Background

 

The objective of dissolution testing is to establish the drug dissolution/release characteristics of a product. However, current practices do not provide such an answer, but suggest choices in selecting experimental conditions to achieve or set desired dissolution results/characteristics of products. Thus, the current practices appear to defeat the purpose of dissolution testing.

The only way the objective of dissolution testing can be achieved is to have some sort of common experimental conditions. Significant work has been done and published for developing such common experimental conditions. The main difference in the current practices and the suggested approach is that of the use of a different type of spindle (stirrer), known as crescent-shaped or brush spindle.

The new spindle has not been officially recognized, however, provides a simple, efficient and product independent approach in determining drug dissolution/release characteristics of a product. Even without official recognition, the spindle may be employed to facilitate developing dissolution test conditions using traditional apparatuses such as Paddle and Basket. This may be achieved by conducting a dissolution test using a single set of experimental conditions with crescent-shaped spindle to establish the drug dissolution characteristics of the product. The observed dissolution characteristics then may be used as reference to obtain experimental conditions using Paddle or Basket apparatus for complying with the regulatory requirements.