Risk Assessment of Naturals

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1 Risk Assessment of Naturals Adip Roy Safety & Environmental Assurance Centre, Unilever R&D, 64 Main Road, Whitefield, Bangalore

2 Naturals Traditional health care systems (Ayurveda & TCM) Time tested - deeply rooted in peoples mind 1/3rd of total world population uses Traditional Medicine Solutions for diverse health care problems Empirical, well documented knowledge, long history of practice Holistic approach

3 Risk Assessment of Naturals Unique characteristics of botanicals e.g. poorly defined chemical composition and inadequate knowledge about the biological activity of these components, make safety assessment of these products a challenging task. Complete risk assessment of a natural extract could involve conducting the complete battery of toxicology tests to cover relevant endpoints.

4 Toxicology Risk Assessment Hazard Endpoints Acute oral toxicity Genotoxicity Sub chronic (NOAEL) Reproductive tox. Developmental tox. Risk = f (Hazard x Exposure)

5 Risk Assessment of Naturals Explore alternate approach for risk assessment Can we use the existing knowledge in traditional medicine to address the safety issues?

6 Risk Assessment of Naturals We can use a risk assessment strategy for naturals of traditional (Ayurvedic/TCM) origin based on History of Safe Use (HoSU) which primarily includes - Similar use of the herbal material in traditional medicine. Dosage prescribed in traditional texts and by practicing physicians. Analytical equivalence (with Ayurvedic/TCM preparations). Knowledge of potential adverse effects

7 HoSU Based Risk Assessment includes: Identity of the ingredient? Proposed Use Comparison of the proposed use with traditional use Method of preparation - as described in Ayurveda. Analytical equivalence between commercial preparation and HoSU preparation. Comparison of the presently exposed population to the target population

8 HoSU Based Risk Assessment Herbals/ Ayurveda: Elements of Safety Assessment History of Safe use (HoSU) Ayurvedic texts/ Formularies/ documented literature Essential safety data generation e.g. Genotoxicity Analytical Equivalence e.g. Standardized water extracts Risk Assessment

9 HoSU Based Risk Assessment Numbers of people currently exposed to the comparator Duration of exposure to comparator Pattern of use or frequency of consumption Intended level of use Bioavailability Biological effects Toxicology data Adverse effects in Man Mechanism of action

10 HoSU Ayurvedic preparations Fresh Herb Coarse Powder (Churna) Extraction in Lipid Medium Juice Swaras Paste Lepa Water Extract Oil (Tailam) Clarified Butter (Ghrita)) Infusion Decoction (Kwatha) Powder Concentrate (Ghana Satva) - Various methods of herbal extraction/preparations as per Ayurveda. Such preparations can be supported basis their history of use

11 Case study Brahmi (Bacopa monnieri) Brahmi for ingestion in a soup in a consumer trial for mental health benefits. Brahmi is an Ayurvedic ingredient A number of health benefits (particularly cognitive benefits) Request was for Brahmi (0.1% w/w) in soup Approx 0.5g of Brahmi per serving x 2 servings per day

12 Brahmi History of Use Brahmi (Bacopa monnieri). Traditionally used in Ayurveda for cognitive benefits. Large amount of historical consumption information. Up to 10g of Brahmi consumed daily as per traditional texts

13 Brahmi History of Use Criteria Response for Brahmi Evidence Origin of Ingredient Identical to traditional/comparator Bacopa monniera used. Whole dried plant cultivated in southern & western India on commercial scale Similarity of Specification Almost the same eg similarity score between 0.7 & 1 FT-IR 0.97 HPLC 0.79 Preparation & Processing Almost the same Aqueous extract -Prepared by boiling as whole, dried & ground herb powder or as whole herb juice. Populations Use encompasses population intend to expose Traditional use no restrictions/contraindications. No. of people exposed Large (millions) Traditional texts/ayurvedic practitioners Duration of exposure Centuries or longer Traditional texts/ayurvedic practitioners Pattern/Frequency of use Similar or less frequent than traditional Used daily Bioavailability Don t know Not known Biological effects Effects in man Traditional use for general well being & enhanced cognitive effects, reduce anxiety or epileptic disorders. Cardiac tonic, digestive aid, improve respiratory function. Toxicological data No concern Some toxicological data on specific fractions not on comparator. Adverse effects in man None known None known Known contraindications Not known None known Mechanism of action Not clear Unknown

14 Brahmi comparison of specification FT-IR spectroscopy and HPLC fingerprint data Similarity score: FT-IR 0.97, HPLC 0.79 Reconstructed FT-IR spectra HoSU Comparator N o rm a lis e d re s p o n s e Wavenumber Confirmation that the material is equivalent to that used historically using finger print analysis

15 Brahmi Risk assessment Traditionally used in Ayurveda for cognitive benefits. Large amount of historical consumption information. Extract prepared the same way and comparable to that mentioned in Ayurveda Requested for similar use as documented in Ayurveda Exposure levels within the range as recommended by practicing physicians and documented in traditional recipes No toxicity and adverse effects known Can be used in the trial based on analytical equivalence.

16 Thank You

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