Claims for Patent: 6,921,528

Summary for Patent: 6,921,528

Title:	Highly efficient delivery of a large therapeutic mass aerosol
Abstract:	A method for delivering a therapeutic dose of a bioactive agent to the pulmonary system, in a single, breath-activated step, comprises administering from a receptacle enclosing a mass of particles, to a subject's respiratory tract, particles which have a tap density of less than 0.4 g/cm.sup.3 and deliver at least about 50% of the mass of particles. Another method of delivering a therapeutic dose of a bioactive agent to the pulmonary system, in a single breath, includes administering from a receptacle enclosing a mass of particles, to a subject's respiratory tract, particles which have a tap density of at least 0.4 g/cm.sup.3 and deliver at least about 10 milligrams of the bioactive agent. The receptacle can have a volume of at least 0.37 cm.sup.3.
Inventor(s):	Edwards; David A. (Boston, MA), Batvcky; Richard P. (Auburndale, MA), Johnston; Lloyd (Belmont, MA)
Assignee:	Advanced Inhalation Research, Inc. (Cambridge, MA)
Application Number:	10/681,416
Patent Claims:	1. A method of delivering a therapeutic dose of a bioactive agent to the pulmonary system of a subject, in a single, breath-activated step, comprising: administering particles comprising a bioactive agent, from a receptacle having a mass consisting of said particles, to a subject's respiratory tract, wherein: i) the particles administered to the subject's respiratory tract have a tap density of less than 0.4 g/cm.sup.3 ; ii) at least 50% of the particles have a fine particle fraction less than 4.0 .mu.m; and iii) at least about 50% of the mass of particles stored in the receptacle is delivered to the pulmonary system of the subject. 2. The method of claim 1 wherein the particles have a tap density of less than about 0.1% g/cm.sup.3. 3. The method of claim 1 wherein the particles have a geometric diameter greater than about 5 .mu.m. 4. The method of claim 1 wherein the receptacle has a volume of at least about 0.37 cm.sup.3. 5. The method of claim 1 wherein the receptacle has a volume of at least about 0.48 cm.sup.3. 6. The method of claim 1 wherein the receptacle has a volume of at least about 0.67 cm.sup.3. 7. The method of claim 1 wherein the receptacle has a volume of at least about 0.95 cm.sup.3. 8. The method of claim 1 wherein delivery is primarily to the deep lung. 9. The method of claim 1 wherein delivery is primarily to the central airways. 10. The method of claim 1 wherein the bioactive agent is albuterol sulfate. 11. The method of claim 1 wherein the bioactive agent is insulin. 12. The method of claim 1 wherein the bioactive agent is growth hormone. 13. The method of claim 1 wherein the bioactive agent is fluticasone. 14. The method of claim 1 wherein the bioactive agent is salmeterol. 15. The method of claim 1 wherein the bioactive agent is hydrophobic drug. 16. The method of claim 1 wherein the bioactive agent is a hydrophilic drug. 17. The method of claim 1 wherein the bioactive agent is a monoclonal antibody. 18. The method of claim 1 wherein the particles are in the form of a dry powder. 19. The method of claim 1 wherein administration to the respiratory tract is by a dry powder inhaler.