Lisa Caralli, Science and Technology director, Pharmaceutics, Catalent, discusses the methods that formulation scientists can undertake on small quantities of API to achieve the greatest possible results to progress through drug product development.
Key insights:
- 3 key factors determine oral API bioavailability are solubility, metabolism and permeability. Candidates that have the greatest potential to be orally delivered are resistant to hepatic metabolism and/or display high permeability.
- Liquid-liquid phase separation (LLPS) occurs when the concentration of the API exceeds its amorphous solubility.
- Time pressures and the amount of available API mean that formulation scientists need to capture as much data as possible with both careful planning and resource management.
At the beginning of an oral drug delivery development programme, it is not uncommon for the quantity of active pharmaceutical ingredient (API) available to formulation scientists to be limited, which can make it difficult to gather sufficient meaningful data to select the most promising candidates to advance into in vivo studies.