Impact of Milling and Humidity on α-Lactose Monohydrate Stability

Monday, November 10, 2025

10:30 AM - 11:30 AM CT

Location:360 Stage #3, Exhibit Hall

Sponsored By

Manufacturing and Analytical Characterization

Partner Presentation-Manufacturing & Bioprocessing

Partner Presentation Speaker(s)

Dan Galvin

Food & Pharma Business Manager
NETZSCH Premier Technologies, LLC
Exton, Pennsylvania
Ligia Elena de Souza, Ph.D

Sector Manager Pharma & Cosmetics
NETZSCH Gerätebau GmbH

Description: This work investigates how milling and humidity influence α-lactose monohydrate, a key pharmaceutical excipient. Milling was carried out with a jet milling device for pharmaceutical applications, and thermal behavior was studied using DSC and TGA. Results show how processing and environmental conditions impact stability and hydration, highlighting the importance of controlling material stressors to support robust drug product development.

Learning Objectives:

Describe how milling with a pharmaceutical jet mill influences the crystallinity and thermal behavior of α-lactose monohydrate.
Explain the effects of humidity on α-lactose dehydration, phase transitions, and stability.
Recognize the importance of controlling processing and environmental stressors to improve excipient performance in drug product development.