Roquette Expands PEARLITOL SD Mannitol Range for Highly Sensitive APIs

Roquette recently announced the addition of a new grade to its PEARLITOL SD mannitol range for direct compression – PEARLITOL 150 SD. Developed specifically for active pharmaceutical ingredients (APIs) that are highly sensitive to reducing sugars, PEARLITOL 150 SD supports opportunities to unlock advanced tablet dosage forms – even when using challenging active ingredients.

Roquette’s spray-dried PEARLITOL SD grades are considered a leading direct compression functional filler/diluent for oral dosage forms in both pharmaceutical and nutraceutical applications. Like PEARLITOL 100 SD and 200 SD, the 150 SD grade enables the direct compression of tablets without compromising quality or performance. The key difference is that PEARLITOL 150 SD is a specifically designed mannitol for direct compression of highly sensitive APIs. It ensures low levels of reducing sugars – below 300 ppm – meaning that it does not affect the stability of reducing sugar-sensitive APIs. Specifically developed with a narrow and controlled particle size distribution, PEARLITOL 150 SD delivers good processability and reliable dosing in every tablet.

“Our PEARLITOL SD excipients are the first choice for direct compression without compromise – even for the most challenging and unstable formulations,” said Steve Amoussou-Guenou, Global Technical Developer, Roquette. “This extension of our one-of-a-kind mannitol range highlights our continuous drive to evolve and offer tailored solutions to better support customers’ needs. We realized that developing a grade of PEARLITOL with low levels of reducing sugars could help our customers overcome the challenge of working with sensitive APIs in direct compression applications. Launching PEARLITOL 150 SD to the market, alongside the other grades in the PEARLITOL SD portfolio, opens up even more possibilities for drug delivery innovation in the pharmaceutical space.”

As well as offering distinct advantages, such as consistent quality, superior functionality and high stability, Roquette’s PEARLITOL SD range brings excellent organoleptic properties and cost savings to direct compression formulations. In addition, it is underpinned by Roquette’s extensive expertise and technical know-how in solid oral dosage formulations, and 40 years of experience supplying industry-leading, plant-based excipients and raw materials. Plus, all PEARLITOL SD mannitol is backed by Roquette’s Quality by Design pledge, with usage-specific documentation to support qualification and registration processes.

For more information about PEARLITOL 150 SD and how it unlocks innovation with sensitive APIs, visit www.roquette.com.

Roquette is a family-owned global leader in plant-based ingredients, a pioneer of plant proteins and a leading provider of pharmaceutical excipients. Founded in 1933, the company currently operates in more than 100 countries, has a turnover of 3.9 billion euros, and employs more than 8,000 people worldwide. Life and nature have been our sources of inspiration for decades. All our raw materials are of natural origin. From them, we enable a whole new plant protein cuisine; we offer pharmaceutical solutions that play a key role in medical treatments; and we develop innovative ingredients for food, nutrition and health markets. We truly unlock the potential of nature to improve, cure and save lives. Thanks to a constant drive for innovation and a long-term vision, we are committed to improving the well-being of people all over the world. We put sustainable development at the heart of our concerns, while taking care of resources and territories. We are determined to create a better and healthier future for all generations.