Patent ID: 6224910
Filing Date: 2001-05-01
Classification: A61K,A61P

Abstract:
A process for the preparation of a high drug load enteric-coated pharmaceutical composition comprising the steps of:(a) preparing a dry blend comprising a medicament, a binder, and a disintegrant, and setting a portion of said dry blend aside;(b) forming a wet mass from the remainder of said dry blend not set aside in step (a);(c) extruding said wet mass to form an extrudate and spheronizing said extrudate into high-potency beadlets by dusting said wet mass extrudate with said portion of said dry blend set aside in step (a);(d) coating said beadlets with an enteric coating polymer and plasticizer in an aqueous media; and(e) blending said coated beadlets with an anti-adherent,wherein the process further comprising the step of separating said spheronized high potency beadlets formed in step c into 10/18 mesh sized beadlets prior to said coating step (d).