A common query concerning a dissolution test is how one should conduct the test for a drug. Further, in response to such queries, different suggestions are made for choosing the apparatus, rpm, medium etc. However, unfortunately, such queries and responses lack scientific merit and logical thinking. The reason is that a dissolution test is conducted for a product and not for a drug (active ingredient). That is why pharmacopeial monographs, particularly USP, do not have dissolution tests under drugs (active ingredients) but products.
Therefore, one can only suggest a testing procedure for products and not for drugs. Further, a testing procedure is not, or should not, be linked to a product because testing is done to evaluate a product. Therefore, the procedure must be product-independent. The question then becomes how one should set up the experimental conditions. The answer is that the dissolution testing conditions should reflect the GI tract environment, particularly intestinal. As the GI tract environment does not change from product to product, the testing procedure should be fixed.
A typical testing environment may be water maintained at 37 °C, with some solubiliser to dissolve low aqueous solubility drugs and a simple stirring mechanism that should provide efficient/thorough product-medium interaction. It is hoped that this suggestion will help in answering the common and frequent queries.