Misuse preventative, controlled release formulation

Abstract

Disclosed is a misuse preventative, controlled release formulation comprising a core comprising a superabsorbent material (for example, polycarbophil), a controlled release coat surrounding the core, and a plurality of controlled release microparticles having a pharmaceutically active agent (for example, an opioid analgesic) disposed within the core, the coat, or both the core and the coat. When crushed, either intentionally or accidentally, and exposed to an aqueous medium, the superabsorbent material present in the core swells to encapsulate the microparticles, which remain substantially intact thereby retarding the release of the pharmaceutically active agent from the formulation. Also disclosed is a method of using the misuse preventative, controlled release formulation to deliver a pharmaceutically active agent to a mammal, for example, a human, in need thereof.

1 . A controlled release formulation, comprising:
 (a) a core comprising a superabsorbent material;   (b) a controlled release coat surrounding the core; and   (c) a plurality of controlled release microparticles having a pharmaceutically active agent disposed therein,   wherein the microparticles are disposed within the core, the coat, or both the core and the coat, and wherein the formulation
 (i) when intact and exposed to an aqueous environment, the pharmaceutically active agent is released from the formulation over a prolonged period of time, and 
 (ii) when crushed to break the controlled release coat and expose the core, and exposed to an aqueous environment, the superabsorbent material swells to create a hard gel that traps the microparticles, and the microparticles provide controlled release of the pharmaceutically active agent. 
   
     
     
         2 - 51 . (canceled)