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Veggie caps capture imagination

Capsules free from animal products are becoming increasingly popular with consumers; Todd Runestad explores some of the technical challenges of making vegetarian capsules and how manufacturers are overcoming them

Nothing changes business paradigms like hard-hitting news. Five years ago, Canadian contract manufacturer Alta Natural started gaining business as a result of ?mad cow? disease coverage in the British media. At the time, Alta used hard gelatin capsules almost exclusively. This past summer, six months after the first case of bovine spongiform encephalopath (BSE) hit the US, Alta now does 60 per cent of its global business in vegetarian encapsulation systems.

?In the past, vegetarian capsules were harder to run because they were more pliable, but now even Pfizer is coming out with a new formula that?s more rigid and works better,? says Alta?s general manager Sherlock Lim. ?They run like a charm with whatever we?re putting inside them.?

Vegetarian capsules have indeed hit their stride. It?s gotten to the point where dietary supplements containing glucosamine sourced from bovine or pig trachea are even being housed in veggie capsules. ?It?s a selling point, regardless of what?s inside,? says Lim.

The most interesting aspect of vegetarian capsules is that their explosion in growth is not merely because they are an alternative to bovine-sourced gelatin.

?People ask for them because of religious or dietary reasons. And vegetarians are staying away from supplements if they?re not delivered in a non-animal format,? says John Barbee, senior vice president of nutritional sales and marketing for Banner Pharmacaps, which unveiled EcoCaps soft gels this year. They are derived from carrageenan, a seaweed extract. ?The key is to have the same characteristics as gelatin in appearance and usage.?

That challenge has been largely overcome, though it has taken some time to get things exactly right. ?The reason we haven?t made the switch to veggie caps for all of our vegetarian granulations is due to production issues,? says Ann Holden, vice president of product control and standards at Standard Process, a supplements maker in Wisconsin that is also sole distributor for MediHerb, an Australian herbal company.

?They really didn?t run that well on our machines at first. We had to run much slower on the capsule machines. The manufacturers must have listened to our complaints because they are much better now. We did buy two different types of capsule machines that are called intermittent, so that may have something to do with it. They seem to perform very well.?

Not only very well but, some would say, even better than gelatin. ?They are easier to work with,? says Ed Heywood, purchasing manager for ProPac Labs, a contract manufacturer in Utah that uses non-animal capsules 40 per cent of the time. ?They come together better. I know a lot of customers prefer them — manufacturers like veggies.?

Pioneering work by Capsugel
Many contract manufacturers have Capsugel to thank for the quantum leap in technological improvements. Capsugel, a division of pharmaceutical giant Pfizer, has dedicated an entire facility in Puebla, Mexico, exclusively to pharmaceutical-grade vegetarian encapsulations. It is the only plant in the world devoted solely to non-animal encapsulations for the dietary supplements industry.

?We have 80 per cent of the pharmaceutical market for two-piece capsules,? says Mark Vieceli, business development manager for dietary supplements in the Americas region for Capsugel. ?Yet only one pharmaceutical company has contacted us for our HPMC caps. Whereas most every dietary supplements company has.?

Capsugel?s Vcaps line actually has two lines. One is HPMC, which stands for hydroxy propyl methyl cellulose, a plant fibre. The second is the new NP cap line of pullulan, a natural polymer. The pullulan line is manufactured in Japan, where it is an accepted alternative to gelatin, whereas regulators there have not allowed the traditional HPMC line in. Meanwhile in Europe, pullulan is not allowed, but HPMC is.

?Pullulan has benefits of clarity over HPMC and has the lowest oxygen permeability on the market,? says Peter Zambetti, global business development manager for dietary supplements at Capsugel. ?Vitamin C, for example, is oxidatively sensitive in a capsule, but put it in pullulan, and you?ll see no browning of the vitamin C. This will extend the shelf life and the potency of the product.

?Gelatin?s a pretty good oxygen barrier,? says Zambetti. ?HPMC is pretty bad, but pullulon?s the best — it?s six times better than gelatin and 30 times better than HPMC. Pullulan is really the best of both worlds.?

Pullulan got its start with the Listerine breath-freshener pocket packs, which are thin polysaccharide polymer strips that quickly dissolve on the tongue. It?s no coincidence that Pfizer owns Listerine as well as Capsugel.

?HPMC is easily continuing that trend of increasing 50 per cent in sales year after year since we began marketing the Vcap in 1996,? says Zambetti. ?Especially after last December when the BSE scare hit the US, a lot of customers started moving away from beef-source gelatin. We also make gelatin from porcine, or pigs.?

The end result of veggie encapsulations is about one penny more per pill for consumers.

An array of options
The development of new technologies is a process itself. Along the way, manufacturers continue to learn about new materials and how they interact with different fill formulas. The result, though, is more options for supplements marketers and more opportunities for contract manufacturers.

?The demand is only increasing,? says Beverly Emerson, director of global communications and consumer health care marketing at Banner Pharmacaps, based in North Carolina. ?Particularly in Europe and Asia, consumers are looking for non-animal alternatives to gelatin.?

Plant-derived capsules are not the only game in town. Roxlor Inc, a European encapsulator, introduced Acticaps in 1999 and Aquacaps in 2001. Acticaps contain plant extracts — pineapple, red grapevine and wheat germ — naturally rich in bromelaine, tannins, flavonoids and vitamin E. These capsules provide a bioavailable supplement of these vitamins and minerals through digestion of the capsule.

Aquacaps, meanwhile, are produced with fish skin gelatin raised with plants, proteins and food in conformity with European guidelines for animal feed. These novel fish capsules are sensitive to temperature, so during processing and shipping, temperatures must be carefully controlled.

Another alternative to animal-derived delivery systems is a beta-carotene beadlet. Buckton Scott Group worked with BioDar in Israel to micro-encapsulate beta-carotene, a process traditionally done with gelatin.

?This is the first time someone?s taken beta-carotene out of a gelatin beadlet,? says Chris Nolte, vice president of sales for Buckton Scott. ?Beta-carotene is non-animal but unstable, so you must coat them to make them stable. You end up with a non-gelatin, non-GM, micro-encapsulated product.?

DSM has developed a non-gelatin, vegetarian-approved, beta-carotene beadlet under the CaroCare name. The beta-carotene is isolated from the fungal biomass of Blakeslea trispora by solvent extraction and crystallized. It is used as an excipient alternative to gelatin. ?Gelatin would be used as an excipient within the tablet-grade beadlets, but DSM beta-carotene beadlets do not need gelatin,? explains spokeswoman Kathy Freeman. ?The beadlets have strong pro-vitamin A activity because of the high number of trans-isomers found in Blakeslea trispora.?

Ultimately, the growing variety of encapsulation systems will benefit the entire industry. ?We respond to what the market demands,? says Alta Natural?s Lim. ?The clientele out there is looking for private-label premium products, there?s a strong switch to something that?s a higher-end capsule shell. And veggie caps is a higher-end product.?

Is gelatin safe?

Aconsumer who is aware that gelatin is derived mainly from cows is a shopper who is quickly looking for an alternative. This fear and loathing is derived mostly from the mad cow scare. Some say those fears are overblown because gelatin processing destroys BSE infectivity. Others aren?t too sure.

Gelatin is obtained from the partial hydrolysis of collagen derived from the skin, connective tissue and bones of animals. During gelatin processing, raw materials are exposed to purification procedures, including prolonged exposure to either acid or alkaline conditions, or both — processes that provide a safe gelatin supply for consumption, according to the Gelatin Manufacturers Institute of America. The raw materials are exposed to sterilisation, filtration and demineralisation, which have also been shown to significantly enhance the safety of gelatin.

There?s a difference, however, between enhancing safety and being safe.

?Alkaline or acid processing in gelatin manufacturing may only reduce rather than eliminate BSE infectivity,? says Morrie Potter, advisory committee member reporting to the FDA in 2003. He said brains and spinal cords from cattle from BSE countries should be excluded from raw materials used to produce gelatin for human consumption.


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