Deterrent Properties of Thermally-Manipulated High Molecular Weight Poly(ethylene oxide) ( HMW PEO)

Nova Southeastern University, Davie, Florida, USA

Objective. In this study, we aimed to manipulate the pure HMW PEO and the tablets containing HMW PEO to evaluate the structural and functional properties of the PEO and the PEO tablets under abuse conditions. Background. In Abuse deterrent formulations (ADFs), the HMW PEO offers extraction resistance properties. They have the potential to decrease opioid abuse by preventing chemical (e.g., drug extraction) tampering. Methods. HMW PEO powder (Sentry™ Polyox™ WSR-301, Mw 4,000,000 Da) was spread over a glass plate, and heated in an air-circulated oven at 180°C for 1 hr. A single station compression press tableting machine was used to prepare tablets (200 mg HMW PEO and 300 mg Avicel) using a direct compression method. The tablets were also heated in an air-circulated oven at 180°C for 1 hr. The dissolution study of tablets was done in 0.1% HCl at 25°C. Results. The FTIR spectra of the HMW PEO powder treated at 180°C indicated an oxidative degradation at 1720 cm -1. The rheological behavior including viscosity and yield stress of the PEO solutions confirmed a pseudoplastic flow behavior for the controlled solution of HMW PEO, whereas the heat-treated sample showed almost no viscosity when manipulated at 180°C. The dissolution study of cured tablet showed that 36.34±10.28% of drug was released after 1 hr; whereas, 19.19±2.13% of drug was in dissolution medium containing control tablet. This confirms that the oxidized PEO backbone (Due to heat-treating to 180°C) releases the drug faster than PEO chains backbone. Conclusion. HMW PEO is extremely sensitive to thermal manipulations. If the dosage forms containing this polymer are thermally manipulated at temperatures as high as its degradation temperature, almost all deterrent features of this polymer will be lost as evidenced by dramatic changes in its structure and flow behavior.