Title:Emerging Trends in Abuse-Deterrent Formulations: Technological Insights
and Regulatory Considerations
Volume: 19
Issue: 8
Author(s): Dhwani Rana, Sagar Salave and Derajram Benival*
Affiliation:
- Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, Ahmedabad
(NIPER-A), Gujarat 382355, India
Keywords:
Abuse deterrent formulations, multipill abuse, opioid, pain management, controlled release, Regulatory considerations.
Abstract:
Background: Opioid medications are an integral part of 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). ADF's 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, 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 the capabilities to deter abuse.
Methods: The method includes the 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 paradigms in the management of severe
pain. We believe that the 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.