article · Pharmaceutics
Diabetic mouth ulcers cause significant damage to the oral mucosa, leading to higher infection risks and delayed recovery, with few natural treatment options currently available. To address this, solid lipid nanoparticles containing marshmallow extract and clove oil were developed and embedded into a cross-linked collagen sponge. Formulation parameters including lipid and surfactant types and concentrations were systematically evaluated to achieve optimal particle size, stability, and encapsulation efficiency. The resulting formulation demonstrated strong antimicrobial activity against Pseudomonas aeruginosa, Escherichia coli, and Candida albicans. When tested in a diabetic mouth ulcer model, the sponge formulation significantly improved wound healing, supported by findings from histological examinations, gene expression analyses, and biomarker assessments.
People with diabetes often suffer from slow-healing mouth ulcers that are prone to persistent infections. By incorporating natural antimicrobial and healing extracts into a targeted nanocarrier sponge, this approach offers a natural therapeutic alternative to improve tissue repair, reduce infection risks, and enhance patient comfort during oral wound recovery.
This technology represents an applied, pre-clinically tested formulation aimed at wound care and oral health markets. It could enable pharmaceutical or biomaterial developers to create targeted topical treatments for diabetic oral lesions. Having demonstrated efficacy in an in vivo animal model and in vitro microbial tests, the formulation is at an intermediate development stage and requires clinical trials before it can reach real-world healthcare use.
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Background/Objectives: Diabetic mouth ulcers are a pathological condition of the oral mucosa leading to increases in susceptibility to infection and prolonged wound healing time. Still, there is a lack of natural formulations for treating this condition. Our principal objective was to formulate solid lipid nanoparticles (SLNs) that contained Althaea officinalis (marshmallow) (M.) extract with clove oil (CO.), subsequently integrated into a collagen sponge for enhancing stability, solubility, sustained release, antimicrobial efficacy, and healing power when targeting diabetic oral ulcers. Methods: A factorial design of 34 trials was established to evaluate the influence of lipid concentration (A), SAA concentration (B), lipid type (C), and SAA type (D). The optimized M-CO-SLNs was selected using Design Expert®, the based Poly dispersibility index (Y2), zeta potential (MV) (Y3), and encapsulation efficiency (%) (Y4). The optimized SLNs were integrated into a collagen sponge matrix and tested for their antibacterial and antifungal efficacy against Pseudomonas aeruginosa, Escherichia coli, and Candida albicans, respectively. Moreover, they were tested for their wound healing power in a diabetic mouth ulcer model. Results: The optimized formula (Run 16: 5% lipid concentration, 4% SAA concentration, capric acid) demonstrated P.S (110 ± 0.76 nm), ZP (−24 ± 0.32 mV), PDI (0.18 ± 0.05), and EE% (90 ± 0.65%.). The optimized M-CO-SLNs formula was incorporated into a cross-linked collagen sponge and showed superior antimicrobial efficacy, an increased swelling ratio, and was effective in an in vivo oral ulcer study, as evidenced by ELISA biomarkers, gene expression analysis, and histological analysis. Conclusions: M-CO-SLNs embedded in collagen sponges is a promising therapeutic formula for clinical application against diabetic mouth ulcers.
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DOI: 10.3390/pharmaceutics17050611
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