Nasal Dry Powder Delivery: Implementing a formulation independent Spray Drying Process    

Mariana F. Silva1,2, Diana A. Fernandes1,2, Maria Braga1, António Eloy1, João Marques1, M. Luísa Corvo2 & Eunice Costa1

1Hovione FarmaCiência SA, Lumiar, 1649-038, Portugal

2Research Institute for Medicines (iMed.ULisboa), Faculdade de Farmácia, Universidade de Lisboa, 1649-003, Portugal

Summary

The aim of this study is to assess the interactions between formulation composition and spray drying (SD) process parameters in enabling nasal powder formulations for the delivery of a diverse array of biopharmaceuticals. A design of experiments was performed on the composition in trehalose and atomization flow rate in order to compare the properties of the generated powders by SD with a Two-fluid nozzle (2FN) atomizing system.  Additionally, a SD with a 25 kHz Ultrasonic Nozzle (USN) to primarily assess the main differences in the properties of the powders obtained with two different atomizing systems was used. SD powders suitable for nasal delivery were successfully generated using the 2FN with particle size (Dv50) between 11 and 39 μm. Furthermore, there appears to be no impact of the formulation composition in the powders properties, providing the ability to adjust the ratio between trehalose and hydroxypropyl methylcellulose E5 (HPMC E5), depending exclusively on the active pharmaceutical ingredient (API) requirements. However, SD powder produced by USN was outside the nasal size range. Future work will be developed using the latter atomizing technology in order to assess the ability of this atomizing system to produce suitable nasal powders.