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Establishing Clinically Relevant Specifications for Carbamazepine Tablets Using Physiologically Based Pharmacokinetic Modeling
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Journal Article
Establishing Clinically Relevant Specifications for Carbamazepine Tablets Using Physiologically Based Pharmacokinetic Modeling
2025
Overview
The purpose of this study was to establish a clinically relevant specification for carbamazepine (CBZ) tablets, a classic narrow therapeutic index drug (NTID), within the Chinese population. By integrating physiologically based pharmacokinetic (PBPK) modeling with
in vitro
dissolution profiles and corresponding pharmacokinetic (PK) data, we developed an
in vitro-in vivo
relationship (IVIVR) by selecting an appropriate dissolution model, and the IVIVR model was validated using
in vitro
and
in vivo
data from external sources to ensure the reliability of the method. Parameter sensitivity analysis was used to examine how the critical parameters influence the drug's absorption fraction (F
a
). Additionally, the sensitivity of T
max
, C
max
, and AUC to physiological and formulation parameters was quantitatively evaluated. Based on the validated model, we also developed and validated a virtual bioequivalence (VBE) approach. Additionally, the safety space of the dissolution (Q
60 min
≥ 80% meanwhile 50% ≤ Q
15 min
≤ 85% and the assay (95 ~ 105%) for carbamazepine tablets (100 mg) were successfully explored depending on the VBE study. This study provides a valuable reference for establishing clinically relevant specifications for NTIDs through PBPK model-informed research.
Graphical Abstract
Publisher
Springer International Publishing,Springer,Springer Nature B.V
