20 febrero 2025

Optimizing Low-Volume Dissolution

In pharmaceutical development, low-volume dissolution testing is essential for evaluating drug release under limited sample conditions, particularly in research involving highly potent compounds, low-dose formulations, and limited API applications.

This process presents unique challenges, including sensitivity limitations, reproducibility concerns, and complexities in method development.

Mini vessels play a critical role in dissolution testing for small-volume applications, providing precise drug release insights for specialized formulations. However, in their most common configurations, mini vessels are merely scaled-down versions of the standard USP Apparatus 2, facing similar hydrodynamic challenges.

Flow-through dissolution (USP Apparatus 4) is a leading technique for overcoming these challenges, offering greater control over hydrodynamics and improved reproducibility in low-volume applications. Our latest application note explores key considerations for low-volume dissolution, compares available techniques—including flow-through dissolution—and highlights innovative solutions to enhance accuracy and efficiency.

Read the detailed application note entitled "Low-Volume Dissolution Testing - Mini Vessels and the Superior Role of USP Apparatus 4".