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Drugs and Health Products

Monograph: Trypsin

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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: 2012-07-12

NHPID Name

Trypsin (IUBMB 2007)

Proper Name(s)

Trypsin ( IUBMB 1972 )

Common Name(s)

Trypsin ( IUBMB 1972 )

Source Material


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:

Digestive enzyme  (NHPD 2012)

Dose(s)

Adults:

Dose(s):
not to exceed 480 Milligrams per day of enzyme preparation , not to exceed 160 Milligrams per single dose
 (Dorr and Herrmann 2007, Martin et al. 2002, Dale et al. 2001)

Directions For Use:
  • Enteric coated products: Swallow whole/Do not crush or chew (CPS 2008)
  • Take with food/meal

Dose(s):
not to exceed 1200000 USP Trypsin units per day , not to exceed 400000 USP Trypsin units per single dose
 (Dorr and Herrmann 2007, Martin et al. 2002, Dale et al. 2001, USP 35)

Directions For Use:
  • Enteric coated products: Swallow whole/Do not crush or chew (CPS 2008)
  • 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 USP trypsin unit is the activity causing a change in the absorbance of 0.003/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 a gastrointestinal lesion/ulcer, are taking an anticoagulant/ blood thinner or an anti-inflammatory, or are having surgery, consult a health care practitioner prior to use.

Contraindication(s):
No statement is required

Known Adverse Reaction(s):
Hypersensitivity/allergy has been known to occur; in which case, discontinue use  (Martindale 2011)

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database and must meet the limitations outlined in the database.

Storage Conditions

Store in a tightly closed, light-resistant container in a cool, dry place (Ph.Eur. 2012 - USP 35).

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 outlined in the current European (Ph.Eur.) or current United States (USP) pharmacopoeias: Ph.Eur: Trypsin or USP: Crystallized Trypsin.
  • 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) or the current United States Pharmacopeia (USP): FCC: TRYPSIN ACTIVITY or USP: Crystallized Trypsin.
  • 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, 26th July 2011 [Internet]. Reading (GB): Species 2000. [Source database: ITIS: The Integrated Taxonomic Information System, Version Apr 2011; Accessed 2012 March 16]. Available from: http://www.catalogueoflife.org
  • CPS 2008: Compendium of Pharmaceuticals and Specialties: The Canadian Drug Reference for Health Professionals. Ottawa (ON): Canadian Pharmacists Association; 2008.
  • Dale PS, Tamhankar CP, George D, Daftary GV. Co-medication with hydrolytic enzymes in radiation therapy of uterine cervix: evidence of the reduction of acute side effects. Cancer Chemotherapy and Pharmacology 2001;47(Suppl):S29-S34.
  • Dörr W, Herrmann T. Efficacy of Wobe-Mugos® E for reduction of oral mucositis after radiotherapy. Strahlentherapie und Onkologie 2007;183:121-127.
  • FCC 8: Food Chemicals Codex, Eighth edition. Rockville (MD): The United States Pharmacopeial Convention; 2012.
  • IUBMB 1972: IUBMB Enzyme Nomenclature [Internet]. London (GB): Queen Mary, University of London. [trypsin: CAS 9002-07-7, EC 3.4.21.4 created 1961 as EC 3.4.4.4, transferred 1972 to EC 3.4.21.4; Accessed 2012 March 16]. Available from: http://www.chem.qmul.ac.uk/iubmb/enzyme/EC3/4/21/4.html
  • Martin T, Uhder K, Kurek R, Roeddiger S, Schneider L, Vogt HG, Heyd R, Zamboglou N. Does prophylactic treatment with proteolytic enzymes reduce acute toxicity of adjuvant pelvic irradiation? Results of a double-blind randomized trial. Radiotherapy and Oncology 2002;65:17-22.
  • Martindale 2011: Sweetman SC, editor. Martindale: The Complete Drug Reference [Internet]. London (GB): Pharmaceutical Press; 2011. [Trypsin: EC 3.4.21.4, CAS 90002-07-7, latest modification 05-Dec-2011; Accessed 2012 July 11]. Available from: http://www.medicinescomplete.com
  • Ph.Eur. 2012: European Pharmacopoeia 2012. Strasbourg (FR): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM), 2012.
  • USP 35: United States Pharmacopeia and the National Formulary (USP 35 - NF 30). Rockville (MD): The United States Pharmacopeial Convention; 2012.

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.