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Unveiling science behind excipients in nutra
Wednesday, 20 September, 2023, 13 : 00 PM [IST]
Shilpa B Bansode
Nutraceuticals, a fusion of "nutrition" and "pharmaceuticals," have garnered significant attention in recent years due to their potential health benefits. These products bridge the gap between traditional foods and pharmaceuticals, offering a convenient way to enhance health and well-being. While the active ingredients in nutraceuticals often steal the spotlight, the role of excipients in these formulations should not be underestimated. Excipients play a crucial role in enhancing the stability, bioavailability, and overall effectiveness of nutraceutical products. In this comprehensive exploration, we will delve into the world of excipients in nutraceuticals, shedding light on their importance and the science behind their use.

The Nutraceutical Revolution
The nutraceutical industry has witnessed remarkable growth, propelled by consumers' increasing awareness of health and wellness. These products encompass a wide range of substances, including vitamins, minerals, herbal extracts, probiotics, and more. Unlike conventional pharmaceuticals, nutraceuticals aim to improve health and prevent diseases through nutritional and physiological mechanisms.

While the active ingredients in nutraceuticals provide the desired health benefits, their efficacy and safety are often dependent on the presence of excipients. Excipients are inert substances added to formulations to serve various functions, such as improving stability, enhancing solubility, and aiding in the delivery of active compounds.

The Role of Excipients
Excipients are an essential component of nutraceutical formulations, serving several critical functions:
    1. Enhancing Stability: Many nutraceutical ingredients are sensitive to environmental factors like heat, humidity, and light. Excipients can protect these ingredients from degradation, ensuring the product's potency and shelf life.
    2. Improving Solubility: Some nutraceutical compounds have poor water solubility, making it challenging for the body to absorb and utilise them effectively. Excipients can enhance solubility, ensuring better bioavailability.
    3. Ensuring Uniformity: Excipients help maintain consistent product quality by preventing ingredient segregation or settling during manufacturing and storage.
    4. Enhancing Taste and Appearance: Nutraceuticals often contain bitter or unpleasant-tasting ingredients. Excipients can mask these flavours or enhance the product's appearance, making it more palatable to consumers.
    5. Facilitating Dosage: Excipients can be used to create specific dosage forms, such as capsules, tablets, or liquid formulations, that are convenient for consumers to use.
    6. Controlled Release: In some cases, nutraceuticals require controlled release to prolong their effects. Excipients can be tailored to achieve this goal.

Types of Excipients
Excipients come in various forms, each with its unique properties and applications. Here are some common types of excipients used in nutraceutical formulations:
    1. Fillers and Binders: These excipients provide bulk to the formulation, making it suitable for tablet or capsule manufacturing. Common fillers include lactose, microcrystalline cellulose, and calcium phosphate.
    2. Coatings and Film Formers: Coatings are applied to tablets and capsules to improve their appearance, taste, and stability. These can be made from materials like shellac, cellulose derivatives, or polymers.
    3. Solubilisers: Nutraceuticals often contain hydrophobic compounds that are poorly soluble in water. Excipients like surfactants or co-solvents can enhance solubility and bioavailability.
    4. Disintegrants: These excipients help tablets or capsules break apart in the digestive tract, releasing the active ingredients for absorption. Common disintegrants include croscarmellose sodium and cross-linked povidone.
    5. Flavouring Agents: Excipients like natural flavours or sweeteners are used to mask the taste of bitter or unpalatable nutraceutical ingredients.
    6. Preservatives: In liquid nutraceuticals or products prone to microbial contamination, preservatives are added to extend shelf life. Natural preservatives like vitamin E or rosemary extract are often preferred.
    7. Antioxidants: These compounds help protect sensitive nutraceutical ingredients from oxidation and degradation. Vitamin C and tocopherols are commonly used antioxidants.
    8. Lubricants: Lubricants are essential in tablet manufacturing to prevent sticking to equipment. Magnesium stearate and stearic acid are common lubricants.

Excipients and Bioavailability
One of the key challenges in nutraceutical formulation is ensuring that the active ingredients are absorbed and utilised efficiently by the body. This aspect is closely tied to the concept of bioavailability, which refers to the fraction of the ingested dose that reaches systemic circulation in an active form.
Excipients play a vital role in improving bioavailability through various mechanisms:

Enhanced Solubility
Many nutraceutical compounds, such as curcumin from turmeric, have poor water solubility. This limits their absorption in the gastrointestinal tract. Excipients like piperine, found in black pepper, have been shown to enhance the solubility of curcumin and improve its bioavailability.

Protection from Degradation
Some nutraceutical ingredients, like vitamins and polyphenols, are sensitive to factors like light, oxygen, and heat. Excipients can act as antioxidants and stabilisers, preserving the integrity of these compounds during manufacturing and storage.

Controlled Release
Certain nutraceuticals require sustained release to maintain therapeutic levels in the body over an extended period. Excipients can be used to create formulations that release the active ingredients gradually, ensuring a prolonged effect.

Regulatory Considerations
The use of excipients in nutraceuticals is subject to regulatory oversight, which varies from country to country. In the United States, for instance, the Food and Drug Administration (FDA) regulates the use of excipients in dietary supplements, defining permissible excipients and their usage limits.

Regulatory bodies typically require manufacturers to provide safety data on excipients used in nutraceuticals. This includes information on the excipient's toxicology, stability, and any potential interactions with other ingredients.

Manufacturers must also adhere to good manufacturing practices (GMPs), which ensure the quality and safety of nutraceutical products, including the appropriate use of excipients.

Case Studies: Excipients in Action
To better understand the impact of excipients on nutraceutical formulations, let's explore a couple of case studies:

Case Study 1: Omega-3 Fatty Acid Supplements
Omega-3 fatty acids, commonly found in fish oil supplements, are well-known for their cardiovascular and cognitive health benefits. However, fish oil can be prone to oxidation, leading to a fishy aftertaste and reduced efficacy.

Excipients like vitamin E (tocopherols) are often added to fish oil supplements as antioxidants to prevent oxidation. These antioxidants protect the omega-3 fatty acids from degradation, ensuring the product remains palatable and effective.

Case Study 2: Curcumin Supplements
Curcumin, the bioactive compound in turmeric, has potent anti-inflammatory and antioxidant properties. However, it has low bioavailability due to poor water solubility and rapid metabolism.

To address this issue, manufacturers often include piperine, an excipient derived from black pepper, in curcumin supplements. Piperine enhances the solubility of curcumin and inhibits certain enzymes that metabolise it, leading to a significant increase in curcumin's bioavailability.

Future Trends in Excipients for Nutraceuticals
As the nutraceutical industry continues to evolve, so too does the role of excipients. Several emerging trends are shaping the use of excipients in nutraceutical formulations:
    • Natural and Clean Label Excipients
Consumers are increasingly seeking natural and clean label products. This trend extends to excipients, with manufacturers exploring plant-based and clean label options to replace synthetic excipients.
    • Personalised Nutrition
Advances in technology and diagnostics are enabling personalised nutrition approaches. Excipients may play a role in customised formulations tailored to an individual's specific health needs and genetic makeup.
    • Nanotechnology
Nanotechnology holds promise for improving the delivery and bioavailability of nutraceutical ingredients. Nano-sized excipients and carriers can encapsulate active compounds, protecting them from degradation and enhancing absorption.
    • Sustainability
Sustainability is a growing concern in the nutraceutical industry. Manufacturers are exploring eco-friendly excipients and packaging materials to reduce their environmental footprint.

Conclusion
Excipients are the unsung heroes of the nutraceutical world, quietly but significantly influencing the efficacy and quality of these health-enhancing products. From enhancing stability and solubility to improving taste and appearance, excipients play a multifaceted role in nutraceutical formulations.

As the nutraceutical industry continues to thrive and innovate, the science of excipients will evolve alongside it. Manufacturers and researchers are constantly exploring new excipient options and formulations to maximise the bioavailability and effectiveness of nutraceutical ingredients.

Consumers, in turn, can make more informed choices about their nutraceutical purchases by understanding the role of excipients and looking for products that utilise these components strategically to optimise health benefits.

In the quest for better health and wellness, excipients stand as vital partners in delivering the promise of nutraceuticals—a promise that continues to unfold as science and technology advance, bringing us closer to realising the full potential of these remarkable products.

(The author is professor, College of Food Technology, Naigaon, Nanded, Maharashtra)
 
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