Patent ID: 8916587
Filing Date: 2014-12-23
Classification: A61K,A61P

Abstract:
1. A method for mitigating dose dumping comprising: administering a drug product comprising at least one drug substance selected from the group consisting of: amorphous racemic-methylphenidate pamoate with a differential scanning calorimetry thermogram exhibiting endothermic phase change of at least 70 J/gram is observed at greater than 200° C.; amorphous racemic-methylphenidate pamoate with a PXRD diffractogram of polymorphic racemic-methylphenidate pamoate with a differential scanning calorimetry thermogram exhibiting endothermic phase change of at least 75 J/gram is observed at greater than 200° C.; polymorphic racemic-methylphenidate pamoate with a PXRD diffractogram of polymorphic racemic-methylphenidate xinafoate with a differential scanning calorimetry thermogram exhibiting endothermic phase change of at least 75 J/gram at greater than 155° C.; polymorphic racemic-methylphenidate xinafoate with a PXRD diffractogram of polymorphic d-methylphenidate pamoate with an endothermic phase change of at least 35 J/gram at greater than 185° C.; polymorphic d-methylphenidate pamoate with a PXRD diffractogram of amorphous dextro-amphetamine pamoate with an endothermic phase change of at least 10 J/gram at greater than 200° C. and an endothermic phase change of at least 75 J/gram at greater than 220° C.; amorphous dextro-amphetamine pamoate with a PXRD diffractogram of polymorphic dextro-amphetamine pamoate has an endothermic phase change of at least 60 J/gram at greater than 200° C.; and polymorphic dextro-amphetamine pamoate with a PXRD diffractogram of wherein said drug substance meets at least one condition in 0.1 N HCl selected from the group consisting of: no more than 35% of said pharmaceutically active compound is released at 30 minutes with 5 wt % ethanol in said 0.1 N HCl; the percentage of said active pharmaceutically active compound released with at least 5 wt % ethanol in said 0.1 N HCl is no more than a percentage of said active pharmaceutically active compound released in said 0.1 N HCl without ethanol; and the percentage of pharmaceutically active compound released with 40 wt % ethanol in 0.1 N HCl does not exceed 60% while the percentage of pharmaceutically active compound released under the conditions selected from water, 0.1 N HCl, 5 wt % ethanol in 0.1 N HCl and 20 wt % ethanol in 0.1 N HCl does not exceed the pharmaceutically active compound released with 40 wt % ethanol in 0.1 N HCl.