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23rd May 2023  Content supplied by: Roquette

Roquette Launches PEARLITOL® ProTec, Excipient to Stabilize Probiotic Supplements


Roquette invites the health and nutrition market to discover a more versatile, stable, and consumer-forward future for probiotic supplements with the launch of its new excipient – PEARLITOL® ProTec. A unique, plant-based co-processed blend of mannitol and maize starch, this solution protects and stabilizes moisture-sensitive active ingredients like probiotics, unlocking longer shelf life, improved consistency, and wider opportunities for consumer-friendly dosage formats.

Assessing the pro-tential

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 [1]. Across the Atlantic, sales of probiotic products have increased by 33% since 2020, and this expanded demand is unlikely to slow [2]. Indeed, the US probiotic market is expected to post a CAGR (compound annual growth rate) of 13.5% between 2022-2027 [3].

Dr. Carin Siow, Senior Pharmaceutical Application Scientist at Roquette, comments: “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.”

Better protection, better performance

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,” continues 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 stabilize 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 stabilization 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.

Clear and compliant

In parallel with 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 U.S. 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 stabilizing qualities also make passing efficacy and viability checks quicker and easier, saving brands time and money while remaining fully regulation compliant.

Learn more about the product PEARLITOL® ProTec Co-processed Mannitol Starch, or use the green Request Information button below to contact Roquette for details.

References
  1. International Probiotics Association (IPA) Europe, Probiotics in Europe: consumer survey in 8 EU countries shows positive consumer perception and regulatory limitations, 12 July 2022, https://www.ipaeurope.org/probiotics-in-europe-consumer-survey-probiotics/
  2. Mordor Intelligence, United States probiotics market - growth, trends, covid-19 impact, and forecasts (2023 - 2028), https://www.mordorintelligence.com/industry-reports/united-states-probiotics-market-industry
  3. Ibid, Mordor Intelligence, United States probiotics market report

    

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Date Published: 23rd May 2023

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