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Solving the developability challenges of New Chemical Entities for oral formulation


Solving the developability challenges of New Chemical Entities for oral formulation: Innovation towards a successful development of drug candidates

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 present the specific challenges encountered by Biotech companies when developing New Chemical Entities from Discovery phase to Early Clinical phases. A case study is 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

Speakers :

  • Lombardo, Sonia, PhD, Engineer Preformulation Solid State, SEQENS
  • Gautier Decock, CRDO Managing Director, SEQENS

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