Abstract
BackgroundChondroitin sulfate (CS) and glucosamine (GLcN) are recommended for the restoration of the articular cartilage surface in patients affected by osteoarthritis. They are commercialized as pharmaceutical-grade products and as food supplements, and there are reports that they do not undergo the strict quality controls of pharmaceuticals. Herein, we evaluated the physicochemical parameters of two raw materials (CS and GlcN) obtained from two distinct suppliers in Brazil and compare the obtained data with the product specification provided by the manufacturer. Also, the homogeneity and purity grade of samples were analyzed by FT-IR spectroscopy.ResultsThe organoleptic properties and solubility of CS and GlcN samples obtained from pharmacy analyses and the supplier’s specifications are in accordance with the standards required by the Brazilian Health Regulatory Agency (ANVISA). However, the intraclass correlation coefficient (ICC) and Bland Altman analysis of pH and the density values of samples are statistically different between the suppliers. In addition, FT-IR analyses indicated that there is non-homogeneity in the CS and GlcN samples tested, showing that both manufacturers distribute the drugs in different concentrations, although both declare the same concentration in the product technical specifications.ConclusionIn summary, our study demonstrated that physicochemical parameters are insufficient to ensure product quality, and it is necessary to implement a more efficient protocol to ensure the quality of the final product.Graphical abstract
Highlights
Chondroitin sulfate (CS) and glucosamine (GLcN) are recommended for the restoration of the articular cartilage surface in patients affected by osteoarthritis
All CS samples were soluble in water, while glucosamine sulfate (GlcN) samples were soluble in water and practically insoluble in alcohol (Table 1)
The pH of CS samples did not show a difference between the suppliers and pharmacy (Fig. 1a), but the GlcN samples were different between supplier 1 (S1) and supplier 2 (S2) (Fig. 1b)
Summary
Chondroitin sulfate (CS) and glucosamine (GLcN) are recommended for the restoration of the articular cartilage surface in patients affected by osteoarthritis. They are commercialized as pharmaceutical-grade products and as food supplements, and there are reports that they do not undergo the strict quality controls of pharmaceuticals. Osteoarthritis is a progressive, degenerative joint and musculoskeletal disease with a huge incidence and economic impact [1]. It involves mechanical overloading of the articular joints, loss of cartilage and synovial fluids, bone degradation, inflammation, and reduction of mobility and quality of life [2]. The EULAR and the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis and Musculoskeletal Disease (ESCEO) have recommended daily dosages of CS and GlcN between 800 and 1200 mg and between 1250 and 1500 mg, respectively [4, 8]
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