Scientific Publications

Category 1 Assessment: Vaping of Abuse Deterrent Opioid Formulations – PAINWeek 2018 Authors Christopher Altomare, Paul Fort, Anthony Costantino, August Buchhalter, Edward Cone from DRUGSCAN and Pinney Associates discuss a laboratory model and process that successfully utilized a commercial vaporizer to deliver opioid vapor (aerosol) derived from a marketed non abuse deterrent formulation and an abuse deterrent formulation Category 1 Assessment of Opioid Vaping: A Focus of FDA Advisory Committee Interest – CPDD 2018 Authors August Buchhalter, Edward Cone, Christopher Altomare and Anthony Costantino from DRUGSCAN and Pinney Associates: An exploratory study assessing the ability to deliver opioids with a commercially available vaping device Laboratory-based testing to evaluate abuse-deterrent formulations and satisfy the Food and Drug Administration's recommendation for Category 1 Testing - Journal of Opioid Management 2017 Nov/Dec;13(6):441-448 Request for Journal of Opioid Management Reprint Authors Christopher Altomare, Eric Kinzler, August Buchhalter, Edward Cone and Anthony Costantino from DRUGSCAN and Pinney Associates review Category 1 testing requirements to satisfy FDA guidance for abuse-deterrent formulations. In Vitro Differentiation of Two FDA-Approved Abuse-Deterrent Opioids’ Resistance to Oral Mastication - PAINWeek 2017 and AAPS 2017In vitro study evaluating the resistance to chewing of an ADF with oral mastication claims relative to another ADF with physical, chemical, and injection claims but, without oral mastication claims. A non–abuse-deterrent commercial product (non-ADF) was included as a control. Abuse-Deterrent Technologies: One Step in the Opioid Epidemic but, How do we Evaluate Them? Chris Altomare from DRUGSCAN discusses in vitro laboratory experiments that are designed to simulate prescription drug abuser techniques in the evaluation abuse-deterrent formulations – AAPS Blog January 2017 Exploratory In Vitro Laboratory Study to Assess Potential Abuse-Deterrent Features of Polyethylene Oxide Extended Release Matrices – AAPS 2016 An exploratory in vitro study assessing the syringe-ability, sniff-ability, extractability and the ability to rectally administer two abuse-deterrent formulations of POLYOX (polyethylene oxide) extended release tablets versus a comparator with no abuse-deterrent features In Vitro Test Characterization of an Immediate Release Product with Abuse Deterrent Features – AAPS 2016 In vitro physical manipulation, syringe-ability, extraction and API isolation studies to characterize the abuse-deterrent properties of an immediate release hydrocodone-acetaminophen tablet compared to a marketed product with no abuse-deterrent features Optimization of a Smoking-Simulation Technique to Investigate Smoke-Ability of Opioids from Pharmaceutical Formulations – PAINWeek 2016 Optimization of a proprietary apparatus that simulates smoking in vitro using two commonly abused opioids Extreme Work Requirement of EG-001, an Abuse-Deterrent, Extended-Release Morphine Product, as Demonstrated with the ALERRT℠ Visual Analog Scales– PAINWeek 2015 Measure the amount of time, effort, and resources required to physically compromise an abuse-deterrent extended release morphine compared to marketed extended release and immediate release morphine products using a novel visual analog scale EG-002, a Novel Proprietary Abuse-Deterrent, Extended-Release Formulation of Oxycodone, Demonstrates Strong Abuse-Deterrent Potential Based on the Results from a Category 1 In Vitro Physical Manipulation Study – PAINWeek 2015 Single-step physical manipulation studies to evaluate the abuse-deterrent properties of an investigational extended release oxycodone tablet in comparison with a marketed abuse-deterrent extended release oxycodone formulation