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Formulation and Characterization of a Mouth Ulcer Spray: Stability, Safety, and Therapeutic Potential

Year: 2025
Type: article
Abstract: Mouth ulcers are a common oral health issue, often causing discomfort and pain.This study aimed to develop and evaluate a novel mouth ulcer spray formulated with key active ingredients, including riboflavin, folic acid, choline salicylate, lignocaine, benzalkonium chloride, and nicotinamide.The formulation process ensured solubility, stability, and uniform dispersion of active components.The spray was assessed for physical characteristics, microbial safety, aerosol performance, and in-vitro efficacy.The final formulation exhibited a clear, pale-yellow appearance, with a pH range of 5.7-6.2,ensuring compatibility with the oral mucosa.Aerosol performance testing demonstrated a consistent spray volume of 0.11-0.16ml per actuation, providing precise dosing.Microbial analysis confirmed the absence of pathogenic contamination, and sensory testing indicated no significant irritation.Stability studies conducted over three months at various storage conditions confirmed the physical and chemical stability of the formulation.Additionally, in-vitro efficacy testing showed enhanced epithelial cell proliferation and a reduction in ulcer healing time.These findings suggest that the formulated mouth ulcer spray meets the required quality and safety standards, making it a promising therapeutic option for managing oral ulcers.
Language: English
Open Access status: bronze
OpenAlex ID: W4409242597
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