Biorelevant Dissolution/Release Test Method Development for Pharmaceutical Dosage Forms

This chapter provides an overview of biorelevant drug dissolution/release method development for pharmaceutical systems for various routes of drug delivery. The information provided attempt to narrow the gap between theoretical (ideal) expectations and practical approaches that should be considered while developing such a method. In so doing, the chapter also presents a roadmap for the scientists working in this discipline for developing a biorelevant dissolution method that is practical, scientifically sound with enhanced capability to predict bioefficacy yet regulatory friendly to support the functional performance of the product and its QC considerations. The quality, safety, and efficacy of an inhaled product are based on the actual dose delivered and its deposition at the target region of the lungs. As a result, the most important step for in vitro performance testing of inhalation products is the delivery of a given drug from the delivery device and its deposition at the target site of the lung.