Characterisation of particle engineered Mannitol as alternative carriers in dry powder inhalation formulations

Nancy Rhein, Gudrun Birk, Regina ScherlieƟ

Lactose is the typical carrier particle in carrier based powder blends for inhalation. Particle engineered Mannitol A and B are tested as potential alternative to the established carrier lactose in dry powder inhaler (DPI) formulations. Particle engineered Mannitol is a well-known product for direct compression in blends with low content of active pharmaceutical ingredients (API). Particle engineered Mannitol A and B are characterised with respect to their physico-chemical properties (particle size distribution, density, crystallinity, hygroscopicity). They are also as carrier material in interactive blends for DPIs and are investigated with respect to their suitability for inhalation (homogeneity and fine particle dose). It is shown that particle engineered Mannitol is a solid, crystalline and non-hygroscopic powder which shows a constant dosing from reservoir-based inhalers. The physical stability is an important factor for storage stability. Blends with an API content of 1.5 % exhibit a low relative standard deviation under 3 % and an FPF of 24.68 % indicating that particle engineered Mannitol could be a good alternative carrier in DPI blends.

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