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By Srinath Muppalaneni, Sampa Mondal, David J Mastropietro and Hamid Omidian


Objective. The purpose of this study was to evaluate the use of DGF as a quantitative measurement in estimating the level of abuse deterrence to intravenous injection. Background. In developing solid oral medications resistant to various forms of recreational abuse, proper selection of inactive ingredients that can resist common tampering methods is critical. Of particular concern is preventing abuse by injecting the drug extract intravenously or intramuscularly. Given the fact that there is no standards which to measure injectability of drug solutions extracted from abuse-deterrent medications, the injectability of such extracts needs to be performed using reliable and reproducible methods. As such, this study suggests the use of DGF as a standard measurement of injectability for quantitative and qualitative purposes related to parenteral resistance. Methods. Using a common abuse deterrent ingredient (Polyox™ WSR Coagulant NF), 2.5% w/v of Polyox solutions were prepared in water, normal saline, pH3 and 40% ethanol solvents. These solutions were loaded into 3 mL syringes with an attached needle (19G X 1.5”), and the DGF of each solution measured at four rates (0.5, 1, 2, and 4 mm/sec) using a texture analyzer equipped with a syringe fixture. Results. DGF increased gradually when rate of injection was increased for all solvents excluding 40% ethanol. DGF increased rapidly with increasing rate for 40% ethanol. Conclusion. DGF can reproducibly be used to measure injectability over a wide range of injection rates and extracting solvents. Grants. NSU grants # 335357 and 33582

Topics: Dentistry, Medicine and Health Sciences, Nursing, Osteopathic Medicine and Osteopathy, Pharmacy and Pharmaceutical Sciences
Publisher: NSUWorks
Year: 2016
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Provided by: NSU Works
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