Risk based in vitro performance assessment of extended release abuse deterrent formulations

International Journal of Pharmaceutics
Xiaoming XuMansoor A Khan

Abstract

High strength extended release opioid products, which are indispensable tools in the management of pain, are associated with serious risks of unintentional and potentially fatal overdose, as well as of misuse and abuse that might lead to addiction. The issue of drug abuse becomes increasingly prominent when the dosage forms can be readily manipulated to release a high amount of opioid or to extract the drug in certain products or solvents. One approach to deter opioid drug abuse is by providing novel abuse deterrent formulations (ADF), with properties that may be viewed as barriers to abuse of the product. However, unlike regular extended release formulations, assessment of ADF technologies are challenging, in part due to the great variety of formulation designs available to achieve deterrence of abuse by oral, parenteral, nasal and respiratory routes. With limited prior history or literature information, and lack of compendial standards, evaluation and regulatory approval of these novel drug products become increasingly difficult. The present article describes a risk-based standardized in-vitro approach that can be utilized in general evaluation of abuse deterrent features for all ADF products.

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Citations

Jun 14, 2016·International Journal of Pharmaceutics·Julien Maincent, Feng Zhang
Aug 23, 2016·Expert Opinion on Drug Delivery·David BoelsCaroline Victorri-Vigneau
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Jun 23, 2019·AAPS PharmSciTech·Xiaoming XuMuhammad Ashraf
Mar 7, 2020·AAPS PharmSciTech·Sogra F Barakh AliZiyaur Rahman
Jan 4, 2020·AAPS PharmSciTech·Xin FengMuhammad Ashraf

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