CHONDROITIN SULFATE

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Monograph: CHONDROITIN SULFATE (PDF Version - 59 KB)

This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.

Notes

  • Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
  • The solidus (/) indicates that the terms and/or statements are synonymous. Either term or statement may be selected by the applicant.

Date

July 1, 2019

Proper name(s), Common name(s), Source material(s)

Table 1. Proper name(s), Common name(s), Source material(s)
Proper name(s) Common name(s) Source ingredient(s) Source material(s)
Common name(s) Proper name(s) Part(s)1

Chondroitin sulfate

Chondroitin sulfate

Sodium chondroitin sulfate
  • Anas platyrhynchos
  • Anser anser
  • Bos taurus
  • Cygnus olor
  • Dromaius novaehollandiae
  • Gallus gallus
  • Meleagris gallopavo
  • Numida meleagris
  • Rhea Americana
  • Struthio camelus
  • Sus scrofa

Cartilage

References: Proper name: O'Neil et al. 2006; Common name: O'Neil et al. 2006; Source information: NIH 2019, USP 31 2008.

1 Cartilage must be derived from healthy and domestic animals used for food by humans (USP 31 2008).

Route of Administration

Oral

Dosage Form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

Acceptable dosage forms for any age category listed in this monograph for the specified route of administration are listed in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

Helps to relieve (joint) pain associated with osteoarthritis (of the knee) (Mazières et al. 2007; Uebelhart et al. 2004; Mazières et al. 2001; Bourgeois et al. 1998; Bucsi and Poor 1998; Uebelhart et al. 1998).

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

800 - 1,200 milligrams of Chondroitin sulfate, per day (Mazières et al. 2007; Hathcock and Shao 2006; Uebelhart et al. 2004; Mazières et al. 2001; Bourgeois et al. 1998; Bucsi and Poor 1998; Uebelhart et al. 1998)

Direction(s) for use

No statement required.

Duration(s) of Use

Use for at least 3 months to see beneficial effects (Bjordal et al. 2007).

Risk Information

Caution(s) and warning(s)

  • Consult a health care practitioner/health care provider/health care professional/doctor/ physician if symptoms worsen.
  • Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you are pregnant or breastfeeding.

Contraindication(s)

No statement required.

Known adverse reaction(s)

No statement required.

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Storage conditions

No statement required.

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the Natural and Non-prescription Health Products Directorate (NNHPD) Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the NHPID.
  • The medicinal ingredient must either:
    • Comply with the specifications outlined in the Chondroitin Sulfate Sodium Monographs published in the British or European Pharmacopoeiae, or the United States Pharmacopoeia or;
    • Be cited in an approved NHP Master File, authorized by a letter of access issued to the applicant by the NHP Master File's registered owner.
  • In order to minimize the risk of Transmissible Spongiform Encephalopathies (TSEs) from products sourced from bovine tissues, product licence applicants must have a veterinary certificate on file and must ensure that the following criteria has been met (EP 2008):
    • Source animal is fit for human consumption;
    • Source material can be traced back to the herd or animal;
    • Avoidance of cross-contamination with high-infectivity tissues is ensured during sourcing;
    • Manufacturing procedures that are known to reduce infectivity are implemented (e.g. procedures that are in accordance with those outlined in Chapter 5.2.8 of the European Pharmacopoeia).

References Cited

  • Bjordal JM, Klovning A, Ljunggren AE, Slørdal L. 2007. Short-term efficacy of pharmacotherapeutic interventions in osteoarthritic knee pain: A meta-analysis of randomised placebo-controlled trials. European Journal of Pain 11(2):125-138.
  • Bourgeois P, Chales G, Dehais J, Delcambre B, Kuntz JL, Rosenberg S. 1998. Efficacy and tolerability of chondroitin sulfate 1200 mg/day vs chondroitin sulfate 3 x 400 mg/day vs placebo. Osteoarthritis Cartilage 6(Suppl A):25-30.
  • Bucsi L, Poor G. 1998. Efficacy and tolerability of oral chondroitin sulfate as a symptomatic slow acting drug for osteoarthritis (SYSADOA) in the treatment of knee osteoarthritis.
  • Osteoarthritis Cartilage 6(Suppl A):31-36.
  • EP 2008: European Pharmacopoeia, 6th edition, Volume 1. Strasbourg (France): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).
  • Hathcock JN, Shao A. 2006. Risk assessment for glucosamine and chondroitin sulphate. Regulatory Toxicology and Pharmacology 47(1):78-83.
  • Mazières B, Combe B, Phan Van A, Tondut J, Grynfeltt M. 2001. Chondroitin sulphate in osteoarthritis of the knee ; a prospective, double-blind, placebo-controlled multicenter clinical study. Journal of Rheumatology 28:173-181.
  • Mazières B, Hucher M, Zaïm M, Garnero P. 2007. Effect of chondroitin sulphate in symptomatic knee osteoarthritis: a multicentre, randomised, double-blind, placebo-controlled study. Annals if the Rheumatic Diseases 66(5):639-645.
  • NIH 2019: National Institutes of Health. The NCBI Entrez Taxonomy Homepage. [online]. Bethesda (MD): Specialized Information Services, National Library of Medicine, National Institutes of Health, US Department of Health & Human Services. [Accessed 2019 May 8]. Available from: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=search&db=taxonomy
  • O'Neil MJ, Smith A, Heckelman PE, Budavari S, editors. 2006. The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals, 14th edition. Whitehouse Station (NJ): Merck & Co., Inc.
  • Uebelhart D, Malaise M, Marcolongo R, de Vathaire F, Piperno M, Mailleux E, Fioravanti A, Matoso L, Vignon E. 2004. Intermittent treatment of knee osteoarthritis with oral chondroitin sulphate: a one-year, randomized, double-blind, multicenter study versus placebo. Osteoarthritis and cartilage / OARS, Osteoarthritis Research Society 12(4):269-276.
  • Uebelhart D, Thonar EJ, Delmas PD, Chant Raine A, Vignon E. 1998. Effects of oral chondroitin sulfate on the progression of knee osteoarthritis: a pilot study. Osteoarthritis Cartilage 6(Suppl A):39-46.
  • USP 31: The United States Pharmacopeia and the National Formulary (USP 31/NF 26). 2008. Rockville (MD): United States Pharmacopeial Convention, Inc.

References Reviewed

  • Bana G, Jamard B, Mazières B. 2006. Chondroitin sulphate in the management of hip and knee osteoarthritis: an overview. Advances in Pharmacology 53:507-522.
  • Boon H. Chondroitin sulfate. In: Chandler F, editor. 2000. Herbs: Everyday Reference for Health Professionals. Ottawa (ON): Canadian Pharmacists Association and the Canadian Medical Association.
  • Clegg DO, Reda DJ, Harris CL, Klein MA, O'Dell JR, Hooper MM, Bradley JD, Bingham CO 3rd, Weisman MH, Jackson CG, Lane NE, Cush JJ, Moreland LW, Schumacher HR Jr, Oddis CV, Wolfe F, Molitor JA, Yocum DE, Schnitzer TJ, Furst DE, Sawitzke AD, Shi H, Brandt KD, Moskowitz RW, Williams HJ. 2006. Glucosamine, chondroitin sulphate, and the two in combination for painful knee osteoarthritis. The New England Journal of Medicine 354(8):795- 808.
  • Conrozier T. 1998. [Anti-arthrosis treatments: efficacy and tolerance of chondroitin sulfates (CS 4&6)]. Presse Médicale 27(36):1862-1865 (in French).
  • Jordan KM, Arden NK, Doherty M, Bannwarth B, Bijlsma JW, Dieppe P, Gunther K, Hauselmann H, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Leeb B, Lequesne M, Mazieres B, Martin-Mola E, Pavelka K, Pendleton A, Punzi L, Serni U, Swoboda B, Verbruggen G, Zimmerman-Gorska I, Dougados M. 2003. EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Annals of the Rheumatic Disease 62(12):1145-1155.
  • Luo XM, Fosmire GJ, Leach RM Jr. 2002. Chicken keel cartilage as a source of chondroitin sulfate. Poultry Science 81(7):1086-9.
  • Malavaki CJ, Asimakopoulou AP, Lamari FN, Theocharis AD, Tzanakakis GN, Karamanos NK. 2008. Capillary electrophoresis for the quality control of chondroitin sulfates in raw materials and formulations. Analytical Biochemistry 374(1):213-220.
  • Mazières B, Loyau G, Menkès CJ, Valat JP, Dreiser RL, Charlot J, Masounabe-Puyanne A. 1992. [Chondroitin sulfate in the treatment of gonarthrosis and coxarthrosis. 5-months result of a multicenter double-blind controlled prospective study using placebo]. Revue du Rhumatisme et des Maladies Ostéo-articulaires 59(7-8):466-472 (in French).
  • Michel BA, Stucki G, Frey D, De Vathaire F, Vignon E, Bruehlmann P, Uebelhart D. 2005. Chondroitins 4 and 6 sulfate in osteoarthritis of the knee: a randomized, controlled trial. Arthritis and Rheumatism 52(3):779-786.
  • Morreale P, Manopulo R, Galati M, Boccanera L, Saponati G, Bocchi L. 1996. Comparison of the anti-inflammatory efficacy of chondroitin sulfate and diclofenac sodium in patients with knee osteoarthritis. The Journal of Rheumatology 23(8):1385-1391.
  • Murray MT. 1996. Encyclopedia of Nutritional Supplements: The Essential Guide for Improving your Health Naturally. Rocklin (CA): Prima Publishing.
  • NIH 2007a: National Institutes of Health. ChemIDplus advanced [online database]. Chondroitin, hydrogen sulfate, sodium salt; RN: 9082-07-9. Specialized Information Services, National Library of Medicine, National Institutes of Health, US Department of Health & Human Services, Bethesda (MD). Available from: http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp [Accessed 17 July 2008].
  • NIH 2007b: National Institutes of Health. ChemIDplus advanced [online database]. Chondroitin sulfates; RN: 9007-28-7. Specialized Information Services, National Library of Medicine, National Institutes of Health, US Department of Health & Human Services, Bethesda (MD).
  • Available from: http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp [Accessed 17 July 2008].
  • Pisenti, ME Delany, RL Taylor, Jr., UK Abbott, H. Abplanalp, JA Arthur, MR Bakst, C Baxter- Jones, JJ Bitgood, FA Bradley, KM Cheng, RR Dietert, JB Dodgson, AM Donoghue, AB Emsley, RJ Etches, RR Frahm, RJ Gerrits, PF Goetinck, AA Grunder, DE Harry, SJ Lamont, GR Martin, PE McGuire, GP Moberg, LJ Pierro, CO Qualset, MA Qureshi, FT Shultz, BW Wilson. 1999. Chapter 2: Avian genetic diversity: Domesticated species. In: Avian Genetic Resources at Risk: An Assessment and Proposal for Conservation of Genetic Stocks in the USA and Canada. Report No. 20. Davis (CA): University of California Division of Agriculture and Natural Resources, Genetic Resources Conservation Program.
  • Reichenbach S, Sterchi R, Scherer M, Trelle S, Bürgi E, Bürgi U, Dieppe PA, Jüni P. 2007. Meta-analysis: chondroitin for osteoarthritis of the knee or hip. Annals of Internal Medicine 146(8):580-590.
  • Richy F, Bruyere O, Ethgen O, Cucherat M, Henrotin Y, Reginster JY. 2003. Structural and symptomatic efficacy of glucosamine and chondroitin in knee osteoarthritis: a comprehensive meta-analysis. Archives of Internal Medicine 163(13):1514-1522.
  • Rovetta G. 1991. Galactosaminoglycuronoglycan sulfate (matrix) in therapy of tibiofibular osteoarthritis of the knee. Drugs under Experimental and Clinical Research 17(1):53-57.
  • Shankland WE. 1998. The effects of glucosamine and chondroitin sulphate on osteoarthritis of the TMJ: a preliminary report of 50 patients. Cranio: the journal of craniomandibular practice 16(4):230-235.
  • Verbruggen G, Goemaere S, Veys E. 2002. Systems to assess the progression of finger joint osteoarthritis and the effects of disease modifying osteoarthritis drugs. Clinical Rheumatology 21(3):231-243.
  • Verbruggen G, Goemaere S, Veys E. 1998. Chondroitin sulfate: S/MOAD (structure/disease modifying anti-osteoarthritis drug) in the treatment of finger joint OA. Osteoarthritis and Cartilage 6(suppl A):37-38.
  • Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. 2008. OARSI recommendations for the management of hip and knee osteoarthritis part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis and Cartilage 16(2):137-162.

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