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NUTRACEUTICALS-‘FOODS AS MEDICINE’



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.

Nutraceuticals are often used in nutrient premixes or nutrient systems in the food and pharmaceutical industries.

Very few of these products, however, have sufficient scientific evidence proving health benefits to consumers. Consequently, few have FDA approval for making health claims on product labels.

When 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 required amount of vitamins, fats, proteins, carbohydrates, etc, needed for its healthy survival. When functional food aids in the prevention and/or treatment of disease(s) and/or disorder(s) other than anemia, it is called a nutraceutical. (Since 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 juice).

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NUTRACEUTICALS OBTAINING WAYS

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HERBAL NUTRACEUTICALS

Abstract

Nutraceuticals 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. Drugs are designed to have medicinal properties for the prevention and treatment of identified diseases or signs and symptoms of disease. Counterfeit drugs contain either placebo, materials not identified in the labeling or substandard or impure materials, which may produce untoward pharmacological or toxicological effects. In addition, the consumer has the right to microbiological safety and prevention from adverse exposure to hazardous chemical(s), and other adverse compounds. Nutraceutical/drug delivery systems are viewed as approaches to (1) enhanced consumer health, (2) decreased healthcare costs, and (3) 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. Significant safety through traceability can be assured by the coupling of the technologies of (a) global positioning (GPS); (b) bar/chip coding; and (c) hazard analysis critical control point (HACCP) management, coupled to rapid nanotechnology marker assays now under development.

HISTORY OF NUTRACEUTICALS

The term “nutraceutical” was coined in 1989 by the Foundation for Innovation in Medicine (New York, US), to provide a name for this rapidly growing area of biomedical research. A 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. Nutraceuticals 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. Doubtlessly, 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. Public 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 quality of life.

· Regulatory norms for nutraceuticals

The World Health Organization (WHO) estimates that 80 percent of the world population uses herbal medicine for some aspect of primary healthcare. WHO notes that of 119 plant-derived pharmaceutical medicines, about 74 percent are used in modern medicine in ways that correlate directly with their traditional uses as plant medicines by native cultures. Major 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

Like ayurveda, there are many other alternative medical sciences in the world. Traditional Chinese medicine (TCM), Tibetian herbal medicine, Japanese herbal medicine (Kampo), Indonesian traditional medicine (Jamu) are some of the oldest medical sciences from other parts of the world which are now becoming quite popular. Due to aggressive marketing tactics of the Chinese, TCM has developed very good market throughout the world. Ayurveda 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. As 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

Ginger, coriander, honey, fenugreek etc are used as culinary items and also used in herbal or Ayurvedic formulations and valued as home remedies. The regulatory bodies started defining the formulations as food supplements or dietary supplements. After recognising the success and potential of such formulations, pharmaceutical companies got into the area of manufacturing dietary supplements with more sophisticated equipment, using improved techniques, adopting high-tech packaging and market the products as OTC 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.Since 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. It is ideal to call them recipes than formulations. The traditional or natural medicines were in use for thousands of years. Various countries have defined their norms for such formulations. India is probably the only country with no fixed parameters for classifying them either as diet or medicine.

· Regulatory obstacles

In connection with the regulatory aspect, the main hurdle appears to be at the level of quality and claim parameters. Manufacturers and marketers want all possible benefits with tall label claims, which regulatory bodies are not allowing. It is essential to govern the disorganised sector with rational attitude. Ayurvedic and unani medicines are herbo-mineral based. But 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 requirements for ayurveda, siddha, unani or homeopathy. The regulatory body may classify the products as purely herbal, which should be endorsed through the PFA act and formulations containing minerals and vitamins through the drug authorities. All the GMP parameters applicable to ayurvedic manufacturing units should be applicable to herbo-mineral formulations and hygiene regulations of PFA 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.

· Proving efficacy

India has the base of ayurveda, and therefore it is easier for Indians to study nutraceuticals and explain and conceive their clinical efficacy. There is a need to understand the situation from different perspective based on Indian socio-economic grounds and logical direction should be given before creating guidelines. The safety aspect should be highlighted in a different way for nutraceuticals. While 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 major side-effects in cases above the age of six years”.

When ayurvedic or unani products are marketed in West, 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.” Some of these herbs are also used in diet and hence they are classified as dietary supplements. They possess the qualities 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. If not, then why ayurvedic and unani medicines are allowed to mention doses? It is rather easier for India 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. Despite this, they are far ahead of us.

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THREE POTENTIALS FOR PROVING EFFICACY OF NUTRACEUTICALS

PURITY IN NUTRACEUTICAL HERBS

Ginger, coriander, honey, fenugreek etc are used as culinary items and also used in herbal or Ayurvedic formulations and valued as home remedies. The regulatory bodies started defining the formulations as food supplements or dietary supplements. After recognising the success and potential of such formulations, pharmaceutical companies got into the area of manufacturing dietary supplements with more sophisticated equipment, using improved techniques, adopting high-tech packaging and market the products as OTC under new mask called nutraceuticals.

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Delivery and Controlled Release of Bioactives in Foods and Nutraceuticals

(1) The Effectiveness of Controlled Release and Delivery Systems

Assessing the bioavailability of nutraceuticals

Structure of the gastrointestinal mucus layer and implications for controlled release and delivery of functional food ingredients

· Understanding the structure of the gastro-intestinal mucus layer

· Implications of the mucin molecules and the mucus layer in controlled release and delivery of functional food ingredients

Testing the effectiveness of nutrient delivery systems

(2)Materials and Techniques for Controlled Release and Delivery of Nutrients Structured lipids as delivery systems

· Synthesis of structured lipids

Micro- and nano-emulsions for delivery of functional food ingredients

Lipid self-assembled particles for the delivery of nutraceuticals

Complexes and conjugates of biopolymers for delivery of bioactive ingredients via food

Food-protein-derived materials and their use as carriers and delivery systems for active food components

(3.) Delivery and Controlled Resease of Particular Nutraceuticals

Encapsulation and controlled release of antioxidants and itamins

· Antioxidants and vitamins in protecting human health

· Advantages of encapsulation over traditional delivery methods

· Top-down techniques used for encapsulation of antioxidants and vitamins in polymeric nanoparticles

· Characterization methods

· Controlled release of antioxidants and vitamins

Encapsulation and controlled release of folic acid

Encapsulation of probiotics

(4) Regulatory Issues and Future Trends

Regulatory aspects of nutrient delivery systems

NEW RESEARCHES ON NUTRACEUTICALS AND ITS APPLICATIONS

Roches vitamin in search of new neutraceuticals

Leading vitamins and carotenoids supplier Roche Vitamins has signed a co-operation agreement with German biotech company AnalytiCon Discovery to assist in its search for new nutraceuticals.

Roche Vitamins is to screen edible plants and other foodstuffs, such as spices, for their potential as sources of nutraceuticals. The Roche project 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.

Based in Potsdam, Germany, AnalytiCon Discovery will develop a programme for the selection and acquisition of materials used in the Roche project, 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. Roche Vitamins, the division recently bought by Dutch group DSM, said that the co-operation is consistent with its search for healthier nutrition, and is in line with the company’s motto “prevention before therapy”.

Dr Manfred Eggersdorfer, head of research and development at Roche Vitamins, welcomed the agreement: “For Roche Vitamins it is an important step to have signed a co-operation agreement with such an innovative company. I am convinced that the high competence of AnalytiCon Discovery in the field of natural compounds makes them an ideal partner for us in our efforts in the nutraceutical business.”

Pierre-Etienne Weber, head of global marketing, said that this initiative fits well with the unit’s strategy of providing innovative products and customers’ solutions.

Roche’s Vitamins and Fine Chemicals unit last year recorded sales of more than SF3.5 billion.

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