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Formulation and Delivery
Keynote

Keynote: Excipient Phase Behavior in Frozen and Freeze-Dried Systems – Potential Implications on Drug Stability

Tuesday, November 11, 2025
1:30 PM - 2:30 PM CT
Location:Stars at Night B1

Formulation and Delivery

The phase behavior of the excipients in multi-component pharmaceutical systems, during the various stages of freeze-drying, is a complex interplay of formulation variables and processing conditions. Rational drug product and process development necessitate: (i) a thorough characterization of the phase transitions of the excipients in the frozen state and during freeze-drying, (ii) gaining an understanding of their crystallization tendency during processing, and (iii) identifying the physicochemical stability requirements and critical quality attributes of the product.

Learning Objectives:

  • Recognize the potential role of excipient phase behavior on the stability of the active pharmaceutical ingredient
  • Discern the complex interplay of formulation composition and processing conditions on excipient phase behavor
  • Identify the strengths and limitations of analytical techniques used to monitor phase transitions in frozen and freeze-dried systems
  • Identify the strategies for controlling the physical form of mannitol crystallizing in frozen solutions
  • Develop strategies to confer multifunctionality to excipients