CELLULASE
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(PDF Version - 62 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) | ||
|
4-(1,3;1,4)-beta-D-glucan 4-glucanohydrolase |
Cellulase |
|
Whole |
References: Proper name: IUBMB 2001; Common name: IUBMB 2001; Source material: CABI 2012, FCC 8 2012, Martindale 2011, 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 (Martindale 2011).
Dose(s)
Subpopulation(s)
Adults 18 years and older
Quantity(ies)
Not to exceed 110,000 FCC CU of enzymatic activity, per day (FCC 8 2012; Glade et al. 2001).
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 cellulase unit (CU) is defined as the amount of activity that will produce a relative fluidity change of 1 in 5 minutes in a defined carboxymethyl cellulose substrate under the conditions of the assay (FCC 8 2012).
Direction(s) for use
Take with food/meal.
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)
Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant, breastfeeding or have diabetes.
Contraindication(s)
No statement required.
Known adverse reaction(s)
Stop use if hypersensitivity/allergy occurs.
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 appropriate stages of formulation and manufacturing using the assay outlined in the current Food Chemicals Codex (FCC): CELLULASE 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 their 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 2008: Compendium of Pharmaceuticals and Specialties: The Canadian Drug Reference for Health Professionals. Ottawa (ON): Canadian Pharmacists Association; 2008.
- FCC 8 2012: 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 2001: IUBMB Enzyme Nomenclature [Internet]. London (GB): Queen Mary, University of London. [cellulase: CAS 9012-54-8, EC 3.2.1.4 created 1961, modified 2001; Accessed 2012 March 28]. Available from: http://www.chem.qmul.ac.uk/iubmb/enzyme/EC3/2/1/4.html
- Martindale 2011: Sweetman SC, editor. Martindale: The Complete Drug Reference [Internet]. London (GB): Pharmaceutical Press; 2012. [Cellulase: EC 3.2.1.4, CAS: 9012-54-8, latest modification: 23-Sep-2011; Accessed 2012 July 11]. Available from: http://www.medicinescomplete.com
References Reviewed
- Elms J, Fishwick D, Walker J, Rawbone R, Jeffrey P, Griffin P, Gibson M, Curran AD. Prevalence of sensitisation to cellulase and xylanase in bakery workers. Occupational and Environmental Medicine 2003;60(10):802-804.
- Evidence for Quality of Finished Natural Health Products, Version 2.0 [Internet]. 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
- Vanhanen M, Tuomi T, Tupasela O, Keskinen H, Tuppurainen M, Hytönen M, Tarvainen K, Kanerva L, Nordman H. Cellulase allergy and challenge tests with cellulase using immunologic assessment. Scandinavian Journal of Work, Environment & Health 2000;26(3):250-256.