If you believe that the foods you consume have an effect on your health status, you are not alone; in fact, you are joined by the likes of the Ancient Egyptians, Native Americans, and an increasing proportion of Western society. Nutraceuticals are food extracts that have a physiological benefit beyond basic nutrition requirements and are classified as dietary supplements in the United States. (1) Nutraceuticals comprise nearly ⅕ of the global pharmaceutical industry income, yet their role in disease prevention and treatment is not clear. Below is a compilation of headaches on both the biochemical and market level, and ways to avoid them in the future:
- High Proportion of Active Ingredients
While traditional pharmaceutical formulas contain 1-4 active ingredients, nutraceutical formulas contain up to 50 actives. This poses challenges around ingredient interaction, particle size, compression, uniformity and more which is why having an exact process for homogenization is critical.
Also problematic is the ratio of active ingredients to excipients; nutraceuticals contain ≥90% active ingredients, as compared to traditional pharmaceutical formulas, which only contain 10-30% actives. The space limitation for excipients is therefore significant in that it can cause problems around disintegration time and hardness. (2)
- Ingredient compatibility (or lack thereof)
Although nutraceuticals are intended to provide supplementary nutrition, some nutrients have an upper limit that, if exceeded, can cause toxicity symptoms or adverse nutrient interactions. For example, 75% of Americans are Vitamin D-deficient and frequently supplement Vitamin D through supplementation. (3) However, some supplements contain more than the recommended dose and, combined with natural intake, can lead to hypercalcemia and soft tissue calcification. People responsible for nutraceutical formulas should be well-versed in nutritional science and potential nutrient interactions, so as to make an informed decision about ingredient choice.
- Formula Packaging
When a manufacturer has optimized its nutraceutical formula, packaging must be carefully considered. Nutraceutical formulas are commonly packaged as pill tablets, gummies, powders, and gel liquids, yet not all modes of packaging are appropriate for all formulas. For example, if a probiotic supplement is intended for the lower intestine, it must be packaged in a way that protects it from the acidic stomach environment. In this case, a protective pill tablet would an appropriate choice over a digestible gummy or powder. Manufacturers should be deliberate in relating their product intent with its ability to affect the intended area. (4)
- Poor Government Regulation
In the United States, dietary supplements (and therefore nutraceuticals) are not subject to the stringent regulations placed on medicines and pharmaceuticals, as per the Dietary Supplement, Health, and Education Act of 1994. Although this may sound good, the FDA can pull a product off the market if it potentially causes harm to consumers, which is incredibly costly to the manufacturer. To avoid this migraine of a headache, nutraceutical companies should incorporate their own regulatory testing to ensure that the products they put on the market are safe, and even beneficial, to consumers.
On the journey to successful manufacture and sale of nutraceuticals, many of the hiccup areas can be avoided by simple experience or collaboration with someone who can lend expertise. In conjunction, use of high quality equipment will lead to production of high quality product. The high pressure homogenizer by Pion Technology, one such example, is renowned for its ability to reduce particle size while maintaining uniformity; this capability is a key need in nutraceutical production.
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