Mechanism of drug release from an acrylic polymer-wax matrix tablet.

An acrylic polymer-wax matrix system was evaluated for oral sustained-release tablets of diphenhydramine HCl. A desirable release profile of diphenhydramine was achieved by incorporating Eudragit L in a carnauba wax matrix. In this polymer-wax system, carnauba wax maintained the integrity of the matrix, whereas Eudragit L slowly eroded in the matrix as the drug was released. Thus, the area-to-volume ratio of the tablet remained constant over the duration of the drug release. In vitro drug release studies were conducted at physiological pHs that exist in the gastrointestinal tract. Drug release rates decreased as the polymer:drug ratio increased from 1:2 to 2:1. The drug release rate was faster in pH 7.5 phosphate buffer than in 0.1 N HCl solution. The drug release from these polymer-wax matrices is described by a combination diffusion/erosion mechanism. Based on the typical pH encountered in intestinal fluids, complete dissolution of the drug and polymer at pH 7.5 in 8-10 h would ensure good bioavailability of the drug following oral administration.