Are people using drug dissolution testing for product development? Not really!

The title of the post is a bit catchy but is factually 100% correct, i.e., no one is using dissolution testing for product development, as explained below:

Suppose a formulator would like to develop a product having a certain dissolution characteristic/profile. The product is to be developed for human use; therefore, the target dissolution characteristic/profile should also be relevant to humans. With this objective in mind, the formulator proceeds to develop a product by mixing some ingredients/excipients and compressing it into tablets, referred to as product “A.” However, the formulator realizes that perhaps all he/she must do is compress the pure drug (powder) into tablets, which might give the desired dissolution characteristic. So, he/she compresses the drug powder into tablets as well, referred to as product “B.” Now the formulator would like to determine/compare dissolution characteristics of these tablets, i.e., if they are able to provide the desirable characteristics or require some adjustments. For this purpose, the formulator requires a dissolution test/method (apparatus and associated experimental conditions). Unfortunately, currently, no such test/method exists. Therefore, a formulator cannot determine the dissolution characteristics of the products and thus cannot develop a product having a desired characteristic. Read the rest of this entry �

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