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US 2012/0258914 A1Published application
Coacervation process
AssigneeAlkermes, Inc.
InventorsRajesh Kumar, Gregory Troiano, J. Michael Ramstack, Paul Herbert, Michael Figa
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Abstract
Methods of forming compositions for the sustained release of water soluble active agents, including biologically active polypeptides and products produced by the process are described. Improved product characteristics and ease of scale-up can be achieved using a novel coacervation process wherein at least one coacervation agent is added to the mixture comprising the active agent and the polymer in at least two distinct stages.
Claims20
A method for preparing microparticles comprising
- (a) providing a first phase comprising an active agent, a biocompatible polymer, and a solvent;
- (b) forming a coacervate;
- and
- (c) combining the coacervate with a quench liquid, thereby forming microparticles containing the active agent;
- wherein step (b) comprises
- (i) adding a first coacervation agent through a first inlet to the first phase;
- and subsequently
- (ii) adding a second coacervation agent through a second inlet.
5 more elements
A method for preparing microparticles comprising
- (a) providing a first phase comprising exendin-4, poly(lactide-co-glycolide), and a solvent;
- (b) forming a coacervate;
- and
- (c) combining the coacervate with a quench liquid, thereby forming microparticles containing the exendin-4;
- wherein step (b) comprises
- (i) adding silicone oil through a first inlet of a continuous flow mixing apparatus to the first phase;
- and subsequently
- (ii) adding silicone oil through a second inlet of the continuous flow mixing apparatus.
5 more elements
Dependencies are inferred from the claim text.