Development of NSAID-containing dry powder inhalation formulation co-spray-dried with sodium stearate


Edit Benke, Piroska Szabó-Révész & Rita Ambrus

Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, Eötvös str. 6., Szeged, H-6720, Hungary


The use of non-steroidal anti-inflammatory drugs (NSAIDs) is well established in local pulmonary therapy, for example in cystic fibrosis. They are able to directly reduce inflammation, even indirectly slowing the progression of this disease. In the case of pulmonary drug delivery, the use of dry powder inhalation (DPI) systems is most common. Spray drying is a popular method for preparing these. The successful use of a number of excipients has already been published, however, there is still little experience with NSAID-containing DPIs. The aim of the present work was to study DPI formulations prepared by co-spray-drying, using meloxicam-potassium (MXP) and different concentrations of sodium stearate (NaSt). Physicochemical, in vitro drug release and in vitro lung deposition studies, were performed with the prepared microcomposites. Based on the results, it can be stated that the use of NaSt during co-spray-drying of MXP has a positive effect on the morphology, particle size and cohesive work of the produced particles, as a result, the in vitro aerodynamic properties were also improved and the dissolution of the drug in simulated lung fluid in the presence of NaSt was improved. Overall, the study of excipients that have already been proven in other pharmacological groups is justified in the case of pulmonary delivery of NSAIDs, and there are still many opportunities for the development of NSAID-containing DPI formulations.

Supported by the ÚNKP-20-3-SZTE-308  New National Excellence Program of the Ministry for Innovation and Technology from the source of the National Research, Development and Innovation Fund.