Simplifying the art of the possible

With softgels becoming increasing popular in both the nutraceutical and pharmaceutical industries, Dr Kevin Robinson recently caught up with Jessica Philipp, Team Leader, Formulation/R&D, to find out how the SIRIO Group is keeping up with demand and exploring new markets.

KSR: How large is your R&D team and can you provide a little more detail in terms of their expertise?

JP: With around 180 scientists working at three global sites, the SIRIO Group probably has the largest team of R&D professionals within any nutraceutical contract manufacturing organisation.

The team is split across both technical disciplines and technology platforms, with specialists covering several softgel types, nutraceutical gummies, tablets, powders, functional beverages and even packaging.

Additionally, we have also developed several cross-functional working groups that are tasked with exploring innovative solutions for various health benefit areas — from immunity and cardiovascular health to stress, digestion and many others.

For example, the European R&D team in Germany specialises in developing complex nutraceutical and pharmaceutical softgels, with 10 scientists spanning roles from pharmacist and biotechnologist to food scientists. However, perhaps our biggest strength is that we are able to work closely with our global R&D counterparts. It really gives the company an unrivalled and incredibly diverse scope of potential research.

KSR: What does a typical development timeline look like for a softgel and what are the challenges that need to be overcome or evaluated?

JP: It’s an interesting question; however, the answer really depends on the type of softgel required, the complexity of formulation, fill and shell type.

For example, at perhaps the most extreme end of the spectrum, the research effort we put into developing a patented softgel containing viable probiotics and omega-3 took the company 10 years! Similarly, if we look at a pharmaceutical softgel, healthcare regulations are quite strict; as such, it’s not uncommon to undertake long-term development plans with our clients that often last several years.

Additionally, novel ingredients or, owing to potential interactions between compounds, mixtures can also be a challenge … and this is absolutely when experience counts.

In fact, our European team is well known in the industry for this, having developed more than 10,000 different formulations. At the other extreme, however, this experience sometimes allows us to expedite the formulation of ingredients, mixtures and capsule into a final dosage form extremely fast. Our record is less than a week.

KSR: Have there been any recent developments that have spurred companies to get new products to market quicker?

JP: Yes, we are always innovating as a company and an industry. Blue light exposure, which is the result of people spending more time in front of digital screens than ever before, is very much a current example. With time, this exposure can cause serious long-term damage to the eyes, including macular degeneration. In response, a few weeks ago, we reviewed and published innovative vision health formulations, carefully selecting evidence-based ingredients for different types of consumers.

Another common problem is the increased prevalence of stress; the amount of people suffering from anxiety, often associated with sleeping disorders, has risen significantly during the past year. So, working on softgel formulations that provide relief is another focus for SIRIO. At the same time, we are also exploring different options for softgel shells, which include both vegetarian and enteric capsules, new colouring methods and shapes. Group-wide, this is a big USP at SIRIO in that we are so heavily focused on pushing boundaries and advancing the products and options available.

KSR: What kinds of softgels does SIRIO have on offer?

JP: SIRIO has one of the largest softgel offerings and capabilities. We can manufacture softgels that, depending on the relevant regulation, can be defined as a food supplement, medical device or medicinal product. I think the first step should always be to take a step back, to look at the bigger picture and determine which health benefits (immunity, heart, digestion, well-being) or combinations thereof should be addressed for which end user (children, elderly, gender-specific, ecofriendly consumers, etc.). Once this has been agreed, it very often determines the type of softgel to be formulated, its fill mix and shell. Depending on the ingredients, fill options can be categorised into oily mixtures or suspensions, which can contain up to 15 ingredients or more.

Shell technologies cover various gelatine types based on source (fish, bovine, pork) and/or function (enteric, chewable) as well as vegetarian shells. But, by taking this further, customers may also have preferences for certified dietary options such as organic, FOS, MSC, Halal or Kosher.

In fact, such is the required level of diversity, we have developed an online product adviser, launched in early 2021, to help nutraceutical brands explore what features and options are most important for their prospective product and how these can be combined. It’s a solution that simplifies the art of the possible and, in some cases, reimagines (improves) the type of product they want to develop.

KSR: For SIRIO, what’s the difference between production in China and in Europe?

JP: In terms of nutraceutical softgel capabilities, we now offer a very similar range in Germany and Shantou (China). Historically, the German facility was more focused on complex formulations, whereas our colleagues in Shantou have a much longer pedigree of making vegetarian softgels.

Having said that, we now manufacture vegetarian softgels in our German plant as well. And, in fact, there has been an increase in demand for plant-based softgels all around the world in the last few years — particularly in Europe and North America.

KSR: What are SIRIO’s manufacturing limitations in terms of shapes and sizes?

JP: The most obvious consideration relates not to manufacturing as such, but the end consumer experience; first of all, softgels must be fit for purpose and the target customer generally must be able to swallow it with ease. Common shapes are oval, about the size of a peanut, but oblong and twist off varieties are also gaining popularity. The largest capsule size we produce is an “oval 40,” which contains 2000 mg of fill material, but is only applied externally as a medical device.

KSR: What are the most important considerations to keep in mind when it comes to chewable softgels?

JP: These are increasingly popular, especially with children needing omega-3 supplementation. Often, paediatric end users have difficulties swallowing a softgel and, instead, bite them. This, of course, leaves a fish oil aftertaste in the mouth, which is unpleasant and puts them off taking these supplements. So, with that in mind, a chewable softgel must, most importantly, deliver a pleasant taste experience and mask the unpleasant flavours of the fish oil fill material.

Chewable softgels are also a good solution for vitamin blends; we are constantly researching how to improve the taste component of these formulations, which often makes the difference between a good product and one that explodes in consumer popularity.

KSR: Can you give us an update on your probiotic-omega-3 softgel? Are there any further advances we can talk about?

JP: Requests for these formulations are increasing rapidly and we are currently running development projects to select new probiotic strains to keep up with demand.

The challenge is that, as probiotics are viable bacteria, the survival rate (measured as colony forming units [CFU]) is unique for each strain. As such, you simply cannot replace one probiotic strain in a softgel containing omega-3 with another one. However, this does mean that each product is very much bespoke to the bacteria, which often increases its end consumer marketability.

KSR: Can you tell me about the hurdles associated with formulating softgels with a viscous fill or a high solids content?

JP: The viscosity of the fill is a crucial factor for encapsulation, which is primarily driven by the amount of ingredient particles and the volume of active that needs to be kept in suspension. Obviously, the higher the viscosity the more difficult it is to encapsulate, owing to issues with homogeneity and mass balance during encapsulation and in the final product.

KSR: For what applications would you recommend using enteric softgels?

JP: Supplements with a high fat content, derived from omega-3s or other essential oils, for example, can cause acid reflux symptoms such as belching and heartburn. Enteric shells are a good option in these instances as they bypass the stomach.