Spray-granulated mannitol as a viable alternative to lactose in DPI formulations: Preparation of ordered mixtures and storage stability

It is known from lactose-based blends, that the choice of blender type and blending conditions can strongly influence aerodynamic properties, whereas this has not yet been examined with mannitol-based blends. In addition, lactose-based blends are sensitive to humidity and their physical properties, as well as their aerodynamic behavior, may change depending on storage conditions. Therefore, the stability of mannitol-based blends stored under three different conditions for 14 months with mannitol as a carrier and two model APIs—namely budesonide (BUD) as a hydrophobic example and salbutamol sulphate (SBS) as a hydrophilic example—was examined with respect to aerodynamic performance during storage.