DEVELOPMENT AND EVALUATION OF ALOE VERA-BASED MUCOADHESIVE BUCCAL FILMS OF TRIAMCINOLONE ACETONIDE FOR LOCALIZED MANAGEMENT OF RECURRENT APHTHOUS STOMATITIS

Mukesh M.*, D. Sudhan

ABSTRACT

Recurrent aphthous stomatitis (RAS) is a common oral mucosal disorder marked by recurrent, painful ulcers. Triamcinolone acetonide (TA) is a topical corticosteroid used for RAS, but conventional topical preparations are quickly cleared from the oral cavity by saliva and mechanical movement. This study aimed to develop and evaluate Aloe vera-based mucoadhesive buccal films of TA for localized delivery. Six formulations (F1–F6) were prepared by solvent casting using HPMC E15 and sodium carboxymethyl cellulose (Na CMC) as film-forming polymers and glycerin as plasticizer, with Aloe vera content increased from 0 mg (F1) to 1.0 mg (F6). Preformulation studies included organoleptic evaluation, melting point, solubility, λmax determination, calibration curve and FTIR compatibility studies. The films were evaluated for appearance, thickness, folding endurance, surface pH, weight uniformity, dispersion and disintegration time, drug content and in-vitro dissolution in phosphate buffer pH 6.8. TA showed λmax at 242 nm, a melting point of 293 °C and a linear calibration curve (R² = 0.9986; 2–10 μg/mL). FTIR showed no evidence of major drug–polymer interaction. All films were smooth and flexible. Thickness was 0.480 ± 0.000 to 0.563 ± 0.012 mm, folding endurance 187.00 ± 5.00 to 222.67 ± 7.77, surface pH 6.52 to 7.28, and weight 48.20 ± 0.84 to 50.00 ± 0.71 mg. Dispersion and disintegration times were 22–30 s, and drug content was 93.33–98.83%. Cumulative drug release at 30 min decreased with increasing Aloe vera content, from 99.2% (F1) to 86.7% (F6). F4 (0.6 mg Aloe vera) gave the best overall balance of clarity, flexibility, near-neutral surface pH (6.98), drug content (97.37%) and drug release (92.6% at 30 min), and was selected as the optimized formulation. Mucoadhesion, permeation and stability studies are still needed to confirm its suitability for RAS.

Keywords: Aloe vera, Mucoadhesive buccal film, Triamcinolone acetonide, Recurrent aphthous stomatitis, HPMC E15, Sodium CMC, Solvent casting, Localized drug delivery.