COMPOSITION AND PROCESS FOR PREPARING NOVEL MATRIX TABLETS WITH MODIFIED RELEASE AND PROLONGED ACTION WITH AMIODARONE CHLOROHYDRATE

摘要

The invention relates to a compressed tablet with modified release and prolonged action, containing amiodarone chlorohydrate, meant to be used in the treatment of severe symptomatic arrhythmia and to a process for preparing the same. According to the invention, the tablet consists of 33.33% amiodarone, 40...60% matrix-forming agent of hydrophilic polymer type, 2...22% microcrystalline cellulose, 0.5% magnesium stearate, 3...7% chitosan, 1% colloidal silicon dioxide. The process, as claimed by the invention, consists in mixing the active substance with the hydrophilic polymer and chitosan, for 5 min, at a speed of 400 rpm, after which the other excipients are added, the resulting homogeneous powder mixture being then screened for granulometric uniformization and further compressed at a compression force of 8...10 kN, to result in tablets with improved release and with the active substance action during 24 h.