Abuse-deterrent formulations: part 1 - development of a formulation-based classification system

Area of Science:

• Pharmaceutical Sciences
• Drug Delivery Systems
• Medicinal Chemistry

Background:

• Prescription medication misuse is a significant public health issue.
• Abuse-deterrent formulations (ADFs) are developed to combat misuse but lack a standardized classification.
• This absence hinders identification, study, and communication regarding ADFs.

Purpose of the Study:

• To introduce a systematic classification for abuse-deterrent formulation (ADF) approaches.
• To examine the physical, chemical, and pharmacological characteristics of ADFs.
• To provide a framework for understanding and communicating about ADF technologies.

Main Methods:

• Development of a three-tiered classification system: primary, secondary, and tertiary approaches.
• Categorization based on the mechanism of deterrence (e.g., blocking tampering, in vivo effects, discouraging abuse).
• Analysis of formulation characteristics within the proposed system.

Main Results:

• Primary approaches directly block physical tampering with the drug product.
• Secondary approaches involve in vivo mechanisms after administration to deter abuse.
• Tertiary approaches utilize materials to discourage abuse without preventing tampering.

Conclusions:

• ADFs have evolved beyond simple deterrents like opioid antagonists.
• Innovations enable deterrence against multiple forms of tampering and abuse (e.g., crushing, extraction, injection).
• Repurposing existing excipients and manufacturing methods is key to advanced ADF development.