Formulation and characterization of new layered diffusional matrices for zero-order sustained release.

Statistical designs were used to study the effect of certain matrix formulation variables on the vitro release of a model compound, pseudoephedrine hydrochloride, from layered diffusional matrices designed for zero-order sustained release. These matrices consist of non-swellable, hydrophobic middle layers containing the active drug to which hydrophilic and/or hydrophobic barrier layers are press-coated. In general, linear release profiles can be obtained by applying hydrophilic barrier layers on both faces of a hydrophobic matrix tablet, or by applying a hydrophilic barrier layer on one face and a hydrophobic barrier layer on the other face of the matrix tablet. However, formulation and matrix variables in the barrier layers need to be controlled in order to achieve zero-order drug release from a hydrophobic matrix tablet coated with hydrophobic barrier layers on both faces.