Nutraceuticals are fast becoming a popular way for consumers to maintain health and wellness. However, behind every nutraceutical supplement is an important supporting component - the excipients.
What are Excipients?
An excipient is any component of a medication or supplement other than the therapeutically active ingredient. Across both pharmaceutical and nutraceutical products, excipients are vital functional agents that allow for proper administration, delivery, stability and tolerability. Common excipients include things like fillers, binders, stabilizers, disintegrants and lubricants. Proper selection and formulation of excipients is crucial to maximize the effectiveness and safety of any supplement.
Ensuring Bioavailability and Absorption
One of the primary roles of excipients is to facilitate the delivery and absorption of active ingredients once ingested. For example, certain prebiotic fibers can be used as excipients to enhance the solubility and bioavailability of probiotic cultures. Surfactants or emulsifiers also allow for better dispersion and absorption of fat-soluble vitamins, minerals and botanicals. Choosing the right excipients helps nutritional compounds reach their target sites of action in the body.
Maintaining Shelf-Stability
Nutraceutical Excipients play a vital preservation role by protecting thermolabile ingredients from degradation due to factors like heat, light, oxygen and moisture. Various antioxidants, inert gases and moisture absorbers are commonly used excipients to extend shelf life. Bulking excipients like microcrystalline cellulose also aid in controlling humidity within formulations. Proper stability testing ensures chosen excipients maintain potency and purity throughout a product's shelf life.
Ensuring Product Quality
Excipients are further instrumental in modulating key quality attributes of supplements related to appearance, handling and dosing accuracy. Flowability excipients allow for uniform filling of capsules and tablets. Disintegrants and binders provide structural integrity during manufacturing and storage. Glidants and lubricants facilitate efficient compression during tableting. Therapeutic-equivalent excipients can even be substituted seamlessly to simplify supply chains or enhance sensory characteristics.
Promoting Tolerability and Compliance
Lastly, excipients play an important role in facilitating tolerability and compliance by helping adjust organoleptic and gastric properties. Flavoring and coloring agents make unpalatable ingredients more appealing. Clove oil or magnesium stearate prevent ingredients from clinging to manufacturing equipment or staining consumer packaging. Buffering agents lower the potential for gastric irritation. Enhanced tolerability and easy dosing greatly improves consumer willingness to persist with supplement protocols for maximum benefits.
Regulatory Standards for Nutraceutical Excipients
Given their inherent functionality in supplements, excipients themselves must undergo stringent screening and approval. The Food Chemicals Codex (FCC) monographs outline purity and testing standards for commonly used excipients across many jurisdictions. Additionally, the FDA maintains an “everything added to food in the United States” (EAFUS) database and Generally Recognized as Safe (GRAS) designation process to monitor excipient safety. Manufacturers must exercise due diligence in sourcing only excipients aligning with regulatory standards to ensure overall product quality and consumer protection.
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