EXPERIMENTAL SUBSTITUTION OF TECHNOLOGICAL PARAMETERS FOR MANUFACTURING OF A GEL WITH ANTI-INFLAMMATORY AND ANALGESIC ACTIVITY

Abstract

Diseases of the musculoskeletal system are among the leading causes of disability worldwide, and pain is the most common complaint. The prevalence of pain among adults with musculoskeletal disorders may range from 18% to 80%. Medical costs associated with the treatment and care of musculoskeletal diseases account for approximately 16.2% of total healthcare expenditures, creating a significant economic burden for society. The burden of musculoskeletal disorders continues to increase due to population growth, urbanization, modern transportation, and increased life expectancy. The aim of the study was to determine the concentration of a hydrophilic non-aqueous solvent and to develop the manufacturing technology of a hydrogel with an original composition containing thienoflogin with anti-inflammatory and analgesic activity. Materials and methods. The objects of the study were samples of hydrogel containing the original synthesized substance thienoflogin, developed by Associate Professor of the Department of Pharmaceutical Chemistry S. Vlasov (Head of the Department Prof. V. Georhiyants), prepared using different technological parameters. Generally accepted organoleptic (appearance, color, odor, etc.), physical (potentiometric determination of pH), structural-mechanical (structural viscosity, shear stress and shear rate, thixotropic properties), biopharmaceutical (osmotic properties), and pharmacotechnological (description, homogeneity, mass of container content) research methods were used. The studies were carried out according to the procedures described in the State Pharmacopoeia of Ukraine (SPU). Results. A technology for the production of a hydrogel intended for the complex therapy of musculoskeletal pain syndrome based on the original substance thienoflogin has been developed. Experimental samples were prepared taking into account the physicochemical properties of thienoflogin, forming a fine suspension in a hydrogel medium. At room temperature, purified water was poured into container No. 1, after which Aristoflex was gradually added, mixed, and left to swell for 15–20 minutes. Then the mixture was stirred using a homogenizer mixer at 80–100 rpm until dissolution, thickening of the mass, and gel formation. After that, glycerin and germaben were added to the gel and mixed until dissolved. In container No. 2, thienoflogin was weighed and the required amount of dimethyl sulfoxide was added, followed by mixing until homogeneous. The dispersion of thienoflogin in dimethyl sulfoxide from container No. 2 was then added to the gel in container No. 1 and homogenized using a homogenizer at 100 rpm until a homogeneous mass was obtained. After that, lemon essential oil was introduced and mixing continued until uniform. The finished product was then transferred for filling. The obtained gel is a homogeneous viscous gel-like mass of light-yellow color with a slight specific odor characteristic of lemon essential oil. The finished hydrogel is filled and packaged in glass or plastic containers. Conclusions. The concentration of glycerin and technological parameters were substantiated, and a technology for manufacturing a hydrogel of the original composition was developed. The process includes the following stages: weighing and measuring of ingredients, preparation of the gel base, obtaining a fine suspension, preparation of the hydrogel, filling the gel into polymer containers, packaging into cartons, and packing cartons into boxes. Technological and critical parameters of the manufacturing process of the original hydrogel were determined.