherein the film is between 10 nm and 5 μ

m thick.

13. The method according to claim 10, wherein the film is less than 3 μ

m thick.

14. The method according to claim 12, wherein the film is between 10 nm and 3 μ

m thick.