The presentation will begin with a description of polymer excipients and formulation systems with a focus on the varying molecular architectures that are present in the commercially available pharmaceutical formulation polymers. This will be followed by details of the balance of mechanisms necessary for a successful selection of a polymer for amorphous solid dispersion or encapsulation vehicle to maintain stability on the shelf while allowing for optimum release of the drug.
The major highlight of the presentation will then be provided with a summary of modern computer simulation technologies with a focus on bottom up techniques to enable down selection from a set of major commercial polymer excipients to provide the best combination of properties for a given active pharmaceutical ingredient. Examples will be provided for this selection process for specific drug - excipient combinations.
The key factors that are included in the screening tools will be reviewed with additional focus on: * Important considerations not included in the analysis * Areas of applicability * Accuracy considerations and appropriate stage in development for inclusion of method, including regulatory concerns
Learning Objectives:
Explain how molecular interaction connects to polymeric formulation considerations.
Identify screening applications where simulation could provide initial downselection.
Understand the expected time-scales and required input data for successful integration of simulation into formulation development.
