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Drugs and Health Products

Monograph: Glucosamine sulfate

This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. It is a referenced document to be used as a labelling standard. Note: Text in parentheses is additional optional information which can be included on the Product Licence Application and product labels at the applicants' discretion. The solidus (/) indicates that the terms are synonyms or that the statements are synonymous. Either term or statement may be selected by the applicant.

Date: 2009-06-11

NHPID Name

Glucosamine sulfate (USNLM 2007)

Proper Name(s)

2-Amino-2-deoxy-D-glucose sulfate ( NLM 2009 )

Common Name(s)

Glucosamine sulfate ( USP 2008 , Sweetman 2007 , Towheed et al. 2007 )

Source Material


The specific organisms used as source material(s) must be indicated in the Animal Tissue Form (ATF) because simply indicating "crustaceans" is insufficient. The source material can be an organism exoskeleton stabilized by a salt or a glucosamine sulfate salt from an organism exoskeleton. Acceptable salts include potassium chloride and sodium chloride (Kralovec and Barrow 2008).

Route Of Administration

Oral

Dosage Form(s)

  • The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.
  • This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of:

Dose(s)

Adults:

Dose(s): 1500 Milligrams per day

Duration of use

Use for a minimum of 4 weeks to see beneficial effects  (Mehta et al. 2007, Usha and Naidu 2004, Houpt et al. 1999, Qiu et al. 1998)

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
  • Consult a health care practitioner if symptoms worsen.
  • Consult a health care practitioner prior to use if you are pregnant or breastfeeding  (Sivojelezova et al. 2007)

Contraindication(s):
No statement is required

Known Adverse Reaction(s):
No statement is required

Non-medicinal ingredients

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

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the NHPD Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredient Database (NHPID).
  • The medicinal ingredient may comply with the specifications outlined in the Glucosamine Tablets, Glucosamine Sulfate Potassium Chloride and Glucosamine Sulfate Sodium Chloride monographs published in the U.S. Pharmacopoeia.

References cited

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  • Houpt JB, McMillan R, Wein C, Paget-Dellio SD. 1999. Effect of glucosamine hydrochloride in the treatment of pain of osteoarthritis of the knee. Journal of rheumatology 26(11):2423-2430
  • ITIS 2009: Integrated Taxonomic Information System, Canadian Biodiversity Information Facility, Government of Canada [Accessed 2009-10-21]. Available from: http://www.cbif.gc.ca/pls/itisca/taxaget?p_ifx=cbif
  • Kralovec A, Barrow CJ. 2008. Glucosamine Production and Health Benefits. Dans: Marine Nutraceuticals and Functional Foods. Colin Barrow and Fereidoon Shahidi, éditeurs, pp198-227. Boca Raton (FL): CRC Press, Taylor and Francis Group
  • Mehta K, Gala J, Bhasale S, Naik S, Modak M, Thakur H, Deo N, Miller JM. 2007. Comparison of glucosamine sulphate and a polyherbal supplement for the relief of osteoarthritis of the knee: a randomized controlled trial. BMC Complementary and alternative Medicine 31(7):34
  • NLM 2009: United States National Library of Medicine. ChemIDplus advanced [online]. Chemical name. RN: 000-00-0. Bethesda (MD): Specialized Information Services, United States National Library of Medicine, National Institutes of Health, United States Department of Health & Human Services. [Accessed 2009 May 19]. Available from: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?CHEM
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  • Sweetman SC , editor. Martindale: The Complete Drug Reference, 35th edition. London (UK): Pharmaceutical Press; 2007.
  • Thie NM, Prasad NG, Major PW. 2001. Evaluation of glucosamine sulfate compared to ibuprofen for the treatment of temperomandibular joint osteoarthritis: a randomized double blind controlled 3 month clinical trial. The Journal of Rheumatology 28:1347-1355
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  • Usha PR, Naidu MUR. 2004. Randomised, double-blind, parallel, placebo-controlled study of oral glucosamine, methylsulfonylmethane and their combination in osteoarthritis. Clinical Drug Investigation 24(6):353-363.
  • USP 32 : United States Pharmacopeial Convention. 2009. United States Pharmacopeia and the National Formulary (USP 32 - NF 27). Rockville (MD): The United States Pharmacopeial Convention.

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