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)

• Identifying Critical Parameters for Physiological Based Pharmacokinetic Modeling of Naloxone Hydrochloride Nasal Sprays

  Chopski, Steven; Al-Ghabeish, Manar; Babiskin, Andrew; Zhao, Laing; Walenga, Ross

• Evaluation of the Pharmacokinetics and Abuse Potential of Intranasally Administered Extended-Release Oxycodone and Naloxone Abuse-Deterrent Formulations Milled to Different Particle Sizes

  Al Ghabeish, Manar; Kinjo, Minori; Boyce, Heather; Oldennhof, John; Raitsin, Sofia; Myong-Jin, Kim

• Development of an In Vitro Method for In Vivo Prediction of Regional Deposition of Nasal Powders

  Holtgrewe, Nicholas; Walenga, Ross; Bielski, Elizabeth; Guo, Changning

• Hybrid CFD-PBPK Model for Prediction of Systemic PK Following Nasal Insufflation of Milled Oxycodone Hydrochloride Extended-Release Tablets

  Walenga, Ross; Boyce, Heather; Feng, Xin; Zidan, Ahmed; Kamal, Nahid; Xu, Xiaoming; Babiskin, Andrew; Kim, Myong Jin; Zhao, Liang

• Evaluation of the Internal and External Structure of Directly Compressed Polyethylene Oxide (PEO) Based Matrix Tablets Before and after Curing Using X-ray Micro-Computed Tomography

  Vaghasia, Brijeshkumar; Aqueel, Mohammad Sabir; Ashraf, Muhammad; Cruz, Celia; Siddiqui, Akhtar

• Physical Manipulation of an Opioid Drug Product Containing Combination of Opioid Agonist and Antagonist

  Sun, Wei Jhe; Boyce, Heather; Tang, Fuxing; Hollenbeck, Robert; Ibrahim, Ahmed; Hoag, Stephen; Kim, Myong Jin

• Development of Mechanistic In Vitro In Vivo Correlation (Ivivc) of Abuse-Deterrent Hydrocodone Bitartrate Extended Release Tablets

  Sharan, Satish; Externbrink, Anna; Sun, Dajun; Zhang, Xinyuan; Fan, Jianghong; Jiang, Wenlei; Gao, Zongming; Keire, David; Lionberger, Robert; Zhao, Liang

• Stability of Abuse-deterrent Properties of PEO-based Abuse-deterrent Formulations

  Cruz, Celia

• Development of in Vitro Permeation Method for Nasally Insufflated Abuse Deterrent Formulations

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

• Strategies for Correcting Peak Fronting of Oxycodone Hydrochloride, Naloxone Hydrochloride and Related Substances Observed in Reversed – Phase Liquid Chromatography

  Ibrahim, Ahmed; Wang, Fang; Hollenbeck, Gary; Mostofa, Agm; Sun, Wei-Jhe; Boyce, Heather; Al Ghabeish, Manar; Hoag, Stephen