Formulations of enzalutamide
This disclosure provides formulations of enzalutamide and their use for treating hyperproliferative disorders.
1. A pharmaceutical composition comprising a solid dispersion consisting essentially of amorphous enzalutamide and hydroxypropyl methylcellulose acetate succinate.
2. The pharmaceutical composition according to claim 1 , wherein the solid dispersion is a spray-dried dispersion.
3. A pharmaceutical composition comprising a solid dispersion consisting essentially of amorphous enzalutamide and hydroxypropyl methylcellulose acetate succinate, wherein the solid dispersion is a spray-dried dispersion, and wherein the amorphous enzalutamide remains amorphous following storage of the spray-dried dispersion at 40° C. and 75% relative humidity for 1 month.
4. A tablet comprising the pharmaceutical composition according to claim 2 .
5. The tablet according to claim 4 , wherein the amount of amorphous enzalutamide is 80 mg.
6. The tablet according to claim 4 further comprising croscarmellose sodium and magnesium stearate.
7. A tablet comprising a pharmaceutical composition comprising:
a solid dispersion consisting essentially of amorphous enzalutamide and hydroxypropyl methylcellulose acetate succinate, wherein the solid dispersion is a spray-dried dispersion,; and
croscarmellose sodium and magnesium stearate, wherein the croscarmellose sodium is 6% to 10% of the total tablet weight.