Manufacturing update: understanding excipients

Our products are formulated for efficacy and as such we choose our raw ingredients carefully, with a focus on factors such as form and bioavailability.  In addition to the active ingredients, we are also very careful when it comes to choosing our excipients.  These non-active but essential additions to our products fill essential roles within the manufacturing process.

The process of tablet and capsule manufacturing can be complex in terms of the excipients required to produce a finished product.  Many excipients are required purely to ensure the processing procedures run smoothly and provide no benefit in terms of increasing the efficacy or adding to the nutritional quality of the finished product – they may be included, for example, to ensure even mixing of different ingredients or to prevent clumping.

According to article 20 of REGULATION (EU) No 1169/2011, it is not a legal requirement to list excipients used as processing aids, or non-active ingredients such as carriers/bulking agents, but we believe in transparency.

We scrutinise all excipients for their effectiveness and quality and list ALL ingredients, both active and non-active, for consumers to make informed choices.

Not all manufacturers and producers choose to follow this ethos, or choose their excipients as carefully as we do (nor will you find any artificial flavouring, colourings or sweeteners in our products); you may therefore encounter manufacturers who appear to use little or no excipients, but, considering the above, you may wonder how and why they claim this.

Here, we explain why excipients are standard in dietary supplement manufacturing and clarify the role of some of the classic excipients:

Lubricants and anti-caking agents are excipients known as ‘flow agents’ which are necessary to reduce resistance during processing, thereby allowing tablets and capsules to flow through the processing steps.  We use a number of standard excipients that are, actually, ubiquitous in supplement manufacturing; these are non-toxic and vegetarian-friendly, such as silicon dioxide, magnesium stearate and stearic acid.  Without the use of flow agents, the powder ingredients would simply stick to the manufacturing equipment and so it is not possible to manufacture tablets or capsules without them.

Binders are (as the name suggests) used to bind the ingredients together and, without them we cannot produce a finished tablet.  In some it is necessary to produce our products as tablets rather than capsules  in order to  overcome issues related to clumping and decolourisation of the powder contents.  Clumping is a common issue with capsules as they cannot be protected from moisture in the same way that tablets can be.  Using tablets in preference to capsules may on occasion require additional binders, but the use of tablets can enhance the stability of the final product. In addition, without the appropriate type and amount of binder, tablets can crumble and disintegrate. Cellulose is a typical example of a binder and, as a plant-derived ingredient, simply becomes a non-digestible fibre when consumed – so may even offer some health benefits!

Thickeners or gelling agents, in the form of plant-derived gums, are also used to help hold the ingredients together, with examples that include acacia gum, guar gum, xanthan gum, acacia gum, and cellulose gum. Like cellulose, colloids fall into the fibre category, and carry some nutritional benefits as fibres. These are typically from vegetarian sources.

Bulking agents are required, in many cases, to increase the volume or size of the finished tablet or capsule. This is important when we consider that many ingredients are added in micro amounts such as the trace and micronutrients, selenium, chromium, iodine and folate.   We select our bulking agents carefully and some even have contributing health benefits.  The dicalcium phosphate used in our Pure Essentials Multivitamin & Minerals supplement is a source of the minerals calcium and phosphate, and we combine this with inulin,  a non-digestible plant starch fibre derived from chicory  that has gut health properties. In addition, these tablets are specifically manufactured as a slow release formula to optimise bioavailability/uptake of the nutrients; certain amounts and ratios of excipients are needed to ensure this.

The use of non-toxic excipients therefore not only contributes to manufacturing processes themselves, but also contributes to the integrity and stability of the supplements.  Although not all excipients contribute significant nutritional health benefits, their addition and function is necessary.

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Dr Nina Bailey

About Dr Nina Bailey

Nina is a leading expert in marine fatty acids and their role in health and disease. Nina holds a master’s degree in Clinical Nutrition and received her doctorate from Cambridge University. Nina’s main area of interest is the role of essential fatty acids in inflammatory disorders. She is a published scientist and regularly features in national health publications and has featured as a nutrition expert on several leading and regional radio stations including SKY.FM, various BBC stations and London’s Biggest Conversation. Nina regularly holds training workshops and webinars both with the public and health practitioners.