Development of a Novel Pastille Formulation to Alleviate Dry Mouth Symptoms
Abstract
Objective: Dry mouth adversely affects oral function and quality of life, necessitating the development of effective salivary-stimulating systems. This study aimed to develop and characterize the properties of salivary stimulating pastilles (SSP) and to conduct a pilot study assessing patient satisfaction and clinical effectiveness in patients with dry mouth.
Material and Methods: SSPs were formulated using gelatin (15.0%) combined with gellan gum, xanthan gum, or pectin, with glycerin as a plasticizer. Nine formulations were prepared and characterized for physicochemical properties, rheological behavior, stability, and microbiological quality. Biocompatibility was assessed using human periodontal and gingival fibroblast cell lines. Salivary mucin levels were quantified using a FITC-based fluorescence method, followed by a pilot clinical evaluation in participants with low salivary flow.
Results: The optimized formulation containing gellan gum (0.3 % w/w) and xanthan gum (0.15 % w/w) demonstrated suitable pH (5.71-5.76), mechanical strength (<12,000 g), elastic-dominant viscoelastic properties (G′>G″), and acceptable disintegration time (200-235 s). Both formulations remained stable under refrigerated conditions and met microbiological standards. Cell viability exceeded 90.0% in the periodontal and gingival fibroblast assays. Clinical evaluation showed a significant increase in unstimulated salivary flow and elevated mucin levels (p-value<0.01).
Conclusion: The results indicate that pastilles containing gellan gum (0.3 % w/w) and xanthan gum (0.15 % w/w) might serve as safe and promising saliva-stimulating systems with potential therapeutic application in the management of dry mouth.
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