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Abuse-Deterrent Opioid Formulations: Pharmacokinetic and Pharmacodynamic Considerations

: Walter, C.; Knothe, C.; Lötsch, J.


Clinical pharmacokinetics 55 (2016), Nr.7, S.751-767
ISSN: 0312-5963
ISSN: 1179-1926
Fraunhofer IME ()

Abuse-deterrent formulations (ADFs) are technologically sophisticated pharmaceutical formulations that impede manipulation and extraction of opioids and/or provoke unpleasant effects when they are taken in excessive quantity. This is implemented by creating physical barriers, inseparably combining the opioid with an opioid antagonist or adding aversive agents to the formulation. These pharmaceutical changes may potentially alter the pharmacokinetics and consequently the pharmacodynamics of the opioid. In this review, comparative evidence on pharmacokinetic differences between abuse-deterrent and classical formulations of the same opioids is summarized; furthermore, pharmacodynamic differences, with a focus on analgesia and abuse-related symptoms, are addressed. Most of the 12 studies comparing opioid pharmacokinetics have judged the physically intact ADF as being bioequivalent to the corresponding classical formulation.