ALPHA-GALACTOSIDASE
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(PDF Version - 75 KB)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
April 29, 2019
Proper name(s), Common name(s), Source material(s)
| Proper name(s) | Common name(s) | Source material(s) | |
|---|---|---|---|
| Proper name(s) | Part(s) | ||
|
alpha-D-galactoside galactohydrolase |
alpha-Galactosidase |
Aspergillus niger |
Whole |
References: Proper name: UBMB 1961; Common name: UBMB 1961; Source material: CABI 2012, FCC 8 2012, Bisby et al. 2010.
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 any age category listed in this monograph for the specified route of administration are listed in the Compendium of Monographs Guidance Document.
Use(s) or Purpose(s)
- Digestive enzyme
- Helps prevent gastrointestinal intolerance of oligosaccharides/fermentable carbohydrates (Di Stefano et al. 2007; Pray 2006; Ganiats et al. 1994).
- Helps reduce gas production/flatulence following a meal rich in oligosaccharides/fermentable carbohydrates (such as vegetables, pulses/legumes/beans and whole grains) (Di Stefano et al. 2007; Pray 2006; Lettieri and Dain 1998; Ganiats et al. 1994).
The following combined use(s) or purpose(s) is/are also acceptable:
- Digestive enzyme that helps reduce gas production following a meal rich in oligosaccharides/ fermentable carbohydrates (such as vegetables, pulses/legumes/beans and whole grains) (Di Stefano et al. 2007; Pray 2006; Lettieri and Dain 1998; Ganiats et al. 1994).
- Digestive enzyme that helps prevent gastrointestinal intolerance of oligosaccharides/ fermentable carbohydrates (Di Stefano et al. 2007; Pray 2006; Ganiats et al. 1994).
Dose(s)
Subpopulation(s)
Adults 18 years and older
Quantity(ies)
Digestive enzyme (not for combined claims)
Not to exceed 3,000 FCC GalU of enzyme activity, per day (FCC 8 2012; Di Stephano et al. 2007; Lettieri et Dain 1998; Ganiats et al. 1994).
Prevention of gastrointestinal intolerance/Reduction of flatulence
260-3,000 FCC GalU of enzymatic activity, per day (FCC 8 2012; Di Stephano et al. 2007; Lettieri and Dain 1998; Ganiats et al. 1994).
Notes
- The Quantity per dosage unit must be the enzymatic activity (FCC unit). The quantity of the enzymatic preparation in mg or ml should also be included as additional quantity.
- One FCC galactosidase activity unit (GalU) is defined as the quantity of the enzyme that will liberate p-nitrophenol at the rate of 1 µmol/min under the conditions of the assay (FCC 8 2012).
Direction(s) for use
Take with first bite of food/meal (Pray 2006; CPS 2005; Lettieri and Dain 1998; Ganiats et al. 1994).
Duration(s) of Use
Consult a health care practitioner/health care provider/health care professional/doctor/physician for prolonged use.
Risk Information
Caution(s) and warning(s)
All products
Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant, breastfeeding or have diabetes (Levine and Weisman 2004; Lettieri and Dain 1998; Ganiats et al. 1994).
Prevention of gastrointestinal intolerance/Reduction of flatulence
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)
Stop use if hypersensitivity/allergy occurs (Pray 2006; CPS 2005; Ganiats et al. 1994).
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.
- Details of the manufacturing of the enzyme at the raw material stage should include fermentation medium and the isolation process of the medicinal ingredient.
- The specifications must include testing for enzymatic activity of the medicinal ingredient at the appropriate stages of formulation and manufacturing using the assay outlined in the current Food Chemicals Codex (FCC): ALPHA-GALACTOSIDASE ACTIVITY.
- Where published methods are not suitable for use, manufacturers will use due diligence to ensure that the enzymes remain active to the end of the shelf life indicated on the product label.
References Cited
- Bisby F, Roskov Y, Culham A, Orrell T, Nicolson D, Paglinawan L. Bailly N, Appeltans W, Kirk P, Bourgoin T, Baillargeon G, Ouvrard D, editors. Species 2000 & ITIS Catalogue of Life, 15th March 2012 [Internet]. Reading (GB): Species 2000. [Source database: Species Fungorum 9.0, Sep 2010; Accessed 2012 March 28]. Available from: http://www.catalogueoflife.org
- CABI 2012: Centre for Agriculture and Bioscience International. 2011. Index Fungorum [Internet]. Wallingford (GB): CABI (Centre for Agriculture and Bioscience International); 2012. [Accessed 2012 March 28]. Available from: http://www.speciesfungorum.org
- CPS 2005. Compendium of Pharmaceuticals and Specialties. Beano®. Alpha-D- Galactosidase/ Alpha Galactosidase Enzyme. GlaxoSmithKline Consumer Healthcare. Canadian Pharmacists Association; 2005.
- Di Stefano M, Miceli E, Gotti S, Missanelli A, Mizzocchi S, Corazza GR. The effect of oral alpha-galactosidase on intestinal gas production and gas-related symptoms. Digestive Diseases and Sciences 2007;52(1):78-83.
- FCC 8 2012: Food Chemicals Codex. Eighth edition. Rockville (MD): The United States Pharmacopeial Convention; 2012.
- Ganiats TG, Norcross WA, Halverson AL, Burford PA, Palinkas LA. Does Beano prevent gas? A double-blind crossover study of oral alpha-galactosidase to treat dietary oligosaccharide intolerance. The Journal of Family Practice 1994;39(5):441-445.
- IUBMB 1961: IUBMB Enzyme Nomenclature [Internet]. London (GB): Queen Mary, University of London. [?-galactosidase: CAS 9025-35-8, EC 3.2.1.22 created 1961; Accessed 2012 March 28]. Available from: http://www.chem.qmul.ac.uk/iubmb/enzyme/EC3/2/1/22.html
- Lettieri JT, Dain B. Effects of beano on the tolerability and pharmacodynamics of acarbose. Clinical Therapeutics 1998;20(3):497-504.
- Levine B, Weisman S. Enzyme replacement as an effective treatment for the common symptoms of complex carbohydrate intolerance. Nutrition in clinical care: an official publication of Tufts University 2004;7(2):75-81.
- Pray WS. Non-Prescription Product Therapeutics. 2nd edition. New York (NY): Lippincott Williams & Wilkins; 2006.
References Reviewed
- Evidence for Quality of Finished Natural Health Products, Version 2.0. Ottawa (ON): Natural Health Products Directorate, Health Canada; 2007. [Accessed 2011 August 2]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/eq-paq-eng.php
- The Merck Index Version 14.1. [Internet]. Whitehouse Station (NJ): Merck & Co., Inc. [Published 2006; Updated 2011; Accessed 2011 August 17]. Available from: http://www.medicinescomplete.com/mc/merck/current/monographs.htm
- Sweetman SC, editor. Martindale: The Complete Drug Reference [Internet]. London (GB): Pharmaceutical Press. [Alpha-galactosidase: latest modification 12-Mar-2011; Accessed 2012 March 28]. Available from: http://www.medicinescomplete.com