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|Title:||Devices, compositions and methods for the pulmonary delivery of aerosolized medicaments|
|Abstract:||According to the subject invention, dispersible dry powder pharmaceutical-based compositions are provided, including methods for their manufacture and dry powder dispersion devices. A dispersible dry powder pharmaceutical-based composition is one having a moisture content of less than about 10% by weight (% w) water, usually below about 5% w and preferably less than about 3% w; a particle size of about 1.0-5.0 .mu.m mass median diameter (MMD), usually 1.0-4.0 .mu.m MMD, and preferably 1.0-3.0 .mu.m MMD; a delivered dose of about >30%, usually >40%, preferably >50%, and most preferred >60%; and an aerosol particle size distribution of about 1.0-5.0 .mu.m mass median aerodynamic diameter (MMAD), usually 1.5-4.5 .mu.m MMAD, and preferably 1.5-4.0 MMAD. Such composition are of pharmaceutical grade purity.|
|Inventor(s):||Platz; Robert M. (Half Moon Bay, CA), Patton; John S. (San Carlos, CA), Foster; Linda (Sunnyvale, CA), Eljamal; Mohammed (San Jose, CA)|
|Assignee:||Inhale Therapeutic Systems, Inc. (San Carlos, CA)|
1. Biocompatible particles for delivery of a therapeutic, prophylactic or diagnostic agent to the pulmonary system; wherein the particles have a tap density of less than
0.4 g/cm.sup.3 , the particle size is less thatn 10 .mu.m , and the particles have a mean aerodynamic diameter between about 1 .mu.m and about 5 .mu.m.
2. The particles of claim 1, wherein 90% of the particlesare <5.0 .mu.m in diameter.
3. The particles of claim 1, wherein the particles have a mean aerodynamic diamter of about 1 .mu.m .
4. The particles of claim 1, wherein the agent is a protein.
5. The particles of claim 1, wherein the particles have a tap density of less than 0.34 g/cm.sup.3.