02. August 2016

ABSTRACT Introduction: Many abuse-deterrent formulations (ADFs) rely on being crush resistant and extraction resistant in order to provide deterrence to abuse by insufflation and injection, respectively. High molecular weight polymers such as poly(ethylene oxide) are commonly used to provide this deterrence. However, these polymers suffer from slow dissolution kinetics, and are susceptible to variety of abuse conditions. Objective: This study was aimed to determine if selected superabsorbent...

17. July 2016

Abstract Objectives: This study was conducted to evaluate suitable methods of testing crush-resistant tablets composed largely of thermoplastic polymers. The objectives were, i) to evaluate the effect of thermal processes on crush resistance, ii) to develop test method(s) to indicate whether a crush-resistant tablet is susceptible to tampering by insufflation based on generated particle sizes, and iii) to find an appropriate analytical tool for discriminatory studies. Methods: We investigated...

15. June 2016

Abstract Over the past decade, the abuse of prescription opioid drugs has become a national health crisis in the United States. Pharmaceutical companies, the Food and Drug Administration, and other government agencies are confronting opioid abuse by developing and commercializing various abuse-deterrent drug delivery technologies. To deter opioid abuse, various strategies including physical barriers, chemical barriers, antagonists, aversive agents, and prodrugs have been investigated. A number...

28. June 2015

Oxycodone DETERx® is an extended-release (ER), microsphere-in-capsule abuse-deterrent-formulation designed to retain its extended-release properties following tampering or misuse (e.g., chewing, crushing). This study assessed the safety and pharmacokinetics of orally administered intact and crushed Oxycodone DETERx® capsules compared with intact and crushed reformulated OxyContin® tablets and crushed immediate-release oxycodone tablets (IR oxycodone). More

29. December 2014

Consultation on the Draft Guidance Document: Tamper-resistant Formulations of Opioid Drug Product Submissions Opioid drugs are subject to the Food and Drugs Act. An opioid drug may be sold in Canada following a decision by Health Canada that the scientific evidence submitted by its manufacturer meets established standards for safety, efficacy and quality for the drug under the recommended conditions of use…....