Claims for Patent: 8,628,754

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.