Absorption Driven Drug Formulation and Real-Time Dissolution Monitoring

The workshop will demonstrate the Absorption Driven Drug Formulation concept, which is a new approach in formulation development to ensure that the drug product meets the expected absorption rate. The demonstrated concept is built on the solubility-permeability interplay and the role of free drug as the driving force for oral absorption. Various case studies will be presented on excipient selection and formulation strategy optimization and how these methods can be incorporated in the complex process of formulation development. Examples utilizing multiple assay setups using the Pion Rainbow Dynamic Dissolution Monitor (RDDMTM) will be shown in order to demonstrate the workflow and characterization of final formulations before in vivo studies are conducted.

• The Absorption Driven Drug Formulation (ADDF) concept will be discussed.

• The solubility-permeability interplay and the role of free drug concentration as the driving force for absorption in the presence of excipients will be presented.

• An example workflow using real-time dissolution-absorption monitoring and illustrating the ADDF concept from candidate selection through to formulation development will be given.

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