To provide a method for preparing microparticles, for accurate and reliable scaling from a laboratory to a commercial batch size while achieving an appropriately narrowed size distribution of the microparticles containing biologically or pharmaceutically active agents.
The method for preparing microparticles comprises as follows. A first phase is prepared, comprising a solution which contains a biodegradable polymeric encapsulating binder, a biological active agent, and a blend of mutually miscible organic solvents having low water solubility and which is free of halogenated hydrocarbons. A second phase is prepared, comprising an aqueous solution of a hydrophilic colloid or a surfactant. The first phase and the second phase are combined in a static mixer to form an emulsion in which the first phase gives a discontinuous phase and the second phase gives a continuous phase. The discontinuous first phase is isolated in the form of microparticles, and a residual solvent is extracted from the microparticles by using a quenching solution.
| WO/2003/026615 | MODIFIED RELEASE DOSAGE FORMS |
| JP6191883 | Controlled release tablet |
| WO/1995/003033 | OSMOTIC DEVICES HAVING VAPOR-PERMEABLE COATINGS |
HERBERT PAUL F
STROBEL JAN
ATKINS THOMAS J
HAZRATI AZAR M
| JPH04505454A | 1992-09-24 | |||
| JPH06506926A | 1994-08-04 | |||
| JPS51111866A | 1976-10-02 |
Takuji Yamada
Kenichi Morizumi
Yasuo Shibata