Quality of different chondroitin sulfate preparations in relation to their therapeutic activity

Abstract

Objectives Chondroitin sulfate is currently recommended by the European League Against Rheumatism (EULAR) as a SYSADOA (symptomatic slow acting drug for osteoarthritis) in Europe in the treatment of knee and hand osteoarthritis based on research evidence and meta-analysis of numerous clinical studies. Furthermore, recent clinical trials demonstrated its possible structure-modifying effects. Chondroitin sulfate, alone or in combination with glucosamine or other ingredients, is also utilized as a nutraceutical in dietary supplements in Europe and the USA. However, it is derived from animal sources by extraction and purification processes. As a consequence, source material, manufacturing processes, the presence of contaminants and many other factors contribute to the overall biological and pharmacological actions of these agents. We aim to review the quality control of chondroitin sulfate in pharmaceutical-grade preparations and nutraceuticals. Key findings Pharmaceutical-grade formulations of chondroitin sulfate are of high and standardized quality, purity and properties, due to the stricter regulations to which this drug is subjected by local national health institutes as regards production and characteristics. On the contrary, as several published studies available in literature indicate, the chondroitin sulfate quality of several nutraceuticals is poor. Additionally, there are no definite regulations governing the origin of the ingredients in these nutraceuticals and the origin of the ingredients in natural products is the most important factor ensuring quality, and thus safety and efficacy, in particular for chondroitin sulfate, due to its extraction from different sources. Conclusions Due to the poor chondroitin sulfate quality of some nutraceuticals, we conclude that stricter regulations regarding their quality control should be introduced to guarantee the manufacture of high quality products for nutraceutical utilization and to protect customers from low-quality, ineffective and potentially dangerous products. There is a need for specific and accurate analytical procedures, which should be enforced to confirm purity and label claims both for raw materials and finished chondroitin sulfate products, and also to govern the origin of ingredients. Until these stricter regulations are in place, then it is strongly recommended that pharmaceutical-grade chondroitin sulfate is used rather than food supplements.

Quality control of chondroitin sulphate used in dietary supplements

“…Since we had no standards of ΔDi-diS, we quantified these disaccharides on the basis of average response factor (peak area corrected on migration time divided by concentration) of ΔDi-4S and ΔDi-6S. Under the term "charge density", usually used in the literature (Volpi 2007(Volpi , 2009Volpi & Maccari 2008), the number of sulphate groups per disaccharide unit of CS is intended. In this context is this term somewhat misleading.…”

“…Some dietary Czech J. Food Sci., 33, 2015(2): 165-173 doi: 10.17221/326/2014 for stricter regulations regarding the quality of CS as well as specific and accurate analytical procedures to confirm the purity and label claims for both the raw bulk materials and finished products (Volpi 2009).…”

Isotachophoretic determination of glucosamine and chondroitin sulphate in dietary supplements

“…Some dietary supplements contain less than the labelled amount of CS, in some cases as little as 10%. Due to the poor CS quality in some nutraceuticals, there is a need for stricter regulations regarding the quality of CS and specific and CS -chondroitin sulfate; GA -glucosamine; MSM -methylsulfonylmethane; HA -hyaluronic acid; HC -hydrolysed collagen; GA*HCl -glucosamine hydrochloride; GA*SO 4 -glucosamine sulphate; GA 1 -expressed as glucosamine hydrochloride accurate analytical procedures to confirm the purity and label claims for both the raw bulk materials and finished products (Volpi 2009). The official method mentioned in European Pharmacopoeia concerning the analysis of chondroitin sulfphate as a bulk material or as an active principle in pharmaceutical preparations is based on the infrared spectroscopy and electrophoretic identification, and on a photometric titration assay using cetylpyridium chloride (European Pharmacopoeia 2006).…”

Chondroitin sulfate in the treatment of osteoarthritis: fromin vitrostudies to clinical recommendations

“…All of these results were obtained in different systems with different dosages. Many reviews have addressed the importance of CS source and purity [Lauder, 2009;Rainsford, 2009;Volpi, 2009;Lauder et al 2000]. In addition, CS sulfated at different positions (e.g.…”