CONTROLLED RELEASE FORMULATION FOR WATER SOLUBLE DRUGS

摘要

A once-a-day controlled release diltiazem formulation comprises: (a) 20-50 wt.% of enteric polymeric membrane coated pellets comprising a polymer membrane coated core which comprises a biologically inert core which is coat ed with a first layer consisting essentially of diltiazem and polymeric binder; and a second layer which comprises a membrane comprising a pH dependent polymeric material; and (b) 50-80 wt.% of delayed pulse polymeric membrane coated pellets comprising a polymeric membrane coated core comprising a biologically inert core which is coated with a first layer which consists essentially of diltaziem a nd a polymeric binder and a second layer which comprises a polymeric membrane and an alkaline earth metal stearate which will substantially maintain its integrity in the varying pH conditions of the gastrointestinal tract but is permeable to diltiazem, and (c) a unit dose containment system.