ArticleCPT: pharmacometrics & systems pharmacology2026
Development of a Predictive Flow Through Cell Dissolution Method for Carbamazepine Modified-Release Tablets.
Article in CPT: pharmacometrics & systems pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Predictive in vitro dissolution methods are crucial for anticipating in vivo drug performance, particularly for poorly soluble drugs like carbamazepine. In vitro-in vivo correlations (IVIVC) link dissolution characteristics to pharmacokinetics, facilitating bioequivalence studies and reducing reliance on clinical trials. This study aimed to develop a predictive in vitro dissolution method using USP Apparatus 4 for a modified-release carbamazepine formulation, optimizing dissolution conditions by using principles of the IVIVC methodology. A Box-Behnken experimental design optimized dissolution parameters, including sodium lauryl sulfate concentration, flow rate, and glass bead quantity. IVIVC was assessed for a single formulation, using the Wagner-Nelson deconvolution method and a two-step scaling approach involving Levy plot transformation and time-scale alignment. Gohel's reconvolution equation predicted absorbed fractions and plasma concentrations. The method's discriminatory power was evaluated using immediate-release (IR) and modified-release (MR) carbamazepine formulations. The refined IVIVC model achieved r
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