Development of Tamper Deterrent Formulations: State of the Pharmaceutical Industry

Ehab      Hamed; Derek      Moe

doi:10.2174/1874473711003030139

Abstract

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.

Keywords: Abuse, tamper deterrent, extended release, opioids, formulations, NSDUH, marijuana, hallucinogens, tranquilizers, sedatives, Drug Enforcement Agency (DEA), diarrhea, anxiety, shortness of breath, widespread problem, innovative solutions, alleviate pain, minor euphoric, implement Risk Evaluation, REMS, physical barrier, epidemiological, hydrocodone, crushing, sophisticated abusers, extractability rating system, pharmacokinetics, excipients, drug-loaded core, reformulated Oxycontin, tapentadol, isobutyrate, morphine, gastrointestinal, enzymatically, oligopeptide, carboxylic group, niacin, emetic, diuretics, Acurox, PDUFA, Valoron N, naloxone, Suboxone, Buprenorphine, naltrexone, sophistication, tampering protocol, recreational drug, deterrent agent