Developing a dissolution method requires an apparatus with associated experimental conditions capable of providing an expected outcome, in this case dissolution characteristics of a reference product. The dissolution characteristics of the reference product must be known and established independently. As, at present, there is no reference product available with known or accepted drug release characteristics, one cannot develop a dissolution method, in the true sense of the concept and/or practice of analytical chemistry.
However, this limitation may be addressed by using the concept of relative dissolution. i.e. developing a method (apparatus and associated experimental conditions) which will be capable of differentiating dissolution characteristics of approved IR and ER products of the same drug. Also, this differentiation in dissolution results should be achieved within the dosing interval of these (IR and ER) products. The practice of such an exercise will be called “dissolution method development” and such a method should be used for determining the dissolution characteristics of a test product. As a rule, an appropriate dissolution method has to be product independent.
It is important to note that a dissolution method cannot be developed using a product which is being developed. One should be careful in reading and interpreting the literature in this regard.
