Solid-State Pharmaceutical Sciences: Past, Present and Future

Speaker:
Susan M. Reutzel-Edens, PhD, FRSC
Senior Research Advisor, Small Molecule Design & Development
Eli Lilly

Abstract:

Understanding both the solid-state chemistry and material properties of a drug molecule is essential to the development of a medicine. However, solid-state pharmaceutical science as a discipline was largely unrecognized in some sectors even two or three decades ago. The realization that solid forms and their properties could no longer be ignored in the design of a drug product came with highly publicized product failures, increased regulatory expectations and the ever-changing legal environment. Dedicated groups emerged in academia and across the industry committed to studying the structures and properties of drugs. Significant investments were made in advanced analytical technologies for structure determination and property characterization, as well as high-throughput screening automation. The ability to control material properties at the molecular, microscopic and macroscopic level fueled interest in crystal and particle engineering as a way to alleviate manufacturability concerns, improve shelf stability and other properties, and address the growing problem of poor water solubility of small molecule drugs. While great progress has been made toward the ultimate goal of designing functional drug materials, the pharmaceutical industry, under immense pressure to shorten development timelines and reduce costs, continues to this day to look for ways to minimize the experimental footprint and expense of developing pharmaceutical solids. This has led to parallelization, miniaturization, and in some cases, elimination of experiments, outsourcing of solid-state development activities to contract research laboratories, and in recent years, to materials design through computational chemistry, modeling and simulation. In this presentation, key events, which have put solid-state pharmaceutical science on the map of scientific disciplines critical to the pharmaceutical industry, will be discussed. The state-of-the-art in solid form development will also be examined, with a look into the future state of digital drug product design.