Roquette Expands PEARLITOL® SD Mannitol Range for Highly Sensitive Active Pharmaceutical Ingredients(APIs)

Roquette, a global leader in plant-based ingredients and a leading provider of pharmaceutical excipients, today announces 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,” says 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.

Download the press release here: Roquette Expands PEARLITOL SD Mannitol Range for Highly Sensitive Active Pharmaceutical Ingredients (APIs) (002)

Source: Press release Roquette Tuesday, July 5th, 2022