Abuse-deterrent formulations of prescription opioid analgesics in the management of chronic noncancer pain.

Misuse, abuse and diversion of prescription opioid analgesics represent a global public health concern. The development of abuse-deterrent formulations (ADFs) of prescription opioid analgesics is an important step toward reducing abuse and diversion of these medications, as well as potentially limiting medical consequences when misused or administered in error. ADFs aim to hinder extraction of the active ingredient, prevent administration through alternative routes and/or make abuse of the manipulated product less attractive, less rewarding or aversive. However, opioid ADFs may still be abused via the intended route of administration by increasing the dose and/or dosing frequency. The science of abuse deterrence and the regulatory landscape are still relatively new and evolving. This paper reviews the current status of opioid ADFs, with particular focus on different approaches that can be used to deter abuse, regulatory considerations and implications for clinical management.

Development of tamper deterrent formulations: state of the pharmaceutical industry.

Prescription drug abuse is a significant and growing health and socio-economical problem in the US and the world. According to the 2008 UN World Drug Report, the number of people who have consumed an illicit drug at least once in 2006/2007 reached 240 million, roughly 6% of the world population aged 15 to 64. In the last few years, pharmaceutical manufacturers started developing new formulations specifically designed to provide tamper deterrent features. The initial focus of these development activities was extended release opioids, owing to their dominant share of reported prescription drug abuse. Tamper deterrent formulations (TDF) for other drugs of abuse, including stimulants and sedatives are also in various stages of development. Three major challenges face the development of TDF: the increased sophistication of the tampering methods used by abusers, the ambiguity of the regulatory requirements for labeling and marketing and the exaggerated expectations of what these formulations can deliver. This review details the approaches used by pharmaceutical manufacturers to impart tamper deterrent features into their formulations; the in vitro and in vivo tests that have been proposed or used to assess the performance of TDF; and the current regulatory landscape.