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Innovations in Vegetarian Softgels

The term vegetarian appeared more than 160 years ago. On Sept. 30, 1847, Joseph Brotherton and others at the inaugural meeting of the Vegetarian Society of the United Kingdom used the term in earnest. The terms original definition was with or without eggs or dairy products, which is still used by the Vegetarian Society. One segment of vegetarianism is veganism, a term that was invented by Donald Wilson in the 1940s, referring to a total lifestyle seeking to exclude the use of animals for any purpose, including food and clothing. Veganism excludes ingestion of animal flesh (meat, poultry, fish and seafood), animal products (eggs and dairy), and, usually, excludes honey; it also bans the wearing and use of animal product, such as leather, silk, wool, lanolin and gelatin.

Today, more consumers are looking for all-natural, vegetarian and vegan products. In fact, a 2002 Time/CNN poll found 4 percent of American adults consider themselves vegetarians, and 5 percent of vegetarians consider themselves vegans, suggesting 0.2 percent of American adults are vegans. And Mintel reported in 2008 that vegetarian/vegan, low-carb, low-fat, gluten-free, light, organic, trans fat-free, natural, healthy and low-calorie are the top 10 health claims on menus.

Manufacturers have responded in new ways to add these new consumer benefit claims to their products. To be truly a vegetarian product, the entire dosage form must not contain any animal products (except egg or dairy). Unfortunately, many so-called vegetarian softgels may contain vegetarian fill ingredients, but are enclosed in gelatinan animal product derived from cattle (bovine), swine (porcine) or fish (piscine). The use of animal gelatin in softgels can be a serious issue for many people or markets in the world because, whether for religious, regulatory, cultural or personal preferences, the ingestion of animal or specific animal products is unacceptable. Thus, non-animal or vegetarian softgels have a growing position in the marketplace.

However, finding a suitable vegetarian substitute is no easy task. A clear definition of a gel has thus far been elusive. Rheologically, a sample is said to form a gel when it acquires a non-zero shear modulus, referred to as a semi-solid colloidal system consisting of a solid dispersed in a liquid. For oral use, many substances can be made into colloidal gelsstarches, gums, celluloses, collagens, etc.; but, most of these compounds simply cannot make gels that are strong enough to work or function as needed in a softgel capsule. In fact, there are very few vegetable-derived substitutes that can become a bio-polymer as strong and tough as animal gelatin that can be ingested. Additionally, there have been some drawbacks in using these kinds of vegetable-based softgels compared to normal gelatin:

  • shell brittleness, resulting in some fragility (easily cracking, breaking open and leaking) of the softgel;
  • size/fill limitations (normally not larger than a 12 oval), a direct result of inherent brittlenessthe larger the softgel, the more apparent the problem;
  • limit of colorant usage and amounts able to be used for coloring the shell; and
  • possible incompatibilities between the fill ingredients and the shell materials, resulting in softgel failure, which is more likely to occur when powdered ingredients are added to the oil-based fill material (e.g., paste products).

Currently, there are non-animal or vegetarian commercially produced softgels available utilizing starches, carrageenans or carrageenan-starch blends to make the shell. Numerous formulation and/or ingredient patent applications have been filed in this area. Single starches (potato or tapioca with carnauba wax) have been somewhat successfully used to make small-sized softgels. Softgels made utilizing starch/carrageenans are a bit stronger than those made simply with starch. Some softgel companies have patented the use of a blend of iota and kappa carrageenans, along with other ingredients (such as starches).

One patented technology in the field was released by FMC Biotechnology using a new form of carrageenan. The company isolated a new carrageenan polysaccharide, kappa-2; it is a single polysaccharide chain that naturally contains both kappa and iota carrageenan. FMC patented the use of this ingredient and its related technology in the manufacturing of softgels; known as Sea Gel, the ingredient is now being used by several softgel companies under manufacturing license from FMC. The material is currently being used to produce strong, pliable softgels in sizes up to 20 oblongs, far exceeding the size capacity of most other options.

Robin Koon is senior vice president of Best Formulations , one of the licensees of FMCs patented SeaGel technology.

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