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Drugs and Health Products

Monograph: Deglycyrrhizinated licorice - Oral

This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) 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. Notes: Text in parentheses is additional optional information which can be included on PLA and on product label at the applicant's 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: 2010-10-15

NHPID Name

Deglycyrrhizinated licorice

Proper Name(s)

Common Name(s)

Source Material


Route Of Administration

Oral

Dosage Form(s)

The acceptable pharmaceutical dosage form for oral administration is limited to chewables (e.g. gummies, tablets).

Use(s) or Purpose(s)

Statement(s) to the effect of:

Dose(s)

Children 2 - 4 years:

Preparation: Dry

Dose(s): 190 - 760 Milligrams per day
Directions For Use:

Children 5 - 9 years:

Preparation: Dry

Dose(s): 285 - 1140 Milligrams per day
Directions For Use:

Children and adolescents 10 - 14 years:

Preparation: Dry

Dose(s): 570 - 2280 Milligrams per day
Directions For Use:

Adults and adolescents 15 and over:

Preparation: Dry

Dose(s): 1140 - 4560 Milligrams per day
Directions For Use:


  • Adult doses are supported by Pizzorno and Murray 2006
  • Children and adolescent doses were calculated as a fraction of the adult dose (JC 2008).The use of licorice in children and adolescents is supported by the following references: McIntyre 2005; Schilcher 1997; Bove 1996

Duration of use

No statement is required

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
  • Consult a health care practitioner if symptoms persist.
  • Consult a health care practitioner if symptoms worsen.

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 finished product must not contain more than 3% of the original quantity of glycyrrhizic acid found in the source material (Bradley 1992)
  • The medicinal ingredient may comply with the specifications outlined in the Deglycyrrhizinised Liquorice Extract of the British Pharmacopoeia (BP 1988).

References cited

  • Blumenthal M, Goldberg A, Brinkmann J, editors. 2000. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications.
  • Bove M. 1996. An Encyclopedia of Natural Healing for Children and Infants. New Canaan (CT): Keats Publishing Incorporated.
  • BP 1988: British Pharmacopoeia Commission. 1987. British Pharmacopoeia 1988, Volume 2. Deglycyrrhizinised Liquorice Extract. London (GB): The Stationary Office.
  • BP 2008: British Pharmacopoeia Commission. 2007. British Pharmacopoeia 2008, Volume 2. London (GB): The Stationary Office
  • Bradley PR, editor. 1992. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 1. Bournemouth (GB): British Herbal Medicine Association.
  • Bruneton J. 1999. Pharmacognosy, Phytochemistry, Medicinal Plants, 2nd edition. Paris (FR) Lavoisier Publishing,
  • Das SK, Das V, Gulati AK, Singh VP. 1989. Deglycyrrhizinated liquorice in aphthous ulcers. Journal of Association of Physicians of India 37(10):647.
  • JC 2008: Justice Canada. Food and Drug Regulations. (C.01.021). Ottawa (ON): Justice Canada; 2008. [Accessed 2010 January 28] Available from: http://laws.justice.gc.ca/eng/C.R.C.-c.870/page-1.html
  • McIntyre A. 2005. Herbal Treatment of Children - Western and Ayurvedic Perspectives. Toronto (ON): Elsevier Limited
  • PasseportSanté.net. 2006. Réglisse. [Online]. [Accessed 2009 November 24]. Available at: http://www.passeportsante.net/fr/Solutions/PlantesSupplements/Fiche.aspx?doc=reglisse
  • Ph. Eur. 2008: European Pharmacopoeia Commission. 2008. European Pharmacopoeia, 6th edition, Volume 2. Strasbourg (FR): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).
  • Pizzorno Jr JEP, Murray MT. 2006. Textbook of Natural Medicine, 3rd edition, Volume 1. St-Louis (MI): Churchill Livingstone Elsevier.
  • PPRC 2005: Pharmacopoeia of the People's Republic of China, Volume 1, English edition 2005. Beijing (CN): The State Pharmacopoeia Commission of the People's Republic of China.
  • Schilcher H. 1997. Phytotherapy in Paediatrics: Handbook for Physicians and Pharmacists. Stuttgart (DE): Medpharm Scientific Publishers.
  • USDA 2001: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). Glycyrrhiza uralensis Fisch. Ex DC. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2010 January 28]. Available at: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • USDA 2002: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). Glycyrrhiza inflata Batalin. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2010 January 28]. Available at: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • USDA 2007: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). Glycyrrhiza glabra L. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2010 January 28]. Available at: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • 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.

References reviewed

  • Agarwal A, Gupta D, Yadav G, Goyal P, Singh PK, Singh U. 2009. An evaluation of the efficacy of licorice gargle for attenuating postoperative sore throat: a prospective, randomized, single-blind study. Ambulatory Anesthesiology 109(1):77-81.
  • Bardhan KD, Cumberland DC, Dixon RA, Holdsworth CD. 1978. Clinical trial of deglycyrrhizinised liquorice in gastric ulcer. Gut 19:779-782.
  • Blumenthal M. 2003. The ABC Clinical Guide to Herbs. New York (NY): Thieme.
  • Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
  • Brinker F. 2010. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications; 2007. [Accessed 2010 April 10]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
  • Brogden RN, Speight TM, Avery GS. 1974. Deglycyrrhizinised liquorice: a report of its pharmacological properties and therapeutic efficacy in peptic ulcer. Drugs 8(5):330-339.
  • D'Imperio N, Piccari GG, Sarti F, Soffritti M, Spongano P, Benvenuti C, Dal Monte PR. 1978. Double-blind trial in duodenal and gastric ulcers: Cimetidine and deglycyrrhizinized liquorice. Acta Gastro-Enterologica Belgica 41:427-434.
  • Doll R, Langman MJS, Shawdon HH. 1968. Treatment of gastric ulcer with carbenoxolone: antagonistic effect of spironolactone. Gut 1969(9):42-45.
  • Engqvist A, von Feilitzen F, Pyk E, Reichard H. 1973. Double-blind trial of deglycyrrhizinated liquorice in gastric ulcer. Gut 14(9):711-715.
  • Feldman H, Gilat T. 1971. A trial of deglycyrrhizinated liquorice in the treatment of duodenal ulcer. Gut 12(6):449-451.
  • Goldman L, Ausiello D, editors. 2004. CECIL Textbook of Medicine, 22nd edition, Volume 1. Philadelphia (PA), Elsevier Inc.
  • Kassir ZA. 1985. Endoscopic controlled trial of four drug regimens in the treatment of chronic duodenal ulceration. Irish Medical Journal 78:153-156.
  • Larkworthy W, Holgate PF. 1975. Deglycyrrhizinized liquorice in the treatment of chronic duodenal ulcer. A retrospective endoscopic survey of 32 patients. Practitioner 215(1290):787-792.
  • Martin MD, Sherman J, van der Ven P, Burgess J. 2008. A controlled trial of a dissolving oral patch concerning glycyrrhiza (licorice) herbal extract for the treatment of aphthous ulcers. General Denistry 56(2):206-210: quiz 211-2, 224.
  • Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. St. Louis (MO): Churchill Livingstone
  • Morgan AG, Pacsoo C, McAdam WAF. 1985. Maintenance therapy: a two year comparison between Caved-S and cimetidine treatment in the prevention of symptomatic gastric ulcer recurrence. Gut 26:599-602.
  • Natural Standard 2009. Licorice (Glycyrrhiza glabra L.) and DGL (deglycyrrhizinated licorice). [Accessed 2009 August 2]. Available from: http://www.nlm.nih.gov/medlineplus/print/druginfo/natural/patient-licorice.html
  • Räikkönen K, Pesonen A-K, Heinonen K, Lahti J, Komsi N, Eriksson JG, Seckl JR, Järvenpää A-L, Strandberg TE. 2009. Maternal licorice consumption and detrimental cognitive and psychiatric outcomes in children. American Journal of Epidemiology 170(9):1137-1146.
  • Strandberg TE, Andersson S, Järvenpää AL, McKeigue PM. 2002. Preterm birth and licorice consumption during pregnancy. American Journal of Epidemiology 156(9):803-805.
  • Sweetman S, editor. 2009. Martindale: The Complete Drug Reference. London (GB): Pharmaceutical Press. [Accessed 2009 August 6]. Available from: http://www.medicinescomplete.com/mc/martindale/current/2021-1.htm
  • Tewari SN, Trembalowicz FC. 1968. Some experience with deglycyrrhizinated liquorice in the treatment of gastric and duodenal ulcers with special reference to its spasmolytic effect. Gut 9:48-51.

Appendix 1: Examples of appropriate dosage preparations, frequencies of use and directions for use

Oral:

380 mg DGL chewable tablets (1-4) between meals or 20 minutes before meals, 3 times per day (Murray and Pizzorno 2006)