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Aims to support successful drug development in applications featuring moisture sensitive active ingredients.
December 1, 2023
By: Anthony Vecchione
Roquette, a company involved in plant-based ingredients and a provider of pharmaceutical and nutraceutical excipients, added three new excipient grades to its portfolio of solutions for moisture sensitive active pharmaceutical and nutraceutical ingredients. Unveiled at CPHI Barcelona, LYCATAB CT-LM partially pregelatinized starch, MICROCEL 103 SD and MICROCEL 113 SD microcrystalline cellulose offer a unique range of stabilizing and moisture protective benefits, giving pharmaceutical manufacturers the tools, they need to optimize any drug delivery, regardless of production method or formulation type. The new grades are the latest addition to Roquette’s wider 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. The latest entry to Roquette’s premier pregelatinized starch range, LYCATAB CT-LM is a multifunctional filler, binder, and disintegrant offering extremely low Aw not more than (NMT) 0.1 percent) for superior stability in solid oral preparations. Suitable for dry granulation, hard capsule filling, and direct compression, with a loss on drying (LOD) NMT 7 percent, LYCATAB CT-LM gives pharmaceutical and nutraceutical producers the freedom to innovate while keeping formulations safe from hydraulic degradation. Like the rest of the LYCATAB portfolio, it helps streamline production processes and assure rapid disintegration in the final formulation for optimal patient experience. Roquette’s expansion of its cellulosic production capacity, following the acquisition of leading excipients manufacturer Crest Cellulose in 2022, has enabled the company to add two new grades to its already extensive MICROCEL microcrystalline cellulose range. Optimized for roll compaction and dry granulation processes, MICROCEL 103 SD offers consistent granulometric distribution and an Aw of NMT 0.2% for improved production efficiency and long-term product quality. MICROCEL 113 SD is similarly primed for repeatable performance, building the benefits for moisture sensitive formulations with an Aw of NMT 0.1%. Lactose-, gluten- and sugar-free with a non-GMO positioning, both grades take hard tablet production up a gear, marrying reliability with superior stability to unlock tablets that stay effective throughout their shelf life, batch after batch. Smaltz, vice president of Pharmaceutical Solutions at Roquette, said, “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 the toughest challenges in drug delivery head on through cutting-edge science and an unwavering drive to improve the experience of patients and producers. 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. We’re delighted to be sharing this news with colleagues and customers at CPHI because it gives industry players the opportunity to discover the transformational impact of our moisture protection portfolio first-hand, straight from our experts.”
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