Drug dissolution testing is commonly performed using vessel based apparatuses with Paddle/Basket spindles. The objective of testing is to establish dissolution or release characteristics of a test product.
Current practices, however, seek and provide experimental conditions such as choice of spindle, rpm, dissolution medium (nature and strength) to define such characteristics based on analysts’ expectations. Another way of saying the same thing is that, an analyst sets the experimental conditions to obtain desired quality of results, or products, e.g. less variable, discriminatory or not, slow or fast, bio-relevant or not. The analyst would never know the actual release characteristics of a product, thus its quality.
The reason for such inadequacy with the use of Paddle/Basket is that they do not provide an efficient mixing and stirring environment within dissolution vessels, the most critical and necessary process for the dissolution itself. Therefore, their future use certainly warrants caution.
