Spray drying of macromolecules to produce inhaleable dry powders

/Home/Lyophilization and Protein Formulation Patents/Patent Articles - Lyophilization

Title: Spray drying of macromolecules to produce inhaleable dry powders
United States Patent: 6,582,728
Issued: June 24, 2003
Inventors: 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)
Appl. No.: 423515
Filed: April 14, 1995
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.