Bioequivalence, Dissolution & Biowaivers

Dissolution testing has been around for some 50 years. During that period we have put a man on the moon, we have made huge advances in computer software and hardware and have moved from vinyl through open reel tapes, cassettes, CD's and mpeg in terms of recording, and yet most dissolution testing is carried out on essentially the same equipment that was introduced into the Pharmaopias back in the '70's.  However the regulatory authorities are demanding more and more data and interpretation of that data derived from equipment that was never intended as anything beyond a relatively crude quality control technique.

It is not surprising therefore that chemists, formulators and regulatory staff are still battling to provide answers to many of the regulatory demands. In order to meet these challenges it is necessary to understand the limitations of the equipment and the dosage form-equipment artifacts that can be created. Unfortunately very often dissolution testing suffers from the classic problem of silo thinking. The analytical chemist (dissolution scientist) looks at the test as a physicochemical process, often not understanding the principles involved in formulating products and the formulator looks at the results as a set of numbers which may or may not satisfy what may appear to be arbitrary requirements of QA or regulatory departments. This is all without even starting on the question as to the relevance or correlation with what is actually happening to the product in the patient.

This course will attempt to tear down the walls of these silos. We will be looking at dissolution from the limitations of the testing procedures, the way different formulations behave in test procedures through to the concepts of pharmacokinetics and the regulatory requirements for submission for marketing authorization.

by Malcolm Ross, President at Generapharm, Switzerland