EP2533766A2 — Pharmaceutical mini-tablets for sustained release of flecainide acetate

USPTO Abstract

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.