QBD-GUIDED DESIGN OF NLC-BASED BUCCAL FILMS OF A PHYTOCONSTITUENT FOR ENHANCED CHEMOPREVENTION
DOI:
https://doi.org/10.22159/ijap.2026v18i1.56754Keywords:
Quercetin, Chemoprevention, Hybrid system, Buccal film, NanocarrierAbstract
Objective: This study aimed to develop and optimize a nanostructured lipid carrier (NLC)-based hybrid buccal film of quercetin (QCT) using a Quality by Design (QbD) approach for potential chemoprevention of oral cancer.
Methods: QCT-loaded NLCs were prepared via the solvent injection technique using pre-screened excipients. A Design of Experiments (DoE) framework using the Box-Behnken Design was employed to assess the influence of total lipid content, surfactant concentration, and liquid lipid proportion on critical quality attributes—namely, particle size and drug entrapment efficiency. Transmission electron microscopy (TEM) was used to analyze morphology. Bilayer hybrid buccal films were cast using ethyl cellulose as the backing layer and a blend of hydroxypropyl methylcellulose and Carbopol 934P for the drug-loaded matrix. These films were evaluated for mechanical strength, in vitro drug release, ex vivo buccal permeation, stability, and cytotoxicity using cell line studies.
Results: QCT-NLCs were successfully formulated with glyceryl monostearate (solid lipid), Transcutol HP and Capmul MCM (liquid lipids), and surfactants including soya lecithin and Poloxamer 188. DoE analysis indicated that higher surfactant levels reduced particle size, while increased lipid content enlarged particles but improved entrapment efficiency. The optimized formulation had particle size of 144 nm and an entrapment efficiency of 90.21%, as verified by TEM. The resultant hybrid film demonstrated sustained drug release (80% over 8 h), excellent tensile strength (3.93 MPa), and was stable under accelerated conditions. Ex vivo studies confirmed 72.8% buccal drug permeation in 6 h. Cytotoxicity assays validated the formulation’s safety and chemopreventive potential.
Conclusion: The QCT-loaded NLC hybrid buccal film demonstrated potential as a safe and effective strategy for oral cancer chemoprevention.
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