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Drugs and Health Products

Monograph: Galactosidase, alpha-

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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: (i) Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion. (ii) The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant.

Date: 2012-07-11

NHPID Name

alpha-Galactosidase (IUBMB 2007)

Proper Name(s)

alpha-D-galactoside galactohydrolase ( IUBMB 1961 )

Common Name(s)

alpha-galactosidase ( IUBMB 1961 )

Source Material

Aspergillus niger (Whole) ( CABI 2012 , Bisby et al. 2010 , FCC 8 )

Route Of Administration

Oral

Dosage Form(s)

  • The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.
  • This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of:

Dose(s)

Adults:

Digestive enzyme; Reduce gas production
Dose(s): not to exceed 3000 FCC alpha-galactosidase units per day
Directions For Use: Take with first bite of food/meal (Pray 2006, CPS 2005, Lettieri and Dain 1998, Ganiats et al. 1994)

Prevent gastrointestinal intolerance
Dose(s): 260 - 3000 FCC alpha-galactosidase units per day
Directions For Use: Take with first bite of food/meal (Pray 2006, CPS 2005, Lettieri and Dain 1998, Ganiats et al. 1994)


  • Dose unit information must include the quantities of both the enzyme preparation (mg or ml) and its enzymatic activity (FCC or USP units). When submitting by ePLA, please put the enzymatic activity quantity in the Quantity/Unit fields (field 77) and the quantity of enzyme preparation in mg or ml in the Additional Quantity/Unit fields.
  • One FCC galactosidase activity unit (GalU) is defined as the quantity of the enzyme that will liberate p-nitrophenol at the rate of 1 micromol/min under the conditions of the assay (FCC 8).

Duration of use

For prolonged use, consult a health care practitioner.

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
  • If you are pregnant or breastfeeding, consult a health care practitioner prior to use
  • If you have diabetes, consult a health care practitioner prior to use  (Levine and Weisman 2004, Lettieri and Dain 1998, Ganiats et al. 1994)
  • Prevent gastrointestinal intolerance:
    If symptoms persist or worsen, consult a health care practitioner.

Contraindication(s):
No statement is required

Known Adverse Reaction(s):
Hypersensitivity/allergy has been known to occur; in which case, discontinue use  (Pray 2006, CPS 2005, Ganiats et al. 1994)

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).
  • 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, Orrell T, Nicolson D, Paglinawan L, Bailly N, 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. Index Fungorum [Internet]. Wallingford (GB): CABI (Centre for Agriculture and Bioscience International); 2012. [Accessed 2012 March 30]. 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: 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. [alpha-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 [Internet]. Ottawa (ON): Natural Health Products Directorate, Health Canada. 2007. [Accessed 2012 March 28]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/eq-paq-eng.php
  • 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
  • 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