STUDY OF COMPONENT COMPATIBILITY AND STABILITY OF A COMBINED CHONDROPROTECTIVE MEDICINE

Abstract

The article presents the results of pharmaceutical development stages, specifically an experimental study of component compatibility and stability of a combined chondroprotective medicinal product intended for the symptomatic and pathogenetic treatment of osteoarthritis. The relevance of the study is determined by the high prevalence of osteoarthritis, the progressive nature of the disease, the decline in patients’ quality of life, and the need to develop effective multicomponent medicinal products with proven stability and pharmaceutical compatibility of ingredients. The object of the study is a combined medicinal product in the form of a powder for oral administration in sachets, containing sodium glucosamine sulfate and sodium chondroitin sulfate as the main active pharmaceutical ingredients with chondroprotective activity, as well as methylsulfonylmethane, ascorbic acid, sodium hyaluronate, and excipients– sorbitol and citric acid. The rationale for the selection of the formulation is based on the need for a comprehensive effect on cartilage tissue metabolism, reduction of inflammatory processes, improvement of the viscoelastic properties of synovial fluid, and enhancement of the bioavailability of active components. The aim of the study was to investigate the physical, physicochemical, and chemical compatibility of active pharmaceutical ingredients and excipients, as well as to establish the stability of the medicinal product during longterm storage. To achieve this aim, a set of pharmacopoeial analytical methods was applied in accordance with the requirements of the State Pharmacopoeia of Ukraine and international guidelines, including hygroscopicity determination, potentiometric pH measurement, ultraviolet absorption spectrophotometry, liquid chromatography, and titrimetric methods for quantitative analysis. Spectrophotometric studies confirmed the absence of spectrophotometrically detectable chemical interactions of the medicinal product. Stability studies conducted under long-term storage conditions (25 ± 2 °C and 60 ± 5% relative humidity) for 24 months demonstrated that the quantitative content of sodium glucosamine sulfate, sodium chondroitin sulfate, methylsulfonylmethane, sodium hyaluronate and ascorbic acid remained within acceptable pharmacopoeial limits. The developed approach is promising for further implementation in pharmaceutical practice and may be used to substantiate the formulation of a combined medicine for the treatment of osteoarthritis.