Processes for making particle-based pharmaceutical formulations for pulmonary or nasal administration

A method for making a dry powder pharmaceutical formulation for pulmonary or nasal administration, comprising the steps of:

• a) providing particles which comprise a pharmaceutical agent;
• b) blending the particles with particles of a pre-processed excipient to form a primary blend, wherein the pre-processed excipient is prepared by
• i) dissolving a bulking agent and at least one non-friable excipient in a solvent to form an excipient solution, and
• ii) removing the solvent from the excipient solution to form the pre-processed excipient in dry powder form;
• and
• c) milling the primary blend to form a milled pharmaceutical formulation blend suitable for pulmonary or nasal administration.

A method for making a dry powder blend pharmaceutical formulation, comprising the steps of:

• a) providing microparticles which comprise a pharmaceutical agent;
• b) blending the microparticles with particles of at least one first excipient to form a first powder blend;
• c) milling the first powder blend to form a milled blend;
• and
• d) blending the milled blend with particles of a second excipient, wherein the particles of second excipient are larger than the microparticles in the milled blend, to form a blended dry powder blend pharmaceutical formulation,
• wherein the blended dry powder blend pharmaceutical formulation from step (d) exhibits an increased respirable dose as compared to a respirable dose of the microparticles of step (a), the first powder blend of step (b), or the milled blend of step (c).

A dry powder pharmaceutical formulation for pulmonary or nasal administration comprising a blend of

• a milled blend of (i) microparticles which comprise a pharmaceutical agent, and (ii) excipient particles;
• and
• particles of a sugar or sugar alcohol, which particles are larger than the microparticles or excipient particles of the milled blend,
• wherein the blend exhibits an increased respirable dose as compared to a respirable dose of combinations of the microparticles, the excipient particles, and the particles of sugar or sugar alcohol, which combinations are not blend-of-milled-blend combinations.