The objective of drug dissolution testing is to determine drug release characteristics of a product i.e. how fast or slow a drug would be released from the product reflecting its formulation and/or manufacturing attributes (properties).
In reality, however, current practices of dissolution testing seek product dependent experimental conditions, based on choices of apparatus, rpm/flow-rate and medium (its pH and strength) to attain a desired or expected dissolution rate. “True” dissolution characteristics of a product can never be known. Using current practice or approach, often multiple dissolution methods are described for the same product under different names such as bio-relevant method, discriminating method, QC method, USP method, FDA method, etc. differing in experimental conditions, each providing different dissolution results.
That is why, it is commonly referred that one should consult the authorities to establish the method and to determine if the results would be acceptable to the authorities.
For establishing “true” dissolution characteristics, like any other analytical method, a dissolution method must be product independent. Developing a product independent test leading to determining “true” dissolution characteristics of a product is relatively simple which would save significant financial and human resources compared to the current practices. For further discussion on this aspect, please see the article and details of the upcoming seminar.
