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Roquette expands mannitol range for highly sensitive APIs

Roquette, a provider of plant-based ingredients and pharmaceutical excipients,  announces the addition of a new grade to its PEARLITOL SD mannitol range for direct compression – PEARLITOL 150 SD.

Key highlights:

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 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 realised 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 consistent quality, superior functionality and high stability, Roquette’s PEARLITOL SD range brings organoleptic properties and cost savings to direct compression formulations. In addition, it is underpinned by Roquette’s expertise and technical know-how in solid oral dosage formulations, and 40 years of experience supplying 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.

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