Leakers are softgels which lose their fill due to faulty capsule seams and are a major cause of lost productivity and reduced yield for producers of softgels, according to the firm.
Easyseal has been created to overcome the issue, with "optimised seam forming" and "enhanced seam thickness and stability" so that soft capsules are more resistant to physical stress.
Additionally, the innovation is less dependent on sealing temperature than other gelatins and has superior drying properties, thereby improving energy efficiency and enhanced production capacity.
Therefore the new product should allow manufacturers to seal capsules reliably, even at high speeds, with suspensions that are normally complicated to fill, and in the creation of products that require special equipment such as double step die tooling.
Jessica Pfoehler, global marketing, business unit performance solutions, Gelita AG, says: “Many manufacturers tolerate a reject rate of up to five percent in soft capsule production due to leakers. With Easyseal, this common industry problem will be a thing of the past – simply by changing one parameter: the gelatin.”
When developing Eeasy, Gelita conducted a survey of softgel manufacturers and found out that lecithin, pastes and (herbal) powders are the most challenging fills. `
As such, in industrial trials, Easyseal was tested using krill oil, soy lecithin, a turmeric extract and suspension based on sunflower oil (a plant extract from berry seeds) in order to ensure it would work with even the most challenging of suspensions.
Pfoehler adds: "For such ingredients, Easyseal is the perfect gelatin solution for manufacturers: It improves softgel seams thus preventing leaks and makes the manufacturing process more robust and cost effective.
"Easyseal is a more sustainable solution, too, as there is less raw material waste and reduced energy consumption due to shorter drying times and a higher yield."
The new solution is available in bovine and porcine forms produced in line with FDA regulations, and a respective China Drug Masterfile is available to ease entering the China market.
The soft capsules market
The firm notes the global pharmaceutical gelatin market for soft capsules was worth more than USD 215 million in 2022 and is expected to grow at a CAGR of 6.1 percent, according to figures from MarketsandMarkets.
Discussing the range of ingredients which work in this format, Pfoehler asserts softgel capsules are the perfect delivery format for oils and the most common ingredient is omega-3 fish oil.
"That said, plant extracts, essential oils (eucalyptus/cineol und peppermint oil), multi-vitamins (especially fat-soluble vitamins such as vitamin D) and multi-minerals are also very common."
She argues the softgels market has been held back by the issue of leakers in the past.
"Softgels are a growing market, yet the use of nutritional ingredients and [active pharmaceutical ingredients] results in complex and challenging fills that require special care when it comes to the manufacturing process.
"As there have been no satisfactory solutions to this problem, manufacturers tended to avoid the use of certain ingredients."
Discussing the consumer benefits of softgel capsules, Pfoehler explains these are often considered easier to swallow than hard capsules.
"Furthermore, consumers appreciate that capsule size and colour can make it easier to identify the respective pharmaceutical drug or nutrient contained within. Softgels are also the perfect format for ingredients with a strong taste or smell."