Clinical Dosage Form Development or an Early Approach to Achieve Peak Sales Step #1

Courtesy of SommaTech

Pharmaceutical Development continues to present many fundamental challenges when dealing with promising drug lead opportunities. This is a factor across all therapeutic areas from Central Nervous System (CNS) to oncology. In an effort to design new molecular entities which are increasingly effective while minimizing unwanted side effects we at times create drug compounds which are poorly soluble or are unstable and difficult to handle during manufacture. While these issues are primarily physicochemical in nature we further complicate the situation by not applying proven techniques during the early phase development of the clinical dosage form to be used in our development program. The thinking here being that we need to minimize early investment while conducting these early studies with the expectation to correct these interim clinical dosage form shortcomings as we approach late phase and commercialization.  This is a flawed approach and ultimately leads to product and process failures during subsequent late phase efforts. How a firm manages the initial steps during development and compound identification may maximize commercial success or set a course for a series of missed opportunities. Success is not necessarily the first to market but rather the first product to achieve peak sales and market dominance. In this series of blogs we plan to touch upon several aspects which will aid formulators, process engineers and project leaders to consider during early phase development leading to late phase and commercialization.

 


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