Abuse-deterrent formulations: part 1 - development of a formulation-based classification system.
BACKGROUND
Strategies have been implemented to decrease the large proportion of individuals misusing abusable prescription medications. Abuse-deterrent formulations (ADFs) have been grown to incorporate many different technologies that still lack a systematic naming and organizational nomenclature. Without a proper classification system, it has been challenging to properly identify ADFs, study and determine common traits or characteristics and simplify communication within the field.


METHODS
This article introduces a classification system for all ADF approaches and examines the physical, chemical and pharmacological characteristics of a formulation by placing them into primary, secondary and tertiary categories. Primary approaches block tampering done directly to the product. Secondary approaches work in vivo after the product is administered. Tertiary approaches use materials that discourage abuse but do not stop tampering. Part 2 of this article discusses proprietary technologies, patents and products utilizing primary approaches.


CONCLUSIONS
Drug products using opioid antagonists and aversive agents have been seen over the past few decades to discourage primarily overuse and injection. However, innovation in formulation development has introduced products capable of deterring multiple forms of tampering and abuse. Often, this is accomplished using known excipients and manufacturing methods that are repurposed to prevent crushing, extraction and syringeability.
Nova Southeastern University, College of Pharmacy, Department of Pharmaceutical Sciences , 3200 South University Drive, Fort Lauderdale, FL 33314 , USA +1 954 262 1334 ; omidian@nova.edu.
David J
DJ
Mastropietro
Hossein
H
Omidian
D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects; D002626:Chemistry, Pharmaceutical / Q000145:classification / Q000379:methods; D005079:Excipients / Q000737:chemistry; D006801:Humans; D009292:Narcotic Antagonists / Q000008:administration & dosage; D009293:Opioid-Related Disorders / Q000517:prevention & control*; D063487:Prescription Drug Misuse / Q000517:prevention & control*; D019966:Substance-Related Disorders / Q000517:prevention & control*
D000701:Analgesics, Opioid; D005079:Excipients; D009292:Narcotic Antagonists
abuse deterrence; nonmedical use; opioids; prescription drug abuse; tamper resistant