Formulation and Regulatory Considerations for Development of a Drug Product with Abuse-Deterrent Properties

摘要

Drug abuse, which is defined as the repeated or sporadic non-medical use of a drug for the positive psychoactive effects it produces, is widespread in the United States. According to the 2011 Vital Signs report from the Center for Disease Control, the legal sale of opioid painkillers has increased by 300% over a decade. This has been accompanied by an increase in the milligram-per-person use of prescription opioids, an increase in opioid overdose deaths (-14,000 death/year), and the rise of concern for their misuse, diversion and abuse.1 Besides marijuana, opioid medications have exceeded other drugs of abuse (e.g. cocaine and heroin) in prevalence of use.