Roquette has launched its new excipient PEARLITOL ProTec, set to “be a more versatile, stable and consumer-forward future for probiotic supplements”.
A unique, plant-based co-processed blend of mannitol and maize starch, this solution protects and stabilises moisture sensitive active ingredients like probiotics, unlocking longer shelf life, improved consistency and wider opportunities for consumer-friendly dosage formats.
Attendees of Vitafoods Europe 2023 are the first to experience the game-changing potential of PEARLITOL ProTec and how it complements Roquette’s extensive range of excipients and active ingredients for nutraceuticals.
The probiotic supplement market is currently undergoing a renaissance. Looking at the European market specifically, there has been a gradual relaxation of guidance surrounding the use of the term “probiotic” on packaging and in sales communications since 2018, leading to a corresponding uptick in shopper interest.
Dr Carin Siow, Senior Pharmaceutical Application Scientist at Roquette, commented: “Awareness of probiotics and their associated health benefits is high in many regions, even among consumers who don’t currently take a probiotic supplement. When we look at dosage formats, hard-shell capsules still dominate, but this picture is beginning to shift. Consumers are searching for convenient new supplement formats that fit easily into their daily routines. Chewable tablets, stick packs and powder sachets are examples of these lifestyle-friendly formats, and we expect such dosage forms to gain market share in years to come.”
Awareness of probiotics and their associated health benefits is high in many regions, even among consumers who don’t currently take a probiotic supplement
There is clearly an appetite among health-conscious consumers for greater choice when it comes to probiotic supplements, but addressing this demand poses challenges for producers. “Probiotics, like other moisture sensitive active ingredients, present stability issues which limit their viability for certain dosage formats,” continued Dr Siow. “In directly compressed tablets for instance, flowability and compactibility are key considerations – which means manufacturers need a flowable excipient that can ensure homogeneity, and impart the desired tablet strength. Most of the currently available tableting solutions, however, require an additional drying process to reach the <0.2 low water activity (Aw) needed to stabilise moisture sensitive actives. The biggest consideration for oral dosage formats like stick packs and sachets, on the other hand, is good organoleptic properties.”
To help manufacturers address these processing challenges and meet today’s consumer preferences, Roquette developed PEARLITOL ProTec, a revolutionary plant-based excipient offering unmatched stabilisation and organoleptic properties. With a measured Aw value of <0.2, moisture content below 1% and good compatibility performance, it helps preserve the integrity of moisture sensitive actives throughout the manufacturing process – and beyond.
In parallel to evolving consumer expectations, the regulatory landscape for nutraceuticals is equally changing. There is a notable shift away from dietary supplements being regulated as ‘food’ products, with new rules trending closer to the stricter standards required for pharmaceuticals. To secure necessary approvals from bodies such as the US Food and Drug Administration (FDA) or the European Food Safety Authority (EFSA), manufacturers must be able to show their products are safe, effective and stable. Meeting these requirements could mean expensive overages to remain compliant with label claims, which combined with the typically long excipient drying times mean a dual hit to profitability and production efficiency.
PEARLITOL ProTec is fully compliant with the standards of all major pharmacopeias, giving producers complete peace of mind. Its superior protective and stabilising qualities also make passing efficacy and viability checks quicker and easier, saving brands time and money while remaining fully regulation compliant.
