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Gestational changes in buprenorphine exposure: A physiologically-based pharmacokinetic analysis.
Hongfei Zhang1, Hari V Kalluri1, Jaime R Bastian2
1University of Pittsburgh, Department of Pharmaceutical Sciences, School of Pharmacy, Pittsburgh, PA.
British Journal of Clinical Pharmacology
|June 7, 2018
Summary
This study developed a pharmacokinetic model to predict buprenorphine (BUP) exposure in pregnant women. The model accurately forecasts BUP levels, aiding in optimized treatment for opioid addiction during pregnancy.
Area of Science:
- Pharmacology
- Pharmacokinetics
- Maternal-Fetal Medicine
Background:
- Buprenorphine (BUP) is FDA-approved for opioid addiction treatment.
- Current dosing for pregnant women relies on adult nonpregnant data.
- Pregnancy-induced physiological changes may affect BUP exposure and efficacy.
Purpose of the Study:
- Develop a physiologically-based pharmacokinetic (PBPK) model for BUP in pregnant women.
- Predict BUP exposure across pregnancy stages.
- Demonstrate PBPK modeling's utility in optimizing BUP pharmacotherapy during pregnancy.
Main Methods:
- A PBPK model for BUP was built and validated in healthy subjects.
- A fetoplacental compartment was incorporated to simulate pregnancy changes.
- Gestational physiological changes were integrated; model predictions were compared to clinical data.
Main Results:
- Predicted BUP plasma concentration-time profiles align with observed data in the 2nd and 3rd trimesters and postpartum.
- Differences in predicted vs. observed drug exposure metrics were generally within ±25%.
Conclusions:
- PBPK model-based simulation can optimize BUP pharmacotherapy during pregnancy.
- This approach may reduce the need for intensive blood sampling in pharmacokinetic studies across trimesters.
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