PEARLITOL® 200 GT Mannitol: Harnessing the potential of higher active ingredient content for smaller, more convenient tablets

February 20, 2024

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The article discusses the development and optimization of PEARLITOL® 200 GT, a new pure beta mannitol grade for direct compression in tablet manufacturing. Mannitol is commonly used as an excipient for oral solid forms, especially for APIs with stability issues. Capping, a tablet production issue, can occur due to various factors, and PEARLITOL® 200 GT is designed to address this by suppressing or shifting capping to higher compression forces and/or speeds.

The study aims to demonstrate that PEARLITOL® 200 GT allows for higher API content and, consequently, smaller tablet sizes compared to other directly compressible mannitol products. The experiment uses sitagliptin as a model drug, known for causing capping issues. The compression simulator STYLCAM 200R and KORSCH XL400 are employed to simulate tablet production conditions.

Results indicate that PEARLITOL® 200 GT exhibits superior behavior in terms of powder properties, ensuring stable tablet production even with a higher ratio of sitagliptin. The TADES powder properties quotation system is used to predict blend behavior in the tablet press, with PEARLITOL® 200 GT showing the best performance among the tested mannitol products.

The findings suggest that PEARLITOL® 200 GT enables the formulation of smaller tablets with the same active ingredient content, making it a promising option for enhancing tablet manufacturing efficiency.