COMPOSITION AND PROCESS FOR PREPARING NOVEL MATRIX TABLETS WITH MODIFIED RELEASE AND PROLONGED ACTION WITH AMIODARONE CHLOROHYDRATE, COMPLEXED WITH HYDROXY-PROPYL- Β-CYCLODEXTRIN

摘要

The invention relates to a compressed tablet with modified release and prolonged action, containing complexed amiodarone chlorohydrate, meant to be used in the treatment of symptomatic arrhythmia and to a process for preparing the same. According to the invention, the tablet consists of 33.3% inclusion complex of amiodarone and hydroxy-propyl- β-cyclodextrin in a molar ratio of 1:1, 40% matrix-forming agent of hydrophilic polymer type, 2...22% microcrystalline cellulose, 0.5% magnesium stearate, 3% chitosan and 1% colloidal silicon dioxide. The process, as claimed by the invention, consists in mixing the components in a usual mixer, for 5 min, at a rotation speed of 400 rpm, after which the mixture is screened through an electromagnetic screen and is subjected to direct compression at a compression force of 8...10 kN, to result in hydrophilic matrix tablets with sustained and prolonged release of the active substance for at least 24 h.