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US 2011/0086104 A1Published application
Residual solvent extraction method and microparticles produced thereby
AssigneeAlkermes, Inc.
InventorsMichael E. Rickey, J. Michael Ramstack, Rajesh Kumar
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Abstract
Methods for preparing microparticles having reduced residual solvent levels. Microparticles are contacted with a non-aqueous washing system to reduce the level of residual solvent in the microparticles. Preferred non-aqueous washing systems include 100% ethanol and a blend of ethanol and heptane. A solvent blend of a hardening solvent and a washing solvent can be used to harden and wash microparticles in a single step, thereby eliminating the need for a post-hardening wash step.
Claims12
A method for preparing microparticles, comprising:
- preparing a first phase comprising an active agent;
- a biodegradable, biocompatible polymer;
- and a solvent;
- preparing a continuous second phase with which the first phase is substantially immiscible;
- combining the first phase and the second phase to form an emulsion;
- extracting the solvent from the emulsion with an extraction medium, to form microparticles containing the active agent;
- and
- washing the microparticles with a non-aqueous washing system comprising ethanol to thereby reduce the level of residual solvent.
5 more elements
Dependencies are inferred from the claim text.