Interested in bioequivalence testing?
Have you heard about simultaneous dissolution and flux testing?
Here is a study that posits that traditional dissolution testing methods, while useful for comparing the performance of different generic drug formulations, may not always accurately predict their in vivo behavior, particularly for poorly water-soluble active pharmaceutical ingredients (APIs). The discrepancies arise due to various formulation additives that enhance dissolution but can also significantly alter drug absorption characteristics.
To investigate this, the study utilized the Rainbow and Flux apparatuses - systems that allow simultaneous monitoring of dissolution and flux, (a proxy for passive membrane permeability,) in a controlled, in vitro environment. By employing this system, the study seeks to elucidate the interplay between dissolution and permeability for formulations, intended to enhance drug absorption.
Key objectives include:
1. Dissolution and Absorption Correlation: To generate data that bridge the gap between in vitro dissolution profiles and the actual absorption rates of drugs when administered, thereby providing a more comprehensive understanding of drug bioavailability.
2. Additive Effects: To assess how various formulation components, like surfactants and polymers, affect not only the dissolution rate but also the permeation of the drug through biological membranes, which is crucial for accurate bioequivalence assessments.
3. Predictive Modeling: To establish a predictive model that can be utilized in early formulation development stages, allowing for more informed decision-making regarding which formulations are likely to exhibit bioequivalence in later studies.
Ultimately, the findings from the simultaneous dissolution-flux studies aim to support regulatory submissions by providing enhanced predictive power concerning the clinical performance of generic drug formulations, thereby improving the efficiency and reliability of the bioequivalence study process. This methodological shift could pave the way for more accurate and representative in vitro tests that could better predict in vivo outcomes.
Get the full application note or contact us today to learn more.
SEE ALSO: Prediction of Bioequivalence and Food Effect Using Flux- and Solubility-Based Methods
