Development of a fast dissolving sublingual film containing meloxicam nanocrystals for enhanced dissolution and earlier absorption

The objective of this work was to prepare and evaluate fast dissolving sublingual films containing meloxicam nanocrystals (MLX-NS-FDSFs). Nanocrystals (NS) were utilized to allow for improved dissolution of the drug, whereas the films were used to shorten the onset of action via the sublingual route. Meloxicam nanocrystals (MLX-NS) were prepared by nanoprecipitation based on acid-base neutralization method and then encapsulated into the films by solvent casting method. The obtained FDSFs exhibited uniform thickness of 82 ± 8 μm and drug content of 7.38 ± 0.011 mg/film (4 cm2) and disintegrated rapidly in 23.08 ± 1.76 s. The MLX-NS-FDSFs with reconstituted particle size of 196.4 ± 6.3 nm showed faster dissolution rate in vitro than the MLX coarse suspension based films (MLX-CS-FDSFs). The SEM images and XRD indicated that MLX nanocrystals were highly dispersed into the films. After administrated to rats, Tmax of MLX was significantly shortened following sublingual administration of MLX-NS-FDSFs. The absorption of MLX from MLX-NS-FDSFs resulted in 3.00 fold increased in bioavailability as compared to MLX-CS-FDSFs and 4.34 times with reference to the MLX-CS. These results indicated that the NS-FDSFs could be a promising delivery system to enhance the dissolution and shorten the onset time of MLX.