| Paul Fagan at Aptuit examines the benefits of identifying pathways and partners to accelerate poorly soluble drug candidates to early clinical studies
An ever-increasing number of development candidates brings pressure to bear on development groups who face the need to get new compounds quickly into the clinic. Many drugs are inherently poorly soluble and as such are more difficult to deliver effectively. This article highlights some current approaches for developing such molecules for use in early clinical studies and identifies the key attributes in a service provider which will ensure speed and quality of delivery to the clinic.
The last decade has brought a shift in emphasis within the pharmaceutical industry when faced with the development of candidates for Phase I and IIa studies. Where previously there was a focus on the development of formulated products which allowed rapid scale-up and support of later studies, there is a growing realisation that enabling formulations which allow key decision points to be reached more quickly can be of great value in a drug development strategy.
Such a formulation may be defined as one which will allow the clinical manufacture of the dosage form in numbers sufficient to perform clinical studies through to proof-of-concept, but which will not be scalable or commercialised. It is recognised that the principal benefit of such an approach is that of speed-to-clinic. This is of equal importance to large pharma companies working towards the selection of the best candidates in a burgeoning early development portfolio, and to the smallest biotech keen to ensure that resources are not squandered in developing formulations for what will prove to be ineffective medicines. |
