INTRODUCTION:

The term “nutraceutical” combines the word “nutrient” (a nourishing food or food component) with “pharmaceutical” (a medical drug). The word “nutraceutical” has been used to describe a broad list of products sold under the premise of being dietary supplements.

Neuraceutical is regarded as the bio active substance and the constituents are either of known therapeutic activity or are chemically defined substance generally accepted to contribute substantially to the therapeutic activity of the drug. Mode of action of nutraceuticals is to provide functional benefits by increasing the supply of natural building blocks in the body. Replacement of these building blocks can work in two ways: to diminish disease signs or to improve performance. The use of nutraceuticals as performance enhancers is much more common than treatment of disease.⁵Phytochemical screening involves botanical identification, extraction with suitable solvents, purification and characterization of the bioactive constituents of pharmaceutical importance. Quality control for the officially and safety of herbal product is essential. Phytochemical is determined either by identity, purity, other chemical, physical biological properties or by manufacturing process.⁷

“Nutraceuticals and functional foods have received considerable interest because of their presumed safety and potential nutritional and therapeutic effects”. The nutraceutical and functional food industry is in a unique position to capitalize on consumers' interest. Be it a multinational pharmaceutical corporation, a nutritional company, a large food multinational or a small vitamin selling firm, all of them recognize the changing trends and are aware of the more health-seeking consumer trend. There is, thus, a proliferation of value-added products aimed at not only keeping oneself healthy but also prevention/treatment of various ailments. Nutraceuticals have come a long way from the time of its inception. The quest for the “safest way to health” and the increasing awareness among consumers about the potential benefits of the nutraceuticals, a relatively safer alternative as compared to the synthetic medicines, has led to the growth of this industry worldwide¹¹

Foods and nutrients play a vital role in normal functioning of the body. They are helpful in maintaining the health of the individual and in reducing the risk of various diseases. Nutraceuticals are medicinal foods that play a role in maintaining well being, enhancing health, modulating immunity and thereby preventing as well as treating specific diseases. Thus the field of nutraceuticals can be envisioned as one of the missing blocks in the health benefit of an individual. It has been scientifically proved and supported by various research articles that nutraceuticals are efficacious to treat and prevent various disease condition⁵.

Nutraceuticals have been claimed to have a physiological benefit or provide protection against the following diseases.^1,12

Cardiovascular agents, Antiobese agents, Antidiabetics, Anticancer agents, Immune boosters,Chronic inflammatory disorders.

Nutraceuticals have been used to:

· Reduce drug cravings

· Boost energy

· Relieve anxiety

· Improve mental clarity

· Enhance sleep quality and quantity

· Provide an overall sense of well-being

· Prevent chronic disease

Categories of nutraceuticals:

Nutraceuticals are non-specific biological therapies used to promote wellness, prevent malignant processes and control symptoms. These can be grouped into the following three broad categories:

· Substances with established nutritional functions, such as vitamins, minerals, amino

· acids and fatty acids - Nutrients

· Herbs or botanical products as concentrates and extracts - Herbals

· Reagents derived from other sources (e.g. pyruvate, chondroitin sulphate, steroid hormone precursors) serving specific functions, such as sports nutrition, weight-loss supplements and meal replacements – Dietary supplements.⁴

Scientific studies have also expanded to these areas and have given support to many of these products and therapeutic services. Most of the immune mediators like lack of exercise, poor diet, negative emotions and environmental toxicity along with the progression of age, cause variable effects on the human system. Various examples of food with high content of specific nutraceutical substances are given below

Nutraceuticals are natural bioactive, chemical compounds that have health promoting, disease preventing or medicinal properties and these includes a wide range of products such as polyphenols, vitamins, calcium fortified juices, theobromine from cacao tree, caffeine from coffee leaves etc. Nutraceuticals overlap with the other health products such as pharmaceuticals and herbals. Nutraceuticals have established safety record and are readily available under Good Manufacturing Practices (e.g. flavonoids), thereby, lowering preclinical burden, toxicity risk and speed to clinic.³

Need of nutraceuticals:

· Consumer concern about the healthier lifestyle and expanding proportion of elderly population.

· Enhanced information and availability of scientific evidence for diet and health.

· Individual concern about health, and feel good among their age’s groups increased the growth of Nutraceuticals market.¹⁰

Examples of foods with higher content of specific nutraceutical substances.⁹

Nutraceutical Substance	Family Foods of Remarkably High Content
Allylsulfur compounds	Onions, garlic
Isoflavones	(e.g., genestein, daidzein) Soybeans and other legumes, apios
Quercetin	Onion, red grapes, citrus fruit, broccoli, Italian yellow squash
Capsaicinoids	Pepper fruit EPA and DHA Fish oils
Lycopene	Tomatoes and tomato products
Isothiocyanates	Cruciferous vegetables
β-Glucan	Oat bran CLA Beef and dairy Beef and dairy
Resveratrol	Grapes (skin), red wine
β-Carotene	Rosemary
Catechins	Teas, berries
Adenosine	Garlic, onion
Indoles	Cabbage, broccoli, cauliflower, kale, Brussels sprouts
Curcumin	Tumeric
Ellagic acid	Grapes, strawberries, raspberries, walnuts
Anthocyanates	Red wine
3-n-Butyl phthalide	Celery
Cellulose	Most plants (component of cell walls)
Lutein, zeaxanthin	Kale, collards, spinach, corn, eggs, citrus
Psyllium	Psyllium husk
Monounsaturated fatty acids	Tree nuts, olive oil
Inulin	Fructooligosaccharides (FOS) Whole grains, onions, garlic
Lactobacilli	Bifidobacteria Yogurt and other dairy
Catechins	Tea, cocoa, apples, grapes
Lignans	Flax

Rationale for use of nutraceuticals:

Dietary factors play an important role in premature chronic disease appearance, disease progression, morbidity and mortality. Approximately 40-50% proportion in cardiovascular disorders, 35-50% proportion in cancers, and 20% proportion in osteoporosis is attributable to dietary factors.

Use of food as medicine for treatment and prevention of various disorders is not a recent development. Fortification of table salt with iodine and wheat flour with iron/folic acid has been used with specific aims of prevention of iodine deficiency goiter and anemia for long. Similarly, food fortified with vitamin A has been found to be a feasible and cost-effective approach to reduce vitamin A deficiency. A growing interest in relationship between diet and health has added impetus to the demand for information on nutraceuticals. This increased interest has been aided by advances in science and technology, increasing health care costs, changes in food laws affecting label, and product claims and aging population in various countries. Along with offering treatment, use of nutraceuticals favours a preventive treatment model as well.²

Role of R and D in nutraceutical:

· To test safety, purity and potency of products.

· To develop more effective and efficient means of producing ingredients for use in products.

· To develop testing methods for ensuring and verifying the consistency of the dosage of

· Ingredients included in the company’s products.

· Develop the new products either by combining existing ingredients used in nutritional

· supplements or identifying new ingredients that can be used in nutritional supplements⁶.

Formulation:

Major nutraceutical ingredients used worldwide are Vitamins, Minerals, lipids, Phytochemicals, Prebiotics, Probiotics, Amino acids, Peptides, Proteins, Fibers, Carotenoids, Glucosamine, Chondroitin, Lipoic acid, Inositol, etc

There are unique challenges in Nutraceutical Formulation development like the large daily doses of herbals, taste-masking, hygroscopic nature of some extracts, higher potential for active-active and active-excipient interactions, etc.Products may come in liquid, pill, powder or capsule form.Stability: Packaging research and the pharmaceutical, chemical and microbial stability of finished product forms containing natural ingredients is a less studied subject but requires urgent industry attention. The guidelines remain the same as for Pharmaceutical preparations.

Evaluation Parameters:

Nutraceuticals used same analytical procedure for identification and quantification as Pharmaceuticals, like HPTLC, HPLC, GC, CC, TLC etc¹⁰. Phytochemicals characterize a poly or monoherbal product including non-chromatographic assays (for groups of compounds like alkaloids, glycosides, etc.). HPTLC fingerprinting and quantification of abundantly available unique markers and HPLC quantification of select markers require higher sensitivity. It is desirable to validate such chromatographic methods for Specificity, Linearity, Range, Accuracy, Precision (repeatability, intermediate precision, and reproducibility), Detection limit, Quantitation limit, Robustness &System suitability testing. Analysis of 3 batches of the finished product and minimum two each of the extracts / herbs and in-process stages is highly recommended to arrive at any limits for the starting materials and finished product.

Impurity Analysis: Choice of tests to be run, the number of batches to be evaluated and the stages of manufacture to be included in the impurity testing program is determined carefully based on the nature of the product, expected impurities if any, results of the reverse testing procedure (finished product first), statistical sampling methods, etc. Tests routinely done are heavy metal testing, pesticide analysis, Microbial analysis etc.

Marketed products of Nutraceuticals⁴

PRODUCTS	CATEGORY	CONTENTS	MANUFACTURER
Coral calcium	Calcium supplement	Calcium and trace minerals	Nature’s answer, Hauppauge, NY, USA
Weight smart TM	Nutritional supplement	Vitamins and trace elements	Bayer corporation, Morristown, NL, USA
Omega woman	Immune supplement	Antioxidants, vitamins and. phytochemicals (eg. Lycopene, and resveratrol)	Wassen, Surrey, U.K
Appetite Intercept TM	Appetite suppressant	Caffeine, tyrosine and Phenylalanine	Natrol, Chatsworth, CA, USA
Chaser TM	Hangover supplement	Activated calcium carbonate, and vegetable carbon	Living essentials, Walled lake MI,USA
Rox®, Glucon-D, Glucose-D	Energy drink	Taurine, caffeine and glucuronolactone Glucose	Rox America, Spartanburg, SA, USA, Heinz, Dabur
Mushroom, optimizer TM	Immune supplement	Mushrooms polysaccharides and Folic acid	Jarrow formulas, Los Angeles, CA, USA
Biovinca TM	Neurotonic	Vinpocetine	Cyvex nutrition, Irvine, CA, USA
Proplus®	Nutritional supplement	Soy proteins	Campbell soup company, Camden, NJ, USA
Snapple-aday TM	Meal replacement beverage	Vitamins and minerals	Snapple beverage group, White Plains, NY, USA
WelLife®	Amino acid supplement	Granulated-L-glutamine	Daesang America Inc., Hackensach, NJ, USA
PNerplus TM	Neuropathic pain supplement	Vitamin and other natural supplement	NeuroHelp, San Antonio, Texas, USA
Olivenol TM	Dietary supplement	Natural antioxidant, Hydroxytyrosol	CreAgri, Hayward, CA, USA
Threptin® Diskettes	Protein supplements	Proteins and vitamin B	Raptakos, Brett & Co. Ltd., Mumbai, India
GRD®	Nutritional supplement	Proteins, vitamins, minerals and carbohydrates	Zydus Cadila Ltd. Ahmedabad, India
Proteinex®	Protein supplement	Predigested proteins, vitamins, minerals and carbohydrates	Pfizer Ltd., Mumbai, India
Calcirol D-3®	Calcium supplement	Calcium and vitamins	Cadilla healthcare limited, Ahmadabad, India.

CONCLUSION:

Nutraceuticals are natural bioactive, chemical compounds that have health promoting, disease preventing or medicinal properties. Quality control is essential for purity. Nutraceuticals have established safety record and are readily available under Good Manufacturing Practices which have lowered toxicity risk. It is natural that people’s focus is shifting from medical treatment for sickness to a positive approach of nutraceutical. In order to prevent diseases and be healthy, new food products as nutraceuticals should gradually penetrate into the society to maintain safety and quality standard meant for human consumption and has provided a wide scope for combining existing ingredients used in nutritional supplements or identifying new ingredients that can be used in nutritional supplement.

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Received on 30.04.2013 Modified on 20.05.2013

Research J. Pharm. and Tech. 6(10): October 2013; Page 1161-1164