Pushing Poorly Soluble APIs Into Development

By Paul Titley, Director of Business and Commercial Development, Aesica Pharmaceuticals & Professor Peter York, Emeritus Professor of Pharmaceutics, Bradford University and Chief Scientist, CrystecPharma

Supercritical fluids technology enables the development of targets that would otherwise be unworkable

The design, development and manufacture of modern medicines pose numerous scientific and technical challenges to drug delivery and pharmaceutical companies. Increasingly, companies are finding that approaches which have traditionally been used to overcome these problems and in-house expertise available are no longer appropriate or sufficiently versatile to solve many of the emerging issues.  In this article, this issue is addressed and, by way of illustrative example, draws on the type of approach that partnerships between companies like CrystecPharma and Aesica Pharmaceuticals bring to the industry.     

The active pharmaceutical ingredients (APIs), both small molecule and macromolecules being discovered, screened and selected to be transformed into efficacious and safe medicines (albeit with reduced frequency now compared with previous decades) often require alternative, innovative strategies in order to facilitate this journey and enable new therapies to enter the market.

A number of innovative approaches for preparing and processing drug substances have emerged over recent years and a growing interest has been in drug particle design; especially given the fact that over 80% of medicines are preparations which contain solid drug particles.  There are a number of exciting new technologies which have the potential to address the urgent need for more efficacious therapies and which overcome the challenging issues faced by new and existing APIs in development or where companies are looking to extend the life of product protection through innovation