Often analysts face a dilemma as how to approach the above mentioned situations, which appear to be quite common in the industry. Such situations arise because of the current practices of developing and using product specific experimental conditions such as apparatuses, rpm, media etc. The experimental conditions are set by obtaining desired or expected drug release characteristics of the test product which are associated with that test product only. If the expectation of dissolution results are changed or change is made to the product (formulation/manufacturing), the test would require different set experimental conditions, reflecting new expectations. In short, the current practices do not provide true dissolution characteristics of products.
To avoid such a situation, or developing a modified method, one should develop a product independent method based on a physiologically relevant environment which does not change from product to product. The physiologically relevant method not only provides appropriate and unbiased dissolution characteristics of the products, but also frees the analyst from a constant struggle of looking into altering and selecting experimental conditions.
There are suggestions in the literature (1, 2, 3) for conducting physiologically relevant tests independent of products, which may provide answers to the above mentioned situations and significantly simplify dissolution testing in general.
