Surprisingly, yes!
When it comes to dissolution testing, USP Apparatus 1 (basket) and USP Apparatus 2 (paddle) are the go-to compendial apparatuses, especially for solid immediate-release forms.
Since differences in hydrodynamic conditions can cause variability in dissolution results, understanding these dynamics is crucial. Researchers have been exploring this topic for years.
USP Apparatus 1: An Overview
While there's been a lot of research on USP Apparatus 2, USP Apparatus 1 hasn't received as much attention. USP Apparatus 1 is a cylindrical glass vessel with a hemispherical bottom and a wire basket rotating at a constant speed. Baskets with different wire openings, such as 10, 20, and 80 mesh, can be used instead of the standard 40 mesh.
Interesting Study on Basket Mesh Sizes
A fascinating study by C.Sirasitthichoke and colleagues examined how different basket mesh sizes (10, 20, and 40) affect hydrodynamics in USP Apparatus 1. They used Particle Image Velocimetry (PIV) to map out velocity profiles in different parts of the vessel, depending on the basket mesh size.
Key Findings
1. Flow Patterns: Flow patterns were similar across different mesh sizes.
2. Velocity Changes: Radial and axial velocities generally increased with larger mesh openings.
3. Agitation Speed: Increasing the agitation speed of the basket sped up the overall velocities under the basket, where drug fragments typically settle.
4. Medium Flow: Dissolution medium flow through the basket varied significantly with mesh size:
- 4 ml/s for the 40-mesh basket
- 7 ml/s for the 10-mesh basket
5. Dissolution Impact: While the study didn't test actual drug dissolution, larger mesh sizes likely lead to faster dissolution due to stronger currents in the dissolution medium.
Conclusion
When developing a drug, it’s important to carefully choose the basket mesh size for dissolution testing to ensure accurate results.
Have you ever noticed a difference in your dissolution results based on basket mesh size? Share your experiences!
Read also:
- Statistical Analysis Practice in Dissolution Profile Comparison
- Non-Sink Conditions in Dissolution Testing
- Coning in Dissolution Vessels
