Solid controlled-release pharmaceutical compositions prepared by means of a thermoforming process

摘要

Controlled release solid pharmaceutical compositions containing an active material and one or more polymethacrylates. The compositions are prepared by thermoforming a mixture of the active material and the polymethacrylate(s), the release properties being determined by the nature of the polymethacrylate(s), their relative amounts, and the technique used to make the compositions. Preferably the polymethacrylate(s) are Eudragit (RTM) RL and/or RS, optionally with Eudragit E. The ingredients are mixed and then thermoformed at 60 - 150 degrees C, preferably 80 - 130 degrees C by an extrusion or injection process. The use of a co-extrusion or co-injection procedure, in which the inner and outer layers have different compositions is particularly preferred. Additional components that may be incorporated include antioxidants, flavors, colors, preservatives, sweeteners, and anti-adherents.