ArticleAAPS PharmSciTech2025
Application of Physiologically Based Biopharmaceutics Modeling (PBBM) to Establish Clinically Relevant Dissolution Specifications for a Prolonged Release Tablet Formulation of Verapamil, a BCS Class I Drug.
Article in AAPS PharmSciTech, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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Who cites it
1 citing paper in PubMed.
- Development of in vitro-in vivo correlation for establishing patient-centric quality standards of dissolution for lamotrigine extended-release tablets.European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V · 2025Article
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Authors and funding
2 authors.
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Abstract
Our work aimed at setting clinically relevant dissolution specifications for a prolonged release formulation of verapamil, a BCS Class I drug. We have used a two-pronged approach- a Level A IVIVC correlation supplemented with virtual bioequivalence assessment using Physiologically based biopharmaceutics modelling (PBBM). Dissolution studies were performed for two batches, Medium-release (BE batch) and Slow-release (non-BE batch), using a biorelevant method. Mechanistic absorption deconvolution method was used to obtain the in vivo release profiles and correlate with the respective in vitro release profiles to develop the IVIVC. Theoretical dissolution profiles for upper and lower limits were generated and used for convolution and calculation of Percent prediction errors (%PE). This was supplemented with virtual bioequivalence (VBE) assessments at each level to select clinically relevant dissolution specifications. A two-step deconvolution-correlation method resulted in a linear Level A IVIVC with R
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