Roquette’s Pearlitol ProTec probiotic meets regulatory compliance for safety, efficacy and “stability”

29 May 2023 --- Pharmaceutical and nutraceutical excipient provider Roquette has developed a mannitol and maize starch blended supplement called Pearlitol ProTec with proven shelf life stability. The supplement has been described as versatile and “safe, effective and stable.”

The plant-based co-processed dietary supplement has approval from the US Food and Drug Administration (FDA) and the European Food Safety Authority (EFSA).

Meeting these requirements is often expensive to remain compliant with label claims, which combined with the typically long excipient drying times can negatively affect profitability and production efficiency.

The Pearlitol ProTec solution protects and stabilizes moisture-sensitive active ingredients like probiotics and unlocks a longer shelf life, improved consistency and further opportunities for consumer-friendly 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,”  says Dr. Carin Siow, senior pharmaceutical application scientist at Roquette.

“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.”

Probiotics power through
According to Roquette, the probiotic supplement market is undergoing a renaissance. Looking at the European market specifically, there has been a gradual relaxation of guidance on the “probiotic” classification which has led to an uptick in shopper interest.  

Sales of probiotic products have increased by 33% since 2020 and are unlikely to slow. Roquette’s research shows that the US probiotic market is expected to achieve a compound annual growth rate of 13.5% between 2022-2027. 

A study by Chr. Hansen in 2022, revealed that consumers worldwide are keen to learn more about probiotics. The interest is driven by growing interest in gut health and immunity support. Surveying 16,000 individuals across 16 countries, the results revealed 71% of consumers would like to learn more about probiotics.

“Awareness of probiotics and their associated health benefits is high in many regions, even among consumers who don’t currently take a probiotic supplement,” says Dr. Carin Siow, 

According to Roquette, there is a notable shift in the regulatory landscape, away from dietary supplements being regulated as “food” products and new rules are trending closer to the stricter standards required for pharmaceuticals. 

Jumping over drying process hurdlesThe stabilizing profile of Pearlitol ProTec makes it quicker and easier to pass efficacy and viability checks, Roquette claims.
Addressing the demand by health-conscious consumers for a broader selection of probiotics presents producers with new processing and formulation challenges. 

Many tableting solutions require an additional drying process to reach the less than 0.2 low water activity (Aw) requirement that stabilizes moisture-sensitive actives. Good organoleptic qualities are preferable for stick packs and sachets. 

“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, flow and compactness are key considerations.”

Essentially manufacturers need a flowable excipient that can ensure homogeneity and produce the desired tablet strength.

Pearlitol ProTec was developed and designed to meet these challenges. It has a measured Aw value of less than 0.2, its moisture content is below 1% and it has good compactibility performance. Pearlitol preserves the integrity of moisture-sensitive actives throughout the manufacturing process.

The product is fully compliant with the standards of all major pharmacopeias. Its superior protective and stabilizing qualities makes it quicker and easier to pass efficacy and viability checks.

By Inga de Jong