GDUFA Research Outcomes

Opioid Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to unique considerations impacting opioid drug products, including abuse deterrent formulations of generic opioid products.

• All(45)
• Posters(21)
• Presentations(8)
• Papers(16)

• Effect of Formulation Variables on the Nasal Permeability and Stability of Naloxone Intranasal Formulations

  Hsu, Haojui; Yang, Yang; Pavuluri, Venkateswara; Abraham, Ciby; Naraharisetti, Suresh; Ashraf, Muhammad; Al Ghabeish, Manar

• Physical Barrier Type Abuse-Deterrent Formulations: Monitoring Sintering-Induced Microstructural Changes in Polyethylene Oxide Placebo Tablets by Near Infrared Spectroscopy (NIRS)

  Boyce, Heather; Ibrahim, Ahmed; Hoag, Stephen

• Particle Size Affects Pharmacokinetics of Milled Oxycodone Hydrochloride Tablet Products Following Nasal Insufflation in Nondependent, Recreational Opioid Users

  Raofi, Saeid; Kinjo, Minori; Sun, Dajun; Li, Zhichuan; Boyce, Heather; Natarajan, Karthika; Frost, Mitchell; Zhao, Liang; Luke, Markham; Lionberger, Robert; Kelsh, Debra; Kim, Myoung Jin

• An In Vitro Approach for Evaluating the Oral Abuse Deterrence of Solid Oral Extended-Release Opioids with Properties Intended to Deter Abuse via Chewing

  Externbrink, Anna; Sharan, Satish; Sun, Dajun; Jiang, Wenlei; Keire, David; Xu, Xiaoming

• Physical Barrier Type Abuse-Deterrent Formulations: Mechanistic Understanding of Sintering-Induced Microstructural Changes in Polyethylene Oxide Placebo Tablets

  Boyce, Heather; Dave, Vivek; Scoggins, Myke; Gurvich, Vadim; Smith, Daniel; Byrn, Stephen; Hoag, Stephen

• Preferential Oxycodone Loss of Physically Manipulated Abuse Deterrent Oxycodone HCl Extended Release Tablets Prepared for Nasal Insufflation Studies

  Meng, Zhengjie; Boyce, Heather; Sun, Dajun; Kinjo, Minori; Raofi, Saeid; Li, Tonglei

• Quantitative Analysis of Opioid ADF PK/PD

  Zhao, Liang

• Foundations of PK Comparisons of Generic Opioids to RLDs with Labeling Describing Abuse-deterrent Properties

  Zhao, Liang

• In Vitro and in Vivo Abuse Deterrence Evaluation of Generic Opioid Products

  Xu, Xiaoming

• Nasal PK Study of Abuse-Deterrent Opioid Products Following Insufflation of Physically Manipulated Products

  Vince, Bradley