Dietary supplement consumers have high expectations for the products they buy. Proven health benefits along with sensory experience, a reasonable price point, and clean labels are key factors for repeat purchase, and overall category growth.
 
To meet these needs, manufacturers today can choose from a broad range of diverse delivery solutions based on the unique needs of their formulation. When it comes to protecting moisture- and acid-sensitive ingredients like probiotics and enzymes, for example, Lonza’s DRcaps^® capsules have been shown to deliver the right dose, at the right time, in the ideal location.
 
Vaughn DuBow, North American Marketing Manager, Lonza Capsules & Health Ingredients, said the DRcaps^® designed release capsule, made from plant-based, vegetarian hydroxypropyl methylcellulose (HPMC), has been proven to release when and where needed in humans.
 
“So many ingredients on paper or in theory sound great, but the human body doesn’t always act the way we’d like it to. For example, probiotics, enzymes, and many herbal ingredients degrade quickly within the stomach. DRcaps^® capsules are designed to protect against the low pH of the stomach and ensure ingredients are brought to the small intestine for actual absorption and increased survivability/bioavailability.”
 
Formulation Advantages & Advancement
Traditional animal-based gelatin capsules start to break down in the stomach right away, opening fully in 2-3 minutes, noted DuBow. But the DRcaps^® dosage form offers unique polymer properties formulated within the capsule itself to slow opening after swallowing, without adding coating ingredients that increase manufacturing time and costs.
 
With a moisture content of 4-6% in 50% relative humidity, low moisture DRcaps^® capsules enhance stability for moisture-sensitive probiotics. The innovative polymer properties also mask the taste and odor of ingredients. By protecting against early disintegration, DRcaps^® capsules can reduce the potential for unpleasant odors, aftertaste, and reflux from ingredients like herbal or mineral compounds.
 
Effectively, DRcaps^® capsules can help formulators improve consumer experiences while enhancing a product’s efficacy; in the case of probiotics for example, DRcaps^® capsules can deliver live bacteria directly to the small intestine.
 
Traditionally, formulators in need of delayed or designed release methods have relied on enteric coating to protect ingredients from the harsh acidic conditions of the stomach before reaching the intestines. However, the practice can add costs and valuable production time.
 
“Instead of using another chemical or compound, which increases production cost, DRcaps^® capsules utilize a specific polymer to provide those same designed release benefits,” said DuBow.
 
Switching to DRcaps^® capsules can not only save money and production time, it also offers the added value of a cleaner label, he added. “Consumer data continues to show preferences for fewer additives and more natural products. With DRcaps^® capsules we’re not only benefitting our customer, the manufacturer, but also giving consumers what they’re asking for.”

Showing the Science
To assess the efficacy of DRcaps^® capsules for resistance to stomach acids for delayed delivery of ingredients, Capsugel^® (acquired by Lonza in 2017) commissioned the independent laboratory Bio-Images Research in Glasgow, Scotland, to conduct a gamma scintigraphic in vivo study. The clinical study was designed to evaluate the disintegration behavior of unbanded DRcaps^® capsules in human subjects. Completed in 2013, the study documented the resistance of unbanded DRcaps^® capsules to stomach acids for the delivery of ingredients. 
 
The study was designed to investigate the in vivo behavior of DRcaps^® capsules using qualitative and quantitative scintigraphic methods to assess the gastrointestinal transit of the capsules and release of capsules based on the images obtained. Gamma scintigraphy is an established technique in which a radio label is swallowed and the disposition in the gut is photographed externally over time. 
 
Results demonstrated the acid-resistant and delayed release properties of DRcaps^® capsules. Data and images showed radiolabeled release began at a mean time of 52 minutes when the capsules were about to leave the stomach—a full 45 minutes later than a typical immediate release capsule.
 
“It’s very common in the dietary supplement industry for companies and manufacturers to make claims. But what do they actually mean, and do they have evidence to prove it? That’s why this study really stands out from the competition,” said DuBow. “We took our research to the next level, in humans, and we saw what actually happens. We’re doing the human studies to put our money where our mouth is and say, we think it works like this, now here’s the proof.”

 
Next Generation Formulation
For years, the prototypical probiotic purchasers have been 40-55-year-old, upper-middle-class, Caucasian women focused on gut health.¹ But beyond the well-established gut health benefits, strain-specific research is uncovering new applications for immune support, sports nutrition, cognitive health, and more.
 
For example, in 2020 Lonza launched its TWK10^® ingredient, a unique strain of Lactobacillus plantarum isolated from naturally-fermented Taiwanese Kimchi. Evidence has shown the ingredient can deliver sports nutrition benefits including enhanced endurance, improved body composition, and energy levels.^2,3
 
As the science drives the market forward, DuBow said, “We think probiotics will be entering that next major phase.” But that potential could be stymied if brands can’t deliver probiotic products that match what the science suggests they should, which is live bacteria into the small intestine where they can populate. “If they degrade in the stomach, people won’t see the benefits, and probiotics may not get the widespread attention that they should.”
 
In order to help lead the market in developing best-in-class products, DuBow said Lonza is looking to work with companies intent on taking probiotics to that next level of condition-specific benefits.
 
Thankfully, industry advancements and technical expertise are well positioned to propel categories like probiotics into a new phase of product development, DuBow said, noting that Lonza offers an extensive range of innovative, high-performance dosage form solutions that can meet varying customer formulation needs.
 
For example, Lonza’s DUOCAP^® capsules, a proprietary capsule-in-capsule delivery system, are well suited for combination or dual release products. Alongside probiotics, prebiotics and postbiotics are gaining attention in the scientific community. Formulators now have the tools to offer a single capsule that combines these ingredients and can effectively deliver each of them at the right time in the right place of the body, DuBow said.
 
Combination formulations take the guess work out of the equation for consumers, improving compliance and product efficacy.
 
For more information on the science behind Lonza’s DRcaps® capsules, visit https://go2.lonza.com/drcaps-capsules.
 
References
1. Natural Marketing Institute, 2018 Lonza SORD report, 2019 (unpublished)
 
2. Huang W.C., Hsu Y.J., Li H., Kan N.W., Chen Y.M., Lin J.S., Hsu T.K., Tsai T.Y., Chiu Y.S., Huang C.C. Effect of Lactobacillus Plantarum TWK10 on Improving Endurance Performance in Humans. Chin. J. Physiol. 2018;61:163–170. doi: 10.4077/CJP.2018.BAH587.
 
3. Huang W.C., Lee M.C., Lee C.C., Ng K.S., Hsu Y.J., Tsai T.Y., Young S.L., Lin J.S., Huang C.C. Effect of Lactobacillus plantarum TWK10 on Exercise Physiological Adaptation, Performance, and Body Composition in Healthy Humans. Nutrients. 2019;11:2836 doi: 10.3390/nu11112836.