By Satu Lakio, Ph.D., Pharmaceutical Development Manager and Professor Niklas Sandler, Chief Technology Officer
It is an established fact that the failure rate of drugs entering Phase I trials is over 90%.1 This is a staggering figure, considering the huge expense and the many years of hard work across the drug discovery and development pipeline that lie behind every investigational drug. As healthcare systems around the world continue to be challenged to create more efficient and effective therapies, there is increasing interest in methods for improving this low success rate.
A significant obstacle to the release of new medicines is the increasing complexity of drug molecules, which contributes to increased hydrophobicity and poorer water solubility. This is clear from the contrast between the solubility of drugs within the development pipeline and those that reach the market: 70–90% of pipeline drugs fall into the low solubility categories of the Biopharmaceutical Classification System (BCS). Meanwhile, fewer than 40% of drugs on the market fall under the same classification.2 With this in mind, it is apparent that technologies which can enhance drug solubility and bioavailability have great potential to improve efficiency within the drug development pipeline. Nanoparticle engineering – the process of shrinking down the size of drug particles – has emerged as a promising solution to this problem.