PROJECT REPORT ON NUTRACEUTICALS-'FOODS AS MEDICINE'

SUBMITTED TO: DR. RAVINDER NAGPAL SENIOR LECTURER OF M.Sc(HONS.)MICROBIOLOGY 1ST YEAR, 1ST SEMESTER, LOVELY PROFESSIONAL UNIVERSITY PHAG ARA SUBMITTED BY: RUCHI!A MAHAJAN ROLL NO:R"#"A$1 REGISTRATION NO.:1$%$$#&' M.Sc (HONS.)MICROBIOLOGY

AC!NO LEDGEMENT

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INTRODUCTION

Nutraceutical, a portmanteau of nutrition and pharmaceutical, refers to extracts of foods claimed to have a medicinal effect on human health. The nutraceutical is usually contained in a medicinal format such as a capsule, tablet or powder in a prescribed dose. More rigorously, nutraceutical implies that the extract or food is demonstrated to have a physiological benefit or provide protection against a chronic disease. Functional foods are defined as being as part of a usual diet but are demonstrated to have physiological consumed benefits and/or reduce the risk of chronic disease beyond basic nutritional functions. Examples of claims made for nutraceuticals are resveratrol from red grape products as an antioxidant, soluble dietary fiber products, such as psyllium seed husk for reducing hypercholesterolemia, broccoli sulforaphane! as a cancer preventative, and soy or clover isoflavonoids! to improve arterial health. "utraceuticals are often used in nutrient premixes or nutrient systems in the food and pharmaceutical industries. #ery few of these products, however, have sufficient scientific evidence proving health benefits to consumers. $onse%uently, few have F&' approval for making health claims on product labels. (hen food is being cooked or prepared using )scientific intelligence) with or without knowledge of how or why it is being used, the food is called )functional food.) Thus, functional food provides the body with the re%uired amount of vitamins, fats, proteins, carbohydrates, etc, needed for its healthy survival. (hen functional food aids in the

prevention and/or treatment of disease s! and/or disorder s! other than anemia, it is called a nutraceutical. *ince most of the functional foods act in some way or the other as antianemic, the exception to anemia is considered so as to have a clear distinction between the two terms, functional food and nutraceutical.! Thus, a functional food for one consumer can act as a nutraceutical for another consumer. Examples of nutraceuticals include fortified dairy products eg, milk! and citrus fruits eg, orange +uice!.

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HERBAL NUTRACEUTICALS

Abstract
"utraceuticals are naturally occurring/derived bioactive compounds that are reported to have health benefits. The delivery systems for nutraceuticals are foods functional foods!, supplements, or both. &rugs are designed to have medicinal properties for the prevention and treatment of identified diseases or signs and symptoms of disease. $ounterfeit drugs contain either placebo, materials not identified in the labeling or substandard or impure materials, which may produce untoward pharmacological or toxicological effects. .n addition, the consumer has the right to microbiological safety and prevention from adverse health, exposure to ha4ardous chemical s!, and other adverse compounds. "utraceutical/drug delivery systems are viewed as approaches to 5! enhanced consumer 6! decreased healthcare costs, and 7! enhanced economic development. Therefore, the nutra/pharma/ceutical industry is reliant upon a strong underpinning of diversified research that addresses safety and assures chemical and biological efficacy. *ignificant safety through traceability can be assured by the coupling of the technologies of a! global positioning 28*!9 b! bar/chip coding9 and c! ha4ard analysis critical control point :'$$8! management, coupled to rapid nanotechnology marker assays now under development.

HISTORY OF NUTRACEUTICALS
The term ;nutraceutical< was coined in 5=>= by the Foundation for .nnovation in Medicine "ew 3ork, ,*!, to provide a name for this rapidly growing area of biomedical research. ' nutraceutical was defined as any substance that may be considered a food or part of a food and provides medical or health benefits including the prevention and treatment of disease. "utraceuticals may range from isolated nutrients, dietary supplements and diets to genetically engineered ;designer< foods, herbal products and processed products such as cereals, soups and beverages. &oubtlessly, many of these products possess pertinent physiological functions and valuable biological activities. The ongoing research will lead to a new generation of foods, which will certainly cause the interface between food and drug to become increasingly permeable. The present accumulated knowledge about nutraceuticals represents undoubtedly a great challenge for nutritionists, physicians, food technologists and food chemists. 8ublic health authorities consider prevention and treatment with nutraceuticals as a powerful instrument in maintaining health and to act against nutritionally induced acute and chronic diseases, thereby promoting optimal health, longevity and %uality of life.

Regulatory norms for nutraceuticals

The (orld :ealth 0rgani4ation (:0! estimates that >? percent of the world population uses herbal medicine for some aspect of primary healthcare. (:0 notes that of 55= plant@derived pharmaceutical medicines, about AB percent are used in modern medicine in ways that correlate directly with their traditional uses as plant medicines by native cultures. Ma+or pharmaceutical companies are currently conducting extensive research on plant materials gathered from rain forests and other places for their potential medicinal value.

 Medicine from the past

/ike ayurveda, there are many other alternative medical sciences in the world. Traditional $hinese medicine T$M!, Tibetian herbal medicine, Capanese herbal medicine Dampo!, .ndonesian traditional medicine Camu! are some of the oldest medical sciences from other parts of the world which are now becoming %uite popular. &ue to aggressive marketing tactics of the $hinese, T$M has developed very good market throughout the world. 'yurveda has a relatively minor share in the global market. Every corner of the world is now easily contactable. Therefore, the knowledge is spreading at lightning speed. 's the technology is spreading at a high speed, the popularity of herbal medicines, plant medicines, nutraceuticals, organic foods, cosmeceuticals reach to even remote places in the world.

Food as medicine
2inger, coriander, honey, fenugreek etc are used as culinary items and also used in herbal or 'yurvedic formulations and valued as home remedies. The regulatory bodies started defining the formulations as food supplements or dietary supplements. 'fter recognising the success and potential of such formulations, pharmaceutical companies got into the area of manufacturing dietary supplements with more sophisticated e%uipment, using improved techni%ues, adopting high@tech packaging and market the products as 0T$ under new mask called nutraceuticals. Further to this, when some plant based products or natural origin products are used in the cosmetic preparations, a new name was given called cosmeceuticals.*ince the concept of such formulations was based on the dietary component, the regulatory norms applicable to the foods were conveniently engaged for approving the formulations. .t is ideal to call them recipes than formulations. The traditional or natural medicines were in use for thousands of years. #arious countries have defined their norms for such formulations. .ndia is probably the only country with no fixed parameters for classifying them either as diet or medicine.

 -egulatory obstacles
.n connection with the regulatory aspect, the main hurdle appears to be at the level of %uality and claim parameters. Manufacturers and marketers want all possible benefits with tall label claims, which regulatory bodies are not allowing. .t is essential to govern the disorganised sector with rational attitude. 'yurvedic and unani medicines are herbo@ mineral based. 1ut ancient books are available as a base to accredit therapeutic claims. Modern medicine has certain parameters related to drug discovery but these parameters are unreasonable to validate nutraceuticals. The guidelines should, therefore, be similar to regulatory re%uirements for ayurveda, siddha, unani or homeopathy. The regulatory body may classify the products as purely herbal, which should be endorsed through the 8F' act and formulations containing minerals and vitamins through the drug authorities. 'll the 2M8 parameters applicable to ayurvedic manufacturing units should be applicable to herbo@mineral formulations and hygiene regulations of 8F' act for herbal compositions. The magic remedy act applied to ayurvedic manufacturers should be stringently followed by nutraceutical manufacturers. They should be allowed to insert printed material with information to empower the user.

8roving efficacy
.ndia has the base of ayurveda, and therefore it is easier for .ndians to study nutraceuticals and explain and conceive their clinical efficacy. There is a need to understand the situation from different perspective based on .ndian socio@economic grounds and logical direction should be given before creating guidelines. The safety aspect should be highlighted in a different way for nutraceuticals. (hile most of the companies claim that natural medicines are totally free from side@effects, it will be right to frame a law to mention, )the composition is safe in recommended dose and not found to have ma+or side@effects in cases above the age of six years). (hen ayurvedic or unani products are marketed in (est, the The interpretation of the issue has to be clear that, )since there is no other base for recognition or defining these

products in other parts of the world, they defined the formulations as dietary supplements. Therefore, it is misleading to understand them as diet.) *ome of these herbs are also used in diet and hence they are classified as dietary supplements. They possess the %ualities of medicines, they have proven clinical efficacy and should be consumed in specific doses. Therefore, it is rational and also essential to mention the dosage on the pack. .f not, then why ayurvedic and unani medicines are allowed to mention dosesE .t is rather easier for .ndia to establish norms for nutraceuticals, as the base is available due to ayurvedic and unani medicines. The task of framing regulatory norms for other countries would have been more difficult as they do not have any base like ayurveda or unani. &espite this, they are far ahead of us.

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2inger, coriander, honey, fenugreek etc are used as culinary items and also used in herbal or 'yurvedic formulations and valued as home remedies. The regulatory bodies started defining the formulations as food supplements or dietary supplements. 'fter recognising the success and potential of such formulations, pharmaceutical companies got into the area of manufacturing dietary supplements with more sophisticated e%uipment, using

improved techni%ues, adopting high@tech packaging and market the products as 0T$ under new mask called nutraceuticals.

&elivery and $ontrolled -elease of 1ioactives in Foods and "utraceuticals

(1) The Effectiveness of Controlled Release and Delivery Systems Assessing the bioavailability of nutraceuticals

Measuring absorption, metabolism and tissue targeting *tudy design and interpretation 0ther considerations :ealth response .mplications of controlled absorption for product development

Structure of the gastrointestinal mucus layer and implications for controlled release and delivery of functional food ingredients ,nderstanding the structure of the gastro@intestinal mucus layer

.mplications of the mucin molecules and the mucus layer in controlled release and delivery of functional food ingredients

Testing the effectiveness of nutrient delivery systems

' holistic view of delivery systems &elivery systemsF formulation, processing and post@processing .n vivo tests .n vitro tests

6!Materials and Techni%ues for $ontrolled -elease and &elivery of "utrients Structured lipids as delivery systems

*ynthesis of structured lipids

"utrition, absorption, transport and metabolism of structured lipids

icro! and nano!emulsions for delivery of functional food ingredients

Microemulsions /oaded microemulsions 1ioavailability of nutraceuticals Microemulsions as microreactors

"ipid self!assembled particles for the delivery of nutraceuticals

*tructure and properties of lipids *elf@assembly and microstructure of lipid systems /iposomes $ubic and hexagonal mesophases and their dispersed nanoparticles

Comple#es and con$ugates of biopolymers for delivery of bioactive ingredients via food

$omplexes and coacervates $on+ugates @ covalently bonded biopolymers $omplexes of a protein with a polysaccharide@protein@con+ugate

%ood!protein!derived materials and their use as carriers and delivery systems for active food components

Food protein hydrogels and related networks as nutraceutical carriers Food protein micro@ and nano@particles

7.! &elivery and $ontrolled -esease of 8articular "utraceuticals Encapsulation and controlled release of antioxidants and itamins 'ntioxidants and vitamins in protecting human health 'dvantages of encapsulation over traditional delivery methods Top@down techni%ues used for encapsulation of antioxidants and vitamins in polymeric nanoparticles $haracteri4ation methods $ontrolled release of antioxidants and vitamins

Encapsulation and controlled release of folic acid

Encapsulation technologies for folates $ontrolled release of folate in the gastrointestinal system 'pplications in functional foods

Encapsulation of probiotics

Encapsulation technologies for probiotics 'pplications in nutraceuticals 'pplications in functional foods

B! -egulatory .ssues and Future Trends Regulatory aspects of nutrient delivery systems

*election of ingredients *tability of the product 1ioavailability of the active ingredient

NE

RESEARCHES ON NUTRACEUTICALS AND ITS APPLICATIONS

Roches vitamin in search of new neutraceuticals /eading vitamins and carotenoids supplier -oche #itamins has signed a co@operation agreement with 2erman biotech company 'nalyti$on &iscovery to assist in its search for new nutraceuticals. -oche #itamins is to screen edible plants and other foodstuffs, such as spices, for their potential as sources of nutraceuticals. The -oche pro+ect comes with increasing knowledge of the free radical@fighting properties of fruits and vegetables and the growing demand from food and pharmaceutical industries for natural source ingredients. 1ased in 8otsdam, 2ermany, 'nalyti$on &iscovery will develop a programme for the selection and ac%uisition of materials used in the -oche pro+ect, and help with the purification and structure elucidation of the compounds found. The company currently specialises in research on active substances based on natural compounds. -oche #itamins, the division recently bought by &utch group &*M, said that the co@operation is consistent with its search for healthier nutrition, and is in line with the companyGs motto )prevention before therapy). &r Manfred Eggersdorfer, head of research and development at -oche #itamins, welcomed the agreementF &%or Roche 'itamins it is an important step to have signed a co!operation agreement (ith such an innovative company) * am convinced that the high competence of AnalytiCon Discovery in the field of natural compounds ma+es them an ideal partner for us in our efforts in the nutraceutical business)& 8ierre@Etienne (eber, head of global marketing, said that this initiative fits well with the unitGs strategy of providing innovative products and customersG solutions. -ocheGs #itamins and Fine $hemicals unit last year recorded sales of more than *F7.H billion.

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