Immediate release tablet of dofetilide
The present invention encompasses immediate release tablets of dofetilide, methods of treatment with them, as well as a process for manufacturing the same.
1. An immediate release tablet formulation comprising:
a) dofetilide or a pharmaceutically acceptable salt thereof in an amount in the range of 0.05 to about 10% w/w;
b) a pharmaceutically acceptable diluent comprising microcrystalline cellulose in an amount ranging from about 5% to about 98% w/w;
c) a pharmaceutically acceptable disintegrant comprising croscarmellose sodium in an amount ranging from about 1% to about 20% w/w;
d) a glidant comprising colloidal silicon dioxide in an amount ranging from about 0.07% to about 3%; and/or a lubricant comprising magnesium stearate in an amount ranging from about 0.1% to about 3%; and
e) optionally a coating comprising a functional or non-functional coating, wherein the formulation releases at least 80 wt. % of the dofetilide or pharmaceutically acceptable salt thereof from the tablet within 15 minutes.
2. The tablet formulation according to claim 1 , wherein dofetilide or a pharmaceutically acceptable salt thereof is present in the range of 0.1 to 0.5% w/w of the tablet formulation.
3. The tablet formulation according to claim 1 , wherein dofetilide or a pharmaceutically acceptable salt thereof is present in the range of 0.1 mg to 0.5 mg.
4. The tablet formulation according to claim 1 , wherein the formulation further comprises at least one pharmaceutically acceptable binder in an amount ranges between 0.02-20% w/w, and optionally a coating.
5. The tablet formulation according to claim 1 , wherein the formulation is coated.
6. The tablet formulation according to claim 1 , wherein the tablet is used for treating arrhythmia in mammals.
7. The immediate release tablet formulation according to claim 1 , wherein said formulation is prepared by the method comprising direct compression, dry granulation, wet granulation, a fluidized technique or extrusion spheronization.
8. The tablet formulation according to claim 1 , wherein at least 85 wt. % of dofetilide or a pharmaceutically acceptable salt thereof in the tablet formulation is dissolved from the tablet within 15 minutes as measured according to USP Type I (basket) at 100 rpm in 900 mL of 0.001 M HCl.
9. An immediate release tablet formulation comprising
a) dofetilide or a pharmaceutically acceptable salt thereof in an amount in the range of 0.05 to about 10% w/w;
b) a pharmaceutically acceptable diluent comprising microcrystalline cellulose in an amount ranging from about 5% to about 98% w/w;
c) a pharmaceutically acceptable binder comprising povidone or/and HPMC in an amount ranging from about 0.02-30% w/w %;
d) a pharmaceutically acceptable disintegrant comprising croscarmellose sodium in an amount ranging from about 1% to about 20% w/w;
e) a pharmaceutically acceptable glidant comprising colloidal silicon dioxide in an amount ranging from about 0.07% to about 3% and/or a pharmaceutically acceptable lubricant comprising magnesium stearate in an amount ranging from about 0.1% to about 3%; and
f) optionally a coating comprising a functional or non-functional coating, wherein the formulation releases at least 80 wt. % of the dofetilide or pharmaceutically acceptable salt thereof from the tablet within 15 minutes.