Preparation and In Vitro Evaluation of Montelukast Sodium-Loaded 3D Printed Orodispersible Films for the Treatment of Asthma

This research aims to produce orodispersible films (ODFs) and determine their potential use in the oral delivery of montelukast sodium for asthma treatment and allergic rhinitis. ODFs were successfully developed by Three-dimensional (3D) printing using propylene glycol (PG), and hydroxypropyl methylcellulose (HPMC), polyethylene glycol 400 (PEG). Finally, the amount of montelukast sodium in the ODFs was 5% (w/w). Drug-excipients compatibility with Fourier Transformed Infrared (FTIR) spectroscopy, mass uniformity, thickness, disintegration time, folding endurance, moisture absorption, pH, in vitro drug release (dissolution), drug content, moisture loss, moisture content, mechanical properties, and cytotoxicity studies were performed on the prepared films.

All formulations disintegrated in approximately 40 s. Over 98% of drug release from all films within 2 min was confirmed. It was reported that Fm1-4 (8% HPMC and 1% PEG) and Fm2-4 (10% HPMC and 3% PEG) are more suitable for drug content, but Fm2-4 may be the ideal formulation considering its durability and transportability properties. Based on the characterization results and in vitro release values, the montelukast sodium ODF can be an option for other dosage forms. It was concluded that the formulations did not show toxic potential by in vitro cytotoxicity study with 3T3 cells. This new formulation can efficiently treat allergic rhinitis and asthma diseases.

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Materials

MK was a present material from Sanovel Pharmaceutical Company (Istanbul, Türkiye). PG was bought from Doğa Pharmaceutical Company (Istanbul, Türkiye). HPMC E15 and Polyethylene glycol 400 (PEG) were purchased from Sigma-Aldrich, Germany. NIH/3T3 cells were obtained from ATCC, USA. Fetal bovine serum (FBS) and Dulbecco’s modified eagle medium (DMEM), along with penicillin/streptomycin (P/S), were bought from PAN-Biotech, Biological Industries, and Thermo Fisher Scientific, respectively. (3-(4,5-Dimethylthiazol-2-yl)-2,5-Diphenyltetrazolium Bro-mide) (MTT) was purchased from Invitrogen, USA. Dime-thyl sulphoxide (DMSO) was obtained from Sigma-Aldrich, USA. Phosphate-buffered saline (PBS) was obtained from PAN Biotech, Aidenbach, Germany. All other chemicals used were analytical grade. Fresh distilled water is used as a solvent.

Özcan-Bülbül, E., Kalender, Y., Bal-Öztürk, A. et al. Preparation and In Vitro Evaluation of Montelukast Sodium-Loaded 3D Printed Orodispersible Films for the Treatment of Asthma. AAPS PharmSciTech 25, 218 (2024). https://doi.org/10.1208/s12249-024-02938-z

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