Tamper resistant co-extruded dosage form containing an active agent and an adverse agent and process of making same

A co-extruded dosage form comprising a plurality of co-extruded multilayer extrudates, each extrudate comprising:

• an extruded core comprising a matrix of an adverse agent and a hydrophobic material, wherein the hydrophobic material is present in an amount of about 30 wt % to about 99 wt % of the extruded core;
• an extruded sheath comprising a hydrophobic material which surrounds at least a portion of the core, wherein the sheath is free of an adverse agent and free of an active agent, wherein the hydrophobic material is present in an amount of about 10 wt % to about 99 wt % of the extruded sheath;
• and
• an extruded shell comprising an active agent and a hydrophobic material which surrounds at least a portion of the sheath, wherein the hydrophobic material is present in an amount of about 1 wt % to about 80 wt % of the extruded shell, and wherein the shell has a thickness of about 0.05 mm to about 3 mm;
• wherein each extrudate is a portion of a multilayer extrudate sheet;
• and
• wherein the dosage form releases about 10% or less adverse agent over a 36 hour period when subjected to an in-vitro dissolution test using USP Basket Method at 100 rpm in 700 ml simulated gastric filled at pH 1.2 without enzyme at 37° C. for 1 hour followed by 900 ml simulated intestinal fluid at pH 7.5 without enzyme for the duration of the test.