Oral drug formulation remains the preferred and most economical administration form to guarantee a successful commercialization. However, 90% of New Chemical Entities are poorly water soluble, which makes oral forms development a challenge. A robust methodology allows to move assets through preclinical phase to First-in-Human formulations with speed and confidence.
During this webinar, we will present the specific challenges encountered by Biotech companies when developing New Chemical Entities from Discovery phase to Early Clinical phases. A case study will be presented on an API presenting a low water solubility and at the same time a low solubility in lipophilic solvents. By selecting and implementing the right approach, the water solubility of the formulated API was increased by a factor 40. This approach, based on the physico-chemical and biological characteristics of the API to design a tailored solution, eases and accelerates the development of Early Clinical Formulations.
During this webinar you will learn:
– How to assess the developability of small molecules beyond Lipinski’s rule-of-five as oral drugs
– How pre-formulation allows to identify improvements around the API for formulation development
– How to identify early on Bioavailability challenges based on the physico-chemical and biological properties of the API
– How to choose the right technique depending on API characteristics