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Abstract

An oral pharmaceutical multi-particulate dosage form comprising at least two populations of particles, a first population of opioid agonist particles and a second population of opioid antagonist particles and a method for producing the dosage form are described. The opioid agonist particles provide an analgesically effective amount of opioid agonist and the opioid antagonist particles provide an amount of opioid antagonist effective to attenuate side effects associated with chronic dosing of the opioid agonist. The first population of opioid agonist particles and the second population of opioid antagonist particles are visually indistinguishable, thereby reducing the potential for drug abuse of the opioid agonist by separation of the two particle populations. In accordance with particular aspects of the invention, the opioid agonist particles and opioid antagonist particles are each provided with sustained release membrane coatings capable of releasing the opioid agonist and opioid antagonist at proportionate rates over a dosing interval. The dosing interval may be at least about 8 hours and preferably from about 12-24 hours. The dosage form in accordance with particular embodiments of the present invention may further comprise a non-opioid analgesic, preferably in the form of immediate release or sustained release particles.

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First Claim