Immediate release tablet of dofetilide

A process for manufacturing an immediate release tablet containing dofetilide or pharmaceutically acceptable salt thereof, microcrystalline cellulose, croscarmellose sodium, silicon dioxide, and magnesium stearate comprising:

• a) sifting of dofetilide or pharmaceutically acceptable salt thereof, microcrystalline cellulose, croscarmellose sodium, silicon dioxide, and magnesium stearate;
• b) dividing microcrystalline cellulose into two equal parts, part 1 and part 2;
• c) adding approximately half of the part 1 microcrystalline cellulose to the dofetilide or a pharmaceutically acceptable salt thereof and then adding the remaining half of the part 1 microcrystalline cellulose to a suitable blender;
• d) mixing the step c) blend (for example, for 10 minutes at 15 rpm (e.g., for 150 tumbles);
• e) sifting the step d) blend through a 40# sieve;
• f) co-sifting of the part 2 microcrystalline cellulose, croscarmellose sodium and silicon dioxide through a 40# sieve;
• g) adding half of the step f) blend to the sifted step e) blend and then adding the remaining half of the step f) blend to a suitable blender;
• h) mixing of the step g) blend in a suitable blender (e.g., for 30 minutes at 15 rpm (e.g., for 450 tumbles));
• i) lubricating the step h) blend with magnesium stearate;
• j) compressing the lubricated blend to form a tablet (for example, using suitable punches such as round/capsule/oval shaped punches and optionally with a score line for dose adjustment);
• and
• k) optionally coating the tablet, wherein the coating comprises a functional or non-functional coating.

A process for manufacturing a dofetilide immediate release tablet comprises:

• a) dry mixing dofetilide or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients;
• b) dissolving (e.g., with stirring until a clear solution is obtained) one or more binders in an aqueous solvent or non-aqueous solvent or mixture thereof (e.g., a mixture of water and isopropanol (IPA)) to form a binder solution;
• c) granulating the blend of step a) with the binder solution of step b);
• d) drying the granulation product of step c);
• and subsequently classify the granules;
• e) lubricating the granules of step d);
• f) compressing the mixture of step e) into tablet (e.g., using round/capsule/oval shaped punches and optionally with a score line for dose adjustment).