Preparation and In Vitro Evaluation of Montelukast Sodium-Loaded 3D Printed Orodispersible Films for the Treatment of Asthma.
Cyclopropanes
/ administration & dosage
Quinolines
/ administration & dosage
Acetates
/ chemistry
Sulfides
/ chemistry
Asthma
/ drug therapy
Drug Liberation
Printing, Three-Dimensional
Polyethylene Glycols
/ chemistry
Administration, Oral
Anti-Asthmatic Agents
/ administration & dosage
Animals
Excipients
/ chemistry
Mice
Drug Delivery Systems
/ methods
Chemistry, Pharmaceutical
/ methods
Hypromellose Derivatives
/ chemistry
Propylene Glycol
/ chemistry
Spectroscopy, Fourier Transform Infrared
/ methods
Solubility
3D printing
asthma
montelukast sodium
oral film
orodispersible film
Journal
AAPS PharmSciTech
ISSN: 1530-9932
Titre abrégé: AAPS PharmSciTech
Pays: United States
ID NLM: 100960111
Informations de publication
Date de publication:
17 Sep 2024
17 Sep 2024
Historique:
received:
11
07
2024
accepted:
06
09
2024
medline:
18
9
2024
pubmed:
18
9
2024
entrez:
17
9
2024
Statut:
epublish
Résumé
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.
Identifiants
pubmed: 39289238
doi: 10.1208/s12249-024-02938-z
pii: 10.1208/s12249-024-02938-z
doi:
Substances chimiques
montelukast
MHM278SD3E
Cyclopropanes
0
Quinolines
0
Acetates
0
Sulfides
0
Polyethylene Glycols
3WJQ0SDW1A
Anti-Asthmatic Agents
0
Excipients
0
Hypromellose Derivatives
3NXW29V3WO
Propylene Glycol
6DC9Q167V3
polyethylene glycol 400
B697894SGQ
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
218Informations de copyright
© 2024. The Author(s), under exclusive licence to American Association of Pharmaceutical Scientists.
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