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<p><b>Background</b>&#xa0;Allergic conjunctivitis is a chronic inflammatory eye condition that can persist year-round but typically peaks during spring and summer. Effective ocular drug delivery remains challenging due to rapid tear clearance and poor residence time.</p><p><b>Objective</b>&#xa0;To develop and optimize a muco-adhesive ocular film incorporating Hibiscus rosa sinensis leaf mucilage together with gelatin and sodium carboxymethyl cellulose (SCMC) for sustained delivery of aceclofenac (ACK) to the eye.</p><p><b>Methods</b>&#xa0;Thirteen ACK-loaded ocular film formulations were prepared based on a Box–Behnken design, varying amounts of SCMC, gelatin and Hibiscus mucilage. Each formulation was evaluated for physicochemical parameters (thickness, weight variation, drug content), pH, osmolarity, swelling index, disintegration time, mechanical strength (tensile strength and folding endurance), sterility, mucoadhesion time, and in vitro drug release. Statistical analysis (ANOVA) was used to assess the influence of polymer concentrations on mucoadhesion.</p><p><b>Results&#xa0;</b>Film thickness ranged from 0.16 ± 0.01 to 0.21 ± 0.01 mm; weight varied between 64.84 ± 0.7 and 75.11 ± 0.7 mg; drug content spanned 87.15 ± 1.05% to 98.81 ± 2.15%. The optimized formulation (F8: SCMC 50 mg, gelatin 20 mg, Hibiscus mucilage 10 mg) achieved physiological pH (7.0 ± 0.1), acceptable osmolarity, and high mucoadhesion (636 ± 3.6 minutes). The films showed sustained drug release consistent with a zero-order, diffusion-controlled mechanism. Among formulations, F6 achieved the highest ACK permeation at 24 h (96.95 ± 2.36%), followed by F12 (96.21 ± 4.57%). Moisture uptake varied (highest in F6: 21.09 ± 0.7%; lowest in F5: 11.36 ± 0.8%). FTIR confirmed drug–excipient compatibility, and ANOVA modelling demonstrated a strong correlation (R² &gt; 0.99) between polymer concentration and mucoadhesion performance.</p><p><b>Conclusions</b>&#xa0;The developed mucoadhesive ocular films leveraging Hibiscus mucilage, gelatin and SCMC offer a sterile, stable, uniform-film platform with enhanced mucoadhesion, sustained drug release and high drug permeation. These characteristics make them a promising alternative to conventional ophthalmic dosage forms for treating ocular pain and inflammation.</p>

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Biocompatible Ocular Films: A Novel Approach to Prolonged Aceclofenac Release and Mucoadhesion

  • 期刊论文

  • 发表日期：

    2025年10月28日

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  • Jyotsana Dwivedi,
  • Namra Aziz,
  • Pranay Wal,
  • Abhishek Bhattacharjee,
  • Mohd Imran,
  • Pankaj Nainwal

摘要

Background Allergic conjunctivitis is a chronic inflammatory eye condition that can persist year-round but typically peaks during spring and summer. Effective ocular drug delivery remains challenging due to rapid tear clearance and poor residence time.

Objective To develop and optimize a muco-adhesive ocular film incorporating Hibiscus rosa sinensis leaf mucilage together with gelatin and sodium carboxymethyl cellulose (SCMC) for sustained delivery of aceclofenac (ACK) to the eye.

Methods Thirteen ACK-loaded ocular film formulations were prepared based on a Box–Behnken design, varying amounts of SCMC, gelatin and Hibiscus mucilage. Each formulation was evaluated for physicochemical parameters (thickness, weight variation, drug content), pH, osmolarity, swelling index, disintegration time, mechanical strength (tensile strength and folding endurance), sterility, mucoadhesion time, and in vitro drug release. Statistical analysis (ANOVA) was used to assess the influence of polymer concentrations on mucoadhesion.

Results Film thickness ranged from 0.16 ± 0.01 to 0.21 ± 0.01 mm; weight varied between 64.84 ± 0.7 and 75.11 ± 0.7 mg; drug content spanned 87.15 ± 1.05% to 98.81 ± 2.15%. The optimized formulation (F8: SCMC 50 mg, gelatin 20 mg, Hibiscus mucilage 10 mg) achieved physiological pH (7.0 ± 0.1), acceptable osmolarity, and high mucoadhesion (636 ± 3.6 minutes). The films showed sustained drug release consistent with a zero-order, diffusion-controlled mechanism. Among formulations, F6 achieved the highest ACK permeation at 24 h (96.95 ± 2.36%), followed by F12 (96.21 ± 4.57%). Moisture uptake varied (highest in F6: 21.09 ± 0.7%; lowest in F5: 11.36 ± 0.8%). FTIR confirmed drug–excipient compatibility, and ANOVA modelling demonstrated a strong correlation (R² > 0.99) between polymer concentration and mucoadhesion performance.

Conclusions The developed mucoadhesive ocular films leveraging Hibiscus mucilage, gelatin and SCMC offer a sterile, stable, uniform-film platform with enhanced mucoadhesion, sustained drug release and high drug permeation. These characteristics make them a promising alternative to conventional ophthalmic dosage forms for treating ocular pain and inflammation.