<i>In Vitro</i>–<i>In Vivo</i> Correlation-Based Evaluation of Bioequivalence in Commercial Paracetamol Brands in Nigeria
DOI:
https://doi.org/10.51412/psnnjp.2025.33Keywords:
paracetamol, bioequivalence, convolution, in vitro-in vivo correlation, AUC, CmaxAbstract
Background: Paracetamol is a widely used over-the-counter analgesic and antipyretic in Nigeria. Ensuring the quality and therapeutic consistency of oral paracetamol products is a critical public health concern. Bioequivalence assessment is essential to confirm that generic drugs match the reference product in terms of rate and extent of systemic drug exposure.
Methodology: This study employed a convolution-based in vitro-in vivo correlation (IVIVC) model to evaluate the bioequivalence of 18 commercial paracetamol tablet brands marketed in Nigeria. The physicochemical properties of the tablets were evaluated, and in vitro dissolution tests were conducted. The IVIVC model was used to predict the pharmacokinetic parameters of the tablets.
Results: While most products met basic pharmacopeia standards for assay, disintegration and dissolution, none reached full bioequivalence when compared to worldwide regulatory benchmarks for systemic exposure. Although C estimates were acceptable for the majority, all generics had high max AUC prediction errors, ranging up to 51.8 % indicating potential underexposure and treatment
variability.
Conclusions: The findings emphasize the limits of using only in vitro testing to determine therapeutic equivalency, particularly for medicines with fast absorption and broad use, such as paracetamol. Regulatory authorities should consider incorporating IVIVC-based assessments and dissolution similarity indicators into routine post-market surveillance to ensure the quality and efficacy of paracetamol products.
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