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
- Lombardo, Sonia, PhD, Engineer Preformulation Solid State, SEQENS
- Gautier Decock, CRDO Managing Director, SEQENS
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This paper presents the different strategies considered to enhance pharmaceutical drugs bioavailability.
A special focus is made on the need
to understand, at early stage, the behaviour and the characteristics of these compounds, especially physical, chemical and biological