Solid dosage formulations of an orexin receptor antagonist
The present invention is directed to a pharmaceutical composition comprising the compound suvorexant, or a pharmaceutically acceptable salt thereof, a concentration-enhancing polymer, and optionally a pharmaceutically acceptable surfactant.
1. A pharmaceutical composition comprising:
suvorexant in an amorphous form; and
a polymer selected from the group consisting of a polyvinylpyrrolidinone-polyvinyl acetate copolymer, a polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer, and hydroxypropyl methyl cellulose acetate succinate;
wherein the pharmaceutical composition comprises 5 mg, 10 mg, 15 mg or 20 mg of suvorexant, and wherein the suvorexant is present in a form that contains at least 90 weight % of the amorphous form of suvorexant relative to other morphological forms of suvorexant.
2. The pharmaceutical composition of claim 1 , wherein the polymer is a polyvinylpyrrolidinone-polyvinyl acetate copolymer.
3. The pharmaceutical composition of claim 1 , wherein the polymer is polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymers.
4. The pharmaceutical composition of claim 1 , wherein the polymer is hydroxypropyl methyl cellulose acetate succinate.
5. The pharmaceutical composition of claim 2 , further comprising silicon dioxide.
6. The pharmaceutical composition of claim 3 , further comprising silicon dioxide.
7. The pharmaceutical composition of claim 4 , further comprising silicon dioxide.
8. The pharmaceutical composition of claim 1 , wherein said composition is prepared by spray drying a composition comprising the suvorexant and the concentration-enhancing polymer.
9. The pharmaceutical composition of claim 1 , wherein said composition is prepared by hot melt extrusion of a composition comprising the suvorexant and the concentration-enhancing polymer.