A MULTIPARTICULATE MODIFIED RELEASE COMPOSITION

摘要

THE INVENTION RELATES TO A MULTIPARTICULATE MODIFIED RELEASE COMPOSITION THAT IN OPERATION DELIVERS AN ACTIVE INGREDIENT IN A PULSED OR BIMODAL MANNER. THE MULTIPARTICULATE MODIFIED RELEASE COMPOSITION COMPRISES AN IMMEDIATE RELEASE COMPONENT AND A MODIFIED RELEASE COMPONENT; THE IMMEDIATE RELEASE COMPONENT COMPRISING A FIRST POPULATION OF ACTIVE INGREDIENT CONTAINING PARTICLES AND THE MODIFIED RELEASE COMPONENT COMPRISING A SECOND POPULATION OF ACTIVE INGREDIENT CONTAINING PARTICLES COATED WITH A CONTROLLED RELEASE COATING; WHEREIN THE COMBINATION OF THE IMMEDIATE RELEASE AND MODIFIED RELEASE COMPONENTS IN OPERATION DELIVER THE ACTIVE INGREDIENT IN A PULSED OR A BIMODAL MANNER. THE INVENTION ALSO RELATES TO A SOLID ORAL DOSAGE FORM CONTAINING SUCH A MULTIPARTICULATE MODIFIED RELEASE COMPOSITION. THE PLASMA PROFILE ACHIEVED BY THE MULTIPARTICULATE MODIFIED RELEASE COMPOSITION IS ADVANTAGEOUS IN REDUCING PATIENT TOLERANCE TO THE ACTIVE INGREDIENT AND IN INCREASING PATIENT COMPLIANCE BY REDUCING DOSAGE FREQUENCY.