Dpi formulation containing sulfoalkyl ether cyclodextrin

An inhalable therapeutic dry powder adapted for administration to a subject with a DPI device, the powder comprising a physical mixture comprising:

• a. a first particulate composition comprising at least one active agent suitable for administration via inhalation, wherein the first particulate composition has a particle size distribution such that at least 90% of the particles are less than 37 microns in diameter;
• and
• b. a dissociable second particulate composition as carrier comprising SAE-CD, wherein the second particulate composition has a particle size distribution such that substantially all or at least about 90% of the particles therein pass through a 40 mesh sieve (420 micron);
• wherein
• c. the first particulate composition is uniformly dispersed throughout the second particulate composition.

An inhalable therapeutic dry powder adapted for administration to a subject with a DPI device, the powder comprising a physical mixture comprising:

• a. a first particulate composition comprising at least one active agent suitable for administration via inhalation, wherein the first particulate composition has a particle size distribution such that at least 90% of the particles are less than 37 microns in diameter;
• and
• b. a dissociable second particulate composition as carrier comprising SAE-CD, wherein the second particulate composition has a particle size distribution such that substantially all or at least about 90% of the particles therein pass through a 40 mesh sieve (420 micron);
• wherein
• c. the first particulate composition is uniformly dispersed throughout the second particulate composition;
• d. the dry powder formulation has a moisture content of less than about 10% wt.;
• e. the second particulate composition has an electrostatic charge of 2 to −3.7 nC/g.

A dry powdered particulate carrier composition comprising an SAE-CD of the Formula 1 or Formula 2 and optionally one or more excipients, wherein the carrier composition possesses the following properties:

• a) a median particle diameter of less than 420 microns, and/or a median particle diameter in the range of about 37 to 125 or about 10 to 300 microns;
• b) an electrostatic charge of 2 to −3.7 nC/g;
• c) a moisture content of 10% wt. or less;
• and
• d) optionally, a particle size distribution span in the range of about 1.5 to 2.9;
• e) optionally, a Carr's Index of about 10% to 40% compressibility;
• f) optionally, a static angle of repose from about 28 to 45 degrees;
• g) optionally, a fractal dimension analysis of about 1.00 to 1.31.

A method of preparing a dry powder carrier composition suitable for use in a DPI device for the delivery of an active agent to a subject, the method comprising the steps of:

• a. providing an aqueous solution comprising water, SAE-CD and optionally one or more other materials;
• b. converting the solution to a foam, and optionally freezing the foam;
• c. dehydrating the foam to form a friable porous glass, which may or may not be particulate;
• d. attritting the porous glass to form microparticles;
• and
• e. screening the microparticles, thereby forming a dry powder carrier.