In defense of a rational approach to formulation design and development for oral solid dosage forms.

Abstract

There have been quite dramatic changes in new drug development over the past 40 years, e.g., the number of poorly water-soluble drug molecules has increased, and new drug development is no longer the preserve of established pharmaceutical companies. Along with these changes, there have also been the increase in contracting organizations and venture capital funding. There is pressure to shorten development times, particularly in early stage development for Phase I clinical (first-in-human) studies. There is now increased interest in very simple formulations to reduce the time to the initiation of the Phase I studies. This need for speed has to be balanced by a sufficient understanding of the biopharmaceutical properties of the new drug molecule in order to determine whether or not a simple drug in a capsule approach will be appropriate. Without this understanding, much effort will be wasted and potentially useful new drugs may be discarded.