GRANFILLER-DExcipient for Orally Disintegrating Tablet

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White paper: Applicability of co-processed excipient to ODT prepared by direct compression continuous manufacturing

We published a white paper titled "Applicability of Co processed Excipient to ODT prepared by Direct Compression Continuous Manufacturing".

Please refer to the attached file. [article2211[daicel].pdf]

Recently, continuous manufacturing (CM) has been actively researched in the pharmaceutical industry. Although several pharmaceutical companies have started producing solid dosage forms by CM, there are some issues to be overcome to spread CM. One of the issues is minimizing a lot-to-lot variation of raw materials. It may affect for the final product quality and easily lead to instability in product quality in continuous process. 
The application of co-processed excipients (CPEs) may be useful in resolving this issue because they allow multiple excipients to be treated like a single excipient. HiSORAD HSR-D03 (HSR) is one of CPEs for direct compressible ODTs.
In this report, HSR was applied to the CM and evaluated in terms of coefficient of variation in tablet weight, content uniformity and tablet performance. Compared to the physical mixture, HSR performed better in all evaluations and meet the set quality target product profile. It was also able to suppress tableting failures and stabilize the production of ODTs. The above results suggest that a co-processed excipient can be applied in CM, and can contribute to maintain stable production and quality.

Related links: White paper archives, HiSORAD