Integrated Continuous Melt Granulation-based Powder-to-Tablet Line: Process Investigation and Scale-Up on the Same Equipment

Záhonyi, Petra and Fekete, Dániel and Szabó, Edina and Madarász, Lajos and Fazekas, Árnika and Haraszti, Anna and Nagy, Zsombor K. (2023) Integrated Continuous Melt Granulation-based Powder-to-Tablet Line: Process Investigation and Scale-Up on the Same Equipment. EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS, 189. pp. 165-173. ISSN 0939-6411 (print); 1873-3441 (online)

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Abstract

In the last decades, continuous manufacturing (CM) has become a research priority in the pharmaceutical in-dustry. However, significantly fewer scientific researches address the investigation of integrated, continuous systems, a field that needs further exploration to facilitate the implementation of CM lines. This research outlines the development and optimization of an integrated, polyethylene glycol aided melt granulation-based powder-to-tablet line that operates fully continuously. The flowability and tabletability of a caffeine-containing powder mixture were improved through twin-screw melt granulation resulting in the production of tablets with improved breaking force (from 15 N to over 80 N), excellent friability, and immediate release dissolution. The system was also conveniently scaleable: the production speed could be increased from 0.5 kg/h to 8 kg/h with only minimal changes in the process parameters and using the same equipment. Thereby the frequent challenges of scale-up can be avoided, such as the need for new equipment and separate optimization.

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