25 April 2024

Understanding the Impact of Solid-State Properties on API Dissolution Performance

To investigate the causality of solid-state properties on dissolution performance and establish accurate in vitro-in vivo correlations, our Pharma Services experts have conducted comparative studies using USP Type 2 and Type 4 dissolution apparatus.

Crystalline materials are fundamental to the pharmaceutical industry, as many active pharmaceutical ingredients (APIs) are formulated in this form. Their multi-layered structure causes crystals to exhibit highly anisotropic properties, which are of significant interest to researchers aiming to understand and control them. These solid-state properties also have a substantial impact on dissolution performance. In our latest study, we analyzed the dissolution profiles of two crystal forms using USP Type 2 and Type 4 dissolution apparatus.

"Effect of Differential Surface Anisotropy on Dissolution Behavior of Fenofibrate Crystal Habits: Comparative Study using USP Type 2 and Type 4 Dissolution Apparatuses"
 
Published 09 February 2024
In Journal of Pharmaceutical Sciences, by Elsevier
 
Abstract:
“The solid-state properties of active pharmaceutical ingredient (API) have significant impact on its dissolution performance.
In the present study, two different crystal habits rod and plate shape of form I of Fenofibrate (FEN) were evaluated for dissolution profile using USP Type 2 and Type 4 apparatuses. Molecular basis of differential dissolution performance of different crystal habits was investigated. Rod (FEN-R) and plate (FEN-P) shaped crystal habits of Form I of FEN were generated using anti-solvent crystallization method. […]”

The study underscores the necessity of recognizing crystal habit as a critical material attribute (CMA) during formulation development and choosing the appropriate dissolution test setup for effective in vitro-in vivo correlation. For assistance in developing a reliable IVIVC model, please contact our Pharma Services experts.