Emerging trends in Abuse-Deterrent Formulations: Technological insights and Regulatory considerations

Abstract

Background: Opioid medications are an integral part in the management of acute and chronic severe pain. However, non-medical practice of these prescription drug products is emerging as a serious public health problem. To control this opioid epidemic, USFDA is encouraging pharmaceutical companies to develop Abuse Deterrent Formulations (ADFs). Abuse Deterrent Formulations are much more difficult to manipulate and abuse when compared to their conventional formulations. This feature of ADFs is due to their ability to incumber extraction of active ingredients, to prevent administration through alternative routes and making abuse of altered product less rewarding. Objective: The main objective of this review is to abridge different ADFs and various laboratory-based in vitro manipulation and extraction studies, demonstrating that these approved ADFs have capabilities to deter abuse. Methods: The method includes collection of data from different search engines like PubMed, FDA guidance documents, ScienceDirect, Google Patents to get coverage of literature in order to get appropriate information regarding ADFs. Results: Various in vitro studies demonstrate that ADFs are effective in minimizing opioid drug abuse including opioid overdose. However, real impact of these ADFs on reducing the drug abuse can be concluded only after receiving the post marketing data. Conclusion: ADFs are embracing fundamentally different paradigm in management of severe pain. We believe that development of abuse deterrent technologies would shift the architype, deterring multipill abuse and can prove as a breakthrough strategy in controlling this opioid epidemic menace.