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Last Updated: March 28, 2024

Claims for Patent: 8,628,754


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Summary for Patent: 8,628,754
Title:Highly efficient delivery of a large therapeutic mass aerosol
Abstract: A method for delivering an agent to the pulmonary system, in a single, breath-activated step or a single breath, 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. The particles are capable of carrying agents. The agent is (1) part of the spray-drying pre-mixture and thereby incorporated into the particles, (2) added to separately-prepared particles so that the agent is in chemical association with the particles or (3) blended so that the agent is mixed with, and co-delivered with the particles. Respirable compositions comprising carrier particles having a tap density of less than 0.4 g/cm.sup.3 and a composition comprising an agent are also disclosed. Methods of delivering these respirable compositions are also included.
Inventor(s): Edwards; David A. (Cambridge, MA), Batycky; Richard P. (Newton, MA), Johnston; Lloyd (Newton, MA)
Assignee: Civitas Therapeutics, Inc. (Chelsea, MA)
Application Number:13/334,236
Patent Claims: 1. A method of delivering an agent to the pulmonary system, in a single, breath-activated step, using a dry powder inhaler, comprising administering particles comprising an agent from a receptacle having a mass consisting of said particles to a subject's respiratory tract, wherein: i) about 50% or more of the mass of dry powder particles stored in the receptacle is delivered to the lungs of the subject; and ii) about 5 milligrams or more of the agent is delivered to the lungs of the subject.

2. The method of claim 1, wherein the particles have a tap density of about 0.4 g/cm.sup.3 or less.

3. The method of claim 1, wherein the particles have a tap density of about 0.1 g/cm.sup.3 or less.

4. The method of claim 2, wherein delivery is primarily to the deep lung.

5. The method of claim 2, wherein the particles are spray-dried particles.

6. The method of claim 1, wherein the agent is non-crystalline.

7. The method of claim 1, wherein at least 50% of the particles have a fine particle fraction less than 4.0 .mu.m.

8. The method of claim 1, wherein at least 75% of the particles have a fine particle fraction less than 6.8 .mu.m.

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