Many of the excipients we use today have been around for more than fifty years. In many cases, the specifications for those excipients have not changed much over the years, either. During that time, we have not really thought about what happens when our existing excipients, and/or their specifications, are no longer able to provide us with the necessary performance to allow effective medicines to be
formulated, developed and manufactured on a routine basis. Things are changing!
We have moved into a new era. With the advent of combinatorial chemistry,
high-throughput screening, recombinant technologies and better understanding of
proteins, drug-receptor interactions, monoclonal antibodies, and the like, today we
have very sophisticated tools which help us to discover very effective drugs we could hardly imagine fifty years ago. However, innovation in excipients has not kept pace with the advances in drug discovery.