Enhancing the Value Proposition of Small Molecule Pharmaceuticals

Small molecules have provided medical breakthroughs for human diseases for over a century. As in any R&D endeavor, science gains momentum with time, and the accretive knowledge of research is due to the collective efforts of many talented scientists and engineers. However, as new knowledge is gathered, it is equally important to integrate it with existing paradigms to make our processes and products more cost-efficient and robust. Small molecule-based drug development is a prime example of an area that can benefit tremendously from such an inclusive and integrative approach. During the design of a dosage form, formulators need to take into consideration challenges associated with stability, bioavailability, manufacturability, acceptability, and business acuity. A formulator must aim to address all of these critical areas, no matter the drug product’s development stage. The failure to address any of these elements can lead to significant manufacturing and performance issues that may not be discovered till late in the development cycle. A formulator needs to realize that decisions made during the design phase of a product’s development determine most of the costs of manufacturing that product. As the design and manufacturing processes become more complex and scale, the formulator will increasingly be called upon to make decisions that involve a significant investment of time, people, and money. Each of these decisions cannot be made in isolation, and a balance must be struck each time to ensure that none of the other design rules of stability, bioavailability, manufacturability, and acceptability are violated. Poor product design without the foresight of scale-up, marketing, and global compliance may lead to wasting precious resources that could have been invested in the company’s pipeline. Embracing new manufacturing philosophies and technologies such as continuous manufacturing, additive manufacturing, artificial intelligence, and Six Sigma pharmaceutical quality can also enhance the value proposition of small molecule-based drug development.