When it comes to delivery format innovations, consumers–especially children and seniors–are willing to give them a try.
“New and improved.” What does that truly mean? If something that already exists is “improved,” can it truly be “new?” To most consumers, the answer is yes. If it is a product that has been dramatically improved, then it does possess the appeal of “new.” And this is where formulating—and reformulating—with newer delivery options may give you that competitive edge.
Tablets, capsules and soft gels remain top-of-mind and the dominant form of consumption; however, when presented with new formats that propose the bonus of flavor (“a little treat”), or a different experience, consumers are ready and willing to give it a shot. Plus, there are many folks who either cannot swallow pills, have some difficulty doing so or just do not prefer it at all.
David Cai, PhD, consumer health business development manager of New Jersey-based BASF Nutrition & Health noted that according to market research, 68 percent of all U.S. adults report taking dietary supplements, yet nearly one-third of consumers do not always comply with their supplement regimen, because they forget, it doesn’t taste good or they have difficulty swallowing pills. “‘Pill fatigue’ is driving the need for user-friendly, novel formats to integrate dietary supplements in one’s daily routine,” he said.
“As the market for natural products has grown, so has the need to develop new ways to take them,” observed Mitch Skop, senior director of new product development for Pharmachem Laboratories, Inc. in New Jersey. “Tablets and capsules are easy and inexpensive to manufacture, however, according to a Harris Interactive Poll, as many as 40 percent of American adults either can’t swallow them or prefer not to.”
Skop reported that with increasing frequency, Pharmchem’s customers have been requesting ingredients suitable for use in a wide variety of new delivery alternatives, including chewable tablets, soft chews, ready-to-mix powders, liquids and blast-cap technologies. In addition, the company is more often asked to provide specific mesh or solubility or flavor profiles to accommodate specific needs, or to solubilize an otherwise insoluble ingredient for use in a beverage.
A main driver of development of innovative delivery system, Cai added, is the increased awareness of supplement needs for specific consumer groups such as children or elderly people who have difficulty swallowing tablets or pills. Because 30 percent of most dietary supplements are still in traditional formats like pills and tablets, other forms are especially relevant for seniors—more than three quarters of the population of those aged 55-plus regularly use vitamins, and usage of vitamins, minerals and supplements increases with age.
Lynda Doyle, vice president of global marketing for New Jersey-based OmniActive Health Technologies asserted that the delivery system “is just as important as the ingredients themselves. No matter how good or potent the ingredient is, without the right delivery system the ingredient may not provide the intended benefit for a number of reasons.” Doyle explained the need for continued R&D in delivery is often based on the raw materials themselves. “Many nutritional ingredients are hard to handle, unstable, insoluble, not bioavailable or have organoleptic issues. Sometimes an ingredient will have all of those characteristics that make it difficult to formulate for mainstream consumers.” The need for the most effective delivery becomes apparent, she said, when an ingredient needs to be converted to forms for specialized applications that require specific features such as solubility, dispersibility, stability, bioavailability or taste-masking.
The disparity of technologies that provide unique delivery experiences for the consumer—as well as the all-important preservation of the actives contained within for optimum bioavailability—showcases the gains in sophistication achieved by the dietary supplement industry, and portends a much more vigorous future.
OmniBead beadletting technology was developed to stabilize ingredients and protect against organoleptic issues, allowing them to be included into a larger variety of products. A prime example is capsaicinoids (from hot peppers), which can cause oral and gastric upset when taken in the amounts needed for weight management.
OmniBead beadleting technology to encapsulate the pungent capsaicinoids of red hot peppers without the burn associated with consuming unprotected capsicum, enables formulators to include it in viable amounts to their products. OmniBead also helps protect the carotenoids lutein and zeaxanthin for greater inclusion into a variety of products.
Capsicum extract has posed challenges not only to consumers but production line employees, noted Doyle, because it is an irritant and is a small particle size, making it difficult to clean machinery after processing. Capsicum particles easily become airborne causing irritation to formulators in the lab and operators on the production floor. OmniBead beadlet technology enrobes the pungent capsaicinoids in a controlled release coating, protecting both manufacturers’ employees from irritation during handling and the consumer from gastric irritation.
UltraSOL is a molecular dispersion ingredient technology that converts lipophilic nutrients into water-dispersible ingredients and enhances the bioavailability of poorly absorbed nutrients. According to Doyle, UltraSOL provides greater dispersibility to ingredients that may be difficult to include in aqueous systems and increased bioavailability of nutrients that poorly absorb naturally in the body. OmniActive employed its UltraSOL technology to enhance the bioavailability and solubility of curcumin by dispersing a highly purified powder (95 percent curcuminoids) in a water-soluble carrier along with other food grade excipients and antioxidants to prevent the degradation of curcumin. CurcuWIN is a turmeric extract powder (20 percent curcuminoids) with solubilized curcuminoids in a special food-grade matrix, which withstands metabolic degradation and enables higher uptake of curcuminoids in a naturally balanced ratio.
“OmniBead and UltraSol platforms allow many new and exciting bioactives to enter the market and these technologies have also been instrumental in creating new categories and allowing formulators the differentiating factors that they would need to make them unique contenders in a competitive landscape,” Doyle explained.
DietSpice is a brand new and tasty way for consumers to control carbohydrate absorption. An example of Pharmachem’s ability to match a need in the marketplace, said Skop, is its concept brand DietSpice, which he called the “world’s first functional seasoning for weight control.” DietSpice is a family of tasty seasoning blends containing Phase 2 Carb Controller, previously only available in tablets and capsules. This new form enables marketers to offer consumers a flavorful way to season their food and reduce carb calories.
Unlike some other ingredients, Phase 2 is essentially odorless and tasteless, yet Skop asserted that the primary challenge was producing it in the proper granule size and adding the appropriate flavor—Italian, Asian, Cinnamon Sweetener or Butter and Spice. Pharmachem relied upon the expertise of its master formulator, Mahesh Desai, to develop each DietSpice packet to not only be delicious but to contain the viable amount of the active Phase 2. “Because of our vertically integrated processing capabilities, we can change particle size, improve solubility, flow characteristics, and taste consistency from batch to batch (blend uniformity),” Skop explained.
BASF delivery systems include a broad range from chewable tablets, orally disintegrating tablets (ODT), gummies, emulsions, stick packs and chewable soft gel capsules. “But,” said Cai, “when certain ingredients are used, integrated taste-masking or modified release technologies may be needed.”
For example, caffeine-containing orally disintegrating tablets with built-in taste masking and modified release technology can deliver the energy boost throughout a period of time without compromising on taste. These types of disintegrating tablets provide consumers convenience to get an energy boost anywhere, anytime without having access to water.
To minimize soft gel sizes for omega-3 supplements, BASF has introduced a broad range of high-concentrate omega oils high in EPA or high in DHA depending upon the consumer target group and targeted health condition. These high concentrate omega oils were developed leveraging BASF’s/ Pronova’s decade-long experience in producing pharma grade omega products (Lovaza, Omacor). These oils are designed to deliver high doses of EPA/ DHA with outstanding purities, low intake of saturated fats and superior oxidation characteristics.
The overarching challenge, Cai noted, is to make the product consumer-friendly with the same effectiveness and health benefits of conventional tablets and capsules. BASF Consumer Health provides differentiation opportunities with delivery forms and technologies to help customers overcome R&D issues. BASF’s proprietary co-processed excipient—Ludiflash—offers customers an all-in-one excipient (filler, disintegrant, flow aid, binder) to make orally disintegrating tablets (ODT) that melt in the mouth within seconds for ease of swallowing.
DRcaps are vegetarian capsules with acid-protective properties that slow down the capsule opening after swallowing. Made of low-moisture hydroxypropyl methylcellulose (HPMC) that helps keep acid-sensitive ingredients stable in the package before ingestion, the capsule also disintegrates more slowly than conventional gelatin or HPMC capsules, helping protect the capsule contents from opening in stomach acid after swallowing, said Capsugel’s Mark Vieceli, senior director, sales, marketing, and business development. The capsules delay opening without the addition of synthetic chemicals, solvents, or other coating ingredients. “Eliminating the coating step could reduce production time and cost for manufacturers. It is also appealing to nutritional health companies whose customers often perceive coatings as ‘unnatural,'” he said.
The impetus for developing DRcaps was three-fold: the booming growth of probiotic use among the general public, the potential takeoff of enzyme consumption, and the recognition that many sports nutrition ingredients are acid-sensitive. Capsugel created a polymer with special inherent properties so the capsule would not disintegrate in the stomach but would open immediately once the pH rose above 6.8, which is the average pH level of the entry into the intestines where probiotics and enzymes work best and most ingredients are absorbed.
Vieceli reported that in 2013, the results of a scintigraphic in-vivo study of DRcaps capsules definitively showed that the specially formulated acid-resistant HPMC capsules are an excellent choice for delayed and targeted delivery of acid-sensitive ingredients like probiotics and enzymes. “Data and images empirically demonstrated the capsules’ effective protection from early activation caused by stomach acids and, for a majority of study subjects, complete release in intestines where products such as probiotics work best. More specifically, the capsules began release in a mean time of 52 minutes after ingestion and when they were about to leave the stomach—a full 45 minutes later than an immediate release capsule. The capsules completely released the ingredients in a mean time of 72 minutes after ingestion and when most of the ingredients would most likely be in the intestines,” he explained.
Coni-Snap sprinkle capsules are hard capsules enabling the contents—usually multi-particulates or bead formulations—to be orally administered by simply opening the capsule and then sprinkling the contents onto soft food. The motivation for development, said Vieceli, was to fit the specific needs of a growing number of consumers who have difficulty swallowing pills and capsules. The “sprinkle capsule” was designed to be much easier to open than the standard capsules used with powder or multi-particulate formulations, to work on standard capsule filling machines and to stay closed once filled.
There were two specific R&D challenges for Coni-Snap sprinkle capsules, Vieceli explained. First, was to create a capsule that was easier for consumers to open and use than the standard capsules for sprinkled contents. Capsugel invented a capsule closure that reduced the force required to reopen from a fully closed position by a factor of four (four times easier to open) compared with standard capsules. A consumer panel of 37 tested the performance of prefilled Coni-Snap sprinkle capsules and traditional standard prefilled capsules, and 81 percent found the Coni-Snap sprinkle capsule “very easy” or “easy” to open, compared to 29 percent favoring the standard capsule opening.
Second was creating a capsule that could withstand normal filling, packaging, and transportation conditions without separation or loss of content due to reduced locking force. Capsugel invented a locking-unlocking component that would work for manufacturers during filling, packaging, and transportation of product as well as for easier end-use opening by the consumer. To test the effectiveness of this newly created locking force mechanics for sprinkle capsules, Capsugel put two lots of 10,000 capsules through a transportation study. Empty locked capsules were reopened for filling, filled with ingredients using a semi-automatic filling machine, closed to recommended closed length, inspected for proper closing and no loose pieces, bulk packaged and shipped via air to a bottling facility, bottled (to include applying sealers, child-resistant caps and neck bands), then shipped to final study destination. According to Vieceli, the capsules maintained robust performance throughout the various processes, showing zero loss of pieces or premature separation after encapsulation, before bottling, after bottling and during final transportation.
According to Michael Bush, senior vice president of Ohio-based Ganeden Biotech, the company partnered with CapAble in order to create a telescoping GanedenBC30 probiotic straw. The straws have 1 billion CFU of GanedenBC30 and can be seamlessly applied to Tetra Pak and other shelf-stable beverage containers, such as milk or juice boxes, pouches and bottles.
“The probiotics are in the straw, so all that is needed is to unwrap the straw and use it to enjoy your favorite drink,” he explained. “The look and feel of the straw is similar to what you would find on your child’s juice box and because GanedenBC30 is extremely safe for all ages and does not change the texture or taste of the product; the straw will be especially attractive to children’s beverage manufacturers.”
The shelf-stable beverage category has always been a technical challenge, Bush emphasized, but this new straw enables GanedenBC30 to be integrated into shelf stable beverages of all types, which he noted was not possible prior to this innovation.
The technical challenges of producing the straw were handled by CapAble while Ganeden Biotech focused on stability and ensuring a beneficial level of GanedenBC30 in each straw. “As far as sensory issues (texture, flavor, fragrance, etc.), drinking through the straw affects none of the parameters as GanedenBC30 has been optimized to impart no sensory changes in finished products,” Bush reported.
These are but a few examples of what supply innovators now offer and a taste of what’s to come. When considering your “new” and/or “improved,” heavily consider new delivery options—the same old same old may lead to line stagnation, if not industry stagnation. “Stagnation occurs when you stay in the same place too long,” Skop said. “Consumer demands are constantly changing. If you’re not moving forward, developing new, convenient delivery systems that meet their needs, you’re going to become stale.” NIE
For More Information:
BASF Nutrition and Health, (800) 526-1072
Capsugel, (888) 783-6361
Ganeden Biotech, (440) 229-5200
OmniActive Health Technologies, (866) LUTEMAX (588-3629)
Pharmachem Laboratories Inc., (800) 526-0609