ALPHA-AMYLASE
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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
- 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
January 26, 2024
Proper name(s), Common name(s), Source information
Proper name(s) | Common name(s) | Source information | |
---|---|---|---|
Source material(s) | Part(s) | ||
4-alpha-D-Glucan glucanohydrolase |
|
|
Whole |
Hordeum vulgare | Seed | ||
Rhizopus oryzae | whole |
References: Proper name: IUBMB 2023; Common names: IUBMB 2023; Source information: CABI 2023; COL 2023; USDA 2023; FCC 8 2012.
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 oral use are indicated in the dosage form drop-down list of the web-based Product Licence Application form for Compendial applications
Use(s) or Purpose(s)
Digestive enzyme
Dose(s)
Subpopulation(s)
Adults 18 years and older
Quantity(ies)
No to exceed 150,000 FCC DU of enzymatic activity, per day; and 34,000 FCC DU per single dose (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 alpha-amylase dextrinizing unit (DU) is defined as the quantity of alpha-amylase that will dextrinize soluble starch in the presence of an excess of beta-amylase at the rate of 1 g/h at 30º (FCC 8 2012).
Direction(s) for use
All products
Take with food/meal.
Enteric-coated products
Swallow whole/Do not crush or chew (CPS 2008).
Duration(s) of Use
Ask a health care practitioner/health care provider/health care professional/doctor/physician for prolonged use.
Risk Information
Caution(s) and warning(s)
- Ask a health care practitioner/health care provider/health care professional/doctor/ physician before use if you are pregnant or breastfeeding.
- Ask a health care practitioner/health care provider/health care professional/doctor/ physician before use if you have diabetes.
Contraindication(s)
No statement required.
Known adverse reaction(s)
Stop use if hypersensitivity/allergy occurs (Martindale 2023).
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
Must be established in accordance with the requirements described in the Natural Health Products Regulations.
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): ALPHA-AMYLASE ACTIVITY (NON-BACTERIAL).
- 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.
EXAMPLE OF PRODUCT FACTS:
Consult the Guidance Document, Labelling of Natural Health Products for more details.
References Cited
- COL: Catalogue of Life [Accessed 2023 September 11]. Available from: http://www.catalogueoflife.org
- CABI 2023: Centre for Agriculture and Bioscience International. Index Fungorum. Wallingford (GB): CABI (Centre for Agriculture and Bioscience International). [Accessed 2023 September 11]. 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 2023: IUBMB Enzyme Nomenclature. London (GB): Queen Mary, University of London. [α-amylase: CAS 9000-90-2, EC 3.2.1.1 created 1961; Accessed 2023 September 11]. Available from: https://iubmb.qmul.ac.uk/enzyme/EC3/2/1/1.html
- Martindale 2023: Sweetman SC, editor. Martindale: The Complete Drug Reference. London (GB): Pharmaceutical Press. [Amylase: syn: EC 3.2.1.1 (α-amylase), CAS 9000- 85-5 (bacterial α-amylase); 9000-90-2 (porcine α-amylase, pancreatic); Accessed 2023 September 11]. Available from: http://www.medicinescomplete.com
- USDA 2023: United States Department of Agriculture Agricultural Research Service (USDA ARS), Germplasm Resources Information Network (GRIN) - Global. U.S. National Plant Germplasm System. [Accessed 2023 September 11]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxon/taxonomysearch
References Reviewed
- 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.
- Nature's Sources. AbsorbAid® A natural Approach.Unlike Antacids and Acid Blockers. Frequently Asked Questions. [Accessed 2012 March 28]. Available from: http://www.naturessources.com/absorbaid_faq.asp