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<p>This research aimed to develop and characterize cisplatin-loaded chitosan nanoparticles (CHNPs) embedded in a mucoadhesive buccal film (MFs) for oral cancer treatment. CHNPs were prepared using the ionic-gelation method, while the MFs were formed by the film-casting technique. Box-Behnken design was used to examine the effects of independent variables on dependent variables and optimize the CHNPs. Optimized nanoparticles (OPNPs) showed particle size of 198.3&#xa0;nm, polydispersity index of 0.181, zeta potential of + 26.2 mV, entrapment efficiency of 84.38%, and drug loading of 25.37%. Fourier transform infrared and Differential scanning calorimetry confirmed the cross-linking between chitosan (CH) and sodium tripolyphosphate and encapsulation of cisplatin within CHNPs. Scanning and transmission electron microscopes revealed the spherical shape with a smooth surface of CHNPs. MFs (CNF1–CNF5) were formulated after incorporation of OPNPs into plasticized solutions of CH, hydroxypropylmethyl cellulose, polyvinyl alcohol, and polyethylene glycol 400. CNF1 films demonstrated acceptable thickness, weight, drug content, pH, highest swelling index, folding endurance, moisture absorption, and retention time. SEM micrograph showed good dispersion, smooth and slightly wrinkled surface, with folded and curled edges. CNF1 films showed sustained drug release of 80.02 ± 0.74% over 16&#xa0;h, with a slower, more controlled release pattern compared to OPNPs and cisplatin. CNF1 showed zero-order release kinetics and lower flux and permeability coefficient as compared to OPNPs and cisplatin indicating slower, more controlled drug release. IC<sub>50</sub> value against the human oral squamous cell carcinoma lines (HSC 3 cells) of CNF1, OPNPs, and pure cisplatin was 74, 141 and 175&#xa0;µg/ml. This suggests that the CNF1 significantly enhanced the cytotoxic effect of cisplatin. The CNF1 also showed good storage stability at 40 ± 2&#xa0;°C and RH 75 ± 5%, for three months. Therefore, MFs containing CHNPs are a promising approach for buccal delivery of cisplatin, especially in oral cancers requiring sustained drug delivery.</p>

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Formulation Development, Box-Behnken Design-Based Optimization and Evaluation of Cisplatin-Loaded Chitosan Nanoparticles Embedded in Mucoadhesive Buccal Film for Targeted Oral Cancer Therapy

  • 期刊论文

  • 发表日期：

    2025年10月29日

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  • Md Moidul Islam,
  • Manish Kumar,
  • Md Ali Mujtaba,
  • Gamal Osman Elhassan,
  • Siham Abdoun,
  • Md Misbah,
  • Ameeduzzafar Zafar,
  • Mohammad Khalid

摘要

This research aimed to develop and characterize cisplatin-loaded chitosan nanoparticles (CHNPs) embedded in a mucoadhesive buccal film (MFs) for oral cancer treatment. CHNPs were prepared using the ionic-gelation method, while the MFs were formed by the film-casting technique. Box-Behnken design was used to examine the effects of independent variables on dependent variables and optimize the CHNPs. Optimized nanoparticles (OPNPs) showed particle size of 198.3 nm, polydispersity index of 0.181, zeta potential of + 26.2 mV, entrapment efficiency of 84.38%, and drug loading of 25.37%. Fourier transform infrared and Differential scanning calorimetry confirmed the cross-linking between chitosan (CH) and sodium tripolyphosphate and encapsulation of cisplatin within CHNPs. Scanning and transmission electron microscopes revealed the spherical shape with a smooth surface of CHNPs. MFs (CNF1–CNF5) were formulated after incorporation of OPNPs into plasticized solutions of CH, hydroxypropylmethyl cellulose, polyvinyl alcohol, and polyethylene glycol 400. CNF1 films demonstrated acceptable thickness, weight, drug content, pH, highest swelling index, folding endurance, moisture absorption, and retention time. SEM micrograph showed good dispersion, smooth and slightly wrinkled surface, with folded and curled edges. CNF1 films showed sustained drug release of 80.02 ± 0.74% over 16 h, with a slower, more controlled release pattern compared to OPNPs and cisplatin. CNF1 showed zero-order release kinetics and lower flux and permeability coefficient as compared to OPNPs and cisplatin indicating slower, more controlled drug release. IC50 value against the human oral squamous cell carcinoma lines (HSC 3 cells) of CNF1, OPNPs, and pure cisplatin was 74, 141 and 175 µg/ml. This suggests that the CNF1 significantly enhanced the cytotoxic effect of cisplatin. The CNF1 also showed good storage stability at 40 ± 2 °C and RH 75 ± 5%, for three months. Therefore, MFs containing CHNPs are a promising approach for buccal delivery of cisplatin, especially in oral cancers requiring sustained drug delivery.