Simulation lung dissolution – fast-tracking DPI development

Beatriz Noriega-Fernandes^1,2, Maria Malmlöf^3,4, Per Gerde^3,4, M. Luisa Corvo², Eunice Costa¹

¹Hovione Farmaciência S.A., R&D Inhalation & Advanced Drug Delivery, Estrada do Lumiar, Campus do Lumiar, Edifício R, 1649-038 Lisbon, Portugal ²iMed.ULisboa, Faculdade de Farmácia, Universidade de Lisboa, Avenida Prof. Gama Pinto, Lisboa, 1649-003, Portugal ³Inhalation Sciences, Hälsovägen 7-9, 141 57, Huddinge, Sweden ⁴Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden

Summary

The present abstract summarizes the development and validation work performed for a novel biorelevant collection and dissolution method for orally inhaled drug products (OIDP), in specific for dry powder inhaler (DPI) products. PreciseInhale^® (Inhalation Sciences, IS) as a breath simulator for particle aerosolization and collection, and DissolvIt^® (IS) as a biorelevant dissolution system were applied. The results showcase the base for decision making during equipment and method development – addition of a pre-separator (PS) during the collection and analysis dissolution optimal concentration. Additionally, the methodology was applied for DPI formulation differentiation for Fluticasone Propionate (FP) and Salmeterol Xinafoate (SX), two active pharmaceutical ingredients (API) with different solubilities, testing particle engineering technologies and formulation strategies. The methodology showed to be suitable for formulation differentiation and ranking.

Key Message

Biorelevant collection and dissolution systems, PreciseInhale and DissolvIt (IS), were optimized and tested for DPI formulation differentiation. The methodology as per developed is capable of differentiating particle engineering technologies, carrier-based and composite formulations, which can be essential for fast-tracking DPI development for both new molecules and generics.