An important part of nutritional supplement manufacturing is the use of processing aids, which are necessary to improve the production efficiency of the manufacturing process itself; as well as the quality, consistency and function of the actual end product.
Most notable in this process is the use of excipients, which are inactive substances that serve as the medium for active substances, and help in areas such as the care and speed of processing machinery and equipment; as well as product flow and preservation, among other benefits.
For nutritional product labeling and classification purposes, a distinction exists for excipients that may be classified as “natural” for FDA-approved use in the production of organic nutritional products vs. what will be referred to hereafter as “conventional” excipients. While conventional excipients are synthetically produced, they are actually approved by FDA as GRAS (generally recognized as safe).
Organic-certified excipients are primarily derived from rice. Most conventional excipients are naturally occurring in nature but are synthetically produced. So from a marketing and consumer mindset, conventional excipients are often viewed in a negative light with a common misconception that they are unnecessary or harmful additives, due in large part to their names typically sounding chemically based. For example, use of a natural substance like rice powder on a package sounds a lot more straightforward than silicon dioxide to a consumer, but associated costs come with that natural label.
In providing an overview of why excipients are used and some of the key differences between conventional and natural excipients, hopefully a sense of clarity and understanding to their purpose in creating supplements results, and a more positive light shines on the benefits of conventional excipients in the manufacturing process.
Supplement manufacturing excipient usage explained
Excipients are commonly used in formulas that require additional flowability and lubrication, and when clumping of powder can occur, such as pre-workouts and multivitamins, along with most capsule and tablet formulas. Formulas that usually do not require excipients are free-flowing powders such as collagen, whey protein and certain amino acids.
Although excipients won’t add any therapeutic benefits to a supplement, when used properly, they add value by bringing efficiency, preservation and consistent quality to the manufacturing process.
Primary uses of conventional excipients
Excipients are added to formulas to increase production and manufacturing efficiencies. This is especially important in cases where a formula is abrasive or dry. Excipients can be used to increase lubrication, flowability and compressibility so production machines can run smoother and faster.
This, in turn, creates faster lead times for the product and less damage on machines. Additionally, excipients help to reduce waste during production by reducing clumping and other processing issues that may result in active ingredients adhering to manufacturing equipment and not being utilized in the end product.
One conventional excipient that helps with efficiency is magnesium stearate, which is used as a lubricant in capsules that have dry or abrasive active materials. Without magnesium stearate, capsules can have trouble closing and machinery can malfunction during production.
Preservative excipients are mainly used in formulas that contain hygroscopic materials. These materials tend to absorb moisture and require excipients that act as a drying or flowing agent to combat clumping. In supplement manufacturing, fewer clumps and greater flowability contribute to a more pleasant experience for the consumer that will last throughout the product’s entirety.
Silicon dioxide and calcium silicate are examples of conventional excipients used in powder formulas to help increase flowability and minimize clumping. If a broken capsule is in a bottle, it was most likely the result of a hygroscopic formula that needed calcium silicate.
A filling agent is used when an active material by itself does not provide enough substance to consistently meet a fill weight or fill line. Fillers are also used to contribute to the aesthetics of a product. In cases where capsules are produced without fillers, it is common to end up with some capsules that look full, some capsules that do not look full, and inconsistent density per capsule. This can lead to concerns and complaints from customers. The addition of a filling agent is a simple, safe and effective solution to maintaining filling consistency.
A common filler is rice powder, which can be used as a filler for products that need a consistent weight and fill line. For a conventional plant-sourced filler, microcrystalline cellulose (MCC) can be used.
Benefits of conventional vs. natural excipients
When considering use of conventional vs. natural excipients, it is important to understand that, when used with the correct practices, conventional GRAS-labelled excipients are harmless and an essential part of creating a supplement. A manufacturer should have complete transparency with clients regarding the excipients being used in their formulas.
Given increasing consumer demand and the direction of the industry in its interest to market products as “natural,” “vegan” or “clean,” one of the biggest concerns among brand owners is using excipients in products that are natural. Although natural excipients are available, these options can result in product prices two to three times higher than conventional excipients and can also result in significant decreases in production efficiency.
Compared to conventional excipients—which can help produce capsules at a maximum rate of 90,000 per hour—organic excipients limit capsule production to a maximum rate of 40,000 per hour.
For some perspective on how organic excipients can reduce efficiency, as noted, rice powder is the primary base of organic excipients. While rice powder is a great medium for reducing moisture—think of the common suggestion to place a water-damaged cell phone in rice to absorb the water—rice can become sticky as it takes on moisture. Similarly, this same stickiness and adhesion can occur in supplement manufacturing, making it a much less efficient process.
Choosing the best excipient path
Ultimately, when making the choice of whether to use a conventional or organic excipient in supplement manufacturing, the brand’s primary product objectives need to be considered. If a brand’s key focus is to be able to label a product as “natural” to reach a certain type of consumer, it may find the reduction in production efficiency and higher cost of the end product are warranted.
For those brands seeking a more cost-effective and efficient process resulting in a less expensive product for consumers, conventional GRAS-certified excipients are an excellent option utilizing FDA-approved, safe processing aids, despite the lack of a natural label. When considering some of the benefits of conventional excipients, brands may in turn be able to better convey the value to their customers through transparency and education.
Tito Sanchez is a supply chain coordinator for Lief Labs. He has been involved with the health and fitness industry for over 15 years. Sanchez has a bachelor’s degree from West Texas A&M University in sports and exercise science. Based in Valencia, California, Lief Labs is an innovator in product ideation and formulation for the dietary supplement market, driven by a passion for collaboration, a determination to offer only the best ingredients and an adaptable mindset. The company also houses a state-of-the-art, full-service cGMP (current good manufacturing practice) manufacturing facility, which offers custom solutions for a multitude of supplement categories.