Overall, the dietary supplement, over-the-counter and pharmaceutical industries are poised for continued growth as more consumers pursue the path toward health and wellness. Millennials are showing significantly increased engagement in the supplement market and report the highest increases in use over the past several years.
According to NMI, one of the major reasons people stop taking supplements is that they “simply got tired of taking them,” indicating an opportunity to increase compliance, or how closely consumers follow their dosing regimen.
A decade ago, according to a 2003 online survey of 679 adults conducted by Harris Interactive, 40% of U.S. adults said they have experienced difficulty swallowing pills, even though most never had problems swallowing food or liquid. Of those who experienced difficulty swallowing their medications, 14% said they delayed taking doses of their medication, 8% skipped a dose and 4% discontinued using their medication. Most described the sensations as having “a pill stuck in their throat” (80%), having a “bad aftertaste in their mouth” (48%) or gagging (32%).
The Right Recipe
While some people still have trouble swallowing pills, technological improvements offer manufacturers and consumers a wide, expanding range of innovative dosage forms. The days of large, chalky, hard-to-swallow “horse pills” are history.
“Higher quality excipients, production methods such as fluid bed granulation, microencapsulation, the emergence of vegan soft gel capsules and the explosion of variety in dosage forms has presented new choices for consumers,” said Sam Wright IV, CEO, The Wright Group, Crowley, LA. “Nutrients can be ingested as coated tablets, which are easier to swallow, soft gel and two-piece capsules, sachets, effervescents, chewables, shots, gummies, chews, dissolvable films and more food-like forms like shakes, functional beverages and nutrition bars.”
One size does not fit all in terms of dosage forms, as manufacturers need to take a tailored approach, according to Kenn Israel, vice president of marketing, Robinson Pharma Inc. (RPI), Costa Mesa, CA. “Different active ingredients perform better in different delivery systems. For example, calcium works very well in tablets and high volume liquids, however, it is not particularly well suited for two-piece hard-shell capsules, soft gels or some other delivery systems. Calcium formulae typically require a substantial volume of material to provide a benefit. We feel that using the right dose form is critical to building formulae that the consumer will yield benefit from.”
On the other hand, ingredients like lutein, lycopene, krill oil and CoQ10, benefit from soft gel encapsulation, he added. “These nutrients are delivered more effectively, they don’t stain your teeth, encapsulation hides bad smells and in a lot of cases the bioavailability of the ingredient is significantly improved, so you’re getting more bang for your buck and less headaches.”
Certain species of probiotics can now be encapsulated in soft gels as well. “Because soft gels in the North American market are the most preferred dosage delivery system, this opens up new markets for these incredibly important bioactives,” said Mr. Israel. “The unique IS-2 bacillus coagulans that we’re marketing is the first shelf stable, clinically proven probiotic available in a soft gel.”
Microencapsulated ingredients, according to Mr. Wright, “work very well in increasingly complex formulations where taste, reactivity, stability and other organoleptic properties are challenging. Time-release ingredients also benefit from microencapsulation technology.”
In addition to tailoring the dosage form to the active ingredients, manufacturers need to consider their target audience. “Older consumers in particular have trouble swallowing tablets,” noted Mr. Wright. “Younger consumers tend to prefer more food-like delivery formats. Every consumer is busier and more mobile, so these new delivery options help to meet consumers’ needs where they are, at any given moment.”
Overall, manufacturers must consider several issues, including stability, solubility in liquid formats, bioavailability, taste, ingredient interaction and expiration dating, noted Mr. Wright. “There are a variety of microencapsulated ingredients available in the market that can help overcome these technical challenges, such as our SuperCoat and SuperTab.”
Consumers today are more aware of nutrient absorption and bioavailability, according to Robin Koon, executive vice president, Best Formulations, City of Industry, CA, and are more discerning in their selection of products. Several technical matters have also improved absorption, he added, including the selection of raw materials for particular dosage forms (e.g., lipid-soluble nutrients like CoQ10 for soft gels); formula enhancements with excipients that aid absorption; and further processing, such as enteric coating or bi-layer tablets.
Cost is also an important factor to many customers. “Certain dosage forms are traditionally more cost effective than others,” Mr. Koon said. “Tablets are the most cost effective dosage forms, generally speaking. Soft gels have always had a more pharmaceutical look and feel, and therefore have a higher perceived value, generally speaking.”
The quality of products on today’s market has improved considerably, he added. “Because of the GMP (Good Manufacturing Practice) regulations, more companies are performing much more testing—stability studies, disintegration/dissolution tests, various assays, microbial, etc.—to ensure the quality of the dosage form.”
Driving a transformation in dosage forms, Millennials and Generation Y consumers are increasingly incorporating supplements into their health regimens; and they are demanding convenience along with an overall pleasant experience, according to RPI’s Mr. Israel. “They are not into their mom’s and dad’s tablets, capsules and soft gels. They are excited by other delivery systems, specifically liquids, functional beverages, strips, chews and other novel dose forms.”
However, recent technological advances are helping to attract and retain a younger demographic. For example, “the push toward clean labels has really heated up,” Mr. Israel added. “The questions are now about providing whole ingredients, non-GMO, organic, raw, unprocessed, with minimal or no excipients, artificial colors, flavors or sweeteners. It is really a return to the roots of what natural was all about.”
Missy Lowery, marketing manager, Capsugel Americas Region, Morristown, NJ, agreed, saying the clean label concept is especially important for the natural, vegetarian and organic-oriented shopper. “A capsule can better address this consumer demand because most capsule formulations require fewer excipients than other dosage forms, especially tablets.”
“In general, capsules lend themselves to ever changing and ongoing development of design for nutrient delivery,” she added. “They are a very flexible delivery form. Key traits include greater functions with excipients, improvement of ingredient bioavailability, better dissolution and enhanced protection of content. They are often easier to swallow as well.”
Capsugel’s technology for hard capsules has improved in recent years with advances for multi-release dosage forms, liquid-fill dosage forms, plant-based polymers and natural colorants, Ms. Lowery noted. “Consumers have increasingly felt that ingredients can be better absorbed and more effective through synergistic combinations and/or via targeted, timed delivery. Indeed, consumers are buying more combination supplements worldwide. In 2011, Euromonitor posted that combination supplements were the third leading sales category ($7.4 billion) globally. Combination supplements also ranked seventh in terms of growth category leaders.”
Busy, stressed consumers are also drawn to the convenience and value of two or more ingredients in one package, such as fish oil paired with CoQ10 for hearth health or increased calcium uptake when taken with vitamin D.
To meet this growing market demand, Capsugel’s Licaps technology has been advanced to handle multi-release products. The company offers two forms of Licaps capsules for such delivery: beads in liquid-fill capsules and a capsule-within-a-capsule. For beads in a liquid-fill capsule, the liquid dose is designed to offer quick release of an ingredient while the beads provide for a controlled or delayed time release. The beads can be floating in liquids; or beads or powders can be contained in an inner capsule suspended in an outer liquid-filled capsule. The thickness of the beads’ coating can be changed so that some beads dissolve as soon as the capsule ruptures, while other beads dissolve later.
A liquid capsule-within-a-capsule is a similar delivery innovation for combination products. It works for incompatible ingredients or ingredients that would separate if mixed together, according to Ms. Lowery. It is different from beads-in-a-capsule in that all the ingredients are in liquid form. Probiotics combined with prebiotics work especially well in this format, she noted.
In such a crowded market for dietary supplements, how can a product stand out? “Research shows that color is the primary way that consumers recognize and remember their dosage forms—more than through shape, size or brand name,” said Ms. Lowery. “Today, you can choose opaque, translucent or transparent capsules in one or two colors. You also can add a pearlescent effect to any color, thanks to a change in U.S. regulations in 2006. You can also choose colorants made from natural sources to appeal to the special lifestyle market.”
Gabriel Eilemberg, director of business development, CapsCanada, Pompano Beach, FL, also said there are some generally accepted advantages to using capsules over other dosage forms. “For manufacturers and formulators, using capsules means fewer excipients, faster development, fewer manufacturing steps and more formulation flexibility. For patients, capsules are easier to swallow than other dosage forms, have better taste-masking properties and result in reduced gastrointestinal irritation.”
In addition, capsules boost compliance with a supplement regimen. “Although often overlooked, high compliance is critical to the effectiveness, and financial success, of any supplement or drug product,” said Mr. Eilemberg. “Capsules are perceived as more effective than other oral dosage forms—they have a higher perceived value. Capsules offer unique opportunities for product/brand identification and differentiation through limitless color combinations and printing options—a benefit other dosage forms can’t match.”
It’s important for manufacturers to consider all the variables and not just focus on production speeds, he added. “It is often the case that when all variables are taken into consideration—including inventory, validation and other operational costs—capsules are the more attractive choice.”
In late 2013, CapsCanada expects to launch AR-CAPS, which the company claims to be the first enteric capsule. AR CAPS resist stomach digestion, protecting ingredients from the acid environment of the stomach, said Mr. Eilemberg. They then disintegrate in the small intestine, delivering ingredients where they are supposed to be delivered. “AR CAPS will be the first truly enteric capsules (i.e., they meet USP enteric requirements) and therefore are approved for both dietary supplement/nutritional and pharmaceutical applications. AR CAPS enhance product appeal while reducing manufacturing costs by eliminating the enteric coating process.”
The company also sells HPMC capsules without gelling agents under its K-CAPS brand. According to Mr. Eilemberg, benefits include increased productions yields, product appearance and USP compliant dissolution—capsules dissolve where they need to dissolve.
Old School vs. New School
Larry Vars, technical support, tablets, PJ Noyes Company, Inc. Lancaster, NH, which specializes in large chewable tablets, said availability and understanding of excipients to enhance product characteristics has progressed significantly.
“The attributes of the excipients and how they interact with other ingredients/raw materials in the tablet formulation have allowed improvements such as reduced tooth packing in a chewable and better flavors due to improved masking of ‘odd’ flavors. As more natural materials are used in dietary supplements, the control of a consistent flavor is challenging. The use of new flavors, flavor enhancers and masking agents facilitates our ability to provide a consistent flavor.”
The source of natural ingredients as well as harvesting and processing techniques have changed to reduce or eliminate undesirable characteristics, such as bitterness, he added. “Another method to create a palatable flavor of a chewable tablet is to choose a flavor that matches the natural ingredient. If you have an ingredient that provides a tart flavor, then choose to flavor your product in a similar way. A tart or tangy ingredient might be flavored ‘sour apple,’ which would meet a consumer’s expectations. You wouldn’t want to have an ‘off’ flavor such as bitterness in a strawberry flavored tablet.”
Technology is constantly improving in both the more traditional delivery systems such as tablets, capsules and soft gels, as well as newer formats such as Strip Melts fast-melting oral strips, according to John G. Tobin, president/CEO at New Jersey-based NutraFood Science Delivery System, Inc. Manufacturers should consider several factors when choosing a supplement form, he said, including the dosage of the active ingredient required to ensure consumers receive a health benefit.
“Ingredients that are mostly destroyed in the GI track, like resveratrol, are ideal for Strip Melts oral strips because the molecular weight of that ingredient can have a rapid uptake in the oral cavity as it is ingested or swallowed. The proprietary technology involved in loading 200-250 mg or more of an active ingredient in an oral film-strip is a benefit to both consumers who cannot take tablets, capsules or soft gels as well as ingredient companies who are looking for new and different ways to differentiate their ingredients for products in the marketplace.”
Strip Melts are convenient, effective and do not require water to aid in the process of ingesting or swallowing the product. However, they are limited to less active ingredients per serving compared to tablets and capsules. “Masking and flavoring the strip with various ingredients can be a marketing asset as well as a drawback if it happens to be a difficult ingredient to mask or flavor in some cases,” said Mr. Tobin.
However, Strip Melts oral strips offer a safe and effective format in delivering condition-specific products to infants or young children as well as seniors, who may have trouble swallowing traditional products.
Overall, advances in dosage forms that allow for tailor-made supplements based on specific demographics will help propel the supplement market forward. “We feel we are entering a new golden age of nutrition,” noted The Wright Group’s Mr. Wright, citing rising healthcare costs and a “proliferation of positive science on nutritional ingredients.”