Natural Products: The Case for a Product Development Paradigm in Malaysian Natural Product Research (2005 p
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Natural Products: The Case for a Product Development Paradigm in Malaysian Natural Product Research (2005 paper)

Natural Products: The Case for a Product Development Paradigm in Malaysian Natural Product Research (2005 paper)

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Natural Products: The Case for a Product Development Paradigm in Malaysian Natural Product Research (2005 p Natural Products: The Case for a Product Development Paradigm in Malaysian Natural Product Research (2005 p Presentation Transcript

  • Natural Products: The Case for a Product Development Paradigm in Malaysian Natural Product Research Mohd. Murray Hunter Kolej Universiti Kejuruteraan Utara Malaysia
  • Traditional Natural Product Research
    • Bio-prospecting/or Flora of Specific Interest
    • Analysis of Compounds/Composition
    • Usually Single Discipline Approach
    • Information Published or Disseminated at Conference/Seminar
    • Work is Usually Forgotten
  • New Expectations
    • Government’s New Bio-Technology Policy
    • Funding Focus on Applications/Potential Commercialisation
    • Universities Becoming Commercially Orientated
    • Research Institutions Want Commercial Results
    • New Community Expectations
    • Peer Hopes and Expectations
  • A New Paradigm Required To Meet Changing Expectations
    • Emphasis Shifting to Development and Potential Applications
    • Possible Commercialisation
    • Research Funding Tied to Results/Outcomes
    • Institution Questions –
    • Can it be Commercialised?
  • This Requires a Change in Natural Product Research
    • What We Investigate?
    • How We Investigate?
    • Change in Outcome Objectives
    • Use Different Milestones
    • Use of Multidisciplinary Approach
    • Need to Consider Wider Issues
    • Less Projects – Longer Projects
    • Higher Degree of Collaboration
  • Requires a Jungle to Marketplace View
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  •  
  •  
  •  
    • Natural Product Development Process (Aromatic)
    Biological Screening Screening For Development Potential Regulatory Screening Market Development Environmental Analysis Evaluation of Capabilites Market Analysis Technical Development Commercialis -ation Strategies Development Process Screening Process
  • Screening Process
  • Biological Screening
    • Bioprospecting
    • Literature Review
    • Consider Reintroduction of a Crop
    • Consider Introduction of New Crop
    • Identify Chemical Constituents of Essential
    • Oil
  • Screening For Development Potential
    • Match Chemical Constituents of Essential Oil to Possible Market Uses
    • Evaluate Application Potential of Essential Oil
    • Evaluate Yields, Cost of production
    • Evaluate Time and Cost of Development
    • Value Determination (Use Criteria)
  • Screening
    • Require Knowledge of Essential Oil Applications
    • Require knowledge of International Market
    • Require Knowledge of International Regulations
    • Need to Collaborate with Industry Parties
  • Screening Protocols
    • Anti inflammatory
    • Anti microbial
    • Skin whitening
    • UV absorbing
    • Anti age actives
    • Flavour & fragrance application
    • Aromatherapy
  • Evaluation Criteria (Aroma)
    • The Novelty of the new essential Oil
    • Dependent on the uniqueness of the flavour/odour profile. Degree of novelty, limited by the availability of substitutes. Can be considered novel, if considered a more cost effective source of a natural aroma chemical. Source of a natural aroma chemical, not previously known to exist in economically extractable quantities.
  • Evaluation Criteria
    • The Perceived Potential uses and Applications of the New Essential Oil
    • Perfumers and Flavourists must perceive applications potential. Material must be stable and versatile in harsh media of end products.
  • Evaluation Criteria
    • The Closeness of any Substitutes to the New essential Oil
    • Degree of ease new aroma from essential oil can be duplicated by synthesis or reconstitution. If close substitutes available, new material must be more cost effective.
  • Evaluation Criteria
    • The Stability of the New essential Oil
    • Stability as an essential oil and stability in end products.
  • Evaluation Criteria
    • The Cost Price/Performance Ratio of the New Essential Oil
    • Important in the application potential of the new essential oil. New material must offer a perceptible odour/flavour at low concentrations
  • Evaluation Criteria
    • The Toxicity Aspects of the New Essential Oil
    • Must be proven beyond doubt through expensive trials. Flavour and Fragrance houses will not consider using a new essential oil unless it meets IFRA safety and Toxicity recommendations and is included in the FEMA GRAS list. EU has recently regulated on a number of aroma materials
  • Evaluation Criteria
    • The General Consistency of Quality and Supply
    • Natural materials vary in quality according to geographic origin, type of soil, level of nutrients in the soil, climate and weather, rainfall, time of harvest, season, methods of extraction, altitude and the incidence of pests and diseases. Risks of supply from natural disasters, wars, political conditions and the inexperience of new producers
  • Evaluation Criteria
    • The Prevailing Market/Product Trends
    • Market and product trends slowly evolve. These are the results of complex forces such as technology, advertising and cultural influence upon consumer tastes and preferences. A particular essential oil may become more or less important to industry, depending upon these trends.
  • Evaluation Criteria
    • The Current Level of Technology
    • Technology influences substitutes that are available and the costs of production.
  • Regulatory Screening
    • United States
    • - GRAS ( Genarally Regarded as Safe)
    • RIFM – Collections of Monographs
    • Food and Drug Administration
  • European Union
    • REACH Registration, Evaluation and Authorisation
    • of Chemicals
  • Objectives of REACH
    • Protection of human health and the environment
    • Maintenance and enhancement of the competitiveness of the EU chemical industry
    • Prevention of fragmentation of the internal market
    • Increased transparency
    • Integration with international efforts
    • Promotion of non-animal testing
    • Conformity with EU international obligations under the WTO
  • REACH Status
    • EU study being conducted on supply chain and innovation – report March 2005
    • EU study on impact of REACH on new MS
    • EU parliament to review REACH legislation second half 2005 (Environment is lead committee)
    • New “slightly modified” version of REACH to be talked about early 2006
  • SCCP Responsibility
    • SCCP (The Scientific Committee on Consumer Products – previously called the SCCNFP: Scientific Committee on Cosmetic & Non Food Products) is an expert committee set up under the EC Health and Consumer Protection DG. SCCP reports to the EC H&CP Scientific Steering Committee on matters relevant to the EC countries in their defined area. The committee comprises a diverse range of experts in toxicology from industry, the medical fields and tertiary institutions.
    • SCCP/SCCNFP have provided scientific opinions on a wide range of ingredients used in personal care products including actives & excipients for oral care, haircare and skincare products.
  • Cosmetic Products in EU are regulated by Directive 76/768/EEC and Amendments
    • Section 7(a) of 76/768/EEC states:-
    • “ Assessment of the safety for human health of the finished product. To that end that manufacturer shall take into consideration the general toxicological profile of the ingredient, its chemical structure and its level of exposure”.
  • Biocidal Products Directive
    • High level of protection of human health and environment.
    • Harmonisation of requirements for authorisation of biocides.
  • Types of Biocidal Products
    • DISINFECTANTS & GENERAL BIOCIDAL PRODUCTS
    • PRESERVATIVES
    • PEST CONTROL
    • OTHER BIOCIDAL PRODUCTS
    • Preservatives for food or feedstocks
    • Antifouling products
    • Embalming and taxidermist fluids
    • Control of other vertebrates
  • Information Required
    • General
    • Nomenclature
    • Purity
    • Physical properties
    • MP
    • BP
    • Density
    • Rel. Vap. Dens
    • VP
    • Log PoW
    • Solubility
  • Information Required
    • SCCP (Cont.)
    • Acute Toxicity
    • Acute Oral
    • Acute Dermal
    • Acute Inhalation
    • Irritation/Corrosivity
    • Skin Irritation
    • Mucous Membrane
    • Skin Sensitisation
    • Dermal/Percutaneous Absorption
    • Repeat Dose Toxicity
    • Repeat Dose oral/dermal/inhalation (28 day)
    • Subchronic 90 day oral/dermal/inhalation
    • Chronic (>12 months)
  • Information Required
    • SCCP (Cont)
    • Mutagenicity/
    • Genotoxicity
    • Carcinogenicity
    • Reproductive Toxicity
    • Two Generation Reproduction Toxicity
    • Teratogenicity
    • Toxicokinetics
    • Photo induced Toxicity
    • - Phototoxicity
    • Human Data
    • Case studies of poisonings, allergic reactions
  • Information Required
    • BPD
    • General:-
    • Substance identification (CAS, IUPAC, formula etc)
    • Substance information – colour, purity, physical properties
    • Spectra
    • Synonyms and trade names
    • Impurities
    • Additives
    • Quantity used in EU
    • Labelling
    • Hazard classification and labelling
    • Usage pattern – including application, types of use, volume per application, recovery, industry types
    • Manufacturing method
    • Existing exposure restriction and limits
    • Hazards
    • Degradation products
  • Information Required
    • BPD (Cont)
    • Physical & Chemical Properties
    • MP
    • BP
    • VP
    • Viscosity
    • Density
    • Granulometry
    • Partition coefficient
    • Solubility in different media
    • Surface Tension
    • Flash point, flammability, explosivity
    • Oxidising properties
    • Dissociation constant
  • Information Required
    • BPD (Cont)
    • Environmental
    • Photodegradation
    • Stability in water and soil
    • Monitoring data
    • Field studies
    • Transport between environmental compartments
    • Actual use degradation model
    • Biodegradation, BOD/COD
    • Bioaccumulation
  • Information Required
    • BPD (Cont)
    • Environmental
    • Photodegradation
    • Stability in water and soil
    • Monitoring data
    • Field studies
    • Transport between environmental compartments
    • Actual use degradation model
    • Biodegradation, BOD/COD
    • Bioaccumulation
  • Information Required
    • BPD (Cont)
    • Ecotoxicity
    • Acute toxicity to:-
        • Fish
        • Aquatic invertebrates
        • Aquatic plants (e.g. algae)
        • Micro-organisms
    • Chronic toxicity to:-
        • Fish
        • Aquatic invertebrates
    • Toxicity to:-
        • Sediment dwelling organisms
        • Terrestrial plants
        • Soil dwelling organisms
        • Other non mammalian terrestrial species
    • Biotransformation and Kinetics
  • Information Required
    • BPD (Cont)
    • Toxicity
    • Acute oral
    • Acute inhalation
    • Acute dermal
    • Skin irritation
    • Eye irritation
    • Sensitisation
    • Repeat dose toxicity
    • Genetic toxicity in vitro
    • Genetic toxicity in vivo
    • Carcinogenicity
    • Toxicity to fertility
    • Developmental toxicity/teratogenicity
    • Exposure experience
  • Information Required
    • BPD (Cont)
    • Effect Against Target Organism
    • Function
    • Effects on organisms to be controlled
    • Organisms to be protected
    • User
    • Resistance
    • End point summary Risk Assessment
  • Information Required
    • Tests Required for Original REACH Registration
    • Melting/freezing point
    • Boiling point
    • Relative density
    • Vapour pressure
    • Surface tension
    • Water solubility (or water extractivity for polymers)
    • n-Octanol-water partition coefficient
    • Flash point or flammability
    • Explosivity
    • Auto-flammability
    • Oxidising properties
    • Granulometry
    • Skin irritation or corrosivity evaluation or in vitro tests
    • Eye irritation evaluation or in vitro test
    • Skin sensitisation evaluation or local lymph node assay
    • Ames test
    • In vitro chromosome aberration test
    • Acute Daphnia toxicity
    • Algal growth test
    • Ready biodegradation
  • Development Process
  • Environment Analysis
    • Opportunities & Threats
  • Evaluation of Resources & Capabilities
    • Resources
    • - Funding
    • - Time
    • - Facilities & Infrastructure
    • - Equipment
    • - Literature
    • Capabilities
    • - Available Skills (Research Team)
    • - Experience
  • Market Analysis
    • Knowledge of Industry
    • Knowledge of Potential Applications
    • Knowledge of Customers
    • Understanding of Derived Demand
    • Understanding of Trends
    • Understanding of Other Developments & Improving Technology and Knowledge
  • Top Twenty Essential Oils Produced in the World Essential Oil Botanical Name Volume (Tonnes) Under Threat Cosmetics Under Threat Biocides Under threat Fragrance Orange Citrus sinensis 26000 X X Cornmint Mentha Arvensis 4300 Eucalyptus Euc. globulus 3728 X X X Citronella Cym winterianus 2830 X X X Peppermint Mentha piperita 2367 Lemon Citrus limon 2158 X X Euc. Citriodora Eucalyptus citriodora 2092 X X X Clove Leaf Syzygium aromaticum 1915 X X X Cedarwood (US) Juniperus virginiana 1640 Litsea cubeba Litsea cubeba 1005 X X Sassafras (Brazil) Ocotea pretiosa 1000 X X Lime Citrus aurantifolia 973 X X Spearmint Mentha spicata 851 Cedarwood (China) Chamaecyparis funebris 800 Lavandin Lavandula intermedia 768 X X Sassafras (China) Cinnamomum micranthum 750 X X Camphor Cinnamomum camphora 725 Coriander Coriandrum sativum 710 Grapefruit Citrus paradisi 694 X X Patchouli Pogostemom cablin 563 X X
  •  
  • Essential Oil Technical Development
    • Project Preparation and Early Work
    • - Stakeholders
    • - Team
    • - Objectives
    • - Funding
    • - Plan
  • Essential Oil Technical Development
    • Land Selection
    • - Suitable (Soil, Rainfall, drainage, access)
    • - Climate
    • - Location
    • - Tenure
    • - Future Expansion
  • Essential Oil Technical Development
    • Development of Propagation Material
    • - Easy to Domesticate?
    • - Seed Collection (genetic variance)
    • - Other Propagation Methods
  • Essential Oil Technical Development
    • Planting
    • Harvesting Techniques
    • Extraction
    • Techniques
  • Essential Oil Technical Development
    • Are Developed Techniques able to Create a
    • Viable and Economic Industry?
  • Marketing Strategies
  • Marketing Strategies
    • Develop in Conjunction with International Company
    • - They will have their own strategy
    • Raw Material
    • Finished Product
    • Local Market
    • International Market
  • Conclusion
    • Emphasis Shifting to Development and Potential Applications
    • Possible Commercialisation
    • Research Funding Tied to Results/Outcomes
    • Institution Questions –
    • Can it be Commercialised?
  • Conclusion
    • Multi-disciplinary Approach
    • Market Orientation
    • Focus on Research Objectives
    • Economic Basis
    • Heavy Influence of Regulatory Restrictions
  • Thank You