Establishing In Vitro-In Vivo Correlation (IVIVC) for Formulations of Vitamin C and Iron in Daily Plus Tablets
Year: 2025
Type: article
Abstract: Introduction: The aim of this study was to establish an in vitro-in vivo correlation (IVIVC) model for ferrous fumarate (iron) and ascorbic acid (vitamin C).Methods: In vitro dissolution data from 13 samples of a multinutrient botanical formulation containing iron and vitamin C (Daily Plus extended-release tablets) were analyzed using mathematical models to estimate the absorption kinetics of vitamin C and iron in vivo following oral administration.Plasma concentrations were estimated for both iron and vitamin C from the generated models.Results: Our analysis revealed a quadratic and a linear relationship between in vivo absorption and in vitro dissolution rates for both vitamin C and iron, respectively, indicating that the dissolution rate of these compounds in vitro is a critical factor affecting their absorption kinetics in vivo.Furthermore, we found that the IVIVC model correlation is specific to the formulation, as different formulations may have different absorption kinetics and IVIVC models.By leveraging this quadratic relationship, we were able to make precise predictions of the entire pharmacokinetic profile based solely on in vitro dissolution data for the formulation.Conclusion: A robust IVIVC (level A) was established for vitamin C and iron release from Daily Plus tablets.This correlation can serve as a surrogate bioequivalence studies.
Source: Dissolution Technologies
DOI: 10.14227/dt320225p82
Authors: Abha Saxena, Siranjeevi Gurumani, Madhusmita Mahapatra, Charulata Prasannan, Aparna Damle, Shyam Ramakrishnan, Palaniyamma Durairaj, Vivek Parashar, Mohit Gusain, Venkatesh V. Kareenhalli
Institution: Indian Institute of Technology Bombay
Language: English
Subfield: Pharmaceutical Science
Domain: Life Sciences
Open Access status: bronze
OpenAlex ID: W4410635336