Prelude

 Stephen DeFelice initially defined nutraceuticals in 1989; they are foods or dietary components that offer health advantages above and beyond those of basic nutrition. Combining the words "nutrition" with "pharmaceutical," the term "nutraceutical" implies that these goods fill the gap between food and medicine. Nutraceuticals come in a variety of formats, including capsules, pills, beverages, and fortified foods. They frequently include vitamins, minerals, herbs, amino acids, or other naturally occurring components that have been demonstrated to have positive effects on health. Probiotics, antioxidants, and omega-3 fatty acids are a few examples of nutraceuticals.

The nourishing elements known as nutraceuticals are biologically active and have the potential to preserve maximum health and benefits. They are a mix of nutrition and medications. These goods are crucial for the continued advancement of therapeutics as well as the maintenance of human health care. In addition to their medicinal effects and safety profile, nutritional supplements have gained prominence for their nutritional advantages. The use of nutraceuticals for services like illness prevention and promotion is expanding rapidly. In this review, many medication and nutraceutical interactions have also been described with numerous examples. Several patents on nutraceuticals are in treating various ailments and in agricultural uses, which supports the fact that the market for these products is expanding exponentially.

Nutraceuticals have been utilized as a support therapy for the prevention and treatment of many diseases, such as to lessen the negative effects of cancer chemotherapy and radiotherapy, in addition to being used for nourishment. The difficulties associated in developing nutraceutical formulations are often overcome by a variety of innovative nanoformulation methods. Prior knowledge of various drug interactions may be useful in reducing negative effects from nutraceuticals products. Other nutraceutical supplements and micronized dietary products with enhanced health advantages are produced as a result of nanotechnology.

Nutraceuticals are defined as "specially designed preparations," created to meet certain dietary needs and/or provide preventive healthcare. In addition to a supplemental diet, nutraceuticals are the formulation of nutrient(s) that aid in the prevention and treatment of some diseases.

These are foods—or portions of foods—that have a variety of health advantages, such as the ability to treat and/or prevent disease. From anticipating dietary deficits to focusing on human health and the prevention and treatment of chronic illnesses, nutrition science has advanced to new heights. 'Nutraceuticals', 'food supplements', and 'dietary supplements' are terms that have developed since Dr. De Felice first proposed the idea.

Regulatory agencies do not clearly distinguish between nutraceuticals and food supplements. Recent literature has focused on redefining the term "nutraceuticals," taking into account the effectiveness, safety, and toxicity of these products. Food products are nourishing substances that are used orally, topically, or in other ways to support life, give energy, and encourage growth. The separation of nutrients from these food products is now widely accepted and employed. The first step in distinguishing between food/dietary supplements and nutraceuticals is the selection of an epidemiological target, which is then followed by efficacy and safety studies that clarify the mode of action.

Nutraceuticals comprise individual pro- and pre-biotic foods as well as food for specific medical purposes, whereas food supplements include individual mineral, vitamin, protein, and vitamin supplements as well as herbal and functional foods.

The inclusion of nutraceuticals in a daily diet may help in the avoidance of pathological illnesses by extending or removing the need for pharmaceuticals in subjects who are suitable for an alternative non pharmacological treatment for a pathological condition. There are suggestions that some foods, such as those flavored with spices and herbs, have a propensity to lower the chance of developing a number of diseases and can significantly enhance quality of life.

Nutraceuticals provide a wide range of advantages, including their promising outcomes in the prevention and treatment of complex disorders. However, in order to prevent their out-of-control use and negative side effects, nutraceuticals must be administered and prescribed, and they must be closely managed.

To increase the efficacy and bioavailability of drug compound-based nutraceuticals, several researchers have investigated them. Different statins have been utilized in the prevention of cardiovascular disorders even in pregnant women due to their safety and effectiveness. For the treatment of diabetes mellitus and hypertension problems, or as an adjunct to regular drug therapy, nutraceuticals with an effective safety profile and well-established influence on pregnancy may be a feasible therapeutic choice. Potentially successful prospects for innovative nutraceuticals include calcium, omega-3 polyunsaturated fatty acids, vitamin D, folic acid, resveratrol, alpha-lipoic acid, zinc, inositol, and probiotic supplements.

Researchers have examined the ezetimibe-associated nutraceutical for patients who are at risk of elevated statin levels, which further contribute to cardiovascular illnesses. It has been established that a novel nutraceutical can treat osteoarthritis when combined with non-steroidal anti-inflammatory medicines (NSAIDs), increasing its effectiveness and safety for usage in commercial applications.

Nutraceuticals like antioxidants, omega-3 fatty acids, algae, aloe vera, seaweed, wheatgrass, teas, and herbs like ginseng and echinacea continue to have a strong and expanding market.

According to a recent analysis, the global market for nutraceuticals is expected to grow, with a chance of up to $340 billion by 2024. From 2016 to 2024, the cumulative annual growth rate (CAGR) for nutraceuticals is predicted to be 7.2%.

Role of Nutraceuticals

 A wide range of therapeutic areas, including the treatment of cancer, depression, diabetes, cholesterol, blood pressure, and painkillers, can benefit from the use of nutraceuticals, including the treatment of cough and cold, anti-arthritis, digestion, sleeping difficulties, and pain relief. In order to determine how diverse nutraceuticals can show to be significant in the pharmaceutical industry, the research and development sectors for nutraceuticals are operating at their top levels. Standardization of ingredients, meticulous protocol creation, and implementation of clinical studies are all necessary due to scientific needs for nutraceuticals, which will have an impact on the industry and the health of consumers.

Nutraceuticals and their use as potent medicinal supplements have seen a significant increase in awareness over the past ten years. Complementary and Alternative Medicine (CAM) now recognizes nutraceutical medicine as a component, and as such, it has been added as a new branch of CAM.

Nutraceuticals have become more popular than medications among the general population and healthcare professionals due to their dynamic action (nutritional and medicinal effect).

Nutraceuticals in Various Diseases

Nutraceuticals support better health, wellbeing, and immune system regulation, preventing and treating a range of illnesses and medical conditions. The following ailments are just a few of the conditions that can be addressed using nutraceuticals:

Nutraceuticals in Cardiovascular Diseases

Cardiovascular diseases stand out among all other illnesses for having considerable risk factors that can be mitigated by nutritional supplementation. Nutraceuticals can be employed in the treatment of cardiovascular illnesses, according to a large body of research.The blood arteries and the heart's functionality are the two main organs affected by cardiovascular diseases (CVDs). As one of the leading causes of death, CVDs account for around 30% of fatalities worldwide each year. Dietary supplements can be broadly categorized as those used to treat arrhythmias, Congestive heart failure, angina, hypertension, and hyperlipidemias. They have been shown to be helpful in risk management and prevention of cardiovascular illnesses. The following section discusses some of the nutraceuticals and dietary supplements that are utilized in the treatment and prevention of CVDs.

Allicin and Alliin

Elevated levels of plasma triglycerides and blood cholesterol are linked to ischaemic heart disease and atherosclerosis. Allium sativum is naturally antihyperlipidemic, and it works by significantly reducing endogenous cholesterol synthesis and removing large amounts of cholesterol and its byproducts from the stool. This results in a more favorable HDL to LDL ratio. If stomach acids can protect them, allicin and alliin can affect cholesterol levels. Thirteen placebo-controlled trials including 781 participants were used to evaluate the effects of garlic supplementation on serum cholesterol. In addition to having antihyperlipidemic properties, garlic also has some natural antihypertensive effects.

Omega-3Fatty Acids

Polyunsaturated fatty acids (PUFAs), from which omega-3 fatty acids are formed, are found in marine sources. Cardiovascular disorders are treated and prevented in large part by docosahexaenoic acid (DHA) and marine omega-3 eicosapentaenoic acid (EPA). In one study, the diet and reinfarction experiment (DART), a randomized trial comprising 2033 men post-myocardial infarction, found that taking fish oil supplements decreased mortality rate by 29% for a period of 2 years. Fish oil consumption significantly reduced cardiovascular disease deaths by 30%, unexpected deaths by 45%, and overall mortality by 20%. Recent clinical trial investigations have revealed that omega-3 fatty acids reduce the risk of cardiac arrhythmias and also improve the health of those who have atherosclerosis-related plaque formation in their arteries. The electrical stability of heart cells is improved by omega-3 fatty acids, lengthening the heart's relative refractory period and assisting in the treatment of arrhythmias.

Soy Isoflavones

With potential medical benefits like antihyperlipidemic, antihypertensive, antihyperglycemic, antioxidant, anticancer, anti-inflammatory, anti-obesity, and neuroprotective activities that support the biological plausibility for observational associations, soy proteins and isoflavones are significant nutrients. Clinical trial results clearly show that soy protein ingestion lowers blood cholesterol levels in people. Additionally, the USFDA has provided data indicating postmenopausal women's blood pressure decreased with a daily intake of 25g of soy proteins or isoflavones. Additionally, soy proteins have a positive impact on serum lipid levels, particularly in hypercholesterolemic patients. According to a study, participants who had a diet reduced in saturated fat had a lower risk of developing coronary heart disease. The lipid profiles weren't affected by soy isoflavone. Additionally, a study found that consuming new soy products (Abaco and Abalon) with high quantities of isoflavones, cotyledon soy fiber, and soy phospholipids significantly reduced the ratio of LDL to HDL.

Proteins, Peptides and Amino Acids

Heart disorders and hypertension go hand in hand. The main treatment for the illness has been ACE (angiotensin converting enzyme) inhibitors, however these medications include adverse effects such hypotension, high potassium levels, reduced renal function, coughing, and skin rashes. Casein and whey protein from milk contain ace inhibitors that are natural. Animal studies have also shown that these milk-derived proteins have antihypertensive properties. In clinical studies where a statistically significant hypotensive impact has been noted, the same has been reported.

Antioxidant Vitamins

In the treatment of chronic conditions including cancer and cardiovascular disease, antioxidants have been proposed as viable supplements. By limiting the negative effects of free radicals, they lessen LDL-cholesterol oxidation. Antioxidant vitamins are found in significant quantities in vegetables, fruits, fish, and fixed oils. These vitamins act by inhibiting the creation of oxygen free radicals or by trapping them. There is evidence that CHD patients who consume a lot of antioxidants had lower rates of morbidity and mortality, according to several epidemiologic research. Antioxidant vitamins C and E found in supplements aid in CHD prevention. However, ß-carotene supplementation can have negative effects and is therefore not advised. The National Health and Nutrition Examination Survey-I cohort study discovered that consuming more vitamin C lowers the risk of coronary heart disease (CHD). This relationship was discovered after ten years of follow-up with American men and women in the age range of 25 to 74.

Phytosterols

In terms of structure, phytosterols resemble cholesterol. They frequently contend with one another for small intestine absorption. These occur naturally in things like wood pulp, seeds, nuts, and vegetable oils. Consumption of phytosterols resulted in higher hepatic LDL uptake, lower blood LDL levels, and lower cholesterol absorption. Studies show that consuming plant sterols can reduce LDL levels by up to 15%.

Natural grains like soy, sunflower, and corn are the source of plant sterols. There is significant individual variance, however several studies have shown that consuming 2-3 g of plant sterols/stanols per day will reduce LDL cholesterol levels by up to 20%.

Nutraceuticals in Cancer Chemo and Radiotherapy

Radiotherapy and chemotherapy are common forms of cancer treatment, but they come with a number of difficulties and major side effects, including pain, exhaustion, nausea, vomiting, diarrhea, and hair loss. Systemic cytotoxic chemotherapy and radiotherapy are not very effective at promoting patient survival because some malignancies are highly resistant to chemo- and radiotherapy. In this instance, several combination therapies cover an effective cancer treatment strategy. Similarly, a number of plants and natural supplements have been found to lessen the negative effects of chemotherapy and radiotherapy.

Therefore, these should be taken in conjunction with radiotherapy or chemotherapy to lessen adverse effects and increase the efficacy of the treatment. The nutraceutical sector is developing to meet customer needs as a result of the need to treat cancer-causing cell proliferation.

The nutraceutical sector has advanced from health promotion to illness prevention, showing how it has changed through time. Numerous currently utilized herbs and phytochemicals are safe from a pharmacological perspective and have been demonstrated to be effective nutraceuticals in reducing the side effects of radiotherapy and chemotherapy and boosting the sensitivity of these treatments.

Curcumin (Diferuloyl-Methane) from Turmeric (Curcuma Longa)

A powerful nutraceutical for the treatment of cancer is curcumin. Curcumin has been shown in pre-clinical tests to decrease carcinogenesis at every stage, including angiogenesis, metastasis, and proliferation, in a variety of malignancies, including pancreatic, colorectal, prostate, gastric, and hepatic cancer. When used in conjunction with chemo- and radiotherapies to treat cancer, it is significantly more successful.

Ginger

Ginger is a natural supplement that is antimutagenic, antioxidant, and anti-inflammatory and is known to lessen the negative effects of chemotherapy and radiation. These characteristics of ginger are what make it a useful radio-protector. Ginsenoside Rf and Ginseng and its polysaccharides are useful in lowering the side effects of cancer treatment therapies, which is reported to produce a 50% less risk in the recurrence of cancer, leading to a loss in the doses of morphine in cancer patients.

Genistein

A strong isoflavone with promising anti-carcinogenic capabilities is genistein. According to in vitro research, some substances must be consumed in higher concentrations than are typically found in food to have the same anticancer effects. As a result, it is challenging to produce the intended effect at the tumor site, which makes us believe that the mechanism of delivery is a crucial aspect that must be taken into account in in vivo investigations and clinical trials. The non-toxicity of the natural ingredients is a key consideration when formulating a remedy. However, it has been discovered that some substances are more effective if given early in life, and genistein is one of them.

Nutraceuticals in the Treatment of Prostate Cancer (PCa)

The most prevalent form of cancer, prostate cancer is also the second greatest cause of cancer-related death in American men. When compared to males of European heritage, those of American and African descent have the greatest prostate cancer mortality rates. Even while the present approaches of therapy are highly potent and successful, there is always a chance that the disease will become resistant, proceed to metastasis, and many other things may happen in the future. To overcome these significant obstacles and effectively manage and cure this condition, more potent and non-harmful therapeutic techniques are needed. As a result, there are numerous potentially secure nutraceuticals that can act as powerful anti-PCa agents. Evidently, the use of nutraceuticals may aid in the improvement of precision in the design of pharmaceuticals, lessen the side effects of chemotherapy, lower disease resistance, and offer the possibility of treating both early and advanced stages of disease.

Silibinin

Silibinin, or flavanolignan, which is derived from milk thistle "Silybummarianum" seeds, has powerful anti-carcinogenic properties for a variety of cancers, including PCa. Significant anticancer potential of silibinin in the treatment of PCa has been demonstrated in a pre-clinical animal model, and phase II clinical trials bioavailability studies have also been assessed. To establish the biological efficiency and effectiveness of silibinin as a nutraceutical for the efficient clinical care of advanced or localized form of PCa, larger clinical trials must yet be conducted.

Soy Isoflavones

Members of the polyphenolic flavonoid family, soy isoflavones are mostly found in soybeans, red clover, kudzu root, etc. They are frequently utilized in Asian and African cuisines. Soy isoflavones have been shown in clinical research to offer some benefits in treating PCa because of their significant impact on insulin and inflammatory signaling. There have been findings that isoflavones, among other things, have immuno-modulatory characteristics in the plasma of people with asymptomatic biochemically recurrent PCa.

Nutraceuticals for Skin Treatment

The skin is the largest organ in the body and provides defense against various pathogens, UV rays, and toxins as well as engaging in sensitivity. Skin plays a significant protective role for the body, but it can also experience changes like immunological dysfunction, photoaging, and inflammation that can be harmful to human health. With the use of nutraceuticals, a feasible technique can be established to alleviate skin-related illnesses and delay or reduce premature skin aging. These nutraceuticals may include carotenoids, bioactive peptides, bioactive polysaccharides, and plant extracts. In numerous human studies, supplementation with these compounds showed reduced aging symptoms as well as protection against UV-radiation aging.

Bio-Active Peptides

Peptide moieties, also known as bioactive peptides, are short, low-molecular-weight compounds made of two or more amino acids. Some of these compounds may have significant biological effects. From a wide range of dietary proteins, including both plant and animal proteins, bioactive peptides have been identified. The most popular sources of animal protein are eggs, milk (casein and whey), and meat. Common plant sources of bioactive peptides include soy, oat, pulses (chickpea, bean, pea, and lentil), canola, wheat, flaxseed, and hemp seed. Because of their improved bioavailability and solubility, peptides utilized for aesthetic purposes are typically generated from collagen and act as nutraceutical formulations.

Bio-Active Polysaccharides

These polymers, which are made of sugar, serve as structural support and a source of energy. They exist in a variety of monosaccharide combinations, physicochemical structures, and living forms, including plants, fungi, mammals, and prokaryotes. The Glycosaminoglycans from the marine origin are the most beneficial of them for the formulations of nutraceuticals. N-acetylglucosamine or N-acetylgalactosamine, an unbranched disaccharide (repeating) unit of amino sugar, and glucuronic or iduronic acid, a uronic acid, are the building blocks of these.

Bio-Active Botanical Extracts

These extracts are complex combinations of many substances with distinct structures and origins. They have been utilized and evaluated for a long time. One of the important natural substances with cosmetic uses is polyphenol, which has a wide range of families and structures. These micronutrients come from plants and can be obtained through food. Both the prevention of diseases and the treatment of diseases are improved by these as support therapies. The bioavailability of different polyphenols varies greatly, and the quantity of active metabolites in target tissues is highest in the most prevalent polyphenols in our diet. The extraction process and families have an impact on their proportion and makeup.

Carotenoids

These are naturally occurring pigments that are present in diverse plants, photo-synthetic microorganisms, and algae. These have a tetra terpenoid structure that is linear. These can be discovered in organic foods including fruits, vegetables, and other foods. The most popular dietary carotenoids include -carotene, -carotene, -cryptoxanthin, lutein, zeaxanthin, and lycopene. These carotenes are used for skin care, including UV protection and anti-ageing. Probiotics and carotenoids have been linked to a reduction in skin cancer risk and a modulation of early skin UV impact indicators.

A carotenoid supplement including lutein, beta-carotene, and alpha-carotene has been shown to be helpful in photoprotection. Similar to this, it has been suggested that a combination of beta-carotene, lutein, and lycopene carotenoids can prevent erythema. Studies on the photoprotective effects of vitamins C and E have shown that they are useful for maintaining skin health. A hydrophilic vitamin, vitamin C is frequently consumed in high amounts through the consumption of various food products with the aim of preventing the creation of cancer-causing nitrous metabolites. It functions as a cofactor for the production of collagen fibers and inhibits the creation of elastin in fibroblasts, limiting the buildup of this protein that is so prevalent in skin that has been exposed to light damage.

Formulations and Challenges Involved

There are numerous difficulties in creating a high-quality nutraceutical formulation that is both physically and chemically stable, sufficiently safe, technologically feasible, and still affordable. Botanicals are complex substances having numerous chemical elements, and typically several classes of compounds are contained in a single product, as opposed to medication molecules which are well defined chemical entities. The majority of these plants are sensitive to heat, light, oxygen, an alkaline pH, and high humidity levels.

These frequently exhibit poor flow, uneven particle size distribution, and bulk density. In order to develop a nutraceutical formulation successfully, it is necessary to understand the fundamental physicochemical characteristics of the various types of ingredients, to use appropriate manufacturing techniques, to choose the proper excipients, and to add the appropriate manufacturing overages based on critical stability studies. Here, the following issues are highlighted: Difficulties with diverse dosage forms; Methods for addressing formulation issues; and Excipients selection.

The insufficient water solubility, high melting point, and chemical instability of the active ingredients provide challenges for creating nutraceuticals. For instance, curcumin, carotenoids, and omega-3 fatty acids have great nutritional value but are not well soluble. As a result, one strategy is to define these as innovative delivery systems. They are pricey due to their innovative delivery methods. Therefore, efforts are required to make these compositions affordable.

The high melting point of nutraceuticals presents another formulation issue. For instance, carotenoids, fatty alcohols, and phytosterols all have high melting points that could make a formulation unstable. As a result, one strategy is to make a solid dispersion or dissolve it in an appropriate grade solvent before adding it to meals as suspended nanocrystals. The problem is that it results in decreased stability and shelf life, an unpleasant look, an offensive odor, and an unpleasant mouthfeel, all of which have an impact on market value and consumer demand. Consequently, there is a need to create technologies that are economical.

Another difficulty is the volatility of chemicals. For instance, the stability of omega-3 fatty acid-rich oils, such as fish, flaxseed, and cod liver oils, as well as carotenoids, lycopene, and curcumin, is a problem. The bioactive product's composition, environmental factors like temperature, pH, pressure, etc., or the presence of metals or other oxidation-promoting substances all have a significant impact on how much chemical degradation occurs. To prevent degradation of such chemicals, the creation of nanoscale products is crucial.

Choosing the right strain and then incorporating it into dishes is a current difficulty. When hazardous or bacterial cultures are applied improperly or handled carelessly, the results can be disastrous. Other concerns include solid dose formulation and process design for nutrition items and medication goods that have similar functions but may have different regulatory restrictions.

The development of dosage forms for nutraceuticals and dietary supplements that are appropriate for various segments of the aging population, particularly older individuals and children, is a challenge. This is due to this population's limitations on solid dose due to dysphagia, which prevents them from swallowing pills or capsules. Therefore, the administration of nutraceuticals and dietary supplements must take into account the use of sophisticated dosage forms, such as orodispersible tablets, fast-dissolving films, and easy-swallowing gels, which are typically employed in pharmaceutical applications.

Future Prospects

In order to ensure integrated medical support, nutraceuticals are a potentially expanding sector that work in both the nutrition and medical treatment domains. These may serve as dietary supplements, prevent illnesses like CVD, support and treat different types of cancer, and provide other health advantages. As a result, the nutraceutical industry today has a comprehensive understanding of and perception of the potential success of nutrients that have an impact on people in healthcare. Currently, it's believed that medications should be used to provide medical care. On the other hand, nutrition is only valued as a tool for leading healthy lives.

It is anticipated that work will be done in the upcoming years because they interact and strengthen one another. The use of emerging technologies, including the use of genetically modified foods in the food sector and nutraceuticals based on nanotechnology, etc., results in better medical care and health advantages, which has further accelerated the growth of the nutraceuticals revenue market. The advancements in safety and potential effects of newly developed nutraceutical products, according to scientific research, will further encourage investments in newer technologies, including nutrigenomics, converging methods, various imaging technologies, and their uses in the development of nutrition and healthcare.

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