June 16, 2024
Nutraceutical Excipients

Emerging role of excipients in nutraceutical formulation

The nutraceutical industry has witnessed tremendous growth in the past few decades owing to rising health consciousness among consumers. As demand for functional foods and dietary supplements rise, product development in this sector focuses on delivering optimal nutrition along with desirable sensory and functional attributes. Excipients play a vital supporting role in nutraceutical product formulation by facilitating nutrient delivery and stability, maintaining sensory appeal and ensuring safety and compliance. With evolving regulatory guidelines and consumer expectations, the role of excipients in nutraceuticals is continuously expanding.

Classification and functions of excipients

Excipients are classified based on their functional roles in formulations. Main categories include fillers, binders, disintegrants, lubricants, glidants, flavors, preservatives etc. Fillers help bulk up tablets and capsules without altering nutritional value. Common filler excipients are microcrystalline cellulose, pregelatinized starch etc. Binders bind powder particles and granules during compression into solid dosage forms. Commonly used binders are povidone, hydroxypropyl methylcellulose etc. Disintegrants ensure rapid breakup of tablets or capsules upon ingestion facilitating nutrient absorption. Superdisintegrants like croscarmellose sodium and crospovidone are widely used. Lubricants minimize friction between formulation components and production machinery to aid manufacturing. Stearic acid and magnesium stearate are popular lubricants. Glidants like colloidal silicon dioxide reduce friction and prevent caking or agglomeration of powders. Excipients also aid sensory delivery through flavors, colors and preservatives that enhance consumer appeal and stability.

Enabling nutrient delivery and bioavailability

By facilitating prompt disintegration and dissolution of dosage forms, excipients play a key role in determining Nutraceutical Excipient bioavailability. Excipients that efficiently deliver actives to absorption sites maximize biological impact. Technology advancement has yielded excipients that target specific absorption windows through novel release mechanisms. For example, L-HPC controlled the release of Coenzyme Q10 and increased its bioavailability by 7-fold compared to plain CoQ10. Similarly, SNAC developed by DFE Pharma improved solubility and absorption of carotenoids like lutein, astaxanthin etc by 600-800%. Nutraceutical excipient choice has a direct nutritional consequence and development focuses on achieving optimal delivery profiles.

Ensuring stability and safety

Owing to complex matrices, nutraceuticals are prone to stability issues like oxidation, hydrolysis and microbial contamination during processing and shelf life. Excipients protect actives through various mechanisms like moisture scavenging, pH buffering, chelation, antioxidant effect etc. Further, certain excipients can improve stability of thermolabile ingredients by inhibiting phase transitions during processing and storage. Safety is a major concern in this largely self-care segment. Excipients approved for pharmaceutical use by regulatory agencies offer an additional edge of documented toxicology. Some also provide intrinsic preservative effects through mechanisms like moisture sorption and free radical trapping. Judicious selection of excipients with proven safety enhances consumer trust in nutraceutical products.

Adapting to regulatory changes

Nutraceutical regulations globally are moving towards stricter evaluation of individual ingredients beyond simple notifications. This necessitates establishing excipient safety equivalent to pharmaceutical grade through non-clinical studies. Further, limits on levels of residual process solvents and genotoxic impurities require adapting extraction and purification techniques. As label claims evolve from generic structure/function to disease risk reduction, demonstrated bioefficacy becomes critical. Novel excipient-mediated delivery approaches could be key to meeting emerging efficacy expectations. Standardization of excipient nomenclature and specifications too is being addressed to facilitate global regulatory compliance. The regulatory tightening thus challenges manufacturers to upgrade excipient characterization and optimize formulation through science-based approaches.

Tailoring delivery for specific health benefits

With growing consumer segments seeking solutions for lifestyle-related illnesses, formulation excipients are being designed to unlock new levels of nutrition targeting. For instance, various polymers enhance bioavailability of resveratrol, an anti-aging compound, thereby potentiating its anti-inflammatory benefits. Nutraceutical companies explore combinations of excipients and actives to provide metabolic support for conditions like diabetes, obesity, cardiovascular and cognitive health. Delivery systems involving micro/nano-encapsulation of nutrients show promise for slowing nutrient release and targeting tissues. Fat-based excipients help water-insoluble vitamins and fatty acids achieve optimized absorption. Thus, tailoring excipients opens up possibilities for precisely delivering active principles with demonstrable clinical efficacy.

Ensuring sensory and shelf-life advantages

Beyond function, excipients play a crucial role in consumer acceptance based on palatability and convenience factors. They impart desired attributes of color, flavor, taste-masking and texture to nutraceutical forms. For example, applications utilize natural flavors, colors and sweeteners to enhance appeal of supplements. Further, intelligent packaging techniques extend shelf-life by using desiccants, oxygen scavengers and other excipients that maintain formulation integrity during distribution cycles.LED UV light exposure inhibits microbe growth and enzymatic degradation through synergistic antioxidant-photoactive excipients. Thus, multi-faceted excipient capabilities help manufacturers address diverse challenges from manufacturing to consumption.

*Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it