GxP Lifeline
Top 5 Nutraceutical Trends in 2018 - Exploring Different Delivery Methods
The image to the left is usually what comes to mind when we think of a vitamin. Historically, most vitamins and supplements have been large pills. In some cases, these giant pills are added to a mound of other giant pills that consumers need to take. Ingesting this small pharmacy day after day, year after year, is enough to make anyone want to try something new — as long as it comes in a form that isn’t a hard, flavorless tablet.
Fortunately, these giant horse pills of the past are just that — a thing of the past. Nutraceutical companies are rapidly discovering new, more consumer-friendly ways to present their supplements.
Challenges With New Delivery Methods
Most new delivery methods are still oral, but some companies have developed lotions and sprays to introduce the supplement through the skin. The transdermal delivery method might be more effective when it comes to absorbing certain vitamins and minerals, but it also comes with its own set of challenges. First, it must be determined if there are any risks with absorbing the supplement in a novel way. Will the delivery method bypass any of the body’s defenses in such a way that there’s a higher risk? Does the delivery method cause different or worse side effects? Since these are new approaches, does research indicate that the supplement can even be absorbed via the new delivery method? These problems are best addressed by looking at the product formulation and the effective performance of clinical trials.
These questions must be considered for new oral delivery methods as well. In the case of certain powders, drops, gums or lozenges, absorption is sublingual or buccal, which bypasses the digestive system and allows the supplement to enter the bloodstream at a much faster rate1. Another problem is simply making the product taste good. Since the market for dietary supplements typically includes those who are health-conscious and staying away from sugar and artificial sweeteners, making a great-tasting product becomes a real challenge. Stevia is the go-to sweetener for this industry, due to its image as natural and the familiarity that many consumers have with it.
Opportunities With New Delivery Methods
Some new delivery methods aren’t designed to circumvent the digestive tract — they’re designed to survive it. New technology presents nutraceutical manufacturers with opportunities that didn’t previously exist. A prime example of this is probiotics, certain strains of which can’t survive prolonged contact with stomach acid. For probiotics to do their job in the small intestine, they have to make it through the stomach. Some companies are now creating capsules specifically designed to remain intact through the stomach and dissolve in the small intestine. Others are focusing on providing a probiotic that doesn’t need to be refrigerated and has a longer shelf life.
New delivery methods — lozenges, drops, gums, lotions, liquids, powders and sprays — are all joining traditional pills on store shelves as viable natural alternatives for anyone who doesn’t want a pill, but the group that lends itself to the most creative delivery forms is the children’s market. A recent example of this creativity is basically a vitamin-fortified Pixy Stix, sans sugar. Manufacturers of children’s products are swapping out the added sugars for stevia extract or other natural sweeteners and making strides in providing gluten-free, dairy-free, soy-free options with short ingredient lists.
Is It a Supplement, Cosmetic or Drug?
When speaking of transdermal delivery forms, it’s very easy to cross over into the realm of cosmetics. If you’re providing a lotion, cream or spray, the language used in packaging and advertising is what determines how the product is defined by the U.S. Food and Drug Administration (FDA). As with other supplements, it’s important to avoid any language that can be construed as a health claim. The example given by the FDA involves essential oils, which are considered cosmetics when marketed as a fragrance, but are a considered a drug if marketed for something like muscle pain relief. The consequences of a spray, lotion or cream being considered a drug by the FDA are the same as they would be for any dietary supplement making similar claims.
As with other product categories, the FDA uses promotional materials to determine if something is a dietary supplement or a cosmetic. If your product’s main purpose is cleansing, beautifying, promoting attractiveness, or altering the appearance, it would be considered a cosmetic. If the purpose is to diagnose, cure, mitigate, treat or prevent a disease, it becomes a drug. The FDA acknowledges that a product may be both, in which case it is held to the requirements of both2.
Pills are a part of life, but many nutraceutical companies are making significant strides in toning down the number of pills that consumers take. Regardless of the supplement in question, creative delivery forms are gaining popularity and momentum. Companies hoping to get ahead will have to embrace innovation as these kinds of supplements become the rule, not the exception.
Time for a Change
No business can flourish if it remains stagnant, but change is one of the hardest things to manage in a nutraceutical business. This is partly because there are so many changes and because manual or paper-based systems take a long time to change. Changing a delivery form requires changes to raw ingredients, suppliers, manufacturing and standard operation procedures (SOPs). All of these changes need to be tracked and implemented quickly to be effective. It can take so long to implement a change in a manual or paper-based system, that by the time that change becomes effective it’s already obsolete.
Trends change so quickly in the dietary supplement world that a nutraceutical company’s best friend is an electronic quality management system (QMS). Automation greatly reduces turnaround times and tracks documentation through the approval process. The right QMS also provides change control, making it an end-to-end solution for change management that allows employees to keep up with the SOP changes and be trained on the most current version. Using a system such as this would allow a nutraceutical company to quickly manufacture supplements that use novel delivery forms while maintaining compliance.
References:
- Sayeed, Vilayat A. November 2, 2014. “Considerations in Developing Sublingual Tablets — An Overview.” Retrieved from http://www.pharmtech.com/considerations-developing-sublingual-tablets-overview
- FDA. April 30, 2012. “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)” Retrieved from https://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm
Sarah Beale is a content marketing specialist at MasterControl in Salt Lake City, where she writes white papers, web pages, and is a frequent contributor to the company’s blog, GxP Lifeline. Beale has been writing about the life sciences and health care for over five years. Prior to joining MasterControl she worked for a nutraceutical company in Salt Lake City and before that she worked for a third-party health care administrator in Chicago. She has a bachelor’s degree in English from Brigham Young University and a master’s degree in business administration from DeVry University.
