ABUSE-DETERRENT DOSAGE FORMS
To address the epidemic rise in prescription drug abuse, pharmaceutical companies have been developing abuse-deterrent formulations that are difficult to physically or chemically manipulate. In April 2015, the FDA released final guidance on “Abuse-Deterrent Opioids – Evaluation and Labeling” to assist developers of abuse-deterrent opioids, which can be applicable to other controlled drugs. The guidance explains Food and Drug Administration’s (FDA) current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties, how those studies will be evaluated, and what labeling claims may be approved based on the results of those studies.
CAT.ONE™ LABORATORY-BASED MANIPULATION AND EXTRACTION STUDIES
At DRUGSCAN© we understand how critical it is for developers to work with an experienced laboratory to obtain Category 1 label claims for their abuse-deterrent products. Employing its state of the art technology and expertise in toxicology testing under a highly regulated environment, DRUGSCAN© has been at the forefront of designing and conducting manipulation and extraction studies and has worked with many of the leading abuse-deterrent opioid developers in the US and around the world.
DRUGSCAN©’s CAT.one™ laboratory-based manipulation and extraction studies are designed and conducted under a rigorous scientific, regulatory and good clinical laboratory practice (GLP) environment to produce data that can predict a product’s strengths and weaknesses to physical and chemical manipulations. Under the supervision of a board-certified toxicologist, CAT.one™ scientists have the capabilities and expertise to simulate physical and chemical manipulations using household tools or experienced abuser’s techniques including crushing, dissolution, syringe-ability, smoke-ability, purification of active ingredients, and dose dumping. DRUGSCAN©’s extensive analytical services are backed with state of the art instrumentation featuring liquid chromatography/with tandem mass spectrometry (LC/MS/MS), high-performance liquid chromatography with UV detector (HPLC-UV), charged aerosol detection (CAD), gas chromatography/mass spectrometry (GC/MC), laser diode thermal desorption (LDTD), and immunoassays.
CAT.ONE ™ studies include:
- Physical Manipulation
- Isolation/Purification of API
DRUGSCAN© CERTIFICATIONS AND ACCREDITATIONS
DRUGSCAN© is certified by CLIA, SAMSHA, the DEA and multiple states. It is accredited by the College of American Pathologists (CAP) and has experience in importing scheduled products from outside of the United States.
DRUGSCAN© is your Category 1 partner. We understand CII drug development, tight timelines and the need for a compelling point of differentiation for your products. We provide exceptional service to our partners by addressing their needs and exceeding their expectations.
Learn how to get started
Learn more about how DRUGSCAN© can assist you in successfully reaching your manipulation and extraction study objectives. Call us at 800-325-4890 or fill out the form below.