Subcutaneous Drug Delivery System for the Reversal of an Opioid Overdose
Abstract
With approximately 64,000 attributed deaths in 2016, opioid overdose related deaths have been ranked as the leading cause of death amongst Americans under the age of 50. The overdose process can be interrupted by the administration of naloxone, a safe and effective opiate antagonist that can reverse the effects of overdose. Amount of time from onset of the overdose until the antagonist is administered needs to be minimized to prevent permanent damage. Even though there are many successful implantable drug delivery systems (DDS) on the market, they are limited in their functionality. These limitations include higher costs due to complex micro fabrication procedure and a need for surgical implantation. We have developed an active emergency DDS that delivers a large dose of naloxone subcutaneously to reverse the effects of an overdose. It is activated using an externally applied time varying magnetic field from a wearable device in development. Bench-top evaluation of release testing, leakage testing and thermal analysis were conducted to evaluate the device. Ex vivo and in vivo studies were carried out to verify device activation and drug release. The liquid drug device released 100% of its drug volume (20 μL) and the powdered drug device released 70% of the entire payload (8.5 mg) in 600 s. The leakage test released 1.75% of total powdered drug in 1000 h which is lower than the minimum amount of drug required to elicit effects of withdrawal. The average amount of time taken for the activation of the device was 10 s based on thermal analysis. The ex vivo and in vivo evaluation demonstrated the proof of concept in the subcutaneous space of the animal. Additional research is needed to verify long term leakage when placed in the subcutaneous space. Our preliminary results show potential benefits of using a simple, low-cost, subcutaneous DDS for emergency reversal of opioid overdoses without the need for assistance.
Degree
M.S.B.M.E.
Advisors
Lee, Purdue University.
Subject Area
Biomedical engineering
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