Design, Development and characterization of fast dissolving oral films for rapid delivery of Loratadine
Keywords:
Loratadine, Fast dissolving oral film, Solvent casting, HPMC E15, HPMC E5, Oral drug delivery, Drug release, Stability studyAbstract
Fast dissolving oral films (FDOFs) represent an innovative drug delivery system that disintegrates rapidly in the oral cavity without water, enhancing patient compliance and therapeutic onset. Loratadine, a second‑generation antihistamine for allergic rhinitis and chronic urticaria, suffers from poor aqueous solubility, limiting dissolution and onset of action. Developing FDOFs of Loratadine offers a promising approach to improve drug release and acceptability.
The present study aimed to design, develop, and characterize Loratadine FDOFs using the solvent casting technique. Hydroxypropyl methylcellulose (HPMC E15 and HPMC E5) served as film‑forming polymers, with polyethylene glycol 400, glycerin, and propylene glycol as plasticizers. Tween 80 was incorporated as a surfactant, while citric acid and sodium saccharin acted as saliva‑stimulating agent and sweetener, respectively. Prepared films were evaluated for physical appearance, thickness, weight variation, folding endurance, surface pH, tensile strength, drug content, disintegration time, in vitro drug release, and stability under ICH guidelines.
All formulations yielded smooth, flexible, uniform films with satisfactory mechanical properties. Among them, formulation F3 demonstrated optimal performance, showing uniform drug content, excellent folding endurance, rapid disintegration, and highest cumulative drug release. Accelerated stability studies at 40 ± 2°C/75 ± 5% RH for 90 days revealed no significant changes in physicochemical properties, confirming good stability.
In conclusion, the optimized Loratadine FDOF exhibited rapid disintegration, efficient drug release, satisfactory mechanical strength, and excellent stability. This formulation represents a promising alternative to conventional oral dosage forms, with potential to improve patient compliance and provide rapid therapeutic action in allergic disorders.
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