How integrating pharmaceutical development and clinical testing can maximize Phase 1 success
- How pharmaceutical spray drying can overcome poor drug solubility
- How to develop solid oral dosage forms containing spray-dried dispersions
- The benefits of integrating GMP manufacturing and clinical testing to drive development efficiency
- Optimising and validating drug product performance based on clinical data
Overcoming poor drug solubility is a common and challenging task facing the formulation scientist today. Over 70% of new chemical entities are reported to have this characteristic which can result in suboptimal oral bioavailability and an inability to demonstrate the therapeutic potential of the candidate drug.
This webinar will focus on the benefits of spray-drying in addressing the solubility challenge, detailing how simple, scaleable systems can be quickly developed to provide drug products for clinical evaluation. Approaches for transitioning spray-dried dispersions to formulated solid oral dosage forms for downstream development will also be described.
The benefits of integrating GMP manufacturing and clinical testing will also be shown in case studies using spray-drying technology. This will illustrate how arising clinical data are used to inform the real-time selection of formulation compositions to be made and dosed in subsequent study periods. Time and cost effective programs can be designed for poorly soluble molecules, to accelerate first-in-human, formulation optimisation and proof-of-concept studies.