High-dose compressible dosage forms manufactured by simultaneous melt-coating and melt-granulation of active pharmaceutical ingredients

An oral pharmaceutical dosage form comprising granulates of a poorly soluble API, wherein the dosage form has a total API content of at least 60 wt %, at least 70 wt %, at least 80 wt %, or at least 90 wt % and a surfactant content of less than or equal to 10 wt %, based on the total weight of the dosage form;

• and wherein the API granulates are capable of being compressed into tablets at a compaction pressure greater than or equal to a pressure selected from 300 psi, 400 psi, 500 psi, 600 psi, 1000 psi, and 1800 psi.

A sustained release oral pharmaceutical dosage form comprising pure API granulates, wherein the dosage form:

• (i) has a total API content of at least 95 wt % based on the total weight of the dosage form;
• (ii) comprises about 200 mg to about 800 mg total API;
• and (iii) has an average breaking force of at least 50 N.

An immediate release darunavir-containing oral pharmaceutical dosage form comprising granulates comprising darunavir and surfactant, wherein the dosage form has a darunavir content of at least 75 wt % and a surfactant content of less than or equal to 10 wt %, based on the total weight of the dosage form;

• and wherein the granulates are capable of being compressed into tablets at a compaction pressure of greater than 300 psi, greater than 400 psi, greater than 500 psi, greater than 600 psi, greater than 1000 psi, or greater than 1800 psi.