OR WAIT null SECS
Concerns such as ingredient compatibility, product stability, and manufacturing capabilities all come into play when facing a novel delivery form. Here’s how contract manufacturers can help.
As ubiquitous as it seems now, the gummy-as-dietary-supplement signaled a turning point for our industry. It made supplementation literally more palatable for everyone from preschoolers to pensioners, and it brought a shot of fun and flavor to a sector that needed a more compelling call to action than “Take your vitamins.”
But despite being ubiquitous as candies before crossing into supplement territory, gummies by no means enjoyed a seamless migration. Dietary supplements, it turns out, are hard to deliver via gummies, which demand very specific formulations and ratios of key ingredients, and often preclude high dose loads or actives that might compromise the finished product’s taste.
Yet manufacturers’ hard work-and formulation and processing savvy-cracked the gummy code. They promise to do the same for emerging supplement delivery forms that already have brands hoping to score another industry turning point.
Those brands will need patience-and a solid relationship with their contract manufacturers-to make it happen. As Eugene Ung, CEO, Best Formulations (City of Industry, CA), says, “New technologies don’t come about overnight, and they typically don’t come for free. But with the right expectations and strategic planning, brands can leverage new technologies to help differentiate themselves.”
Inside the Lines
The first step in using that leverage involves determining whether or not a new technology even falls within FDA’s definition of a dietary supplement.
That definition describes products containing a dietary ingredient that are taken by mouth and intended for ingestion. “There are two points to this definition,” Ung notes: “that the delivery form be taken orally and meant to be ingested, and that the product contain dietary ingredients.”
Traditional formats like tablets, capsules, and powders get a pass. FDA even recognizes gummies as a valid dietary supplement dosage form. But the lines blur when it comes to melts, sublinguals, sprays, and even tinctures, which arguably aren’t ingested, and whose regulatory status FDA hasn’t entirely clarified.
That hasn’t stopped some brands from commercializing them. But, says Shaheen Majeed, president worldwide, Sabinsa (East Windsor, NJ), “You’ll see that most of the time-or at least for brands following regulatory guidelines-the directions for delivery systems like melts, liquid extracts, and sprays that are really absorbed sublingually say to hold in the mouth and then swallow.”
You almost can’t blame brands for pushing the envelope, given increased interest in innovative supplement forms. Comparing 2013 to 2018, Nutrition Business Journal estimates that alternative and novel delivery options, including powders, effervescent products, and gummies, are all up 12%.1
Notes Vincent Tricarico, vice president, contract manufacturing, NutraScience Labs (Farmingdale, NY), “While the majority of our clients opt for either capsules or powders, we’ve absolutely seen more inquiries for vegetarian capsules and clean powders.”
Similarly, Brad Buchholz, vice president of sales, Robinson Pharma (Santa Ana, CA), observes that clean label, vegetarian, non-GMO, and organic have all been popular marketing terms with upstart supplement brands for years-but that the restrictions the terms impose have made it difficult for supplement manufacturers across the board to bring such products to market.
Tricarico agrees, noting that brands’ insistence upon using fewer and cleaner excipients and binders “creates challenges with the physical integrity and stability of the product.”
But growing demand for clean and “free-from” supplements is hard to ignore, Buchholz concedes, “and our industry has stepped up to meet these requirements, crossing over into established retailers with some success.”
For example, time was when the softgel category had nothing to offer consumers with religious or dietary restrictions prohibiting consumption of the gelatin used in softgel encapsulation. But with the advent of vegetarian softgels, such consumers “can meet their nutritional requirements without violating their principles,” Buchholz says.
Ung and colleagues have been making non-animal softgels for 14 years, and despite the form’s being “exceptionally challenging to produce,” he says, “we’re learning and innovating every day-from using different ingredients for the shell to improving machine and production efficiency.”
He still fields taxing requests, like those for tapioca-based non-animal softgels. “The technical characteristics of the starch itself, as well as the scaled softgel manufacturing process, have made meeting those requests harder,” Ung says. “New technologies aren’t often fully vetted when launched, and there’s a learning curve for all parties involved.”
In fact, whether vegetarian or not, softgels in general inherently test manufacturers’ capabilities. As Steve Holtby, president and CEO, Soft Gel Technologies Inc. (SGTI; Commerce, CA), says, “Softgel production is a very unique and complicated process.” And given his company’s softgel focus, he should know: “Not every manufacturer can do it.”
Among the challenges is the high level of training and skill operators need to run encapsulation equipment smoothly and efficiently. For example, “During the rotary process,” Holtby explains, “the gelatin temperature, ribbon thickness, seam width, and fill quantity all need monitoring and control. This involves high precision and requires constant oversight. Inaccuracies make production costlier.”
Yet the quest for newer delivery forms continues.
The difference, Ung says, is that he sees experienced brands taking “a much deeper dive” into their target formats’ requirements, better to grasp-and clear-the three main hurdles to launch: equipment, ingredient compatibility, and stability.
Consider equipment. “With novel dosage forms, there isn’t a lot of equipment or expertise on how to run it,” Ung says. “Oftentimes, novel delivery forms are manufactured using customized or modified equipment. Then there’s a whole other discussion regarding equipment validation, maintenance, parts changes, and more, which all factor into novel format production.”
Buchholz knows this firsthand. “Our management realized that we wouldn’t be able to use existing equipment to make the highest-quality product, so we looked globally for technology, equipment, and production leaders and began vegetarian softgel production from the ground up,” he says. “Many of the machines we use today are customized to our facilities and unique requirements.”
Can’t We All Just Get Along?
As for ingredient compatibility, it may be the most tenacious sticking point to bringing new delivery forms online.
“One of the biggest challenges we encounter is when a brand owner wants a dose form for a product that’s simply not compatible,” Tricarico says. “A perfect example is a tablet that contains an oil-based ingredient, such as vitamin E or fish oils. The oil makes it incredibly difficult to compress the tablet, and thus an alternative dose form needs to be selected.”
Given that oil-based actives are often as incompatible with capsule, gummy, and water-based formats as they are with tablets, Holtby says, “they often need to be converted into water-dispersible or dried forms” prior to incorporation. “While this allows for their inclusion in such formats, it also typically reduces the nutrient’s potency significantly.”
Other compatibility challenges involve incorporation of oxygen-sensitive components into tablets or two-piece capsules that see exposure to air. (Holtby’s suggestion: Don’t do it; opt for softgel encapsulation instead.)
Majeed points to his company’s Bi-Layer INC integrated nutritional composites as a tablet technology that lets brands keep two ingredients separate while delivering them in a single tablet. He says the format is great for physically or chemically incompatible ingredients-think acids and bases, or enzymes and substrates-and for situations when seeing the two separate layers helps educate consumers as to each one’s unique role in the formulation. Even better, Majeed adds, “The resulting bilayer tablets are almost the same size as regular tablets.”
Close kin to the hurdle of ingredient compatibility is finished-product stability. And though FDA requires no expiration date on dietary supplements, “brands have an expectation of printing an expiration date anyway, and the date needs to be substantiated by stability studies,” Ung says.
Several years ago, Buchholz’s team accepted the challenge of making a shelf-stable softgel-encapsulated probiotic. “Probiotics have been among the most popular categories within the past few years, but production proved challenging because most strains are sensitive to heat, moisture, and oxygen-and softgel production requires heat and moisture,” he says. In response, his team developed a platform that delivers viable probiotics and maintains viability for two years. Says Buchholz, “It’s now astounding that there once was no way of producing a shelf-stable encapsulated softgel probiotic.”
His stability advice for brands: “Run pilot tests when possible. That can be expensive, but in the long run it may end up saving time, stress, and money by taking care of the prep work at the start.”
One advantage of contracting with manufacturers is that they can shoulder this prep work-from dotting FDA’s “i”s to scheduling pilot runs and testing shelf life. But brands only benefit from this expertise if they know how to access it. And that involves clear communication.
Or, as Ung says, “Communicate, communicate, communicate.”
Tricarico agrees. “If your account or order manager isn’t updating you regularly during the manufacturing process or answering your calls and emails, those should be red flags that you’re working with the wrong contract manufacturer,” he says. “You also don’t want a contract manufacturer who’s a ‘yes man.’ A good contract manufacturer will push back to an extent and offer either constructive feedback or an alternative solution.”
Adds Holtby, “Clearly articulated requests are important to a successful partnership. It’s imperative for a customer to establish clear priorities that meet the company’s needs.” That means not only tending to matters of product integrity-using clinically substantiated ingredients, say-but minding factors like price, timelines, and batch sizes. His company spends considerable time advising customers on what is and isn’t realistic. “One advantage of having a skilled and experienced sales team like ours is that it promotes clarity and understanding of the customer’s expectations.”
Oh, expectations. “Today’s market is driven by consumers doing research, and sadly, some of that research isn’t always correct,” Buchholz says. “Our team has had numerous conversations that began with, ‘I saw this product online so I know it’s possible,’ while in reality some of those products may not be or do all they claim.”
Ung sums it up simply. “There’s a well-known scenario of being able to pick only two out of these three: good, fast, and cheap,” he says. “You can realistically expect only two when it comes to new product dosage formats.”