Current approaches in tamper-resistant and abuse-deterrent formulations

Area of Science:

• Pharmaceutical Sciences
• Drug Delivery Systems
• Medicinal Chemistry

Background:

• Escalating prescription drug abuse necessitates the development of novel formulations resistant to tampering and misuse.
• This has led to the creation of abuse-deterrent or tamper-resistant dosage forms.

Purpose of the Study:

• To provide an overview and classification system for formulation approaches used in abuse-deterrent dosage forms.
• To categorize existing and emerging technologies for tamper-resistant drug delivery.

Main Methods:

• Conducted a comprehensive literature search in Embase and Medline using keywords 'abuse deterrent' and 'tamper resistant'.
• Examined issued patents from the United States Patent and Trademark Office using the phrase 'abuse deterrent composition'.
• Gathered additional data from press releases and product innovator websites.

Main Results:

• Formulation approaches were categorized into physical (solids, gels, non-intentionals) and chemical (agonists/antagonants, aversives, metabolics).
• Nine diverse abuse-deterrent methods were identified among issued patents.
• Many formulations combine approaches and utilize proprietary technologies; development often involves multiple pharmaceutical manufacturers.

Conclusions:

• Prodrug and agonist/antagonist formulations are prevalent in marketed products; solid and gel approaches are newer.
• Incorporating aversive agents or enzyme inhibitors presents developmental challenges.
• Formulation and manufacturing details remain largely undisclosed to protect public health; the efficacy of these novel formulations in the general population is yet to be proven.