Advances in softgels, capsules, and tablets are keeping these formats at the forefront of the industry

November 12, 2018
Mike Straus

Volume 21, Issue 9

Capsules, softgels, tablets continue to hold their own thanks to the undeniable benefits they offer: consumer familiarity, format reliability, and robust quality controls.

What once was a dietary supplement landscape dominated by pills has since diversified, with delivery systems spanning everything from gummies and liquids to sublinguals, injectables, inhalables, chews, stick packs, and serving pods. Despite the competition, those longstanding, classic delivery systems are still going strong, and for good reason. While they may not have the novelty “flash” factor of a crystalline sprinkle system or edible wafer, these mainstays-capsules, softgels, tablets-continue to hold their own thanks to the undeniable benefits they offer: consumer familiarity, format reliability, and robust quality controls.

Recent technological advancements have made today’s softgels, capsules, and tablets even more convenient and more effective for consumers, and this next generation of classic delivery systems is well equipped to hold its own against newer formats. Here are just some of the scientific developments that are keeping traditional delivery systems at the top of the market.

 

Vegetarian Softgels Are Popular, but Still Challenging

The softgel industry is undergoing a shift with regard to ingredients and formulations in response to vegetarian demands. Steve Holtby, president and CEO of Soft Gel Technologies Inc. (Los Angeles, CA), says that rising demand for non-animal products is driving innovation in softgels-but further research and development is still needed to continue to improve the viability of non-animal softgels.

“There’s an increasing number of consumers who, for cultural, religious, or personal preference reasons, adhere to vegetarian, kosher, or halal diets,” Holtby says. “Additionally, the fear of animal-transmitted diseases is a growing concern. Softgel capsules can now be made from a variety of materials, including fish, chicken, and non-animal-derived gelatin, but vegetarian alternatives still present some drawbacks.”

Holtby says vegetable-derived gelatin substitutes lack the strong shell that characterizes animal gelatin, instead having a porous outer wall. This can mean vegetarian softgels have weaker shells than animal-derived gelatins, and are less capable of protecting ingredients from oxidation and degradation.

“Many find the oil inside vegetarian softgels to be rancid after only a few months,” Holtby explains. “Further research and development is needed on this front.”

Robin Koon, executive vice president of contract manufacturer Best Formulations (City of Industry, CA), says vegetarian starch–based technologies are gaining popularity in capsules and tablets as well. However, Koon says that manufacturer adoption is a slow process.

“We’re seeing interest in tapioca, pullulan, and enteric hardshell capsules,” Koon says. “Vegetarian technologies are continuing to expand, and there’s key interest in using various technologies to improve absorption and bioavailability. However, we’re not seeing any change in orders or production compared to traditional dosage forms, mainly due to price differential. Newer technologies generally cost more, so not everyone is switching to newer delivery systems.” Several companies like Captek Softgel International (Cerritos, CA) and SwissCaps USA (Miami, FL) are already using vegetarian options like HPMC, carrageenan, and tapioca starch.

The higher cost of materials and specialized equipment involved in making vegetarian delivery systems still presents challenges, but expect more advancements in the years to come.

 

LMP Technology Opens the Door to Fine-Tuned Delivery Systems

Recent developments in delivery technologies are improving the effectiveness of ingredients by allowing manufacturers to better design supplements with specific dissolution rates and release times. Tyler White, head of global consumer solutions innovation for Lonza (Basel, Switzerland), says that a delivery system known as Lipid Multi-Particulate (LMP) technology is starting to take hold in the industry for a variety of reasons.

A new form of microencapsulation, LMP enables manufacturers to vary the timing and rate of dissolution and ingredient release by enclosing active ingredients inside microspheres, White explains. These microspheres can be formulated to contain a specific microdose of active ingredients like botanicals, amino acids, or vitamins, and can deliver a metered dose at a timed release.

“LMPs also mask the taste of bitter ingredients like theacrine and botanical extracts,” White says. “Because LMP microspheres have excellent flow properties, they work in a broad range of finished dose formats, including powders and sticks for reconstitution in liquids, powder-filled capsules, liquid-filled capsules, ‘sprinkle’ capsules, and even tablets.”

White says that delivery system innovation trends are emphasizing a better consumer experience through easier use, and that the functional-food trend is evidence of this. If manufacturers can better align supplements with the experience provided by functional foods, he says, consumers may better incorporate supplements into their daily routine.

 

Easier to Swallow

Another recent development improving the user experience of softgels and capsules is addressing a common consumer frustration: difficulty swallowing supplements. Humera Ahmad, director of product development for Softgel–Asia Pacific for Catalent (Somerset, NJ), says that chewable softgels are now on the market, making swallowing problems a thing of the past.

“Catalent’s EasyBurst is a chewable softgel that delivers a strong burst of flavor along with the nutritional supplement,” Ahmad says. “It helps avoid problems swallowing, and it doesn’t require water.”

Ahmad points to consumer studies showing that softgels remain consumers’ preferred dosage format due to their ability to deliver a uniform dose and oxidant-resistant shell. Overcoming oxidation, Ahmad says, is a key manufacturer priority, especially as delivery systems become more innovative.

Says Ahmad: “With omega-3 delivery systems in particular, oxidation is a concern. Oxidation of omega-3 oils is irreversible, can introduce unpleasant physical characteristics, and may also reduce their nutritional value. One technique manufacturers are implementing to overcome this challenge is to introduce an antioxidant molecule to scavenge the free radicals that oxidation produces.”

Ahmad says manufacturers commonly use tocopherol, citric and ascorbic acid, and various spice extracts as antioxidant agents in omega-3 supplements. She notes that Catalent also uses a closed manufacturing system that blankets omega-3 oils in an inert gas from storage to processing to packaging, thereby preventing oxidation.

Delivery Systems to Become More Diverse, More Personalized

White says that traditional delivery systems are facing heightened competition from newer options, a challenge he says is typical of all longstanding technologies. A smaller barrier to entry means more diversity in delivery systems, with formats like gummies quickly gaining attention thanks to their novelty.

However, Barri Sigvertsen, Lonza’s marketing manager for consumer health and nutrition, cautions that gummies are not the nail in the coffin for capsules and tablets. Rather, Sigvertsen says traditional formats have a staying power built on consumer trust.

“The 2018 SORD study ”-produced from NMI’s Supplements/OTC/Rx Database and co-sponsored by Lonza-”shows that capsules are still preferred by 41% of supplement users,” Sigvertsen says, “with tablets and softgels in second and third place at 36% and 33%, respectively. Traditional delivery systems have proven performance and experience, while novel solutions might not be effective or fit into routine use.”

Holtby notes that classic formats are faring well against newer competitors like gummies, mostly because manufacturers have had quite some time to maximize active ingredient bioavailability with these older delivery systems. Factors like disintegration time, dissolution percentage, type of excipient, and nutrient form can all impact the bioavailability of any given supplement’s active ingredient, and manufacturers of classic deliveries have had time to work out the kinks-and excel. Softgels in particular, Holtby says, are widely recognized for their ability to increase bioavailability.

Sigvertsen says that consumers may experiment with newer delivery formats out of a drive to have more diverse experiences. However, consumers who are following a regular supplement regimen, Sigvertsen claims, will ultimately lean on the tried-and-true formats.

“While they might like to try the latest delivery innovation, consumers still prefer the simplicity, convenience, and ease of swallowability of established formats,” Sigvertsen says. “And with an encapsulated supplement, you’re only consuming what you need instead of the fillers that are present in bars and liquids.”

White expects that as personalized nutrition continues to evolve, mass manufacturing of small-batch delivery formats will drive success. While tablets, capsules, and softgels demand large batch sizes to maximize cost-efficiency, White says that the personalized nutrition market will result in innovations that make customized small batches of 30 to 50 units easier to manufacture.

Holtby says that an industry push to create a more substantial effect with a smaller supplement or dose size is going to open up opportunities in delivery systems. Synergistic ingredient blends, he adds, are enabling manufacturers to fit more functional ingredients into smaller supplements. “Convenience still has to remain top of mind for supplement manufacturers. Compliance increases with fewer doses and pills, capsules, and softgels that are easy to swallow,” he says.

As delivery systems continue to advance, softgels, capsules, and tablets will combine the benefits of a tried-and-true format that has widespread consumer familiarity with innovations that improve effectiveness and ease of use. Ultimately, these delivery systems combine the best of old and new technology, hence their staying power.

 

Sidebar 1:

Preventing Oxidation: Nitrogen Flushing and Hermetic Seals

Lonza’s Tyler White says that introducing established ingredients to new delivery systems sometimes demands an evolution of machinery and processes synthesizing past knowledge and new technologies. One of those innovations involves Lonza’s proprietary liquid encapsulated micro-spray sealing technology (LEMS) that can seal ingredients inside a liquid-filled hard capsule. After using nitrogen flushing to minimize oxygen levels and prevent oxidation, LEMS technology hermetically seals the capsule to prevent seepage of the filling and keep oxygen out of the capsule.

 

Sidebar 2:

Barriers to Innovation: The First-to-Market Pandora's Box

Best Formulations’ Robin Koon says that delivery system innovation in general is facing a very specific barrier: No manufacturer wants to be first to market with a new delivery system unless there is a clear market-based need or demand. The high cost of and unknown demand for new technologies make delivery system innovation an uncertain realm, and some of the newer technologies available to manufacturers have a steep and costly learning curve. However, Koon also notes that emerging approaches in the prescription drug industry may soon move into the nutritional supplement industry.

Says Koon: “Enteric systems, floating drug delivery systems, swelling and expanding systems, polymeric bioadhesives, and delayed gastric emptying are just some of the approaches in the drug channel. Oral dosage has progressed from immediate release to targeted delivery, and a variety of modified-release systems have emerged. These approaches, currently used in the prescription drug channel, will move into the nutritional channel,” he predicts.

 

Sidebar 3:

Working around Current Limitations

Established delivery systems can present challenges to innovation due to the nature of their design. Soft Gel Technologies’ Steve Holtby says that softgels are better suited to lipophilic compounds like oils and that sometimes water-soluble nutrients cannot be easily encapsulated.

“Softgel finished dosage forms aren’t suitable for hygroscopic ingredients due to moisture migration from the wet capsule shell into its fill,” Holtby explains. “Lost moisture from the shell creates brittleness, which makes the softgel fragile and can lead to cracking and leaking of the fill material.”

Holtby says that volatile water-based and hygroscopic compounds, emulsions, aldehydes, water-soluble compounds, and acidic or alkaline solutions can sometimes cause leakage, too. An experienced softgel provider can help companies determine whether softgels are suited to their application.

Holtby notes that problems with hydrophilic materials can be-and have been-solved through innovation. Soft Gel Technologies, for instance, uses a paste powder suspended in carrier oils to create a fine paste that can hold hydrophilic nutrients inside a soft gelatin capsule.

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