Abstract: The apparatus and methods of the present invention are of use for the production of emulsion-based microparticles containing a biological or chemical agent. In particular, the apparatus provides a vessel; packing material situated inside such vessel and may further provide material capable of insertion into both ends of said vessel for enclosure of the packing material. In a particular embodiment, the apparatus is a packed bed apparatus. The methods include production of emulsion based microparticles containing a biological or chemical agent. The usefulness of the present invention is that the apparatus and methods of the present invention provide for a low-shear, non-turbulent, production of emulsion-based microparticles that provides a narrow, reproducible, particle size distribution, capable of use with both large and small volumes that is capable of being conveniently scaled up while providing predictable emulsion properties.

Abstract: The methods disclosed herein are of use for the production of controlled release compositions. In particular, the methods provide the contacting of an organic phase containing a bioactive agent and a polymer with an aqueous phase containing an organic ion to create controlled release compositions containing bioactive agents. The present invention also includes controlled release compositions including a polymer, an organic ion and a bioactive agent. The present invention also includes methods of using such controlled release compositions. The usefulness of the present invention is that the methods result in the production of controlled release compositions containing bioactive agent capable of administration in a concentrated low-dose form, having low burst and reduced production of degraded bioactive agent.