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)

• 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

• Preparation and Characterization of Physically Manipulated Abuse-Deterrent Formulation of an Opioid Product Prepared for Nasal Insufflation Studies

  Gabal, Yasmine; Boyce, Heather; Sun, Wei Jhe; Al Ghabeish, Manar; Ibrahim, Ahmed; Hollenbeck, Gary; Hoag, Stephen; Mostofa, AGM; Kim, Myong Jin

• Preparation and Characterization of Physically Manipulated Abuse-Deterrent Formulation of an Opioid Product Prepared for Nasal Insufflation Studies

  Gabal, Yasmine; Boyce, Heather; Sun, Wei Jhe; Al Ghabeish, Manar; Ibrahim, Ahmed; Hollenbeck, Gary; Hoag, Stephen; Mostofa, AGM; Kim, Myong Jin

• A Flow-Through Dissolution Method for Evaluation of 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

• Development of an In-Vitro Chewing Method for Determining Opioid Availability Following Chewing of Solid Oral Extended-Release Opioids

  Externbrink, Anna; Sun, Dajun; Sharan, Satish; Saluja, Bhawana; Gao, Zongming; Keire, David; Jiang, Wenlei

• Physiologically-Based Pharmacokinetic Model to Describe the Pharmacokinetics of Crushed Morphine Sulfate and Naltrexone Hydrochloride Extended-Release Capsules with Abuse Deterrent Properties

  Chopski, Steven; Walenga, Ross; Boyce, Heather; Babiskin, Andrew; Kim, Myong Jin