ARROYO HIDALGO SERGIO,RIZO MARTINEZ JOSE MIGUEL,CASTILLA TERESA,ARROYO HIDALGO Sergio,RIZO MARTINEZ Jose Miguel,CASTILLA Teresa
申请号：
SI201030262
公开号：
SI2533766T1
申请日:
2010.12.29
申请国别(地区):
SI
年份:
2013
代理人:
摘要：
The invention relates to a pharmaceutical mini-tablet for sustained release of flecainide acetate which exhibits a different sustained profile, comprising a core including flecainide acetate, microcrystalline cellulose, and a disintegrant, and an outer cover layer including a pH-dependent release polymer and excipients. Also relates to a process for the preparation of said mini-tablet which comprises a) blending flecainide acetate with microcrystalline cellulose and disintegrant to obtain a blended mixture； b) granulating the blended mixture with an aqueous solution of a binder； c) drying the obtained granulate； d) lubricating, when present, the dried granules and compressing it to obtain the core； and e) preparing an aqueous dispersion which comprises the pH-dependent polymer with excipients and coating the core to obtain the outer cover layer. Thus, it provides an efficacious sustained release of flecainide acetate in a pharmaceutical form for oral administration in the treatment of cardiac arrhythmias.
