Drug product performance modelling – Advancements in in vivo and in vitro system modelling

Drug product performance models are applied across the development lifecycle, supporting preclinical activities, through to pivotal trials and post approval changes. Drugs are delivered in many different dosage forms with complex structures, materials and behaviours, yet scientists are often limited to using models that only cover the properties of the API and which have minimal description of the formulation and its effect.

Working closely with our partners in industry and academia, PSE has substantially advanced the ability to model solid oral dosage form performance in in vivo and in vitro systems. The result is gPROMS FormulatedProducts^® v1.3 - a tool based on state-of-the-art science that can address practical challenges.

Models now include:

• Advanced dosage forms
  • Capsules, multiparticulates; controlled, sustained and targeted release
• Hierarchical material structures
  • Tablets, granules, API and excipients
• Additional solid types
  • Freeforms, hydrates, salts, cocrystals, polymorphs, amorphous forms
• Complex in vitro / in vivo behaviour of the dosed solid materials
  • Precipitation (primary nucleation and particle growth); controlled, sustained and targeted release
• Effects of dosed excipients and buffers in solution

The models can be utilised within the gPROMS FormulatedProducts framework which brings advanced simulation, model validation, optimisation, uncertainty analysis, sensitivity analysis and custom modelling capabilities. This webinar will demonstrate benefits with illustrative examples from leading pharmaceutical companies. With gPROMS FormulatedProducts, you can turn data into knowledge to make better decisions throughout the development lifecycle.

Presenter(s)

Edd Close, Senior Consultant, BU Formulated Products, PSE

Edd Close is a Senior Consultant with PSE's Formulated Products business unit. He is the leader of the Product Performance practice area. Edd completed his EngD in Biochemical Engineering at University College London.