PANCREATIN MICROSPHERES SUITABLE FOR ENTERIC COATING.

摘要

A process for manufacturing pancreatin microglome nuclei, comprising the steps of: a. prepare an extrudable mixture comprising: i. 10% to 95% pancreatin; ii. 5% to 90% of at least one pharmaceutically acceptable binding agent; iii. from 0% to 10% of at least one pharmaceutically acceptable excipient; and iv. one or more organic solvents compatible with enzymes in an amount sufficient to form an extrudable mixture; in which the percentages of components are weight to weight of the pancreatin microglome nuclei and the constituents i.), ii.) and iii.) up to 100% by weight are added; b. extrude the extrudable mixture to create pancreatin microglome nuclei; C. forming pancreatin microglome nuclei in an approximately spherical or approximately ellipsoidal manner in the presence of an organic solvent compatible with additional enzymes; and d. separating the one or more enzyme compatible organic solvents from the pancreatin microglome nuclei such that the pancreatin microglome nuclei are substantially free of the one or more enzyme compatible organic solvents; in which the pancreatin microglome nuclei are substantially free of synthetic oils.