A Chewing Study of Abuse-Deterrent Tablets Containing Polyethylene Oxide Using a Robotic Simulator

Area of Science:

• Pharmaceutical Sciences
• Drug Delivery Systems
• Formulation Technology

Background:

• Abuse-deterrent formulations (ADFs) are designed to prevent manipulation and abuse of prescription drugs, particularly opioids.
• Assessing ADF performance against various abuse methods, including manipulation like chewing, is crucial.
• Chewing is a complex oral bioprocess influenced by factors like tooth crushing, tongue mixing, and saliva lubrication.

Purpose of the Study:

• To evaluate the abuse-deterrent properties of polyethylene oxide (PEO) tablets using a novel chewing simulator.
• To investigate the impact of simulated chewing parameters on tablet particle size and chewing force.
• To determine the effectiveness of a chewing simulator in mimicking oral processing of ADFs.

Main Methods:

• Utilized a chewing simulator capable of replicating human molar grinding with adjustable parameters (molar trajectory, chewing frequency, saliva flow rate).
• Assessed tablet disintegration by measuring particle size distribution after simulated chewing.
• Measured chewing force as an indicator of the mechanical forces involved in the process.
• Employed Analysis of Variance (ANOVA) to analyze the significance of different chewing parameters.

Main Results:

• The chewing simulator successfully broke down 34 out of 40 PEO tablets into smaller particles.
• Molar trajectory and saliva flow rate were found to significantly reduce particle size (p < 0.05).
• The effect of chewing frequency on particle size reduction was not statistically significant.

Conclusions:

• A chewing simulator can effectively assess the physical deterrent properties of ADFs against manipulation.
• Simulated chewing parameters, specifically molar trajectory and saliva flow, significantly influence the disintegration of PEO tablets.
• Chewing force serves as a valuable metric for evaluating the performance of ADFs in simulated chewing.