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Both excipients have been specially developed to overcome unique drug formulation challenges in the pharmaceutical space.
November 11, 2022
By: Charlie Sternberg
Roquette, a leader in plant-based ingredients and a leading provider of pharmaceutical and nutraceutical excipients, has launched two next-generation mannitol products for direct compression – Pearlitol CR-H and Pearlitol 200 GT. Both excipients have been specially developed to overcome unique drug formulation challenges in the pharmaceutical space, helping manufacturers optimize direct compression processes and expand into novel application areas, like controlled release tablets and mini tabs. Pearlitol CR-H is a patented blend of mannitol and hydroxypropyl methylcellulose (HPMC) that allows for the sustained release of active pharmaceutical ingredients in direct compression formulations. The first mannitol-based excipient of its kind to support this functionality, it creates new opportunities to enter the controlled release drug delivery space – an application which typically requires wet granulation processes. As well as removing the extra drying step necessary with wet granulation, the co-processed mannitol and HPMC brings superior functional properties, like flowability, that help optimize tablet processibility. Pearlitol 200 GT is a granulated mannitol excipient designed to enhance tableting performance. In addition to addressing the capping and sticking issues commonly observed with other excipient solutions, it offers high-speed, high-volume continuous manufacturing – enabling the production of up to 250,000 tablets per hour without compromising on tablet quality. Meanwhile, it supports patient-friendly innovation by facilitating the development of harder, smaller tablets and can be used in novel pharmaceutical applications, such as fast-dissolving medications. “A global leader in the excipient market, we’re passionate about evolving our offering to enable even the most complex drug formulations to meet their full potential,” comments Paul Smaltz, vice president of Pharmaceutical Solutions at Roquette. “Our latest Pearlitol excipients bring unique benefits that address the very specific processing challenges that we know formulators are experiencing today, including capping, flowability, tablet hardness, performance, and stability. With no equivalent solutions on the market, both Pearlitol CR-H and Pearlitol 200 GT offer manufacturers the opportunity to push the boundaries of drug development and truly innovate in the direct compression space, while making it possible to explore novel drug applications, like controlled release. We’re so excited to meet with our customers and partners and reveal the potential of these two new additions to our well-established portfolio.”
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