Particle Engineering Via Dry Coating: Development of a Novel Material Sparing Technology for Pharmaceutical Powders

Typically, most Active Pharmaceutical Ingredients (APIs) are extremely cohesive which adversely affects manufacturing processes such as feeding, blending, tabletting and leads to inferior quality of the product. In this work, different pharmaceutical powders (several APIs and excipients) of varying size range are considered for flow and packing density improvement via dry coating based surface modification. The main focus of this presentation is on developing a novel material sparing method that utilizes only small amount of API powders. The idea is to generate information during early API development to assess if the API requires flow improvement and to what extent the flow improvement can be achieved via dry coating. This methodology is validated via multi-faceted characterization, as well as comparison with other batch as well as continuous dry coating methods. Morphology, size and size distribution of these powders are characterized by Scanning Electron Microscopy (SEM) and laser diffraction (Sympatec Helos/Rodos) respectively. Flow characterization is performed using angle of repose (AoR), bulk and tapped density, critical outlet diameter via flodex, Vibration Packed Density (VPD) and shear testing (Freeman FT4). This allows for developing guidelines for the applicability of the novel technology as well as the dry coating approach. The results presented are expected to have an impact on the formulation development of poorly flowing APIs.