Pharmaceutical and nutraceutical ingredient supplier Roquette launched Pearlitol ProTec, a co-processed mannitol and starch excipient, at Vitafoods Europe.
 
The excipient is compatible with probiotics by protecting and stabilizing moisture-sensitive active ingredients, unlocking a longer shelf life, improved consistency, and new dosage format options.
 
The probiotic supplements market is undergoing a renaissance, Roquette reports. In the European market, there has been a gradual relaxation of guidance surrounding the use of the term probiotic on packaging and in sales communications since 2018. In the U.S., probiotics have experienced a 33% increase in sales since 2020, and is anticipated to post a CAGR of 13.5% between 2022 and 2027, according to Mordor Intelligence.
 
“Awareness of probiotics and their associated health benefits is high in many regions, even among consumers who don’t currently take a probiotic supplement,” said Dr. Carin Siow, senior pharmaceutical application scientist at Roquette. “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.” 
 
Addressing the demand for new delivery formats comes with challenges, Siow said.
 
“Probiotics, like other moisture sensitive active ingredients, present stability issues which limit their viability for certain dosage formats,” said Siow. “In directly compressed tablets for instance, flowability and compactability 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 less than 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.”
 
Pearlitol ProTEc, which can achieve a measured Aw value of less than 0.2, moisture content below one percent, and compactibility performance, helps to meet stability needs in new delivery formats.
 
According to the company, Pearlitol ProTec can help manufacturers substantiate that their products are safe, effective, and stable to the U.S. Food and Drug Administration, and European Food Safety Authority.
 
The excipient is fully compliant with the standards of all major pharmacopoeias, and can enable a product to pass efficacy and viability checks quickly and more easily, the company reports, saving manufacturers time and money.