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

Keynote Speaker(s)

Raj Suryanarayanan, Ph.D.

Professor of Pharmaceutics
University of Minnesota
Minnapolis, Minnesota

Moderator(s)

Jayasree Srinivasan, PhD (she/her/hers)

Research Scientist
Simtra BioPharma Solutions
Bloomington, Indiana

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