Overdose protection and abuse deterrent immediate release drug formulation

A solid oral immediate release multi-particulate dosage form with abuse deterrent and enhanced overdose protection properties comprising:

• a first population of crush resistant Active Particulates comprising a therapeutically effective amount of an opioid embedded in a polymer matrix, and an acid labile functional coat comprising two functional coat layers over the polymer matrix;
• wherein the two functional coat layers comprise functional coat layer 1 and functional coat layer 2, and
• wherein functional coat layer 2 surrounds functional coat layer 1;
• wherein functional coat layer 1 comprises a nonionic rate-controlling polymer insoluble in physiological fluids and/or organic solvents, and at least one cationic polymer, in a ratio of 80:20, and functional coat layer 2 comprises at least one cationic polymer and, optionally, a nonionic rate-controlling polymer;
• and
• a second population of Triggering Particulates comprising an alkaline agent;
• wherein the enhanced overdose protection properties comprise resistance to release of the opioid from the dosage form when three or more units of the dosage form are consumed intact, such that less than about 50% of the opioid is released at 30 minutes;
• and
• wherein the presence of functional coat layer 2 further enhances the resistance to release of the opioid from the dosage form provided by functional coat layer 1.

A solid oral immediate release multi-particulate dosage form with abuse deterrent and enhanced overdose protection properties comprising:

• a first population of crush resistant Active Particulates comprising a therapeutically effective amount of an opioid embedded in a polymer matrix, and an acid labile functional coat comprising two functional coat layers over the polymer matrix;
• wherein the two functional coat layers comprise functional coat layer 1 and functional coat layer 2, and wherein functional coat layer 2 surrounds functional coat layer 1;
• wherein functional coat layer 1 comprises a nonionic rate-controlling polymer insoluble in physiological fluids and/or organic solvents, and at least one cationic polymer, in a ratio of 80:20, and functional coat layer 2 comprises at least one cationic polymer and, optionally, a nonionic rate-controlling polymer;
• and
• a second population of Triggering Particulates comprising an alkaline agent;
• and
• wherein the enhanced overdose protection properties comprise resistance to release of the opioid when three or more units of the dosage form are subjected to dissolution in a medium at pH 1.6 for 30 minutes, such that less than about 50% of the opioid is released at 30 minutes.