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 (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.

Notes

Date

October 30, 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)
Proper name(s) Part(s)

Deglycyrrhizinated licorice

  • Deglycyrrhizinated licorice
  • DGL
  • Glycyrrhiza glabra
  • Glycyrrhiza inflata
  • Glycyrrhiza uralensis
  • Root
  • Root and stolon
  • Root and rhizome
  • Root, rhizome and stolon

References: Proper name: NHPID 2018; Common names: Pizzorno and Murray 2006, Blumenthal et al. 2000; Source materials: USDA 2018, USP 32 2009, BP 2008, Ph. Eur. 2008.

Route of Administration

Buccal

Dosage Form(s)

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

Acceptable dosage forms by age group:

Children 2 years:The acceptable dosage forms are limited to emulsion/suspension and solution/liquid preparations (Giacoia et al. 2008; EMEA/CHMP 2006).

Children 3-5 years:The acceptable dosage forms are limited to emulsion/suspension, powders and solution/liquid preparations (Giacoia et al. 2008; EMEA/CHMP 2006).

Children 6-11 years, Adolescents 12-17 years, and Adults 18 years and older: The acceptable dosage forms for this age category and specified route of administration are indicated in the Compendium of Monographs Guidance Document.

Note

Dosage forms must be suited for buccal administration which allow for direct contact between the affected tissue and the medicinal ingredient (i.e. liquid preparations, gargles, and mouthwashes.

Use(s) or Purpose(s)

(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)

Subpopulation(s)

As specified below.

Quantity(ies)

Method of preparation: Dry extract

Table 2. Dose information for Deglycyrrhizinated licorice extract

Subpopulation(s)

Deglycyrrhizinated licorice extract (milligram)
Minimum/single dose Maximum/single dose
Frequency
Minimum
Maximum

Children 1

2-4 years

33 mg

190 mg

4

4

5-9 years

50 mg

285 mg

4

4

10-11 years

100 mg

570 mg

4

4

Adolescents 1

12-14 years

100 mg

570 mg

4

4

15-17 years

200 mg

1140 mg

4

4

Adults 2

18 years and older

200 mg

1140 mg

4

4

Table 2 Footnotes

Table 2 Footnote 1

Children and adolescent doses were calculated as a fraction of the adult dose (JC 2018). The use of licorice in children and adolescents is supported by the following references: McIntyre 2005; Schilcher 1997; Bove 1996.

Return to Table 2 footnote1 referrer

Table 2 Footnote 2

Adult doses are supported by Pizzorno and Murray 2006 and Das et al. 1989.

Return to Table 2 footnote2 referrer

Direction(s) for use

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 if symptoms persist or worsen.

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

References Cited

References Reviewed