The excipient is a co-processed blend of plant-based mannitol and maize starch, said the company, that “protects and stabilizes moisture sensitive active ingredients like probiotics, unlocking longer shelf life, improved consistency and wider opportunities for consumer-friendly dosage formats”.
Speaking with NutraIngredients at the recent Vitafoods in Geneva, Switzerland, Dr Carin Siow, Senior Pharmaceutical Application Scientist at Roquette, explained that delivery of probiotics is still dominated by hard-shell capsules, but the market is seeking alternatives.
“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,” she said.
Prior to Pearlitol ProTec, probiotic tablets would involve a step of drying the probiotic before formulation, she explained, but this is no longer required.
Arnaud Verhaeghe, Roquette’s Head of Marketing – Pharma Oral Dosage, added that the company has already been sharing the technology with select partners and it has got “great traction”, with products on the market potentially this year.
After several pre-pandemic years of low single digit growth, the US probiotic dietary supplements market was re-energized in 2020, with sales increases by 33% since then. The US probiotic market is expected to post a CAGR (compound annual growth rate) of 13.5% between 2022-2027, said Roquette.
On the other side of the pond, a gradual relaxation of guidance surrounding the use of the term “probiotic” on packaging and in sales communications since 2018 in select companies is also leading to an uptick in shopper interest.
As with other supplement categories, consumers are seeking out alternative delivery formats.
“Probiotics, like other moisture sensitive active ingredients, present stability issues which limit their viability for certain dosage formats,” said Dr 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 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.”
Pearlitol ProTec has a measured Aw value of <0.2, moisture content below 1% and good compactability performance, it helps preserve the integrity of moisture sensitive actives throughout the manufacturing process, said the company.