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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.
Route Of Administration
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:
not to exceed 110000 FCC lipase units
not to exceed 30000 FCC lipase units
per single dose
(Glade et al. 2001
, FCC 8
Directions For Use:
Enteric coated products: Swallow whole/Do not crush or chew
Take with food/meal
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 lipase unit (LU) is defined as the quantity of enzyme that will liberate 1 micromol of butyric acid per minute under the conditions of the test (FCC 8).
Duration of use
For prolonged use, consult a health care practitioner.
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
No statement is required
Known Adverse Reaction(s)
Hypersensitivity/allergy has been known to occur; in which case, discontinue use
Must be chosen from the current Natural Health Products Ingredients Database and must meet the limitations outlined in the database.
- 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) : LIPASE 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.
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 2008: Compendium of Pharmaceuticals and Specialties: The Canadian Drug Reference for Health Professionals. Ottawa (ON): Canadian Pharmacists Association; 2008.
FCC 8: Food Chemicals Codex, Eighth edition. Rockville (MD): The United States Pharmacopeial Convention; 2012.
Glade MJ, Kendra D, Kaminski MV. Improvement in protein utilization in nursing-home patients on tube feeding supplemented with an enzyme product derived from Aspergillus niger and bromelain. Nutrition 2001;17(4):348-350.
IUBMB 1961: Nomenclature Committee of the International Union of Biochemistry and Molecular Biology [Internet]. London (GB): Queen Mary, University of London [lipase: CAS 9001-62-1, EC 18.104.22.168 created 1961; Accessed 2012 March 28]. Available from: http://www.chem.qmul.ac.uk/iubmb/enzyme/EC3/1/1/3.html
Martindale 2011: Sweetman SC, editor. Martindale: The Complete Drug Reference [Internet]. London (GB): Pharmaceutical Press; 2011. [Pancreatic enzymes latest modification 09-Apr-2011; Accessed 2012 March 28]. Available from: http://www.medicinescomplete.com
Cichoke AJ. Pancreatic Enzymes. In: Pizzorno JE, Murray MT, editors. Textbook of Natural Medicine, Third edition, volume 1. St. Louis (MI): Churchill Livingstone Elsevier; 2006 p. 1131-1146.
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
Food Standards Australia New Zealand (FSANZ). 7 April 2010 [9-10]. Application A1036 Lipase derived from Aspergillus niger as a Processing Aid (Enzyme) Assessment Report [Internet]. [Accessed 2011 August 15] Available from: http://www.foodstandards.gov.au/_srcfiles/A1036%20Lipase%20AR%20FINAL.pdf