Highly efficient delivery of a large therapeutic mass aerosol
View Patent ↗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 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 3 and deliver at least about 10 milligrams of the bioactive agent. The receptacle can have a volume of at least 0.37 cm 3 .
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 3 ;
ii) at least 50% of the particles have a fine particle fraction less than 4.0 μm; 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 3 .
3. The method of claim 1 wherein the particles have a geometric diameter greater than about 5 μm.
4. The method of claim 1 wherein the receptacle has a volume of at least about 0.37 cm 3 .
5. The method of claim 1 wherein the receptacle has a volume of at least about 0.48 cm 3 .
6. The method of claim 1 wherein the receptacle has a volume of at least about 0.67 cm 3 .
7. The method of claim 1 wherein the receptacle has a volume of at least about 0.95 cm 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.