HIGHLY LOADED AMORPHOUS EFAVIRENZ COMPOSITION AND PROCESS FOR PREPARING THE SAME

摘要

A stable and high loading ternary solid dispersion composition comprising (a) about 50% wt. to about 90% wt. of amorphous Efavirenz; (b) about 10% wt. to about 50% wt. of polyvinyl pyrrolidone (PVP), a first polymer; (c) about 1 % wt. to about 30% wt. of a water-soluble second polymer; and (d) optionally about 0.1% wt. to about 50% wt. of at least one pharmaceutically acceptable excipient. Also disclosed is a high loading ternary composition comprising (a) a solid dispersion composition comprising (i) about 50% wt. to about 90% wt. of amorphous Efavirenz; (ii) about 10% wt. to about 50% wt. of polyvinyl pyrrolidone, a first polymer; (b) about 1 % wt. to about 30% wt. of a water-soluble second polymer blended with the solid dispersion composition and (c) optionally about 0.1 % wt. to about 50% wt. of at least one pharmaceutically acceptable excipient. Additionally disclosed is a method for preparing solid dosage forms comprising (i) amorphous Efavirenz and (ii) polyvinyl pyrrolidone (PVP), a first polymer; (iii) a water-soluble second polymer; and (iv) optionally, at least one pharmaceutical excipient.