Pharmaceutical compositions of semi-ordered drugs and polymers

1. A process for forming a pharmaceutical composition, comprising the steps:

(a) forming an amorphous dispersion comprising a low-solubility drug and a concentration-enhancing polymer;

(b) treating said amorphous dispersion to increase the mobility of said drug in said amorphous dispersion by at least one of (1) heating said dispersion and (2) exposing said dispersion to a mobility-enhancing agent; and

(c) converting at least 20 wt % of said low-solubility drug to a semi-ordered state.

2. The process of claim 1 wherein step (b) comprises both heating said dispersion and exposing said dispersion to said mobility-enhancing agent.

3. The process of claim 1 wherein said mobility-enhancing agent is a vapor.

4. The process of claim 1 wherein said mobility-enhancing agent is selected from the group consisting of water, acetone, ethyl acetate, methanol, ethanol, propanol, butanol, methyl ethyl ketone, methyl isobutyl ketone, acetonitrile, tetrahydrofuran, methylene chloride, toluene, 1,1,1-trichloroethane and or mixtures thereof.

5. The process of claim 1 wherein step (b) comprises heating said dispersion to a temperature T such the T g /T is less than or equal to about 1.0, wherein T g is the glass transition temperature of said solid amorphous dispersion in the presence of said mobility-enhancing agent, and T and T g are measured in Kelvin.

6. The process of claim 1 wherein step (c) is conducted to as to achieve a maximum rate of conversion of said low-solubility drug to said semi-ordered state of at least 0.25 wt % per hour.

7. The process of claim 6 wherein said maximum rate of conversion is at least 1.7 wt % per hour.

8. The process of claim 1 wherein at least 40 wt % of said low-solubility drug is converted to said semi-ordered state within 48 hours.