| 摘要 |
A method for the preparation of homogenous microparticles containing a H+, K+ - ATP-ase inhibitor using a fluid-bed granulation technique is disclosed, wherein the method comprises: providing a granulation liquid medium having a solid content and comprising: (i) an acid labile H+, K+ - ATP-ase inhibitor, an alkaline salt thereof, or one of its single enantiomers, or an alkaline salt thereof; (ii) a polymer selected from the group consisting of a water soluble or water insoluble polymer, wherein the polymer is at least 5 % by weight based on the solid content; and (iii) a liquid in which the polymer is soluble or dispersible; spraying the liquid medium into a fluidized bed; and selecting out microparticles that have a desired size distribution, thereby obtaining dry, homogeneous microparticles, wherein at least 80 % by weight of the microparticles based on their dry weight content is the acid labile H+, K+ - ATP-ase inhibitor.
|
