Roquette launches three moisture-protecting ingredients for nutraceuticals at CPhI Barcelona

26 Oct 2023 --- Roquette has added three excipient grades for moisture-sensitive active pharmaceutical and nutraceutical ingredients to its existing range. Excipients are vital components for drug stabilization.

The excipient grades include partially pregelatinized starch Lycatab CT-LM, Microcel 103 SD and Microcel 113 SD, which are microcrystalline cellulose that offers a “unique” range of stabilizing and moisture-protective benefits. The ingredients were made to give pharmaceutical manufacturers the tools to optimize drug delivery, regardless of production method or formulation type.

The plant-based ingredients and pharmaceutical and nutraceutical excipients provider is unveiling the solutions at CPhI Barcelona, Spain, ending today.

“We’re delighted to be sharing this news with colleagues and customers at CPhI because it allows industry players to discover the transformational impact of our moisture protection portfolio first-hand, straight from our experts,” says Paul Smaltz, VP of Pharmaceutical Solutions at Roquette.

Streamlining production
The new grades are the latest addition to Roquette’s broader moisture protection portfolio — a comprehensive range of low water activity (Aw) excipients demonstrated to support successful drug development in applications featuring moisture-sensitive active ingredients.

“Joining the ranks of our Pearlitol ProTec co-processed mannitol-starch solution launched earlier this year, these new Lycatab and Microcel grades solidify our position as the leading provider of excipients for moisture-sensitive applications,” asserts Smaltz.

Three excipient grades were added to Roquette’s Pearlitol ProTec co-processed mannitol-starch solution. Lycatab CT-LM is a multifunctional filler, binder and disintegrant offering “extremely” low Aw — not more than 0.1% for stability in solid oral preparations.

It is suitable for dry granulation, hard capsule filling and direct compression, with a loss on drying not more than 7%. The grade is safe from hydraulic degradation and helps streamline production processes while assuring rapid disintegration in the final formulation for optimal patient experience.

Ensuring drug effectiveness
The Microcel 103 SD and Microcel 113 SD expand Roquette’s cellulosic production capacity. The expansion follows the acquisition of excipients manufacturer Crest Cellulose in 2022, which has enabled the company to add two new grades to its Microcel microcrystalline cellulose range.

The excipient grades are optimized for roll compaction and dry granulation processes. Microcel 103 SD offers granulometric distribution and an Aw of not more than 0.2% for improved production efficiency and long-term product quality.

The Microcel 113 SD is similarly primed for repeatable performance, building the benefits for moisture-sensitive formulations with an Aw under  0.1%.

Lactose-, gluten- and sugar-free with a non-GMO positioning, both grades improve complex tablet production, combining reliability with stability to create tablets that stay effective throughout their shelf life with each batch.

“Pharmaceutical and nutraceutical manufacturers have grappled with the issue of active ingredient hydrolysis and moisture-related degradation for decades. At Roquette, it’s our mission to tackle challenges in drug delivery head-on through cutting-edge science and an unwavering drive to improve the experience of patients and producers,” Smaltz concludes.

Edited by Sabine Waldeck