In June 2023, Chris Roe, Principal Research Fellow, and Ricardo Diaz de Leon Ortega, Modelling and Simulation Research Fellow, attended and presented at the Basic Biopharmaceutics Workshop hosted by The Biopharmaceutics Focus Group of the Academy of Pharmaceutical Sciences UK in London. The workshop's objective was to present and discuss the basic principles of biopharmaceutics and how they can be applied in the development of oral drug products.
Presentations throughout the day covered topics including the physicochemical properties of molecules (e.g., solubility, lipophilicity), dissolution, absorption, and modeling and simulation. Many biopharmaceutics topics and themes were discussed by the speakers, including the importance of using both the Biopharmaceutic Classification System (BCS) and the Developability Classification System (DCS) for regulatory purposes and to have a clear strategy for drug product development.
As part of the presentations, Chris Roe discussed intestinal permeability and its impact on absorption. Two factors affect absorption: the compound in solution and intestinal permeability. Solubility/dissolution issues can be addressed with changes in the formulation. At the same time, a low intestinal permeability could be a limiting factor for absorption and could lead to an investigation of different administration routes. Identifying these issues early in development can save time and money in compound and formulation development.
Ricardo Diaz de Leon participated in leading the discussion of the topics presented during the talks. Most participants showed interest in improving in vitro testing (particularly in vitro dissolution testing) to translate this information into a meaningful input for modeling and simulation. There is an increasing interest in modeling and simulation as it is a powerful tool for making predictions and explaining in vivo pharmacokinetic data, using, dissolution data, physiology characteristics of relevant species, physicochemical characteristics, and ADME data of the compound.
Biopharmaceutics is an important tool that drug developers can leverage for better decision-making. It can help facilitate better understanding and prediction of compound behavior before, during, and after a clinical trial. At Quotient Sciences, several teams can use this knowledge to improve the performance of the drug product in early development. From predicting these risks using modeling and simulation, to addressing them through formulation development, we can support a wide range of programs.
See the full summary of the event at Basic Biopharmaceutics Workshop 2023 - The Academy of Pharmaceutical Sciences
To hear about the strategies being used by biotech and pharmaceutical companies to overcome biopharmaceutic challenges for small molecules in today's drug development pipeline, watch our on-demand webinar, "Getting it Right Early: The Importance of Biopharmaceutics in Early Drug Development."