High precision determination of amorphous lactose formed during comminution processes
Ross Blezard1, Timo Roelofs1 & Pauline H.M. Janssen1,2
1DFE Pharma GmbH & Co. KG, Klever Str 187, Goch, 47574, Germany
2Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, Antonius Deusinglaan 1, 9713 AV Groningen, The Netherlands
Summary
The presence of amorphous lactose in commercially available lactose grades used as a carrier in dry powder inhalers has been the subject of much discussion. In order to understand if the presence of amorphous lactose can impact drug performance one must first be able to measure and control amorphous lactose precisely. When formed through comminution processes such as milling or micronisation, the amorphous lactose phase is particularly unstable, making precision determination challenging. In this study an existing Differential Scanning Calorimetry (DSC) method was optimized such that the precision of the method for comminution formed lactose was improved by approximately one order of magnitude. This enables more reliable measurements and subsequently better understanding of correlations between this specific property and drug product performance.