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FY2016 Regulatory Science Report: Advances in Predictive Dissolution and Physiological Models of Drug Absorption

This section contains only new information from FY2016. For background scientific information and outcomes from previous years on this research topic, please refer to the FY15 Regulatory Science Research Report on Advances in Predictive Dissolution and Physiological Models of Drug Absorption.

ORS staff facilitating research in this area

  • Xinyuan Zhang, Hong Wen, Jianghong Fan, Dajun Sun, Zhanglin Ni, Andrew Babiskin, Eleftheria Tsakalozou, Ross Walenga, Satish Sharan, Ming Qin, and other ORS staff members

Projects and Collaborators

  • Effect of different preparation methods on the in vitro and in vivo performance of solid dispersion formulations
    • Site PI: Lynne Taylor
    • Grant #: 1U01FD005259-01
  • Prediction of in vivo performance for oral solid dosage forms. Gordon Amidon, University of Michigan
    • Site PI: James Brasseur
    • Contract #: HHSF223201310144C
  • Pharmacokinetic study of bupropion hydrochloride products with different release patterns
    • Site PI: Duxin Sun
    • Contract #: HHSF223201310164C
  • Correlation of mesalamine pharmacokinetics with local availability
    • Site PI: Duxin Sun
    • Contract #: HHSF223201300460A
  • Warfarin bioequivalence study
    • Site PI: Bradley Vince
    • Contract #: HHSF223201210030I
  • Excipients’ impact on bioavailability of BCS Class 3 drugs
    • Site PI: Jim Polli
    • Contract#: HHSF223200910020C
·         In vivo predictive dissolution (IPD) to advance oral product bioequivalence (BE) regulation
    • Site PI: Gordon L. Amidon
    • Contract#: HHSF 223201510157C
  • Wireless sampling pill to measure in vivo drug dissolution in GI tract and computational model to distinguish meaningful product quality differences and ensure bioequivalence in patients
    • Site PI: Duxin Sun
    • Contract #: HHSF223201510146C

Publications and Presentations

  • Trasi NS, Purohit H, Wen H, Sun D, Taylor LS. Non-sink dissolution behavior and solubility limit of commercial tacrolimus amorphous formulations. Journal of Pharmaceutical Sciences. 2017 Jan;106(1): 264-272.
  • Purohit H, Gao Y, Zhang G, Sun S, Wen H, Taylor L. Limitations in the Pharmacopeial Dissolution Testing of Marketed Tacrolimus Amorphous Solid Dispersions. AAPS Annual Meeting and Exposition, Denver CO (Nov 2016)
    • Wen H, Zhang X. “The Science of Therapeutic Equivalence”. UCSF, San Francisco, CA (Sep 2016). Invited Speech
    • Sun D, Wen H, Taylor LS. Non-sink dissolution conditions for predicting product quality and in vivo performance of supersaturating drug delivery systems. Journal of Pharmaceutical Sciences. 2016 Sep;105(9): 2477-2488.
  • Vaithianathan et al. Effect of Common Excipients on the Oral Drug Absorption of Biopharmaceutics Classification System Class 3 Drugs Cimetidine and Acyclovir. J Pharm Sci (Sep 16, 2015)
  • Talattof A. et al. A stochastic fluid packet emptying and transit model: a physiological approach to gastrointestinal transit of fluid. AAPS, Denver, CO (2016)
  • Tsume Y. et al. The incorporation of absorptive phase into the in vivo predictive dissolution (iPD) system to predict better in vivo dissolution for ketoconazole and raloxifene. AAPS, Denver, CO (2016)
  • Yu A. et al. Modeling dynamic gastrointestinal fluid transit as a basis for dissolution and absorption. AAPS, Denver, CO (2016)

Outcomes

  • Research projects in progress

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