Something to Chew On: Analytical Challenges in Testing Gummies
Additional Contributors:
Edgar Grigorian / Managing Director at Dyad Labs
Todd Napolitano / Director, Segment Strategy: Dietary Supplements, Plant-Based & Novel Foods, GMO Services
The market for vitamins, dietary supplements, and functional foods is expanding and overlapping rapidly. Numerous analytical challenges come with this blurring of boundaries, particularly regarding matrix, stability and bioavailability. Accordingly, testing labs must develop methods to stay ahead of future industry and consumer trends.
Gummy products are a good example. Gummies, or Chewable Gels as the USP designates them, have become an extremely popular nutritional supplement dosage form among consumers. Indeed, under 10% of all new product launches in the last year have involved gummy delivery systems.
Originally designed as a children’s candy, gummies have become immensely popular with adults as a vehicle for supplements spanning everything from vitamins to CBD. Even THC is commonly found in gummy form. The first gummy formulations used gelatin as the base. Gelatin is an animal-derived protein and, as such, is not suitable for consumers on vegetarian or vegan diets. Recent formulations use polysaccharides such as pectin or modified starches as the gel base. Although chemically and physically different, both bases can provide an effective delivery system that consumers will accept.
Consumer demand notwithstanding, the gummy dosage form is not without its unique challenges in manufacturing and analytical testing. On the manufacturing side, the relatively high moisture content makes side reactions between active ingredients and the gummy base or between different active ingredients much more likely. In addition, the conditions that create a desirable gummy base, such as high temperature and low pH, often create a hostile environment for the actives in the mix. Manufacturers have been extremely ingenious in addressing these issues, using low-temperature processes, multi-layered gummies, and encapsulated or otherwise protected actives to avoid thermal degradation and minimizing cross-reactions between ingredients.
Unfortunately, at least for analytical labs, these changes have created even more challenges in obtaining the reliable, reproducible analytical results necessary to validate label claims and monitor stability in an already challenging matrix. Generally, methods quite suitable for tablets and capsules may not suit gummies. Nevertheless, labs are well advised to follow the basic principles behind these methods. The first issue is homogenization. Blending and size reduction of gummies will always require a different approach. Freezing through dry ice or liquid nitrogen with or without adding a material to prevent re-combination is often needed. Thereafter, exposure of the target analyte may require degradation of the gummy matrix and disencapsulation of the target. Enzymatic digestion or the use of more aggressive solvents may be required. Typically if the “front-end” preparation and extraction are done thoughtfully, no changes, or perhaps only minor changes, are required with the final determination steps on the instrument. Of course, when significant alterations are made to any part of the method, verification of the method's performance is required, and data should be available on file.
As with all successful product analysis, communication, cooperation, and transparency in both directions between the manufacturer, distributor, and laboratory is essential. The more information provided on the gummy composition, the better the chemists can modify the existing methodology, thus avoiding a trial-and-error approach with a low chance of success. Conversely, open, two-way communication will greatly increase the chance of obtaining reliable, defensible analytical results in gummies or whatever dosage form is submitted.
With growing consumer demand for fortified or functional foods, the traditional lines between dietary supplements, food, and beverages are blurred. New combinations of actives in new matrices may meet consumer trends, but they also present new challenges for analytical testing labs. Labs must develop their methodologies given our current environment of increasing regulatory scrutiny.