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

• 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)

Table 1. Proper name(s), Common name(s), Source material(s)

Proper name(s)	Common name(s)	Source material(s)
		Proper name(s)	Part(s)
Trypsin	Trypsin	Bos taurus Sus scrofa	Pancreas

References: Proper name: IUBMB 1972; Common name: IUBMB 1972; Source materials: FCC 8 2012; USP 35 2012; Bisby et al. 2011.

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

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Not to exceed 1,200,000 USP trypsin units of enzymatic activity, per day; and 400,000 USP trypsin units per single dose (USP 35 2012; Dörr et al. 2007; Martin et al. 2002; Dale et al. 2001).

Notes

• The Quantity per dosage unit must be the enzymatic activity (FCC or USP units). The quantity of the enzymatic preparation in mg or ml should also be included as additional quantity.
• 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 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

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, have gastrointestinal lesion/ulcer or are having surgery.
• Consult a health care practitioner /health care provider/health care professional/doctor/ physician prior to use if you are taking an anticoagulant/blood thinner or anti-inflammatory medications.

Contraindication(s)

No statement required.

Known adverse reaction(s)

Stop use if hypersensitivity/allergy occurs (Martindale 2011).

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

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

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) or the current United States Pharmacopeia (USP): FCC: TRYPSIN ACTIVITY 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 FA, Roskov YR, Orrell TM, Nicolson D, Paglinawan LE, Bailly N, Kirk PM, Bourgoin T, Baillargeon G, Ouvrard D, editors. Species 2000 & ITIS Catalogue of Life, 15th March 2012 [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 2012: 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 2012: 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. Chapter 112. In: Pizzorno JE, Murray MT, editors. Textbook of Natural Medicine, Third edition, volume 1. St. Louis (MI): Churchill Livingstone Elsevier; 2006.