EASYSEAL® consigns a perennial problem to the past

December
05, 2023

4 min

#AmazingGelatin

Softgel capsules are a hugely popular delivery method among consumers of medicines and nutraceuticals, but for manufacturers, creating perfect capsules can be hit and miss.

The market for softgels is buoyant. Grand View Research valued it at USD 7.67 billion in 2022 and predicts that it will grow at a CAGR of 6.9 per cent from 2023 to 2030.¹ Consumers like softgels for several reasons, including ease of swallowing and effective masking of odor and taste. Softgels also offer good absortption, bioavailability and shelf life stability. However, during manufacture, things don’t always go according to plan and leakers are a common problem that can hamper quality as well as production efficiency.

Triggered by a variety of factors, including machine speed, processing temperature and raw materials in the capsule shell as well as the fill, leakers occur when softgel seams are not properly sealed. For manufacturers, this can cause multiple problems, including waste of ingredients, damage to additional capsule coatings, and contamination of surrounding capsules and production areas. For the consumer, leakers can mean they don’t receive the correct dose of active ingredient and they may experience unpleasant tastes and oral irritation.

We conducted a survey among the world’s leading softgel capsule manufacturers to establish the true extent of the leaker problem, and discovered they are a universal issue.

Our survey found that 100 per cent of manufacturers experience leakers, and there is a general feeling that they just have to be lived with. Despite trying various things to prevent them, including tweaking temperature and reducing machine speed (which hampers yield), more than half were prepared to put up with around 5 percent of leakers as an inevitable part of production.

We felt that 5 per cent leakers was 5 per cent too much. So we set out to develop a solution.

Eliminating leaking softgels

What we discovered was that by changing just one production parameter – the gelatin – leakers could be eliminated, or at the very least, significantly reduced. How? Well, all gelatins consist of complex chains of proteins, but they have different makeups, and these can be altered to achieve different end results. Our scientists discovered that one particular combination – we’ve called it EASYSEAL^® – delivers particularly impressive results and leads to more dependable, higher quality, less-likely-to-leak softgels.

The power of EASYSEAL^®

Following pilot trials with the University of Heidelberg, proof-of-concept has been demonstrated in industrial production conditions by several softgel manufacturers. In fact, EASYSEAL^® was proven to boost production efficiency by more than 30 percent, with reduced waste, shorter drying times and higher yield.

EASYSEAL^®increases capsule seam thickness by up to 50 percent, delivering robust capsules even at high speeds and regardless of whether the wedge temperature is 38°C or 43°C. Standard gelatin does not perform nearly as consistently under temperature fluctuation. In practical terms, this means far fewer losses, and no need for endless optimization of temperature parameters.

There are benefits during drying too. In a tumbler drying trial, the gelatin produced a leaker-free tumbler rate of 89 percent, whereas standard gelatin capsules were 0 percent leaker-free (i.e. every single tumbler had leakers). Importantly, EASYSEAL^® also shortens drying time by 50 per cent, meaning less energy is required and capsule throughput is increased. With energy prices at an all-time high, this has significant benefits for the bottom line.

Application-wise, the innovative gelatin makes things also easier. It is compatible with ingredients that typically cause filling challenges (e.g. suspensions), and for products that require special equipment such as double step die tooling.