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Drugs and Health Products

CHITOSAN

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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

December 18, 2018

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 material(s)
Common name(s) Organism group(s) Part(s)

Poly-beta-(1,4)-2-amino-2-deoxy-d-glucose

  • Chitosan
  • Poliglusam
  • Poly-D-glucosamine
  • Polyglucosamine

Chitin

  • Clam
  • Crab
  • Krill
  • Oyster
  • Shrimp

Exoskeleton

References: Proper name: Martindale 2010; Common names: Martindale 2010; Source materials: EBSCO 2018, Martindale 2010, Dutta et al. 2004.

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 the age category listed in this monograph and specified route of administration are indicated in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

  • Helps lower blood total (and LDL) cholesterol (Bokura and Kobayashi 2003; Tai et al. 2000).
  • Helps maintain healthy cholesterol levels (EFSA 2011; Mhurchu et al. 2004).
  • Could be a complement to a healthy lifestyle that incorporates a calorie-reduced diet and regular physical activity for individuals involved in a weight management program (Willers et al. 2012; Jull et al. 2008; Mhurchu et al. 2005).

The following combined use(s) or purpose(s) is/are also acceptable:

Helps lower blood total (and LDL) cholesterol and maintain healthy cholesterol levels (EFSA 2011; Mhurchu et al. 2004; Bokura and Kobayashi 2003; Tai et al. 2000).

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

0.5 - 3 grams of chitosan, 2 times per day (Mhurchu et al. 2004; Bokura and Kobayashi 2003; Tai et al. 2000).

Direction(s) for use

Take with meals (Bokura and Kobayashi 2003).

Take two hours before or after taking other medications or natural health products since the absorption of these products may be delayed (EBSCO 2018).

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

  • Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you are pregnant or breastfeeding (EBSCO 2018).
  • Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you are taking blood thinners (Pittler et al. 1999).

Contraindication(s)

Do not use this product if you have an allergy to seafood

Known adverse reaction(s)

May cause abdominal pain, bloating, constipation, indigestion and/or diarrhea (Mhurchu et al. 2004; Pittler et al. 1999).

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 degree of deacetylation for chitosan should be above 75%.

References Cited

Bokura H, Kobayashi S. Chitosan decreases total cholesterol in women: a randomized, doubleblind, placebo-controlled trial. European Journal of Clinical Nutrition 2003;57(5):721-725.

Dutta PK, Dutta J, Tripathi VS. Chitin and chitosan: Chemistry, properties and applications. Journal of Scientific & Industrial Research 2004;63:20-31.

EBSCO 2018: EBSCO Complementary and Alternative Medicine (CAM) Review Board. Herbs and Supplements. Chitosan. [Internet]. 2011 EBSCO Publishing. [Last reviewed 2013 August; Accessed 2018 September 25]. Available from: http://therapy.epnet.com/nat/GetContent.asp?chunkiid=21656

EFSA 2011: European Food Safety Authority. SCIENTIFIC OPINION: Scientific Opinion on the substantiation of health claims related to chitosan and reduction in body weight (ID 679, 1499), maintenance of normal blood LDL-cholesterol concentrations (ID 4663), reduction of intestinal transit time (ID 4664) and reduction of inflammation (ID 1985) pursuant to Article 13(1) of Regulation (EC) No 1924/20061; EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), European Food Safety Authority (EFSA), Parma, Italy. [Accessed 2018 September 25]. Available from: http://www.efsa.europa.eu/en/efsajournal/doc/2214.pdf

Jull AB, Ni Mhurchu C, Bennett DA, Dunshea-Mooj CAE, Rodgers A. Chitosan for overweight or obesity (review). The Cochrane Collaboration; John Wiley and Sons Ltd; 2008.

Martindale 2010: Sweetman SC (ed), Martindale: The Complete Drug Reference. [Internet] London (GB): Pharmaceutical Press; Copyright 1933-2010. [Accessed 2018 September 25]. Available from: http://www.medicinescomplete.com

Mhurchu CN, Poppitt SD, McGill AT, Leahy FE, Bennett DA, Lin RB, Ormrod D, Ward L,Strik C, Rodgers A. (on behalf of the Effect of Chitosan on Health and Obesity (ECHO) Collaboration). The effect of the dietary supplement, Chitosan, on body weight: a randomised controlled trial in 250 overweight and obese adults. International Journal of Obesity 2004;28: 1149-1156.

Pittler MH, Abbot NC, Harkness EF, Ernst E. Randomized, double-blind trial of chitosan for body weight reduction. European Journal of Clinical Nutrition 1999;53(5):379-381.

Tai TS, Sheu WH, Lee WJ, Yao HT, Chiang MT. Effect of chitosan on plasma lipoprotein concentrations in type 2 diabetic subjects with hypercholesterolemia. Diabetes Care 2000;23(11):1703-1704.

Willers J, Plotz SC, Hahn A. The combination of a high-protein formula diet and polyglucosamine decreases body weight and parameters of glucose and lipid metabolism in overweight and obese men and women. European Journal of Food Research and Review 2012; 2(1):29-45.

References Reviewed

Ausar SF, Morcillo M, Leon AE, Ribotta PD, Masih R, Vilaro Mainero M, Amigone JL, Rubin G, Lescano C, Castagna LF, Beltramo DM, Diaz G, Bianco ID. Improvement of HDL- and LDLcholesterol levels in diabetic subjects by feeding bread containing chitosan. Journal of Medicinal Food 2003;6(4):397-399.

ChemId Advanced. Full record Poliglusam RN: 9012-76-4. [Internet]. United States National Library of Medicine. 2012 [Accessed 2013 April 23]. Available from: http://chem.sis.nlm.nih.gov/chemidplus/ProxyServlet?objectHandle=DBMaint&actionHandle=d efault&nextPage=jsp/chemidheavy/ResultScreen.jsp&ROW_NUM=0&TXTSUPERLISTID=0009012764

European Bioinformatics Institute. Chitosan (CHEBI: 16261). [Internet] European Molecular Biology Laboratory. 2012. [Accessed 2013 April 23]. Available from: http://www.ebi.ac.uk/chebi/searchFreeText.do?searchString=9012-76-4

Kaats GR, Michalek JE, Preuss HG. Evaluating efficacy of a chitosan product using a doubleblinded, placebo-controlled protocol. Journal of the American College of Nutrition 2006;25: 389-394.

Maezaki Y, Tsuji K, Nakagawa Y, Kawai Y, Akimoto M. Hypocholesterolemic effect of chitosan in adult males. Bioscience, Biotechnology, and Biochemistry 1993;57(9):1439-1444.

Metso S, Ylitalo R, Nikkilä M, Wuolijoki E, Ylitalo P, Lehtimäki T. The effect of long-term microcrystalline chitosan therapy on plasma lipids and glucose concentrations in subjects with increased plasma total cholesterol: a randomised placebo-controlled double-blind crossover trial in healthy men and women. European Journal of Clinical Pharmacology 2003;59:741-746.

Natural Standard. Chitosan (Deacetylated chitin biopolymer). Natural Standard Professional monograph. [Internet] Natural Standard Inc. 2012 [Accessed 2013 April 23]. Available from http://www.naturalstandard.com/databases/herbssupplements/chitosan.asp

Schiller RN, Barrager E, Schauss AG, Nichols EJ. A randomized double blind placebo controlled study examining the effects of a rapidly soluble chitosan dietary supplement on weight loss and body composition in overweight and mildly obese individuals. Journal of the American Nutraceutical Association 2001;4(1):42-49.

Tapola NS, Lyyra ML, Kolehmainen RM, Sarkkinen ES, Schauss AG. Safety aspects and cholesterol-lowering efficacy of chitosan tablets. Journal of the American College of Nutrition 2008;27(1):22-30.

Wuolijoki E, Hirvela T, Ylitalo P. Decrease in serum LDL cholesterol with microcrystalline chitosan. Methods & Findings in Experimental & Clinical Pharmacology 1999;21(5):357-361.

Ylitalo R, Lehtinen S, Wuolijoki E, Ylitalo P, Lehtimaki T. Cholesterol-lowering properties and safety of chitosan. Arzneimittelforschung 2002;52(1):1-7.

Zhang J, Xia W, Liu P, Cheng Q, Tahirou T, Gu W, Li B. Chitosan Modification and Pharmaceutical/Biochemical Applications, Marine Drugs 2010;8:1962-1987.