pH-independent immediate release polymethacrylate formulations--an observational study.

摘要: Using Eudragit® E PO (EudrE) as a polymethacrylate carrier, the aim of study was to develop pH-independent dosage form containing ibuprofen (IBP) an active compound via chemical modification polymer (i.e. quaternization amine function) or addition dicarboxylic acids (succinic, glutaric and adipic acid) create pH micro-environment during dissolution. Biconvex tablets (diameter: 10 mm; height: 5 mm) were produced hot melt extrusion injection molding. In vitro dissolution experiments revealed that minimum 25% sufficient partially (up 5) eliminate pH-dependent effect EudrE/IBP formulation. The did not alter IBP release in 1 3 medium dimethyl amino groups EudrE are already fully protonated, while solvent significantly improved (cf. from 0% 92% after h upon 20 wt.% succinic acid). Hence, both approaches resulted immediate However, presence positively charged induced stability issues (recrystallization API) formulations classified mechanically unstable. further research is needed obtain formulation using polmethacrylate carrier.