3D printed elastic mould granulation

Abstract

In the pharmaceutical industry, enhanced process understanding resulting in superior control of product attributes, has the potential to save up to 20 % of process engineering and product development costs during drug development. With the aim of achieving enhanced process understating, a novel approach for granulation of fine powders is presented. First, a mould with the desired particle shape and size is created using 3D printing followed by casting using elastomeric material. The formulation is prepared through wet massing and tested as a thin film on flat elastomeric membranes. The thin film itself can be a product but it also gives a good indication of coating performance before coating the patterned elastic membrane with the formulation i.e., 3D printed elastic mould granulation. Results show that following granulation and drying, granules of controlled size and shape (e.g. cubic and 500 μm), strength, friability and flowability can be formed. The method presented may allow for more robust process development in particle engineering.