Baxter International Inc.

Baxter Healthcare Sa

Ed O'Connell

Larry Richard Brown

Uri Piran

John K McGeehan

Mark X Yang

Julia E Rashba-Step

Ramin Darvari

Adam Lambert

Junhong Zhang

Eugene Mehr

The present disclosure relates to compositions of methods of making and compositions small compositions of particles of an active agent. In accordance with the method of production, the active agent is dissolved in an aqueous or aqueous-miscible solvent containing a dissolved phase-separation enhancing agent (PSEA) to form a solution in a single liquid phase. The solution is subjected to a liquid-solid phase separation to cause the active agent to form small spherical particles that are substantially amorphous or non-crystalline and are injectable through fine bore needles at high concentrations. The particles exhibit the pharmacokinetic and pharmacodynamnic properties of the active agent. The disclosure has special application for higher molecular weight proteins such as antibodies.

Protein microspheres retaining pharmacokinetic and pharmacodynamic properties

A method for processing multi-phasic dispersions is provided. The method comprises providing a multi-phasic dispersion including dispersed and continuous phases, providing one or more non-solvents comprising an aqueous solution containing at least one multivalent cation, exposing the multi-phasic dispersion to the non-solvent to form a suspension containing one or more liquid phases and the solid microparticles, and removing at least a portion of the resulting one or more liquid phases while retaining at least the microparticles, thereby removing at least a portion of the non-volatile material from the microparticles.

Methods of processing compositions containing microparticles

Methods for processing microparticles involve providing a composition comprising a plurality of solid microparticles and at least one non-volatile material, providing a non-solvent, and exposing the composition to the non-solvent to remove at least a portion of the non-volatile material from the composition while retaining at least the microparticles.

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Brighton, MA, United States of America

Ed O'Connell