Formulation considerations for the development of medications with abuse potential

Area of Science:

• Pharmaceutical Sciences
• Pharmacokinetics
• Drug Development

Background:

• Advanced drug formulations and delivery systems present new development opportunities.
• These innovations can enhance drug bioavailability and alter pharmacokinetic parameters, potentially reducing dosing frequency or adverse events.
• While drug abuse potential assessment is understood, formulation's influence remains understudied.

Purpose of the Study:

• To highlight the need for improved understanding of how drug formulation influences abuse potential.
• To propose factors for industrial sponsors to consider when making formulation choices for drugs with abuse potential.
• To advocate for further research in formulation science and pharmacokinetics to predict prescription drug abuse.

Main Methods:

• The study reviews existing knowledge on drug formulation, pharmacokinetics, and abuse potential assessment.
• It discusses the challenges in evaluating formulation's impact during drug development.
• It proposes areas for future research, including pharmacokinetic parameter validation and product tampering assessment.

Main Results:

• Drug formulation significantly impacts pharmacokinetic parameters and bioavailability.
• Current methods for assessing formulation's influence on abuse potential are often limited.
• Further research is needed to predict and mitigate the abuse potential of pharmaceutical products.

Conclusions:

• Industrial sponsors need to consider formulation choices carefully for drugs with abuse potential.
• Validating new pharmacokinetic parameters and standardizing methods for assessing product tampering are crucial.
• Enhanced understanding can improve risk assessment for both innovator and generic controlled-release formulations.