Title:Application of Hot Melt Extrusion Technology in the Development of Abuse-Deterrent Formulations: An Overview
VOLUME: 18 ISSUE: 1
Author(s):Arun Butreddy, Dinesh Nyavanandi, Sagar Narala, Fischer Austin and Suresh Bandari*
Affiliation:Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, Oxford, MS 38677, Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, Oxford, MS 38677, Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, Oxford, MS 38677, Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, Oxford, MS 38677, Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, Oxford, MS 38677
Keywords:Hot melt extrusion, abuse, opioids, manipulation, abuse deterrent formulations, polymer.
Abstract:The misuse, abuse, and illicit use of prescription opioid analgesics is a global public health
concern. However, there are many viable therapeutic options for the treatment of patients with chronic
pain. Both intact and manipulated opioid drug products are abused by various routes such as oral, nasal,
and injection, which may lead to overdose, drug addiction, and even death. To combat the abuse of these
medications, regulatory agencies and pharmaceutical companies are switching their interest towards
developing Abuse Deterrent Formulations (ADFs), with the intent to deter the abuse of opioid products
to a maximum extent. There are several manufacturing strategies implemented in an attempt to develop
ADFs. An example includes matrix tablets of high molecular weight polymers such as polyethylene
oxide. The scalable and continuous manufacturing techniques, such as Hot-Melt Extrusion (HME), is
increasingly accepted by pharmaceutical companies to advance the development and manufacturing of
ADFs. The application of the HME technique in the development of ADFs may overcome the challenges
of opioid analgesic formulation development and provide improved protection against misuse and abuse,
while also ensuring access to safe and effective use in patients with chronic pain. This review deals with
a brief overview of strategies, with emphasis on HME to deter opioid abuse, in vitro characterization
methods, commonly used excipients in the development of ADFs, and regulatory standards to meet the
requirements of ADFs.
