Potential for pharmacokinetic interactions between Schisandra sphenanthera and bosutinib, but not imatinib: in vitro metabolism study combined with a physiologically‐based pharmacokinetic modelling approach
Aims This study aimed to investigate the potential interaction between Schisandra sphenanthera, imatinib and bosutinib combining in vitro and in silico methods. Methods In vitro metabolism of imatinib and bosutinib using recombinant enzymes and human liver microsomes were investigated in the presenc...
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| Veröffentlicht in: | British journal of clinical pharmacology Jg. 86; H. 10; S. 2080 - 2094 |
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| Format: | Journal Article |
| Sprache: | Englisch |
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John Wiley and Sons Inc
01.10.2020
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| ISSN: | 0306-5251, 1365-2125, 1365-2125 |
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| Abstract | Aims
This study aimed to investigate the potential interaction between Schisandra sphenanthera, imatinib and bosutinib combining in vitro and in silico methods.
Methods
In vitro metabolism of imatinib and bosutinib using recombinant enzymes and human liver microsomes were investigated in the presence and absence of Schisandra lignans. Physiologically‐based pharmacokinetic (PBPK) models for the lignans accounting for reversible and mechanism‐based inhibitions and induction of CYP3A enzymes were built in the Simcyp Simulator (version 17) and evaluated for their capability to predict interactions with midazolam and tacrolimus. Their potential effect on systemic exposures of imatinib and bosutinib were predicted using PBPK in silico simulations.
Results
Schisantherin A and schisandrol B, but not schisandrin A, potently inhibited CYP3A4‐mediated metabolism of imatinib and bosutinib. All three compounds showed a strong reversible inhibition on CYP2C8 enzyme with ki of less than 0.5 μmol L−1. The verified PBPK models were able to describe the increase in systemic exposure of midazolam and tacrolimus due to co‐administration of S. sphenanthera, consistent with the reported changes in the corresponding clinical interaction study (AUC ratio of 2.0 vs 2.1 and 2.4 vs 2.1, respectively). The PBPK simulation predicted that at recommended dosing regimens of S. sphenanthera, co‐administration would result in an increase in bosutinib exposure (AUC ratio 3.0) but not in imatinib exposure.
Conclusion
PBPK models for Schisandra lignans were successfully developed. Interaction between imatinib and Schisandra lignans was unlikely to be of clinical importance. Conversely, S. sphenanthera at a clinically‐relevant dose results in a predicted three‐fold increase in bosutinib systemic exposure. |
|---|---|
| AbstractList | Aims
This study aimed to investigate the potential interaction between Schisandra sphenanthera, imatinib and bosutinib combining in vitro and in silico methods.
Methods
In vitro metabolism of imatinib and bosutinib using recombinant enzymes and human liver microsomes were investigated in the presence and absence of Schisandra lignans. Physiologically‐based pharmacokinetic (PBPK) models for the lignans accounting for reversible and mechanism‐based inhibitions and induction of CYP3A enzymes were built in the Simcyp Simulator (version 17) and evaluated for their capability to predict interactions with midazolam and tacrolimus. Their potential effect on systemic exposures of imatinib and bosutinib were predicted using PBPK in silico simulations.
Results
Schisantherin A and schisandrol B, but not schisandrin A, potently inhibited CYP3A4‐mediated metabolism of imatinib and bosutinib. All three compounds showed a strong reversible inhibition on CYP2C8 enzyme with ki of less than 0.5 μmol L−1. The verified PBPK models were able to describe the increase in systemic exposure of midazolam and tacrolimus due to co‐administration of S. sphenanthera, consistent with the reported changes in the corresponding clinical interaction study (AUC ratio of 2.0 vs 2.1 and 2.4 vs 2.1, respectively). The PBPK simulation predicted that at recommended dosing regimens of S. sphenanthera, co‐administration would result in an increase in bosutinib exposure (AUC ratio 3.0) but not in imatinib exposure.
Conclusion
PBPK models for Schisandra lignans were successfully developed. Interaction between imatinib and Schisandra lignans was unlikely to be of clinical importance. Conversely, S. sphenanthera at a clinically‐relevant dose results in a predicted three‐fold increase in bosutinib systemic exposure. This study aimed to investigate the potential interaction between Schisandra sphenanthera, imatinib and bosutinib combining in vitro and in silico methods. In vitro metabolism of imatinib and bosutinib using recombinant enzymes and human liver microsomes were investigated in the presence and absence of Schisandra lignans. Physiologically-based pharmacokinetic (PBPK) models for the lignans accounting for reversible and mechanism-based inhibitions and induction of CYP3A enzymes were built in the Simcyp Simulator (version 17) and evaluated for their capability to predict interactions with midazolam and tacrolimus. Their potential effect on systemic exposures of imatinib and bosutinib were predicted using PBPK in silico simulations. Schisantherin A and schisandrol B, but not schisandrin A, potently inhibited CYP3A4-mediated metabolism of imatinib and bosutinib. All three compounds showed a strong reversible inhibition on CYP2C8 enzyme with k of less than 0.5 μmol L . The verified PBPK models were able to describe the increase in systemic exposure of midazolam and tacrolimus due to co-administration of S. sphenanthera, consistent with the reported changes in the corresponding clinical interaction study (AUC ratio of 2.0 vs 2.1 and 2.4 vs 2.1, respectively). The PBPK simulation predicted that at recommended dosing regimens of S. sphenanthera, co-administration would result in an increase in bosutinib exposure (AUC ratio 3.0) but not in imatinib exposure. PBPK models for Schisandra lignans were successfully developed. Interaction between imatinib and Schisandra lignans was unlikely to be of clinical importance. Conversely, S. sphenanthera at a clinically-relevant dose results in a predicted three-fold increase in bosutinib systemic exposure. This study aimed to investigate the potential interaction between Schisandra sphenanthera, imatinib and bosutinib combining in vitro and in silico methods.AIMSThis study aimed to investigate the potential interaction between Schisandra sphenanthera, imatinib and bosutinib combining in vitro and in silico methods.In vitro metabolism of imatinib and bosutinib using recombinant enzymes and human liver microsomes were investigated in the presence and absence of Schisandra lignans. Physiologically-based pharmacokinetic (PBPK) models for the lignans accounting for reversible and mechanism-based inhibitions and induction of CYP3A enzymes were built in the Simcyp Simulator (version 17) and evaluated for their capability to predict interactions with midazolam and tacrolimus. Their potential effect on systemic exposures of imatinib and bosutinib were predicted using PBPK in silico simulations.METHODSIn vitro metabolism of imatinib and bosutinib using recombinant enzymes and human liver microsomes were investigated in the presence and absence of Schisandra lignans. Physiologically-based pharmacokinetic (PBPK) models for the lignans accounting for reversible and mechanism-based inhibitions and induction of CYP3A enzymes were built in the Simcyp Simulator (version 17) and evaluated for their capability to predict interactions with midazolam and tacrolimus. Their potential effect on systemic exposures of imatinib and bosutinib were predicted using PBPK in silico simulations.Schisantherin A and schisandrol B, but not schisandrin A, potently inhibited CYP3A4-mediated metabolism of imatinib and bosutinib. All three compounds showed a strong reversible inhibition on CYP2C8 enzyme with ki of less than 0.5 μmol L-1 . The verified PBPK models were able to describe the increase in systemic exposure of midazolam and tacrolimus due to co-administration of S. sphenanthera, consistent with the reported changes in the corresponding clinical interaction study (AUC ratio of 2.0 vs 2.1 and 2.4 vs 2.1, respectively). The PBPK simulation predicted that at recommended dosing regimens of S. sphenanthera, co-administration would result in an increase in bosutinib exposure (AUC ratio 3.0) but not in imatinib exposure.RESULTSSchisantherin A and schisandrol B, but not schisandrin A, potently inhibited CYP3A4-mediated metabolism of imatinib and bosutinib. All three compounds showed a strong reversible inhibition on CYP2C8 enzyme with ki of less than 0.5 μmol L-1 . The verified PBPK models were able to describe the increase in systemic exposure of midazolam and tacrolimus due to co-administration of S. sphenanthera, consistent with the reported changes in the corresponding clinical interaction study (AUC ratio of 2.0 vs 2.1 and 2.4 vs 2.1, respectively). The PBPK simulation predicted that at recommended dosing regimens of S. sphenanthera, co-administration would result in an increase in bosutinib exposure (AUC ratio 3.0) but not in imatinib exposure.PBPK models for Schisandra lignans were successfully developed. Interaction between imatinib and Schisandra lignans was unlikely to be of clinical importance. Conversely, S. sphenanthera at a clinically-relevant dose results in a predicted three-fold increase in bosutinib systemic exposure.CONCLUSIONPBPK models for Schisandra lignans were successfully developed. Interaction between imatinib and Schisandra lignans was unlikely to be of clinical importance. Conversely, S. sphenanthera at a clinically-relevant dose results in a predicted three-fold increase in bosutinib systemic exposure. |
| Author | Boddy, Alan V. McLachlan, Andrew J. Adiwidjaja, Jeffry |
| AuthorAffiliation | 3 University of South Australia Cancer Research Institute University of South Australia Adelaide SA Australia 1 Sydney Pharmacy School The University of Sydney Sydney NSW Australia 2 School of Pharmacy and Medical Sciences University of South Australia Adelaide SA Australia |
| AuthorAffiliation_xml | – name: 2 School of Pharmacy and Medical Sciences University of South Australia Adelaide SA Australia – name: 1 Sydney Pharmacy School The University of Sydney Sydney NSW Australia – name: 3 University of South Australia Cancer Research Institute University of South Australia Adelaide SA Australia |
| Author_xml | – sequence: 1 givenname: Jeffry orcidid: 0000-0002-6781-2113 surname: Adiwidjaja fullname: Adiwidjaja, Jeffry organization: The University of Sydney – sequence: 2 givenname: Alan V. orcidid: 0000-0002-8920-9286 surname: Boddy fullname: Boddy, Alan V. organization: University of South Australia – sequence: 3 givenname: Andrew J. orcidid: 0000-0003-4674-0242 surname: McLachlan fullname: McLachlan, Andrew J. email: andrew.mclachlan@sydney.edu.au organization: The University of Sydney |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/32250458$$D View this record in MEDLINE/PubMed |
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| Keywords | physiologically-based pharmacokinetic (PBPK) modelling and simulation herb-drug interactions drug metabolism |
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This study aimed to investigate the potential interaction between Schisandra sphenanthera, imatinib and bosutinib combining in vitro and in silico... This study aimed to investigate the potential interaction between Schisandra sphenanthera, imatinib and bosutinib combining in vitro and in silico methods. In... This study aimed to investigate the potential interaction between Schisandra sphenanthera, imatinib and bosutinib combining in vitro and in silico... |
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| SubjectTerms | drug metabolism herb–drug interactions modelling and simulation Original physiologically‐based pharmacokinetic (PBPK) |
| Title | Potential for pharmacokinetic interactions between Schisandra sphenanthera and bosutinib, but not imatinib: in vitro metabolism study combined with a physiologically‐based pharmacokinetic modelling approach |
| URI | https://onlinelibrary.wiley.com/doi/abs/10.1111%2Fbcp.14303 https://www.ncbi.nlm.nih.gov/pubmed/32250458 https://www.proquest.com/docview/2386433221 https://pubmed.ncbi.nlm.nih.gov/PMC7495297 |
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