ABUSE VULNERABILITY OF CURRENTLY-MARKETED ABUSE-DETERRENT MEDICATIONS
Abstract
Objective. Determine the effect of high temperatures on the stability and abuse deterrent functionality of PEO. Background. PEO is used as the main component in many recently marketed medications having resistance to abuse. When heated and cooled, PEO becomes extremely hard and is resistant to crushing. Additionally, it forms viscous solutions when mixed with small amounts of liquid to prevent being injected. However, one major drawback of PEO is its susceptibility to heating processes used in manufacturing. Methods. For each heat treatment, 500 mg of PEO (Polyox™ WSR Coagulant) powder was 19 placed in a hot air oven and subjected to temperatures of 80, 110, 150, and 180 degrees Celsius for 1 hour. Thermal analysis on cooled samples was then performed using DSC at a heating/cooling rate of 10 degrees Celsius per minute under nitrogen purge. Structural changes were examined using FTIR spectrometer. Viscosity of 2% w/v aqueous solutions from treated samples was measured by using a cone-plate rheometer. Result. DSC showed a decrease in enthalpy, melting point, and onset of melting with increased treatment temperatures. FTIR also showed degradation peaks (1720 cm-1) resembling polymer depolymerization at higher temperatures. Similarly, solution viscosities were found lower for samples treated at higher temperature. The PEO solutions treated at temperatures above 150 degrees Celsius showed almost no viscosity. Conclusion. PEO is thermally degraded at high temperatures, losing its abuse deterrence potential. If abusers attempt to heat the medication at high temperatures, they can abuse the drug by insufflation and by injection, therefore necessary provisions need to be made to proper processing PEO – containing formulations at higher temperatures. Grants. #PFRDG 335357, #PFRDG 335867
ABUSE VULNERABILITY OF CURRENTLY-MARKETED ABUSE-DETERRENT MEDICATIONS
Morris Auditorium
Objective. Determine the effect of high temperatures on the stability and abuse deterrent functionality of PEO. Background. PEO is used as the main component in many recently marketed medications having resistance to abuse. When heated and cooled, PEO becomes extremely hard and is resistant to crushing. Additionally, it forms viscous solutions when mixed with small amounts of liquid to prevent being injected. However, one major drawback of PEO is its susceptibility to heating processes used in manufacturing. Methods. For each heat treatment, 500 mg of PEO (Polyox™ WSR Coagulant) powder was 19 placed in a hot air oven and subjected to temperatures of 80, 110, 150, and 180 degrees Celsius for 1 hour. Thermal analysis on cooled samples was then performed using DSC at a heating/cooling rate of 10 degrees Celsius per minute under nitrogen purge. Structural changes were examined using FTIR spectrometer. Viscosity of 2% w/v aqueous solutions from treated samples was measured by using a cone-plate rheometer. Result. DSC showed a decrease in enthalpy, melting point, and onset of melting with increased treatment temperatures. FTIR also showed degradation peaks (1720 cm-1) resembling polymer depolymerization at higher temperatures. Similarly, solution viscosities were found lower for samples treated at higher temperature. The PEO solutions treated at temperatures above 150 degrees Celsius showed almost no viscosity. Conclusion. PEO is thermally degraded at high temperatures, losing its abuse deterrence potential. If abusers attempt to heat the medication at high temperatures, they can abuse the drug by insufflation and by injection, therefore necessary provisions need to be made to proper processing PEO – containing formulations at higher temperatures. Grants. #PFRDG 335357, #PFRDG 335867