Processes for making particle-based pharmaceutical formulations for parenteral administration

A method for making a pharmaceutical formulation for parenteral administration, comprising the steps of:

• a) providing particles which comprise a pharmaceutical agent;
• and
• b) blending the particles of step a) with particles of a pre-processed excipient to form a dry powder 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,
• wherein the dry powder blend can be reconstituted in an aqueous vehicle suitable for parenteral administration.

A method for making a pharmaceutical formulation for parenteral administration, comprising the steps of:

• a) providing particles which comprise a pharmaceutical agent;
• b) blending the particles of pharmaceutical agent with particles of at least one excipient to form a first blend;
• and
• c) milling the first blend to form a milled blend which comprises microparticles or nanoparticles,
• wherein the milled blend exhibits a greater dispersibility or suspendability as compared to the particles of step a) or the first blend.

A parenteral dosage form of a pharmaceutical formulation comprising:

• a milled blend of
• microparticles or nanoparticles of a pharmaceutical agent which has a solubility in water of less than 10 mg/mL at 25° C. and
• particles of at least one excipient comprising at least one sugar, sugar alcohol, starch, amino acid, or combination thereof;
• a pharmaceutically acceptable liquid vehicle for injection in which the milled blend is dispersed;
• and
• wherein (i) the excipient particles are pre-processed to comprise a surfactant, or (ii) the liquid vehicle comprises an aqueous solution of a surfactant, or (iii) both (i) and (ii).