CHYMOTRYPSIN
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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)
Proper name(s) | Common name(s) | Source material(s) | |
---|---|---|---|
Proper name(s) | Part(s) | ||
Chymotrypsin |
|
|
Pancreas |
References: Proper name: IUBMB 1972; Common names: IUBMB 1972; Source materials: FCC 8 2012, USP 35 2102, 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 480,000 USP chymotrypsin units of enzymatic activity, per day; and 160,000 USP chymotrypsin units per single dose (USP 35 2012; Dörr and Herrmann 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 Chymotrypsin Unit is defined as the activity causing a change in absorbance at the rate of 0.0075/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 lesions/ulcers or are having surgery.
- Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you are taking 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): CHYMOTRYPSIN 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.
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: ITIS Global Apr 11; Accessed 2012 March 28]. 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: results of a prospective, randomized, placebo-controlled, triple-blind phase III multicenter study. 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 [chymotrypsin: CAS 9004-07-3, EC 3.4.21.1 created 1961 as EC 3.4.4.5 and EC 3.4.4.6, transferred 1972 to EC 3.4.21.1; Accessed 2012 March 28]. Available from: http://www.chem.qmul.ac.uk/iubmb/enzyme/EC3/4/21/1.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. [Chymotrypsin: syn: ?-Chymotrypsin, EC 3.4.21.1, CAS 9004-07-3, latest modification 05-Dec-2011; Accessed 2012 March 28]. Available from: http://www.medicinescomplete.com
- Ph.Eur. 2012: European Pharmacopoeia. 7th edition. 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. In: Pizzorno JE, Murray MT, editors. Textbook of Natural Medicine, Third edition, volume 1. St. Louis (MI): Churchill Livingstone Elsevier; 2006. p. 1131-1146.