Open Access Open Access  Restricted Access Subscription or Fee Access

In vitro evaluation of a novel immediate-release formulation of oxycodone (RoxyBond™) for the potential for abuse via injection

Eric R. Kinzler, PhD, Carmela Pantaleon, BS, Matthew Iverson, MPH, Stefan Aigner, MD


Objective: Immediate-release (IR) oxycodone formulations may be manipulated for nonoral routes of administration. Oxycodone abuse-resistant immediate-release (ARIR) is a novel abuse-deterrent formulation (ADF) of IR oxycodone. This study aimed to assess the intravenous (IV) abuse potential of Oxycodone ARIR relative to commercially available IR oxycodone tablets using in vitro laboratory studies.

Design: Intact or manipulated tablets were incubated in 5 or 10 mL of room temperature water for increasing amounts of time. For each timepoint, syringeability, defined as the ability to draw up water-immersed intact or manipulated tablets into a syringe, was assessed on a scale of 1 (very easy) to 10 (impossible). If the prepared sample could be drawn into a syringe, the proportion of syringeable oxycodone was measured analytically.

Results: In all conditions, it was nearly impossible to draw any liquid into a syringe from samples containing manipulated Oxycodone ARIR tablets (N = 5/ group), and most samples released very low concentrations (<10%) of their total oxycodone content, regardless of sample volume. In contrast, samples containing crushed IR oxycodone (N = 5/group) in small volumes of fluid were easily drawn into a syringe through the smallest needle, and more than 90% of the oxycodone content was released from relatively small sample volumes (5 mL).

Conclusion: The difficulty required to prepare an injectable solution from Oxycodone ARIR when manipulated suggests that Oxycodone ARIR has abuse-deterrent properties that may deter IV abuse.



abuse, abuse-deterrent, immediate-release, intravenous, opioid

Full Text:



Centers for Disease Control and Prevention: National Center for Injury Prevention and Control. Division of Unintentional Injury Prevention. Policy Impact: Prescription Painkiller Overdoses. Atlanta, Georgia: Centers for Disease Control and Prevention. Available at Accessed December 13, 2018.

Substance Abuse and Mental Health Services Administration: Key substance use and mental health indicators in the United States: Results from the 2017 National Survey on Drug Use and Health (HHS Publication No. SMA 18-5068, NSDUH Series H-53). Rockville, Maryland: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. Available at Accessed April 30, 2019.

US Food and Drug Administration: Abuse-deterrent opioid analgesics. Available at Accessed December 11, 2018.

US Food and Drug Administration: RoxyBond Briefing Document. Silver Springs, Maryland: US Food and Drug Administration. Available at Accessed January 2, 2019.

Butler SF, Cassidy TA, Chilcoat H, et al.: Abuse rates and routes of administration of reformulated extended-release oxycodone: Initial findings from a sentinel surveillance sample of individuals assessed for substance abuse treatment. J Pain. 2013; 14(4): 351-358.

Cassidy TA, DasMahapatra P, Black RA, et al.: Changes in prevalence of prescription opioid abuse after introduction of an abuse-deterrent opioid formulation. Pain Med. 2014; 15(3): 440-451.

Iwanicki JL, Severtson SG, McDaniel H, et al.: Abuse and diversion of immediate release opioid analgesics as compared to extended release formulations in the United States. PLoS One. 2016; 11(12): e0167499.

Nalamachu SR, Shah B: Abuse of immediate-release opioids and current approaches to reduce misuse, abuse, and diversion. Postgrad Med. 2018: 1-7. doi: 10.1080/00325481.2018.1502569.

Bruneau J, Roy E, Arruda N, et al.: The rising prevalence of prescription opioid injection and its association with hepatitis C incidence among street—drug users. Addiction. 2012; 107(7): 1318-1327.

Conrad C, Bradley HM, Broz D, et al.: Community outbreak of HIV infection linked to injection drug use of oxymorphone—Indiana, 2015. MMWR Morb Mortal Wkly Rep. 2015; 64(16): 443-444.

Lankenau SE, Kecojevic A, Silva K: Associations between prescription opioid injection and Hepatitis C virus among young injection drug users. Drugs (Abingdon Engl). 2015; 22(1): 35-42.

Surratt H, Kurtz SP, Cicero TJ: Alternate routes of administration and risk for HIV among prescription opioid abusers. J Addict Dis. 2011; 30(4): 334-341.

Ghuran A, van Der Wieken LR, Nolan J: Cardiovascular complications of recreational drugs. BMJ. 2001; 323(7311): 464-466.

RoxyBond (oxycodone HCl) tablets [package insert], Cerovene for Inspirion Delivery Sciences LLC, Valley Cottage, New York. Available at Accessed January 24, 2019.

Center for Drug Evaluation and Research (CDER): Abuse-deterrent opioids—evaluation and labeling guidance for industry. Silver Spring, Maryland: US Food and Drug Administration. Available at Accessed December 13, 2018.

Webster LR, Iverson M, Pantaleon C, et al.: A randomized, double-blind, double-dummy, placebo-controlled, intranasal human abuse potential study of oxycodone ARIR, a novel, immediate-release, abuse-deterrent formulation. Pain Med. 2019; 20(4): 747-757.

Cicero TJ, Ellis MS, Kasper ZA: Relative preferences in the abuse of immediate-release versus extended-release opioids in a sample of treatment-seeking opioid abusers. Pharmacoepidemiol Drug Saf. 2017; 26(1): 56-62.

Moorman-Li R, Motycka CA, Inge LD, et al.: A review of abuse-deterrent opioids for chronic nonmalignant pain. Pharm Ther. 2012; 37(7): 412-418.

Vosburg SK, Jones JD, Manubay JM, et al.: Assessment of a formulation designed to be crush-resistant in prescription opioid abusers. Drug Alcohol Depend. 2012; 126(1-2): 206-215.

Vosburg SK, Jones JD, Manubay JM, et al.: A comparison among tapentadol tamper-resistant formulations (TRF) and OxyContin(R) (non-TRF) in prescription opioid abusers. Addiction. 2013; 108(6): 1095-1106.

Rahman Z, Yang Y, Korang-Yeboah M, et al.: Assessing impact of formulation and process variables on in-vitro performance of directly compressed abuse deterrent formulations. Int J Pharm. 2016; 502(1-2): 138-150.

Rahman Z, Zidan AS, Korang-Yeboah M, et al.: Effects of excipients and curing process on the abuse deterrent properties of directly compressed tablets. Int J Pharm. 2017; 517(1-2): 303-311.



  • There are currently no refbacks.