Tablets, capsules and soft gels represent a basic need to the nutraceuticals industry. However, most experts would agree that these delivery vehicles are anything but basic. Indeed, these formats require precise engineering and development to get consumers the nutrients they need in order to maintain optimal health. Trends & IssuesTablets, capsules and soft gels have undergone several significant transformations over the years, resulting in improved formulations and delivery of ingredients. The increasing consumer demand of dietary supplements, which brought in $18.7 billion in sales in 2002, according to Nutrition Business Journal, San Diego, CA, has forced a competitive environment for companies vying to meet varied consumer needs by making slight alterations to existing products.Discussing this trend was Bill Chekan, global director of marketing, Capsugel, Greenwood, SC. “In the battle for market share, particularly when the product lines of many nutraceutical companies include the same product (i.e., glucosamine, ginkgo, MSM, etc.), there has been heightened activity to show that the dosage form itself is a form of differentiation,” he said. “At a ‘tactical’ level, labels that used to simply say ‘60 capsules’ now say things such as ‘60 Easy-to-Swallow Capsules,’ ‘60 Enterically Coated Capsules,’ or ‘60 Vegetarian Liquid-Filled Capsules.’”Additionally, as pointed out by Marco Bootz, sales and marketing manager, Gum Base, Lainate, Italy, the growing popularity of supplements has also pushed companies to make these products more pleasant to consume. As a result, companies have strengthened their positions by building brands that distinguish their products from others out there, a challenge made increasingly urgent if their patents are expiring or can be bypassed. “Increasing functional product lifecycles through brand extensions and brand innovations is one tactic being pursued,” Mr. Bootz said. “But another major tactic is looking at new vehicles for delivering existing functional products. The selection of the delivery system has to be done on a case-by-case basis through the evaluation of the total product concept. In the end, however, the objective still needs to be to deliver an enjoyable experience to consumers.”At Arizona Nutritional Supplements (ANS), Chandler, AZ, Greg St. Clair, president, said he has seen requests come in that run the gamut. “ANS has seen an increase in requests for unique forms of tablets and capsules,” he said. “The developments in aqueous-based coating systems have led to an increase in the amount of unique color coatings requested. In addition, requests for vegetarian products have increased leading to use of more vegetarian capsules and use of excipients, which meet vegetarian standards. Lastly, there has been an increase in the availability and requests for liquid capsules.” Discussing trends in all three segments—tablets, capsules and soft gels—was John Altenberg, vice president—Marketing, Leiner Health Products, Carson, CA. “Tablets are still the dosage form of choice for supplements in general due to price and familiarity. If a company brings forth a product in a tablet and then introduces it in a soft gel, consumers may not want to pay the premium,” he explained. “However, for the fat-soluble ingredients such as CoQ10, fish oils and vitamin E, soft gels are the preferred form of delivery and continue to do well.” He added, “Some people shy away from capsules because of potential tampering issues. However, I know there is technology now where the capsules can be heat sealed to minimize tampering. In addition, I believe two-piece capsules are still the dosage form of choice when it comes to herbals because they capture the value and benefit of the whole herb.”Mr. Altenberg also discussed the issue of compliance, singling out “swallowability” as a barrier for some dosage forms. “Swallowability is still a big issue with larger tablets and soft gels,” he said, adding, “Also, consumers do not comply with directions that advise them to take a certain amount of pills throughout a given day. Asking consumers to take two to three pills a day of a particular product is a very difficult proposition with respect to dietary supplements. Some products lend themselves very well to once-a-day dosing but others are more challenging.”The issue of compliance was also highlighted in the 2003 Health & Wellness Trends report published by the Natural Marketing Institute (NMI), Harleysville, PA. According to the report, 17% of consumers are dissatisfied with the quantity of pills they take, while 17% claim to have difficulty swallowing pills/capsules. As a result, almost a quarter (23%) prefer to get their supplements in other forms besides pills or capsules. That said, tablets, capsules and soft gels still lead the pack in the dietary supplement arena with a majority of consumers still preferring to get their supplements in these formats—tablets (66%), capsules (65%) and soft gels (60%). Another trend, according to Mr. Chekan, points to the use of new or novel nutraceutical products, where the “protective” aspects of the dosage form play a strong functional role. For example, he said, some extracts of natural products derived from fruits and vegetables require protection against oxidation during manufacture, shipment and storage. Additionally, he said, such novel extracts may be sensitive to moisture. In such cases, the selection of the right dosage form is critical to maintaining product stability and performance.
Dosage Form DevelopmentsCompanies are experimenting with innovative means of delivery on a regular basis. One company that has been busy researching how its product could play a part in the supplement market is Gum Base. Mr. Bootz explained, “Companies exploring innovations in functional products are taking a closer look at our compressed powder gum concept as a viable delivery system because it allows for easy and pleasant administration of active principles, and makes them easier to consume at any time.”At the heart of this approach, said Mr. Bootz, is chewing gum that can be manufactured in powder form to which active principles can be added and compressed into tablets—ready to be coated and/or packed. In addition, Mr. Bootz said, “Gum is particularly suitable for a pleasant, sub-lingual absorption of actives. When low temperature processing is needed to accommodate the use of active principles that are heat-sensitive, including bioactives and phytochemical components, compressed gum is an appropriate vehicle.”Another advantage of Gum Base’s technology, according to Mr. Bootz, is that it allows functional products to be tailored to individual brands and flavors, giving the manufacturer a greater amount of flexibility. And manufacturing the compressed powder gum is relatively hassle-free. “Launching compressed gum products can be an easy operation since (with some technical support and adaptations) conventional tablet presses can be used for production—a very important consideration when ‘time to market’ is key,” said Mr. Bootz.Liquid-filled dosage forms are growing, as consumers inherently relate “liquids” with positive perceptions of faster acting, and easier and gentle absorption, according to Capsugel’s Mr. Chekan. “Liquids typically allow ‘combination’ products to be formulated easier,” he said. “Furthermore, fast-melt formulas, which do not require water for administration, certainly have appeal for pediatric and geriatric populations, where swallowing can be problematic.”
The Potential GMP ImpactMr. Bootz of Gum Base said the proposed GMPs (good manufacturing practices) would impose stricter controls on raw materials and finished products in terms of identification, quality, purity, composition and strength. In addition, he said the degree of impact would depend on the size of the company. “The companies that would most be affected by these new requirements would most likely be smaller companies that need to put more quality checks in place. In general, larger companies already apply these guidelines,” he said, adding, “But overall, the effect will be positive since everyone will be following the same guidelines, creating more of a level playing field in the market. Furthermore, the resulting stricter regulation and control can be expected to raise consumer confidence and lower skepticism regarding quality and validity of new functional products coming to market.”Capsugel’s Mr. Chekan offered his perspective on the potential GMP impact. “Long term, from a dosage form perspective, one potential impact will be that dissolution issues related to over-compressing of tablets will not be as prevalent as today,” he said. “Also, tablet-manufacturers will likely stress the use of formulations that require less chemical binders and fillers to minimize the investment in GMP documentation and validation resources.” He continued, “For capsule companies, who have already implemented GMP controls to meet the needs of pharmaceutical customers, there may be a need to expand the capability of their quality systems in order to meet a wider array of individual customer requirements.”To ANS’ Mr. St. Clair, the finalization and implementation of the proposed GMPs will be one of the most important issues companies will face in 2004. “The biggest issue we will see this year, which dominated last year as well, is the finalization and implementation of the new GMPs,” he said. “ANS and others within the industry have been asking for enforceable standardized GMPs for a considerable time. Some manufacturers have raised the bar for quality standards and have voluntarily taken part in GMP certifications offered by groups like NSF and the NNFA; but as long as others are allowed to not follow GMPs, the rest of the industry suffers.” Mr. St. Clair said it is difficult to speculate as to what the finalized GMPs will look like. However, he said, the need for comprehensive testing of raw ingredients will surely be an integral part. “Having an in house laboratory will be crucial to success in the future,” he explained. “ANS’ testing capabilities include high performance liquid chromatography (HPLC), FT-IR spectrometer, thin layer chromatography (TLC), gas chromatography, microbial analysis, friability, moisture analysis, disintegration, dissolution and stability. Regardless of the final form of the GMPs, it is important that manufacturers can be assured they are meeting the proper specifications for the products they manufacture.”Of major concern to ANS and numerous industry groups, according to Mr. St. Clair, was the amount of duplicate testing required above and beyond what is required for the manufacturing of drugs. “Many of the formulas out on the market have complex matrices of multiple ingredients, which can be incredibly costly and, in some cases, impossible to test in finished form,” he said. “GMPs that are stricter than those in place for pharmaceutical products would have the effect of unnecessarily raising costs to the consumer and could unfairly deprive customers of many specialized formulations.” Richard Salzstein, pharmaceutical sales and marketing manager, Aqualon Division of Hercules Inc., Wilmington, DE, said he believes that the quality aspect of tablets and capsules will take a larger command of R&D and manufacturing with the focus on GMPs and the constant need for cost-effective and general cost improvement. “GMPs will indeed require some companies to improve their processing and documentation to ensure quality products compete,” he said. “Manufacturing will no longer be considered at the end of the line for product development in some houses, but will be an integral part in the product development lifecycle, knowing the requirements for GMP and cost-effectiveness. This could cause a shake-up in some production units but the strong will survive for the industry good.”
The FutureIt is hard to make predictions about the future, especially with finalized GMPs for dietary supplements being a huge question mark at the moment. However, Capsugel’s Mr. Chekan offered a few predictions. “Future drivers of capsule preference will likely remain intact. Health conscious consumers tend to be well informed, and they will remain sensitive to avoiding the added sugars and starches that can be associated with chemical-based tableting agents,” he said. “Other considerations that will continue to drive capsule preference include ease-of swallowing, as well as an elegant visual appearance.”Aqualon’s Mr. Salzstein believes the industry will continue to trend toward ever-larger active doses in individual tablets and capsules. “This mounts a manufacturing challenge, which I find a good one for Aqualon,” he said. “We provide efficient tablet binding with our Klucel Nutra™ modified cellulose tablet binder. As in the pharmaceutical industry, nutraceutical producers have embraced the ability to provide smaller tablets with efficient low-volume binders, displacing larger volumes of less efficient binders and fillers.”Mr. Altenberg feels the future for dietary supplements hinges on improving compliance. “Glucosamine and chondroitin started out as six pills a day and now it’s down to two pills a day to get the same amount of active ingredients,” he said. “There is always going to be a convenience factor that will be important to supplement manufacturers and although the industry has made considerable progress, there is still a long way to go. Clearly one pill a day dosing is the ultimate goal.”