Often analysts face a dilemma as to how to approach the situations mentioned above, 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 only associated with that test product. If the expectation of dissolution results are changed or change is made to the product (formulation/manufacturing), the test would require a different set of 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 that does not change from product to product. The physiologically relevant method provides appropriate and unbiased dissolution characteristics of the products and 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 answer the above-mentioned situations and significantly simplify dissolution testing in general.