Green Tea Extracts (Camellia sinesis, Thea sinesis) o “Traditionally used in Herbal Medicine to help relive the symptoms of upper respiratory tract infections: Garlic Echinacea Angustifolia Ingredient Monographs 1. Proper and common names 2. Source material 3. Dose 4. Dosage form 5. Route of administration 6. Health claim 7. Risk information 8. Duration of use Multiple Ingredient Monographs (Finished products) -As long as 2 ingredients are on the monograph match a formulation it is accessible, and a health claim can be used Aromatherapy – essential oils Cognitive function products Flower essences Homeopathy Marigold extract and isolates (lutein and zeaxanthin) TCM ingredients Triphala Risk-Based Approach to Pre-Market Review 3 tiered system based on the level or certainty associated with the product with a corresponding level of pre-market review o Pre-market review of product license applications (Classes I, II, III)
Proportionate to level of risk and to the standard of evidence necessary Class I = lowest class = single ingredient coming from the monograph = licensed in 10 days Class II = more than one on monograph can form health claim = 30 business days Class III = highest class = no pre-cleared information = 180 day review If the o Safety must be showed for every ingredient but only efficacy showed for one o If the product has failed efficacy it may not cause any harm to the individual, depending on the product it may cause extreme harm to one individual Product license application (PLA) Should have the following: Reference Monograph Proper name Common name Quantity Potency (if available) Source information (where dose it come from? Root? Etc.) Extract (if applicable) Method of preparation Need to know- Should also have: Recommended use/purpose o Health claim Recommended conditions of use o Dosage form, route of administration, duration of use Recommended dose o Sub-population, amount to be taken, frequency, directions of use Risk information o Caution statements, contraindications, known AEs Sponsor Attestation Health Canada Licensed NHP Database (LNHPD) Last year Canada licensed over 120,000 products
NHP Quality Requirements Identity Dosage form Product type Physical identity o Medical ingredients o Potency (i.e. standardized extracts) o Constituents Purity General Parameters (for all finished products): o Microbial Contaminants o Heavy Metals o Solvent Residues o Stability Ingredient-specific requirements: o Oxidative stability o Pesticides o PCBs(Polychlorinated Biphenyls) o Antibiotic Residues o Mycotoxins/Aflatoxins o Sterility of Nosodes (Homeopathics only) o Antimicrobial Resistance Quantity Quantity Testing o Must be performed on EACH medicinal ingredient o Should represent quantity per dosage unit o Tolerance range = 80% to 120% of the label amount OR conformity to a relevant pharmacopoeial standard Note the 40% range that is due to natural variation
Disintegration/dissolution testing Uniformity of dosage forms Stability also plays a role Ensure: o
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- Fall '16
- Nutrition, health claims, NHPs, health claim