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Category 1 Resources

Read the latest research studies conducted and published by our CAT.one experts.

Category 1 Resources

Read the latest research studies conducted and published by our CAT.one experts.

There are continual changes in how prescription and illicit drugs are used and abused. The experts at DRUGSCAN’s CAT.one laboratory continue to focus on research to inform the makers of prescription drugs on ways to defeat or compromise their products. Check back often for research from DRUGSCAN and other authorities.

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Exploratory In-vitro Mastication to Assess the Potential Accelerated Release of Fentanyl from a Transdermal Patch

PAINWeek 2019

Authors Christopher Altomare, Paul Fort, Eric Kinzler and Anthony Costantino discuss using an in vitro mastication apparatus to assess fentanyl release when a commercially available fentanyl transdermal patch is chewed. Chewing fentanyl patches are a common route of abuse

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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

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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

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In Vitro Differentiation of Two FDA-Approved Abuse-Deterrent Opioids’ Resistance to Oral Mastication

PAINWeek 2017 and AAPS 2017

In 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.

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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

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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

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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

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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

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.

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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

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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

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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

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