By Joanna Cosgrove
These concerns begin with the sourcing of raw ingredients. “The most important issues for Greenwood, SC-based Capsugel are safety and quality of raw ingredients in our products and the uninterrupted flow of product supply to our customers,” said the company’s Mark Vieceli, manager, Marketing and Business Development, Americas region. “We go to great lengths to make sure that the raw ingredients used for making the capsules—gelatins from bovine, porcine or fish sources, pullulan and HPMC—come from appropriate sources that can be traced and documented.”
Mr. Vieceli continued, “We also have a detailed audit procedure, which ensures our vendor’s processes are appropriate, so that when we receive our raw materials they are up to our standards. We verify that our materials are not adulterated through rigorous testing standards.”
Andrew Goldman, web marketing manager for Nutricap Labs, Farmingdale, NY, expressed similar thoughts. “[Safety and quality] is especially important when it comes to manufacturing tablets or capsules that need to be organic, vegan, kosher, herbal, all natural, non-allergenic, soy or gluten free,” he said. “Failure to manufacture a product to the exact specifications requested could spell disaster for a product line before it even gets off the ground.”
The safety and efficacy of capsule and tablet ingredients is especially important because many suppliers manufacture the products for both nutraceutical and more heavily regulated pharmaceutical applications. “We don’t distinguish between the quality of ingredients for capsules used in dietary supplements or pharmaceuticals,” commented Mr. Vieceli. “All are subjected to the same high level of quality and safety standards. We are audited by top multinational pharmaceutical companies. Our goal is to produce safe products because they are used for medicine as well as dietary supplements.”
As marketers look to create differentiation and a more pleasing consumer experience, an important trend impacting the dietary supplement market is the growth and diversity of new solid dosage forms. “Orally Disintegrating Tablets (ODTs) and chewable tablets offer young children, seniors and consumers known to have difficulty swallowing tablets a way to consume tablets virtually the same way as they do food,” said Tim Bee, senior director of pharmaceuticals for International Specialty Products (ISP) Corp., Wayne, NJ.
ISP’s Polyplasdone XL-10 disintegrant is used in fast melting forms because of its disintegration efficiency and excellent mouthfeel. “When introduced into water, the Polyplasdone XL-10 disintegrant quickly wicks water into the tablet through capillary action, creating the internal pressure that disintegrates the tablet,” explained Mr. Bee. “At the same time, the small particle size and narrow particle size distribution imparts a smooth mouthfeel consumers prefer.”
Another market trend is the growth in “high nutrient” content nutraceuticals, as developers of these products look to pack ever higher levels of actives into increasingly exotic formulas. “These denser formulas allow less room for binder ingredients and are more difficult to coat,” said Mr. Bee. “High efficiency materials developed by ISP for the pharmaceutical industry are finding their way into these formulas, including Plasdone S-630 Copovidone copolymer, which is self-affirmed GRAS (Generally Recognized As Safe). The chemical structure of the copolymer offers excellent adhesion properties, providing the benefit of efficiency-in-use.”
According to Mr. Bee, an additional trend pertains to poor solubility of “actives.” “Given that inefficiency in this area is believed to impact the bioavailability of nutrients…particularly with reports in the mass media questioning the efficacy of vitamins and supplements, conscientious producers want to be sure the products they make perform as intended,” he said. “ISP’s Polyplasdone superdisintegrant is relevant to this discussion because it enhances the solubility of poorly soluble actives. Given that bioavailability is often a function of the dissolution rate, it is best to source a disintegrant that provides maximum solubility.”
One of the hottest trends in encapsulation is controlled-release and multi-release products, which entails putting multiple components in one convenient package. A new product format from Capsugel places beads within a liquid-filled capsule (pictured above). “The liquid dose is designed to offer quick release of an ingredient. The beads provide for a controlled or delayed time release,” said Mr. Vieceli. “The thickness of the bead’s coating can be changed so that some beads dissolve as soon as the capsule ruptures, while other beads dissolve later. The ‘beads-in-a-capsule’ product is also visually attractive—an added boost for product differentiation and instant consumer appeal. This novel design allows companies to design a multitude of looks using colorful beads, as well as colored and printed capsule combinations.”
Just as consumers are increasingly particular about the types of foods they purchase, they also are more carefully scrutinizing the ingredient panel of their supplements. “They are looking for natural solutions, products without additives and potential allergens, and freshness in food and other products,” said Capsugel’s Mr. Vieceli. “The group that wants vegetarian products continues to grow, even in this economy.”
To meet the increased demand for clean-label vegetarian capsules, the company is expanding its manufacturing capabilities for its HMPC capsules—a lineup that includes a new 16-color palette of natural colorants for gelatin and HPMC capsules.
Visual appeal was also a consideration at CapsCanada, which recently launched Platinum Caps, a two-piece capsule with a metallic look. Platinum Caps are available in a range of colors and color combinations (green, red, purple, blue, turquoise, orange, silver, gold, platinum, bronze, etc) in gelatin or vegetable HPMC according to customers’ needs. The metallic look is obtained with a light-reflecting pigment, Candurin, composed of titanium dioxide and natural mica (FDA-approved for use in food and supplements and a registered trademark of Merck KGaA).
On the tablet front, late last year, ISP introduced a unique solution to improve the efficiency of tablet coating. Called Advantia Preferred HS Coatings, the high solids system offers a very high level of adhesion. “This ‘super adhesion’ capability is significant in that it improves the appearance of tablets, and at the same time, reduces quality problems that may not otherwise be solved easily,” said Mr. Bee. “Advantia Preferred HS coatings are also a time saver. Production-scale coating trials conducted by ISP have demonstrated that spraying Advantia Preferred HS coating suspensions at up to 25% solids translates into a 43% savings in process time over traditional HPMC-based coating suspensions.”
Enteric coatings are another area of interest. “It’s a longer more costly process however enteric coating breaks down not in the stomach but in the intestines for different absorption,” commented Darren Schneider, vice president, CapsuleWorks, Ronkonkoma, NY.
Among other trends, Mr. Vieceli reported that the consumer desire for liquid capsule offerings is on the rise. “Tablets and chewables are steadily losing ground as capsules, and liquid-filled capsules in particular, are gaining,” he said. “Our survey of 1500 consumers in 25 markets at the end of 2008 verified this shift over the last five years. The reason is that people want dosage forms that are easier to swallow—and they attribute that to capsules. They also believe that liquid-filled capsules work faster and better.”
Capsugel manufactures a unique liquid capsule within a capsule, and like the “beads-in-a-capsule” it can combine multiple ingredients with different release profiles in a single dosage as well, including incompatible ingredients that must be delivered at different times and places in the body for optimum impact. The difference is that all the ingredients are in liquid form. “One specific product category that can benefit from a ‘capsule-in-a-capsule’ approach is probiotics,” said Mr. Vieceli. “The Pre-Pro Combo developed by Capsugel, for example, delivers a liquid prebiotic outer layer surrounding a quality probiotic contained in the inner capsule. The design enhances product stability by protecting the probiotic inner capsule in an HPMC capsule suspended in a glycerin formula. This creates an effective barrier to moisture, which helps the probiotic remain inactive until it is ready to go to work in your system.”
By all accounts, tablet and capsule innovation and manufacturing technologies are on the rise, which will no doubt solidify their position as the go-to delivery format preferred by nutritional supplement consumers.