Natural Products Insider

MAY-JUN 2019

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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24 INSIDER May /June 2019 Contract Manufacturing: Premixes The Proper Role of Pre-Blends of Nutrients in Production of Dietary Supplements by Mark LeDoux The requirement for stable products is elevated with the requirement that dietary supplements meet 100 percent of ingredient label claims at the end of their shelf life. Too often in the past, brands made assumptions regarding shelf life and naively placed shelf-life data on products without adequate scientifi c corroboration. Now that the plaintiff's bar is active in providing imputed protections for consumers, the supplement industry can expect more inquiry into best practices to help avoid costly and embarrassing fi ndings of insuffi ciencies. Three things can adversely affect potencies of complex dietary supplement formulations. Two that come to mind immediately are the presence of moisture and oxygen. Understanding that moisture can precipitate chemical or biological reactions in fi nished products is elementary, and companies have destroyed many batches due to excessive moisture in fi nished products leading to degradation of potency, discoloration of the products, and unpleasant odors emanating from the tablet or capsule. Oxygen, when exposed to unprotected components of certain supplements, can initiate or precipitate oxidation of the compound, leading to reduced shelf life. A third issue is the impact of ultraviolet (UV) spectrum light, which can negatively impact several popular compounds, such as B vitamins. In general, the UV challenge has been handled by presenting fi nished products in either opaque, amber plastic or glass packages. Special care must be taken for supplement formulation if one believes the fi nished product is only as valuable and stable as the sum of its individual parts. History is replete with examples of improperly formulated compounds, where micronutrients were not properly dispersed within large amounts of blended ingredients. Content uniformity is often assumed, to the peril of the formulator and brand owner. Brands need to validate the identity and potency of initial and subsequent blends of complex compounds per GMPs (good manufacturing practices) and good laboratory practices (GLPs). Furthermore, micronutrients that have label claims in the amounts of micrograms, when presented with macro ingredients such as calcium or vitamin C, can often be diffi cult to fi nd using high-performance liquid chromatography (HPLC) or other

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