Impact of Co-Processing on the Structural Evolution of Lactose and MCC, Investigated by Laboratory SAXS and WAXS

MEGGLE Excipients and the Xenocs have joined forces to shed light on this interesting topic. 

Introduction

Within the last decades a new subgroup of diluents, so called Co-processed Excipients (CPE), found its way into pharmaceutical practice [1]. After a seemingly endless discussion about their definition, state, and boundaries to a simple physical admixture (PAM), CPE have been defined as a combination of two or more compendial or non-compendial excipients designed to physically modify their properties in a manner not achievable by simple mixing. Thereby, a significant chemical change has to be excluded [2]. Typically, CPE offer a benefit beyond the simple admixture, may be manufactured by a specialized process, where spray-drying is the most frequently used platform. However, little is known about the intensity of such physical modifications defining a CPE, and causing its functional supremacy over its corresponding PAM. The crucial question is, down to which particle level physical alterations in raw materials have to take place for achieving additional blend performance? What are the smallest structural particle units necessary for e.g., synergies in compaction, disintegration, or lubrication behavior? The aim of this study was to compare the samples inner morphology and crystallinity before and after co-processing by means of Small and Wide-Angle X-ray Scattering (SWAXS) technique using relative scale invariant calculation of parameters such as surface volume (Sv) or correlation length (Cl).

Authors

Many thanks to the authors for this exciting publication.

Aden Hodzic¹, Sanaullah Khan¹, Franz K. Penz^2
1Xenocs Nordic, Diplomvej 381, Kongens Lyngby 2800, Denmark, [email protected]
²MEGGLE GmbH & Co. KG, Megglestr. 6-12, 83512 Wasserburg, Germany, [email protected]