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(36)
• Posters(18)
• Presentations(8)
• Papers(10)

• In Vitro Assessment of Nasal Insufflation of Comminuted Drug Products Designed as Abuse Deterrent Using the Vertical Diffusion Cell

  Boyce, Heather; Smith, Dan; Byrn, Steve; Saluja, Bhawana; Qu, Wen; Gurvich, Vadim; Hoag, Stephen

• Evaluation of Abuse-Deterrent Characteristics of Tablets Prepared via Hot-Melt Extrusion

  Xu, Xiaoming; Siddiqui, Akhtar; Mohammad, Adil; Srinivasan, Charudharshini; Rahman, Ziyaur; Korang Yeboah, Maxwell; Feng, Xin; Khan, Mansoor; Ashraf, Muhammad

• Association of Partial Systemic Exposure and Abuse Potential for Opioid Analgesics with Abuse Deterrence Labeling Claims Supporting Product-Specific Guidance

  Zhao, Liang; Li, Zhichuan; Fang, Lanyan; Kim, Myong Jin; Nallani, Srikanth; Sahajwalla, Chandrahas; Calderon, Silvia; Roca, Rigoberto; Feng, Kairui; Zineh, Issam; Lionberger, Robert

• Assessing Drug Release from Manipulated Abuse Deterrent Formulations

  Feng, Xin; Zidan, Ahmed; Kamal, Nahid; Xu, Xiaoming; Sun, Dajun; Walenga, Ross; Boyce, Heather; Cruz, Celia; Ashraf, Muhammad

• 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