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Anti aging cancer herbal_cam

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Cancer prevention and Herbal , Complementary Medicine

Anti aging cancer herbal_cam

  1. 1. Presented by : Dr Ling Sien Ngan Anti Aging medical practioner Lowel Anti aging & aesthetic center 27A Jln SS2/75, 47300 PJ. GLOBAL & LOCAL SCENARIOS OF HERBAL/PHYTOCHEMICAL INDUSTRY Chemical Engineering Pilot Plant Universiti Teknologi Malaysia *Materials- courtesy of CEPP
  2. 2. ISSUES OF THE 21 ST CENTURY ISU-ISU ABAD KE-21
  3. 3. ISSUES OF THE 21 ST CENTURY CHRONIC DISEASES
  4. 5. WHEN WILL WE CURE CANCER ? ISSUES OF THE 21 ST CENTURY
  5. 6. CANCER ISSUES OF THE 21 ST CENTURY
  6. 7. <ul><li>40,000 new cases every year. </li></ul><ul><li>One every four Malaysian will suffer a cancer in a lifetime. </li></ul><ul><li>Most frequent cancer in Malaysian men were lung, nasopharynx, colon, leukemia, rectum and prostate cancer. </li></ul><ul><li>While most frequent cancer in Malaysian women were breast, cervix, colon, ovary, leukemia, and lungs. </li></ul><ul><li>Chinese were found to have the highest risk of cancer ratio of (4:1) followed by Indians (5:1) and Malays (7:1) </li></ul>M alaysian Facts and Figures on Cancer Cancer Facts and Figures
  7. 8. 2003 Global Estimates of HIV and AIDS Source : Population Reference Bureau , 2005
  8. 10. OBESITY ISSUES OF THE 21 ST CENTURY
  9. 14. Stay Young??
  10. 15. Food
  11. 16. What’s happening to our food industry?
  12. 17. Medicine TRADITIONAL MODERN
  13. 18. vs Wellness Industry Sickness Industry
  14. 19. Introduction to Complementary Alternative Medicine Acupuncture Thai massage Japan hot bath Jamu Indonesia Ayurveda Mandi lulur Bali
  15. 20. Evolution of Integrated Medicine Traditional Medicine Modern Medicine Medicine Modern Medicine <ul><li>Before 18th Century : </li></ul><ul><ul><li>Traditional Medicine is the only form of Medicine in the East. </li></ul></ul><ul><ul><li>Survival and Quality of Life dependent on Traditional Medicine </li></ul></ul><ul><li> 19th Century </li></ul><ul><ul><li>Influx of Modern Medicine </li></ul></ul><ul><ul><li>-noted for its ease and effectiveness </li></ul></ul>Increasing popularity of TCM <ul><li>21st Century </li></ul><ul><ul><li>Efforts towards </li></ul></ul><ul><ul><li>Integration of </li></ul></ul><ul><ul><li>Modern and TCM </li></ul></ul>20 th century Integrated
  16. 21. Definitions <ul><li>Complementary Medicine (CM) </li></ul><ul><ul><li>Diverse practices and products that are not presently considered to be part of conventional (modern) medicine </li></ul></ul><ul><ul><li>Used together with conventional medicine </li></ul></ul><ul><li>Alternative Medicine </li></ul><ul><ul><li>Medicine used in place of conventional medicine </li></ul></ul><ul><li>Traditional Medicine </li></ul><ul><ul><li>Traditional medicine is based on theory, beliefs and experiences that are indigenous to the different cultures, and that is developed and handed down from generation to generation. </li></ul></ul><ul><li>Integrated / Integrative Medicine </li></ul><ul><ul><li>Medicine that combines mainstream medical therapies and TCM therapies for which there is some high-quality scientific evidence of safety and effectiveness </li></ul></ul>Bomoh/ Witch Doctor Ayurveda Chinese Sinseh
  17. 22. Integrated Medicine <ul><li>“ Integrated Medicine” </li></ul><ul><li>attempts to combine the best of both systems, but it is not just about adding a bit of acupuncture to the aspirin; it is about restoring an understanding of the patient, his or her attitudes, beliefs, personal history, and life situation to health care </li></ul><ul><li>Jack Czauderna, Centre for Institute of Integrated Medicine, Sheffield </li></ul>
  18. 23. HERBS then as Traditional and now a Complementary Alternative Medicine Herbs and botanicals have been used for centuries for a variety of ailments. Growing interest in alternative medicine and natural remedies to modern medicines has led to a dramatic growth in the herbal market over the last decade. But herbs increasingly finding application in a variety of foods being promoted on a health platform. (Leatherhead Food Research Association)
  19. 24. DEFINITIONS OF HERB <ul><li>The English word ‘ HERB ’ is originally from a Sanskrit word, ‘BHARB’ which means to EAT. </li></ul><ul><li>Also from Latin word ‘HERBA’ meaning GRASS or FODDER </li></ul><ul><li>As defined by Merriam-Webster’s Dictionary: </li></ul><ul><ul><li>‘ Herb is a plant or parts of plant valued for its medicinal, savory or aromatic qualities’ </li></ul></ul><ul><li>Herb Society of America describe Herbs as : </li></ul><ul><ul><li>‘ Any plant that may be used for pleasure, fragrance or physics’ </li></ul></ul>
  20. 25. DEFINITION OF TERMS <ul><li>PHYTOCHEMICAL </li></ul><ul><ul><li>From the Greek word “Phyto” for plant. </li></ul></ul><ul><ul><li>Refers to every naturally occurring chemical presents in plants. </li></ul></ul><ul><ul><li>Estimated that approximately ¼ drugs contain plant extract or active ingredients obtained from plant substances. </li></ul></ul><ul><li>COSMECEUTICAL </li></ul><ul><ul><li>Cosmetic containing ingredients that are bioactive, exerting effects on people. </li></ul></ul><ul><ul><li>A blend of cosmetic and pharmaceutical which has appeared only in the nineties. </li></ul></ul><ul><ul><li>Examples: anti-wrinkles creams, baldness treatments, moisturizers and sunscreens . </li></ul></ul>
  21. 26. DEFINITION OF TERMS <ul><li>NUTRACEUTICAL </li></ul><ul><ul><li>Any substance that may be considered a food or part of a food that provide medical and health benefits, including the prevention and treatment of disease. </li></ul></ul><ul><ul><li>Might be isolated nutrients, dietary supplements or diets, processed foods, herbal products or genetically engineered “designer foods”. </li></ul></ul>
  22. 27. Healing Power Around the Globe <ul><li>Chinese herbalism </li></ul><ul><li>Ayurvedic </li></ul><ul><li>Western herbalism </li></ul><ul><li>Homeopathic Remedies </li></ul><ul><li>Native Tribes of the Americas </li></ul><ul><li>Traditional Malay medicine </li></ul><ul><li>Modern herbalism </li></ul><ul><li>Antioxidant </li></ul>
  23. 28. SCOPE OF THE HERBAL INDUSTRY Herbal Products Industry Insect Repellant, Pesticides & Household Items Industry Insect Repellant, Pesticides & Household Items Industry Cosmetics/ Cosmeticeuticals & Toiletries Industry Cosmetics/ Cosmeceuticals & Toiletries Industry Essential Oils, Flavours Colours & Fragrance Industry Essential Oils, Flavours Colours & Fragrance Industry Healthcare/ Nutraceutical Industry Healthcare/ Nutraceutical Industry Biopharmaceutical Industry Biopharmaceutical Industry Pharmaceutical Industry (Drugs & excipients ) Pharmaceutical Industry (Drugs & recipients ) Herbal/ Traditional Medicine Industry Herbal/ Traditional Medicine Industry M i GHT M i GHT
  24. 29. CONTRIBUTING FACTORS <ul><li>These food are gaining popularity amongst consumers due to: </li></ul><ul><ul><li>Time </li></ul></ul><ul><ul><li>Performance enhancement </li></ul></ul><ul><ul><li>Fitness </li></ul></ul><ul><ul><li>Alternative medicine </li></ul></ul><ul><ul><li>Age </li></ul></ul><ul><ul><li>Cost of health care </li></ul></ul><ul><ul><li>Crop genetic </li></ul></ul>
  25. 30. GLOBAL SCENARIO
  26. 31. GLOBAL SCENARIO <ul><li>The world health care industry is driven by two dominant trends: </li></ul><ul><ul><li>Tremendous development of biotechnology industry </li></ul></ul><ul><ul><li>More recognition, acceptance and use of Traditional Medicine as natural medicine, health food and food supplements at National, Regional and Global level. </li></ul></ul><ul><li>Key Emerging Trends </li></ul><ul><li> Discerning consumers concern with: </li></ul><ul><li>- quality </li></ul><ul><li>- safety </li></ul><ul><li>- efficacy, & </li></ul><ul><li>- traceability of health products </li></ul><ul><li>(Controlling product quality & safety in the entire supply chain & trading network, </li></ul><ul><li>“ FROM SEED TO SHELF ”) </li></ul><ul><li> Increasing significant portion of herbal medicine taken as prophylactic/preventive rather than curative/remedy. </li></ul><ul><li>However, periodic negative press or concern regarding safety & efficacy of herbal medicine largely because of fraudulent claims & unscrupulous manufactures. </li></ul>
  27. 32. GLOBAL TRENDS <ul><li>World Health Organization (WHO) consistently reported that 80% of the world’s population depends on herbal medicine . </li></ul><ul><li>Tropical forests contribute 25% of the world’s medicinal products and nearly half of the prescription drugs are plant derived. </li></ul><ul><li>The global herbal trend shows that herbal therapy enters the mainstream medicine from 1970 -2000. </li></ul><ul><li>WHO – estimated USD 60 billion in 2003 </li></ul><ul><li>MIGHT – market will reach USD 200 billion in 2008 </li></ul><ul><li>World Bank – market to reach USD 5 Trillion in 2050 </li></ul><ul><li>Europe is the largest herbal products market </li></ul><ul><li>-USD 6 billion (led by Germany & France. </li></ul><ul><li>Japan – USD 2.1 million </li></ul><ul><li>Asia excluding Japan – USD 2.3 billion </li></ul><ul><li>North America – USD 1.5 billion. </li></ul><ul><li>Middle East countries become largely untapped </li></ul>M i GHT M i GHT
  28. 33. <ul><li>Traditional medicine has been fully integrated into the health systems of China, North and South Korea and Vietnam </li></ul><ul><li>In western countries, growing numbers of patients rely on alternative medicine for preventive or palliative care </li></ul><ul><li>In France, 75% of the population has used complementary medicine at least once </li></ul><ul><li>In Germany, 77% of pain clinics provide acupuncture </li></ul><ul><li>The global market for traditional therapies stands at US$ 60 billion a year and is steadily growing </li></ul>TRADITIONAL AND ALTERNATIVE MEDICINE
  29. 34. M i GHT M i GHT Herbs and medicinal plants are mainly used for phytomedicines , flavours and fragrance, biopesticides and pharmaceuticals / nutraceuticals . Market growth in medicinal herbs and botanicals was to an average of 7.6% a year between 1999 and 2002. Worldwide sales figures for herbal remedies in year 2000 and projection figures for year 2002 are as follows: Global Trends HERBAL INDUSTRY Billion US$(retail prices) 2001 2002  Europe 6.9 7.5  Asia 5.1 6.2  North America 3.9 4.3  Japan 2.3 2.6  South America 0.6 0.8  Australia / New Zealand 0.3 0.4  Mid East 0.1 0.1  Africa 0.1 0.1  RoW 0.3 0.4 Total Value 19.6 22.4 Estimate based on IMS market analysis for 1997 plus main growth rates and side markets
  30. 35. Unmistakable trends US 1998 0 2 4 6 8 10 12 14 16 18 Acupuncture Hypnosis Homeopathy Aromatherapy Spiritual healing Chiropractic Massage Herbal remedies Relaxation therapy Percentage of population using therapy 42.1 % used a CAM therapy US$21.2 billion spent 6.29 million visits CAM has become more popular, as is evident in these figures that shows the popularity of various healing methods “ New Scientist's ”
  31. 36. Unmistakable trends ENGLAND 1999 0 2 4 6 8 10 12 14 16 18 Acupuncture Reflexology Aromatherapy Chiropractic Osteopathy Massage Herbal remedies Percentage of population using therapy 28.3% used a CAM therapy £ 450 million spent in UK 50,000 CAM practitioners in UK 12.7 million visits in UK Homeopathy “ New Scientist's ” CAM has become more popular, as is evident in these figures that shows the popularity of various healing methods
  32. 37. US Herbal and Plant Product Sales Sales, US$ Source: China Economic Information Network, 2003 441,502,560 Total 2,950,132 Kava Kava 3,037,672 Milk Thistle 4,555,723 Bilberry 6,104,450 Valerian 6,182,210 Cranberry 7,299,353 Evening Primrose Oil 9,965,772 Grapeseed 18,381,592 Saw Palmetto 38,341,632 Goldenseal 47,774,792 St John's Wort 49,189,576 Echinacea 71,474,288 Garlic 86,048,080 Ginseng 90,197,288 Ginkgo Product
  33. 38. LOCAL SCENARIO
  34. 39. <ul><li>Malaysia’s rainforest is the world’s oldest rainforest </li></ul><ul><li>4 th most bio-diverse nation in Asia after India, China and Indonesia </li></ul><ul><li>The one of the only 12 countries in the world with mega diversity of plants, medicinal and aromatic plants </li></ul><ul><li>Home to about 12% of all the plant species on earth, which has not been fully exploited and cultivated </li></ul><ul><li>One of the primary centres of biodiversity with an estimated 15,000 known plant species, 3,700 are known to be useful, 2,000 species with medicinal value and the balance remain largely unexploited. </li></ul>Malaysia’s Rich Herbal Heritage M i GHT M i GHT
  35. 40. The total value of the domestic market for herbal and medicinal plants is now estimated to reach up to RM4.55 billion . Industrial uses of herbs in Malaysia MALAYSIAN SCENARIO (Dr Azizol Abdul Kadir, formerly FRIM) RM 4.55 billion Total RM 2.00 billion Herbal Remedies RM 0.95 billion Pharmaceuticals/nutraceuticals RM 1.60 billion Flavour & Fragrance Value Herbal Uses
  36. 41. Malaysian Herbal Industry Market Projection vs Target Year Projected Market Value Targeted Local Content % Share 2000 2005 2010 RM 2.0 b RM 3.2 b RM 5.0 b RM 100 m RM 500 m RM 2.5 b 5% 15% 50% HERBAL INDUSTRY M i GHT M i GHT
  37. 42. SWOT Analysis Opportunities HERBAL INDUSTRY <ul><li>Insufficient supply of local raw material </li></ul><ul><li>Lack of large scale cultivation activities </li></ul><ul><li>Lack of technological mechanism </li></ul><ul><li>Shortage of skilled HR </li></ul><ul><li>Little participation of big companies </li></ul><ul><li>Lack of scientific evidence for health </li></ul><ul><li>related claims </li></ul><ul><li>Commercial production – Good </li></ul><ul><li>Agriculture Practice </li></ul><ul><li>Supply chain management </li></ul>Weaknesses Opportunities <ul><li>Development of new and improved </li></ul><ul><li>products </li></ul><ul><li>Development of new and improved </li></ul><ul><li>processing technologies </li></ul><ul><li>Use of biotechnology and cell culture </li></ul><ul><li>Untapped opportunity – global Muslim </li></ul><ul><li>(& non-Muslim) in OIC countries </li></ul><ul><li>Huge potential but flaws in current </li></ul><ul><li>M’sian Herbal Medicine sector </li></ul><ul><li>Government’s standing in Islamic </li></ul><ul><li>world & inherent support </li></ul>Strengths <ul><li>Diversity of genetic </li></ul><ul><li>resource and germplasm </li></ul><ul><li>collection </li></ul><ul><li>Excellent tropical climate </li></ul><ul><li>Increasing R&D interest </li></ul><ul><li>Acceptance and </li></ul><ul><li>increasing demand </li></ul><ul><li>Indigenous knowledge – </li></ul><ul><li>mixed cultural ethnics </li></ul><ul><li>Good infrastructure </li></ul><ul><li>Established current Good </li></ul><ul><li>Manufacturing Practise (GMP) </li></ul>Threats <ul><li>Market flooded with </li></ul><ul><li>cheaper products </li></ul><ul><li>Inferior and fake products </li></ul><ul><li>1 st mover advantage- </li></ul><ul><li>Competition from other </li></ul><ul><li>countries </li></ul>
  38. 43. Bioresources Identification of suitable herbs Strategic Analysis-core competencies Strong Competencies Product design & development Primary processing Of herbs (post-harvest Processing) New herbal products marketing End users Natural Bioactive Compounds Development of Required herb for Industry / New Herbal outlets Commercial production of Required herbs Clinical research Manufacturing Distribution Weak Competencies Weak Competencies Weak Competencies Weak Competencies Weak Competencies Weak Competencies Weak Competencies Ref : Malaysian Herbal Industry Outlook (Might ) Strong Competencies Strong Competencies Strong Competencies Strong Competencies Strong Competencies
  39. 44. From Seed to Shelf… The Concept <ul><li>Select good quality </li></ul><ul><li>seed for the plantation </li></ul><ul><li>following GAP </li></ul><ul><li>methods. </li></ul>Processing of the herbal using the suitable methodology -Herbal approach / Phyto approach Product formulation & manufacturing according to GMP Product marketing 1 2 3 4
  40. 45. Product Development THE CHALLENGES .... Plantation Harvesting & Processing Product Formulation & Manufacturing Product Marketing Safety, Quality, Standard, Efficacy Raw material sourcing
  41. 46. Highly knowledge industry requires highly knowledge workers <ul><li>Requires expertise in all sectors of the business chain, i. e. from planting  marketing </li></ul><ul><li>Important area include: </li></ul><ul><ul><li>New plant & drug discovery </li></ul></ul><ul><ul><li>Phytochemical studies </li></ul></ul><ul><ul><li>Biological & clinical studies </li></ul></ul><ul><ul><li>Drug testing </li></ul></ul>
  42. 47. RAW MATERIAL SOURCING AND PLANTATION - QUANTITY, QUALITY, RELIABILITY 1
  43. 48. Why the raw material sourcing is important??  Large volume of raw materials needed for getting little product Rose : 60,000 blooms to produce 1 ounce of oil Jasmine : 8,000,000 handpicked flower for 1 kg of oil {France : US$ 15,000 / kg, India : US$ 4,000 / kg} Lavender : 100 kg of lavender for 3 kg of oil Tongkat Ali : 45 kg root for 1 kg extract Pegaga : 15 kg dried leaves for 1 kg extract Kemunting Cina : 15 tonnes of leaves for 1 ounce of vincristine extract Examples :
  44. 49. What to be done? <ul><li>Be able to confine collection of species , varieties or hybrid to desired characteristics. </li></ul><ul><li>Seeds & propagation material </li></ul><ul><ul><li>Verified botanically & guaranteed healthy </li></ul></ul><ul><ul><li>Avoid adulteration & genetically modified items comply with regulations </li></ul></ul><ul><li>Propagation and Fertilizer </li></ul><ul><ul><li>Need to choose the right technique to optimize the harvesting and yield </li></ul></ul><ul><li>Better development of the plants’ growth ; conditions of soil, pruning, control of the insects pest, harvesting time, etc </li></ul><ul><li>Develop planting material and production methods for selected herbs according to GAP procedures as well as HALAL procedure. </li></ul><ul><li>Collaborate will appropriate agencies to develop GAP procedures and certification process for HALAL GAP. </li></ul><ul><li>Supervise contract farmers and provide technology . </li></ul><ul><li>Strong tie-up with R&D and herbal collection. </li></ul>Source: INS,2005, Prof Zhari Bin Ismail
  45. 50. PLANTLETS DERIVED FROM TISSUE CULTURE Source: Dr Ilham,FRIM
  46. 51. GOOD AGRICULTURAL AND COLLECTION PRACTICE FLOW OF ACTIVITY 1.Plant identification: species, variety or hybrid 2.Locality identification: suitability of soil and climate conditions 3. Propagation technique 4. Pests and weeds control and other contaminants 5. Harvesting technique 6. Cleaning (Wash) technique 7. Drying Method; sun or oven dry 8. Pack and storage Source: Prof Zhari Bin Ismail
  47. 52. Organic Farming <ul><li>Horticultural research in the growing of herbal plants will emphasize organic farming in view of consumer demand. </li></ul><ul><li>Quality control, safety and efficacy issues are vital to the long-term success of the herbal products industry. </li></ul><ul><li>In the current industry trend towards natural ingredients, organic farming is gaining its prestige. </li></ul>(FLAVOURS, March-May 2001)
  48. 53. Contract Farming <ul><li>Why contract farming? </li></ul><ul><li>Controlling the entire supply chain and trading network, FROM SEED TO SHELF </li></ul><ul><li>Ensuring product quality, safety, efficacy, and traceability </li></ul><ul><li>Enable higher recognition, acceptance and trust on traditional herbal medicine </li></ul><ul><li>Engage contract farmer to ensure constant supply of raw material to manufacturing center for developing of new halal -herbal medicine product </li></ul><ul><li>Supervise contract farmer and provide technology </li></ul><ul><li>Nurture and develop “master farmer” for the development of nucleus estate </li></ul><ul><li>Collaborate will appropriate agencies to develop GAP procedures and certification process for HALAL GAP. </li></ul><ul><li>Supervise contract farmers and provide technology. </li></ul><ul><li>Strong tie-up with R&D and herbal collection. </li></ul>Source: INS,2005
  49. 54. Example: Tongkat Ali Planted Under Open Condition Source: Dr Ilham,FRIM
  50. 55. Tongkat Ali: under oil palm Source: Dr Ilham,FRIM Tongkat Ali: under rubber tree Tongkat Ali: under coconut tree
  51. 56. 3 in 1... Source: Dr Ilham,FRIM
  52. 57. HERBS CULTIVATION CASE STUDY ON TURNING PEGAGA (Centella asiatica) Source : Dr. Zainal Abidin, MARDI
  53. 58. <ul><li>In Malaysia commonly consumed as </li></ul><ul><li>- Salad vegetable among Malays </li></ul><ul><li>- Cooling drink by the Chinese </li></ul><ul><li>- Brain tonic by the Indians </li></ul><ul><li>Currently pegaga is the active ingredient of </li></ul><ul><li>many drugs and cosmetic preparation in </li></ul><ul><li>Europe, USA and Japan </li></ul><ul><li>It contain chemical mainly asiaticoside, </li></ul><ul><li>asiatic acid, madecassic acid and </li></ul><ul><li>madecassoside, </li></ul>Source : Dr. Zainal Abidin, MARDI
  54. 59. VARIETIES OF PEGAGA Source : Dr. Zainal Abidin, MARDI
  55. 60. Source : Dr. Zainal Abidin, MARDI Chemical contain in 3 major species of Pegaga Variety Chemical contain (mg/g crude extract) Madecassoside Asiaticoside Madecassic acid Asiatic acid Salad 67.8 26.7 12.6 9.8 Nyonya 69.5 31.8 14.5 14.4 Kampong 92.6 41.3 11.7 9.9
  56. 61. Planting Weed Control Harvesting Post Harvesting Handling Source : Dr. Zainal Abidin, MARDI
  57. 62. Estimated cost of production and return from planting I ha of pegaga ‘Nyonya’ atPaya Rumput. Malacca. Source : Dr. Zainal Abidin, MARDI 3.72 4.68 4.56 3.82 3.52 1.19 Cost/Benefit Ratio 31,256.75 37,376.81 36,155.88 42,786.68 45,899.21 8,862.15 Nett Income (RM) 11,475.81 10,152.26 10,152.26 15,192.97 18,225.79 47,671.28 Total Costs of Production (RM) 6,668.02 5,196.22 5,196.22 6,649.71 7,376.44 12,630.82 Subtotal Costs (RM) - - 6,668.02 - - 5,196.22 - - 5,196.22 - - 6,649.71 - - 7,376.44 1,308.14 1,744.19 9,578.49 Labour Costs (RM) Land preparation Planting Miscellaneous 4,807.79 4,956.04 4,956.04 8,543.25 9,076.10. 35,040.45 Subtotal Costs (RM) - 4,807.79 - 4,956.04 - 4,956.04 - 8,543.25 - 9,076.10 22,790.70 12,249.75 Input Cost (RM) Planting material (RM 2.00/kg) Miscellaneous 42,732.56 47,529.07 46,308.14 57,979.65 64,125 56,533.43 Gross Income (RM2,500/t) 17,093.02 19,011.63 18,523.26 23,191.9 25,650.0 22,613.4 Biomass Yield (t/ha) Ratoon 5 Ratoon 4 Ratoon 3 Ratoon 2 Ratoon 1 Main Crop Items/Crop Harvest
  58. 63. Source : Dr. Zainal Abidin, MARDI
  59. 64. HERBAL AND PHYTOCHEMICAL PROCESSING 2
  60. 65. WOOD OR BARKS FLOWERS SEEDS OR GRAINS LEAVES ROOTS OR RHIZOMES DETERMINE PREPROCESSING NEEDS (DRYING, COMMUNITION ETC.)
  61. 66. Raw material <ul><li>Treatment after harvesting </li></ul><ul><li>Size reduction </li></ul><ul><li>Checking for the insects or fungi </li></ul>
  62. 67. Packing and Storage <ul><li>Factors need to consider: </li></ul><ul><li>Temperature </li></ul><ul><li>Humidity </li></ul><ul><li>Pests </li></ul>Source: Prof Zhari Bin Ismail
  63. 68. OVERALL PROCESSING FLOW CHART Harvesting Inspection Cleaning Size reduction Drying Extraction Clean up Fractionation Dried herbal product Pure phytochemical
  64. 69. Extraction of Phytochemical Valuable bio active compound Non-bio active compound Extraction process Normal method of processing
  65. 70. Chart of Classification and Separation of Plant Material Based on Solvent Polarity and Process (Herbal Approach) Plant Material Solvent Extract filtrate Freeze dried Whole concrete extract Membrane Filtration or Low T vacuum evaporation Whole concentrate extract Water Extract Spray dried Whole powder extract Freeze dried Whole freeze dried extract Spray dried Concentrate extract
  66. 71. Chart of Classification and Separation of Plant Material Based on Solvent Polarity and Process (Phyto Approach) Plant Material H2O-Glycerol Extraction Non-Polar compound extraction SFE (Phytonics: Phytosol) Terpenoids Essential Oil (e.g. mono & Esquiterpenes: geraniol, limonese Diterpenoids (Phytol, abietic acid) Triterpenoids (Cucurbitacin) Carotenoids ( β-Carotene, lutien, Zeaxanthin, etc) Multi Solvent Extraction Process Terpenoids (e.g. Menthol, carrone, squalene, α-Carotene, lycopene) Lipids Polar Compound Extraction Flavanoid (e.g. anthocyanin-cyanidin, flavanols- Kaemferol, isoflavanoid-rotenone) Polar alkaloid (e.g. Ephedrine) Sugar & Derivatives (e.g. monosacharide, Oligosacharide, sugar alcol) Fiber Acid Hydrolysis filtrate Cellulose filtrate Hemicellulose filtrate Lignin
  67. 72. technology used must be able to produce… MAXIMUM QUANTITY OF PRODUCTS OF HIGHEST QUALITY (eg. ACTIVITY) AT THE LOWEST POSSIBLE COST
  68. 73. Raw Materials Product PROCESS Root / Rhizomes Bark / wood Leaves / Vegetables Flower Fruit / seed / nuts Fruit or vegetable juice / medicinal concentrate High-grade alcohol Concrete/Oleoresin Aqueous aroma Essential oil Extraction Of Specialty Chemical From Plant Utilizing Turbo Extractor Distillator
  69. 74. TONGKAT ALI EXTRACTION PROCESS RAW MATERIAL EXTRACTION PROCESS FILTERING PURE TONGKAT ALI EXTRACT SPRAY DRIED PROCESS PACKAGING Case study :
  70. 75. PROCESS IN THE PREPARATION OF TONGKAT ALI AQUEOUS EXTRACT Source: Dr Ilham,FRIM
  71. 76. THE DRYING PROCESS OF TONGKAT ALI AQUEOUS EXTRACT Source: Dr Ilham,FRIM
  72. 77. TONGKAT ALI CAPSULES mmbpp (spray dried) Commercial A (saw dust) Commercial B (saw dust mixture) Physical characteristics of Tongkat Ali capsules containing aqueous soluble extract Source: Dr Ilham,FRIM
  73. 78. Product Formulation & Manufacturing 3 Good Manufacturing Practice (GMP) Good Manufacturing Practice ( GMP ) guidelines is to ensure that products are consistently manufactured and controlled to the specified quality. It is concerned with all aspects of production and quality control. <ul><li>Ministry of Health </li></ul><ul><li>National Pharmaceutical Control Bureau </li></ul>Malaysia <ul><li>GMP by Belgium Ministry of Public Health </li></ul><ul><li>self-issued GMP endorsed by Ministere Des Affaires Sociales De la Sante Et De D’Environnement and Inspection des Denrees Alinmentaires </li></ul>Belgium Self issued CFS endorsed by F.C.I.O- Fachverband der Chemischen Industrie Osterreich Austria <ul><li>GMP (for anti-perspirant and sunscreen only) by TGA ( Therapeutic Goods Administration) </li></ul><ul><li>License to Manufacture by TGA </li></ul>Australia Types of certification & its recognized bodies Countries
  74. 79. Plant Identification <ul><li>To identify right species, varieties or hybrids which possess desired chemical content or meant for desired therapeutic applications </li></ul><ul><li>Studies involved: Taxonomy, TLC, HPLC </li></ul><ul><li>For Misai kucing, species: Orthosiphon stamineus, Benth , purple and white flower variety </li></ul>
  75. 80. Chemical Profile High Perfomance Liquid Chromatography (HPLC) HPLC Profile Tongkat Ali Pegaga
  76. 81. Challenges in Product Formulation <ul><li>Herbal dosing in order to meet the taste and/or health condition criteria for a specific product. </li></ul><ul><li>Issue on the taste, texture, potency and ingredient interaction are important at the early stage of the product development. </li></ul><ul><li>Able to provide data justifying excipient, ingredient or preservative level and effect absorption etc. </li></ul><ul><li>Validation on the new product </li></ul>
  77. 82. TRADITIONAL/ HERBAL MEDICINES: SIDE EFFECTS??? <ul><li>Toxic plants </li></ul><ul><li>Microbial contamination </li></ul><ul><li>Steroid adulteration </li></ul><ul><li>Heavy metals </li></ul><ul><li>Over-dose </li></ul><ul><li>Synergistic effects </li></ul>Source: Dr Ilham,FRIM
  78. 83. 0 2 4 6 8 10 12 14 16 Discovery (2-10yrs) Phase I 20-80 healthy volunteers used to deterrmine safety and dosage Phase II 100-300 patient volunteers used to look for efficacy and side effect Phase III 1000-3000 patient volunteers used to monitor adverse reactions to long term use FDA review/ approval Compound success rates by stages 5,000 - 10,000 screened 250 5 1 Source: Dr Ilham,FRIM Preclinical testing laboratory & animal testing
  79. 84. MARKET VALUE OF HERBAL PREPARATIONS Fresh materials (roots, leaves, etc) Dried powder Non-standardized extract Standardized extract Phytomedicine Freeze/spray dried extracts Value added 4 Product Marketing Source: Dr Ilham,FRIM
  80. 85. Example: Price of Pegaga after processing USD 100 Standardization RM40 RM25 RM10 RM2 Freeze-drying Extraction Juice, dried herbs or powder Raw material Ref : Malaysian Herbal Industry Outlook (Might )
  81. 86. Final Product – Register with National Pharmaceutical Control Bureau (BPFK) Safe to consume or apply ADA OOHMP!!!
  82. 88. Marketing strategy: Wellness Shop <ul><li>To create a dynamic market for promoting the herbal products. </li></ul><ul><li>A platform for introducing product develop by the local research groups. </li></ul><ul><li>To support and fulfilled the industry chain for the herbal products. </li></ul><ul><li>To provide variety of local herbal products, consultant and service such as aromatherapy, massage and etc. </li></ul>
  83. 89. HERBAL PRODUCTS IN MALAYSIA MARKET Alterni Clara International Nona Roguy Victus Semulajadi NEW IMAGE OF HERBAL PRODUCTS Source: Dr Ilham,FRIM
  84. 90. Source: Dr Ilham,FRIM
  85. 91. Source: Dr Ilham,FRIM
  86. 92. AKARpull ® Source: Dr Ilham,FRIM
  87. 93. <ul><li>Thank you </li></ul>

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