Biopharmaceutics

Biography

Biography: Alex Nivorozhkin

Abstract

Abuse of opioids and other prescription controlled substances is a recognized nation-wide problem in United States and around the globe. Emerging FDA guidelines are setting up the ground rules for related evaluation and product labeling. As these documents point out, science of abuse deterrence is relatively new, and both the formulation technologies and the analytical, clinical, and statistical methods for evaluating those technologies are rapidly evolving. This presentation will focus on the overview of the existing and novel formulation approaches to enable tamper-resistant properties to include approaches involving physical/chemical barriers, agonist/antagonist combinations, aversion, delivery, and prodrug. Neither of the approaches can provide absolute protection and eliminate all the illicit options. So the question is, if there are clear pathways is assessing suitability of an appropriate technology for a given drug candidate or product and evaluating their readiness to be deployed. Up to date only a handful of tamper-resistant technological solution advanced far enough to be implemented into the market product. This number will certainly increase in near future as nascent and established tamper-resistant formulations will be further tested in clinical trials and interrogated by FDA.