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RESEARCH PRODUCT

Polymorphism and solvates of flecainide base

subject

description

Flecainide base is pharmaceutically active substance used for production of flecainide acetate which is known in market as Tambacor, Almarytm, Apocard, Ecrinal or Flecaine. It is determined that flecainide base forms four polymorphic forms abbreviated as Ib, IIb, IIIb and IVb. Flecainide base form Ib is thermodynamically stable form at laboratory temperature while form IIIb is stable at higher temperatures. Flecainide form Ib absorbs water in its structure between layers and forms non-stoichiometric hydrate. Flecainide base binds with organic solvents and form monosolvates. Flecainide base form Ib crystallizes in orthorhombic crystals with lattice parameters a = 27.88 Å, b = 13.78 Å, c = 9.98 Å and two independent molecules in unit cell (Z' = 2; Z = 8). Molecule arrangement in flecainide base form Ib structure is not dense and it forms a channel-type structure, where molecules of water and alcohols are placed.