Purpose: The use of e-cigarettes, also called vaping and more recently “JUULing”, is a well documented method used to administer nicotine and cannabis products. In 2014, teenage use of vaping devices surpassed that of smoked cigarettes and its prevelance continues to increase across all age groups. Although e-cigarettes are not designed with the intent to administer opioid drug products the success of newer e-cigarettes brands and technologies in administering alternative cannabis forms such as herbal, wax and concentrates, indicates other material forms, like ground opioid formulations, might be possible. Some laboratory studies with rodents have reported success with other drug classes, e.g., methamphetamine, MDPV, alpha-PVP. Online drug tampering forums mention vaping marketed opioid formulations however, the success of such attemps is mostly undetermined. Questions have been posed by FDA Advisory Committee members regarding the potential for vaping opioids. To address the feasibility of e-cigarette devices to successfully deliver opioids, a laboratory model was developed and tested with pure oxycodone and a marketed abuse-deterrent formulation.
Methods: A laboratory model was assembled that consisted of a commercial vaping device connected to an air vacuum sampling bag and flow meter control. A preliminary optimization and verification procedure was conducted using pure oxycodone hydrochloride (HCl) diluted to a total volume of 2 mL with 50:50 propylene glycol/vegetable glycerin; for a final concetration of 10 mg/mL in the vaping concentrate. The vaping device was set to “VW” mode and 100 watts; causing the device to set the maximum watts and automatically apply voltage to avoid damage to the heating coil. The flow rate of air passing through the device was allowed to equilibrate to a range of 1800 – 2500 mL/min, typical of a human inhalation rate. Once the flow rate reached an acceptable range, the vaping device was turned on for 5 seconds, off for 2 seconds, and then back on for 5 more seconds. The vacuum flow was left on until the vapor ceased and then the tubing was immediately introduced into a collection solvent, thus rinsing the inside of the vapor tubing and collecting the oxycodone residue in the air sampling bag. The contents of the bag were analyzed by LC-MS/MS for total oxycodone recovery.
Experiments involving an abuse-deterrent tablet required a 3-5 minute thermal extraction process to yield a concentrated solution of oxycodone, without significant tablet excipient and gelling. The resulting tablet extract was diluted to a total volume of 2 mL with 50:50 propylene glycol/vegetable glycerin; for a final concetration of approximately 10 mg/mL. The vaping procedure optimized using pure oxycodone HCl was applied to the formulation derived vaping concentrate.
Results: Results from optimization and verification of the laboratory model showed vaporization of oxycodone HCl in the range of 1.6 – 2.2 mg. When the API measurement is taken in context of the total volume of vaping concentrate vaped, mass difference pre versus post vaping, approximately 57-63% (efficiency) of the oxycodone HCl was successfully transferred to the collection bag. The method was very consistent as shown by a CV < 6%. The same process with the abuse-deterrent formulation showed similar results in the range of 50-60% efficiency.
Conclusion: Based on this study, a laboratory model and process was developed that successfully utilized a commercial vaporizer to deliver oxycodone vapor (aerosol) derived from a marketed abuse-deterrent formulation in amounts likely to produce pharmacological effects. Given the trending popularity of vaping as a means of drug delivery (nicotine, cannabis), it is feasible that this laboratory method will be realized in the “real-world” to successfully administer and conceal opioid abuse.
Paul Fort– Principal Scientist, Drugscan, Inc.
Anthony Costantino– CEO, Drugscan, Inc.
August Buchalter– Director, Abuse-Deterrent Drug Products, Pinney Associates, Inc.
Edward Cone– Principal Scientist, Drug Delivery and Abuse Deterrent Drug Products, Pinney Associates, Inc.
Christopher Altomare– Drugscan, Inc., Philadelphia