Successful Scale-Up Of A Spray Dried Formulation For Nasal Drug Delivery

By Lara Penn, Senior Development Scientist II, Upperton Pharma Solutions

Spray drying is an effective particle engineering technique that is extensively utilized in the pharmaceutical industry. A critical aspect of the spray drying process is atomization, which determines the particle size of the resulting dry powder. The most commonly employed nozzles for this process include rotary, pressure, two-fluid, and ultrasonic nozzles. Particle size plays a vital role in several key characteristics of pharmaceutical products.

According to the European Medicines Agency, nasal formulations should limit the presence of particles smaller than 10 µm to ensure effective deposition in the nasal cavity and minimize the risk of lung deposition. However, scaling up the spray drying process can present significant challenges, particularly in maintaining precise control over particle size.

This study investigates how particle size, morphology, and deposition profiles are affected by the scale-up of the spray drying process. A single formulation was spray dried using both a laboratory-scale spray dryer (ProCepT 4M8Trix) and a commercial-scale spray dryer (Niro Mobile Minor), employing various nozzle types to identify effective scaling strategies for producing powders intended for nasal drug delivery.