Patent ID: 8476291

Claim:
A method of administering an active pharmaceutical comprising: providing a drug substance consisting of an organic acid salt of an opioid as said active pharmaceutical wherein said drug substance does not have a wt % released at 30 minutes in 0.1 N hydrochloric acid in USP water comprising 20% USP ethanol which is higher than in 0.1 N hydrochloric acid in USP water without ethanol forming a drug product comprising said drug substance suitable for achieving a therapeutic dose of said drug substance in a predetermined time wherein when administered said therapeutic dose is not exceeded by ingestion of alcohol at biological pH; wherein said drug substance is selected from the group consisting of: amorphous oxycodone pamoate characterized by a method selected from the group consisting of: a differential scanning calorimetery thermogram of FIG. 1 ; an FTIR of FIG. 2 ; and an X-ray diffraction diffractogram of FIG. 3 ; polymorphic oxycodone pamoate characterized by a method selected from the group consisting of: a differential scanning calorimetery thermogram of FIG. 4 ; an FTIR of FIG. 5 ; and an X-ray diffraction diffractogram of FIG. 6 ; polymorphic oxycodone pamoate characterized by a method selected from the group consisting of: a differential scanning calorimetery thermogram of FIG. 98 ; an FTIR of FIG. 99 ; and an X-ray diffraction diffractogram of FIG. 100 ; hydrocodone xinafoate characterized by a method selected from the group consisting of: a differential scanning calorimetery thermogram of FIG. 16 ; an FTIR of FIG. 17 ; and an X-ray diffraction diffractogram of FIG. 18 ; and amorphous hydromorphone pamoate characterized by a method selected from the group consisting of: a differential scanning calorimetery thermogram of FIG. 19 ; an FTIR of FIG. 20 ; and an X-ray diffraction diffractogram of FIG. 21 .