Hydrating dental gel for symptomatic treatment of xerostomia: requirements and research design

Xerostomia (dry mouth) is a common syndrome with multiple causes that tends to increase in prevalence as the population ages. The imitation of physiological saliva is a modern concept in the development of saliva replacement agents, with the gel dose form being considered optimal. This article provides a scientific rationale for the requirements and design of the pharmaceutical development of a hydrating dental gel for the symptomatic treatment of xerostomia in the context of import substitution. The information-retrieval stage of pharmaceutical development of artificial saliva is based on an understanding of the pathophysiology and etiology of xerostomia, as well as modern treatment approaches and knowledge of the composition, properties, and biological functions of human physiological saliva. The research stage of pharmaceutical development includes identifying potential molecules and compounds capable of mimicking the properties and functions of saliva, as well as formulating and improving the gel composition. An essential aspect is selecting a polymer combination with mucoadhesive properties. The search for a polymer composition includes cellulose derivatives, acrylic acid copolymers, alginates, hyaluronates, pectins, carrageenans, and fucoidans. Further expansion of structure-forming mucoadhesive polymers is possible through the use of recombinant mucins obtained by genetic engineering and plant extracts rich in polysaccharides that mimic mucin properties. Lysozyme, peroxidase, and lactoferrin, which are currently produced as bulk substances, as well as plant extracts, provide antimicrobial effects of artificial saliva. Buffering properties are maintained by potassium, sodium, and calcium bicarbonates and phosphates. Calcium lactate and fluorides impart remineralizing properties. The formulation of saliva substitutes includes organoleptic corrigents and preservatives. Selection criteria for compositions include quality parameters, biopharmaceutical performance, and antimicrobial and antioxidant characteristics of the saliva substitute. The proposed packaging for the hydrating dental gel includes 10–30 mL tubes, single-use stick packs, or strip packaging. The standardization stage involves modifying and validating analytical procedures specific to the composition, conducting stability tests, determining shelf life, and developing the process flowchart and regulatory documentation drafts. The composition and functions of salivary gland secretions serve as the foundation for defining the requirements and characteristics of the hydrating dental gel intended for pharmaceutical development. The optimal formulation is sought among combinations of mucoadhesive polymers with compounds exhibiting antimicrobial and remineralizing activity. Scientific data were analyzed and organized into a unified design framework for the pharmaceutical development of a hydrating dental gel for xerostomia therapy, comprising information-retrieval, research, and standardization stages. This design framework can be applied in research laboratories and educational institutions to train pharmaceutical industry professionals.