Monograph: Deglycyrrhizinated licorice - Buccal

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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: 2018-10-30

NHPID name

Deglycyrrhizinated licorice

Proper name(s)

Common name(s)

Deglycyrrhizinated licorice - Buccal

Source material

Route Of administration

Buccal

Dosage form(s)

Those dosage forms suited to buccal administration which allow for contact between the affected tissue and the medicinal ingredient including but not limited to lozenges, chewables (e.g. gummies, tablets), strips and liquids (such as gargles, rinses).

Use(s) or purpose(s)

Statement(s) to the effect of:

(Used in Herbal Medicine to) help(s) relieve minor inflammations of mucous membranes of the mouth (such as canker sores) (demulcent). (Pizzorno and Murray 2006, Bruneton 1999, Das et al. 1989)

Dose(s)

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/health care provider/health care professional/doctor/physician if symptoms persist or 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

Buccal:

Gargle four times daily with 200 mg DGL powder dissolved in 200 ml of warm water, 4 times per day (Das et al. 1989)