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Drugs and Health Products

Monograph: Lactase

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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: 2012-07-09

NHPID Name

Lactase (IUBMB 2007)

Proper Name(s)

Common Name(s)

Source Material

Aspergillus flavus var. oryzae (Whole) ( CABI 2012 , Bisby et al. 2010 )

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; Digestive aid
Dose(s): not to exceed 18000 FCC acid lactase units 1-3 times per day
Directions For Use: Take with or immediately before a meal/food.

Lactose digestion
Dose(s): 3000 - 18000 FCC acid lactase units 1-3 times per day
Directions For Use: Take with or immediately before a meal/food.


  • 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 lactase unit (ALU) is defined as that quantity of enzyme that will liberate o-nitrophenol at a rate of 1 Ámol/min under the conditions of the assay.

Duration of use

Digestive aid: For prolonged use, consult a health care practitioner.

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
  • If symptoms persist or worsen, consult a health care practitioner.
  • If you have diabetes, consult a health care practitioner prior to use  (Groff and Gropper 2000)

Contraindication(s):
No statement is required

Known Adverse Reaction(s):
Headaches, heartburn, bloating and hypersensitivity (e.g. allergy) have been known to occur; in which case, discontinue use.  (Health Canada 2011)

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 medicinal ingredient may comply with the specifications (quality specifications only) outlined in the current United States (USP) pharmacopoeial monograph: Lactase.
  • The specifications must include testing for enzymatic activity of the medicinal ingredient at appropriate stages of formulation and manufacturing using the assay outlined in the current Food Chemicals Codex (FCC): Lactase (Acid) (Beta-Galactosidase) activity (ALU).
  • 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

  • Biller JA, King S, Rosenthal A, Grand RJ. 1987. Efficacy of lactase-treated milk for lactose-intolerant pediatric patients. The Journal of Pediatrics 111: 91-94
  • 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. Aspergillus flavus var. oryzae. Wallingford (UK): CABI (Centre for Agriculture and Bioscience International). [Accessed 2012 March 28]. Available at: http://www.speciesfungorum.org/Names/SynSpecies.asp?RecordID=130238
  • FCC 8: Food Chemicals Codex, Eighth edition. Rockville (MD): The United States Pharmacopeial Convention; 2012.
  • Groff J, Gropper S. Advanced Nutrition and Human Metabolism, 3rd edition. Belmont (CA): Wadsworth/Thomson Learning; 2000.
  • HC 2011: Canada Vigilance Adverse Reaction Online Database. [Accessed 2012 March 16]. Available from: http://www.hc-sc.gc.ca/dhp-mps/medeff/databasdon/index-eng.php
  • IUBMB 1980: Nomenclature Committee of the International Union of Biochemistry and Molecular Biology. [Internet]. London (GB): Queen Mary, University of London [beta-galactosidase: EC 3.2.1.23. created 1961, modified 1980; Accessed 2012 March 28]. Available from: http://www.chem.qmul.ac.uk/iubmb/enzyme/EC3/2/1/23.html
  • Lin MY, Dipalma JA, Martini MC, Gross CJ, Harlander SK, Savaiano DA. 1993. Comparative effects of exogenous lactase (beta-galactosidase) preparations on in vivo lactose digestion. Digestive Diseases and Sciences 38(11):2022-2027
  • Moskovitz M et al. Does Oral Enzyme Replacement Therapy Reverse Intestinal Lactose Malabsorption? The American Journal of Gastroenterolgy 1987; 82(7): 632-635
  • Ramirez FC, Lee K, Graham DY. 1994. All lactase preparations are not the same: results of a prospective, randomized, placebo-controlled trial. The American Journal of Gastroenterology 89(4): 566-570
  • USP 35: United States Pharmacopeia and the National Formulary (USP 35 - NF 30). Rockville (MD): The United States Pharmacopeial Convention; 2012.