Papain
Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.
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) | ||
Papain |
Papain |
Carica papaya |
|
References: Proper name: IUBMB 2000; Common name: IUBMB 2000; Source material: Merck 2012, USDA 2011, Morton 1987.
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 the age category listed in this monograph and specified route of administration are indicated in the Compendium of Monographs Guidance Document.
Use(s) or Purpose(s)
Digestive enzyme (Merck 2012)
Dose(s)
Subpopulation(s)
Adults 18 years and older
Quantity(ies)
Not to exceed 7,200,000 FCC PU of enzymatic activity, per day; and 2,400,000 FCC PU per single dose (Martin et al. 2002; Dale et al. 2001).
- 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.
- For multi-ingredient products containing both papain and bromelain (fruit and/or stem), the combined proteolytic activity should not exceed the maximum proteolytic activity of 130,000, 000 FCC PU per day.
- One papain unit (PU) is defined as that quantity of enzyme that liberates the equivalent of 1 microgram of tyrosine per hour under the conditions of the assay (FCC 8 2012).
- One FCC papain unit is approximately equivalent to one USP papain unit (1 FCC PU ? 1 USP PU).
Direction(s) for use
Take with food/a 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, have a gastrointestinal lesion/ulcer or are having surgery (Martindale 2011).
- Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use are taking an anticoagulant/blood thinner or anti-inflammatory medications (Martindale 2011).
- Consult a health care practitioner/ health care provider/health care professional/doctor/ physician prior to use if you have an allergy to latex or fruits (e.g. avocado, banana, chestnut, passion fruit, fig, melon, mango, kiwi, pineapple, peach, and tomato) (US FDA 2008; APhA 2006; Brehler et al. 1997).
Contraindication(s)
No statement required.
Known adverse reaction(s)
Stop use if hypersensitivity/allergy occurs (HC 2011; Martindale 2011; US FDA 2008).
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 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): PLANT PROTEOLYTIC 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
- APhA 2006: Berardi RR, Kroon LA, McDermott JH, Newton GD, Oszko MA, Popovich NG, Remington TL, Rollins CJ, Shimp LA, Tietze KJ, editors. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care. 15th edition. Washington (DC): APhA Publications; 2006.
- Brehler R, Theissen U, Mohr C, Luger T. 1997. ''Latex-fruit syndrome'': frequency of cross- reacting IgE antibodies. Allergy 52(4):404-410.
- Dale PS, Tamhankar CP, George D, Daftary GV. 2001. Co-medication with hydrolytic enzymes in radiation therapy of uterine cervix: evidence of the reduction of acute side effects. Cancer Chemotherapy and Pharmacology 47(Suppl):S29-S34.
- FCC 8 2012: Food Chemicals Codex. Eighth edition. Rockville (MD): The United States Pharmacopeial Convention; 2012.
- HC 2011: Canada Vigilance Adverse Reaction Online Database. Search Criteria: Papain. [Accessed 2012 March 16]. Available from: http://www.hc-sc.gc.ca/dhp-mps/medeff/databasdon/index-eng.php
- IUBMB 2000: Nomenclature Committee of the International Union of Biochemistry and Molecular Biology. [Internet]. London (GB): Queen Mary, University of London [papain: CAS 9001-73-4, EC 3.4.22.2 created 1961 as EC 3.4.4.10, transferred 1972 to EC 3.4.22.2, modified 1976, modified 2000; Accessed 2012 March 16]. Available from: http://www.chem.qmul.ac.uk/iubmb/enzyme/EC3/4/22/2.html
- Martin T, Uhder K, Kurek R, Roeddiger S, Schneider L, Vogt HG, Heyd R, Zamboglou N. 2002. Does prophylactic treatment with proteolytic enzymes reduce acute toxicity of adjuvant pelvic irradiation? Results of a double-blind randomized trial. Radiotherapy and Oncology 65:17-22.
- Martindale 2011: Sweetman SC, editor. 2011. Martindale: The Complete Drug Reference. [Internet]. London (GB): Pharmaceutical Press. [Papain: CAS 9001-73-4, syn: EC 3.4.22.2, latest modification: 10-Oct-2011; Accessed 2012 July 9]. Available from: http://www.medicinescomplete.com
- Merck 2012: The Merck Index Version 14.1 [Internet]. Whitehouse Station (NJ): Merck & Co., Inc. [published 2006, updated 2012; Accessed 2012 July 10]. Available from: http://www.medicinescomplete.com/mc/merck/current/monographs.htm
- Morton J. 1987. Papaya. In: Morton JF. Fruits of Warm Climates. Miami (FL): Julia F. Morton;
- p. 336-346. [Accessed 2012 March 16]. Available from: http://www.hort.purdue.edu/newcrop/morton/papaya_ars.html
- USDA 2011: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN) [online database]. Beltsville (MD): National Germplasm Resources Laboratory. [Carica papaya L. (Caricaceae): Last updated 09-May-2011; Accessed 2012 March 16]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
- US FDA 2008: Topical Drug Products Containing Papain; Enforcement Action Dates. Department of Health and Human Services. Docket No. FDA-2008-N-0481.
References Reviewed
- Dörr W, Herrmann T. 2007. Efficacy of Wobe-Mugos® E for reduction of oral mucositis after radiotherapy. Strahlentherapie und Onkologie 183:121-127.
- Repchinsky C, editor-in-chief. Patient Self-Care: Helping Patients Make Therapeutic Choices, 1st edition. Ottawa (ON): Canadian Pharmacists Association.