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Upping the Game in Softgel Quality


Softgel capsules offer many patient benefits as a delivery format, including ease of swallowing and good bioavailability, but for manufacturers, producing a quality product is not at all straightforward

Advances in APIs have not made the situation any easier, with many compounds known to interact with ingredients in the shell and to cause issues with capsule stability. For instance, surface-active compounds like phospholipids and components used in self-(nano)- emulsifying drug delivery systems (SEDDS/SNEDDS) tend to inhibit capsules seam formation. Poor seam formation can then cause capsule contents to leak, either during production, packaging or storage, with substantial negative consequences.

Why are leakers a problem?

Leaking capsules (leakers) can cause multiple problems, including waste of ingredients, damage to additional capsule coatings, contamination of surrounding capsules and production areas, and the need for downtime and cleaning. For patients, leakers can mean they don’t receive the correct API dose and they may experience unpleasant tastes or irritation of oral mucosa. In the worst-case scenario, leakers can lead to expensive product recalls.

Traditionally, if leakers do occur during pharmaceutical production, manufacturers have to laboriously clean every capsule in the batch (i.e. by passing them through an ethanol bath to strictly rule out the possibility that residual API remain on their surfaces). All occurrences of leaks must be carefully recorded and records meticulously kept.

Unfortunately, a survey undertaken recently by leading gelatin supplier GELITA has confirmed that leakers have, until now, been a universal issue.

What the survey found

GELITA surveyed major softgel players around the world and found that all of them experienced leakers. While the producers did all they could to maintain capsule integrity, including modifying production parameters such as temperature settings in the machine and machine speed, they all said that leakers were unavoidable. Indeed, more than half were prepared to put up with around 5 percent leakers as an inevitable part of production.

Believing that 5 percent leakage was 5 percent too much, GELITA has worked on developing a solution – a new type of gelatin called EASYSEAL® that has been proven to deliver more reliable softgels of superior quality with a vastly reduced chance of leaking.

A game changer

Gelatin dominates the market as the preferred excipient for softgel shells, thanks to its unmatched advantages over other options. However, not all gelatins are equal, and EASYSEAL® has been shown in lab trials at the University of Heidelberg as well as during industrial production to eliminate or vastly reduce the likelihood of leakers.

“EASYSEAL® outshines other gelatins with its exceptional qualities, ensuring more dependable capsule sealing,” says Dr. Ulrich Mach, Application Technology & Product Development at GELITA. “Furthermore, EASYSEAL® is compatible with ingredients that typically cause filling challenges.”

What is EASYSEAL®?

EASYSEAL® is a natural, pharmaceutical grade gelatin. It tolerates equipment temperature changes during production and is suitable for any type of fill, including Rx, OTC and herbal medicines, as well as food supplements such as vitamins, minerals, and fish oils. Its special properties enable trouble-free filling of traditionally difficult to handle or surface-active fill components, including SEDDS and SNEDDS.

EASYSEAL® has been shown to increase capsule seam thickness by at least 50 percent, delivering robust capsules even at high production speeds. It also makes capsules less likely to leak during drying, as well as cutting time required for drying by as much as 50 per cent. This enhances production capacity and cuts energy requirements. Standard gelatin does not perform nearly as consistently under temperature fluctuation as EASYSEAL® does – due to the very exceptional production process.

“Overall, EASYSEAL® has been shown to boost production efficiency significantly, thanks to reduced waste, shorter drying times and better yield,” says Mach. “It reduces the incidence of leakers, generating substantial cost savings and improved production efficiency. Ultimately, this new type of gelatin delivers a superior end product for the pharmaceutical industry and for patients.”

EASYSEAL® is available in bovine and porcine forms and is produced in line with FDA regulations, HACCP, ISO9001:2015 and FSSC22000. A China DMF (Drug Master File) is also available to ease entry into the Chinese market.

Click here to find out more

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Automated, single-use system from Precision NanoSystems for clinical and commercial production of lipid nanoparticles

The NanoAssemblr™ commercial formulation system is an automated, single-use system for the clinical and commercial production of lipid nanoparticles (LNPs). The system simplifies GMP manufacturing while addressing the unique challenges of genomic medicine development through an automated workflow that guides the user through the process of priming, calibration, formulation, and in-line dilution. Intuitive software enables 21 CFR Part 11 compliance and electronic batch records capture real-time reporting of flow rate and pump speed.

The commercial formulation system builds on the innovative NxGen™ technology that minimizes process development during scale-up to commercial manufacture while providing precise control of mixing parameters. Its single-use flow path minimizes the need for sanitizing and performing cleaning validation, enabling efficient changeover between production runs, minimizing the risk of cross-contamination, and supporting multi-product manufacturing.

Considering the number of variables throughout the production workflow, flexible and robust technologies will be key to expanding LNP drug development to new therapeutic targets. The NanoAssemblr commercial formulation system standardizes workflows, increases operational flexibility, and reduces process development, accelerating time to market of RNA vaccines and therapeutics.

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