Determination of Ribbon Solid Fraction in Roll Compaction using Ibuprofen DC100

Abstract

Process Analytical Technology (PAT) plays a crucial role in the design of today’s manufacturing lines as continuous manufacturing becomes more important. Until now PAT tools to measure the ribbon solid fraction (SFribbon) in-line are not commonly used in roll compaction. The aim of this study was therefore to establish a new approach as PAT for in-line ribbon solid fraction determination. Different placebo formulations with different binders and one formulation containing active pharmaceutical ingredient were investigated using in-line laser triangulation measurement to detect the ribbon thickness after compaction. With this the ribbon elastic recovery was determined in-line (ERin−line) while the ribbons are attached to the roll surface. It was found that the ratio (ERratio) between the total elastic recovery and ERin−line is formulation specific and not influenced by any process parameters. This enables ERratio as prediction tool for SFribbon, if the solid fraction at gap (SFgap) width is known. SFgap was determined with ribbon mass flow measurement or based on the Midoux model, a simplified Johanson model, gaining two prediction models for SFribbon. Both models showed good agreement of the predicted SFribbon and the measured one.

Ibuprofen DC100 in this context

In the context of this publication, Ibuprofen DC100 likely serves as a model drug to investigate the efficacy of direct compression techniques in tablet formulation. Its unique properties make it an ideal candidate for studies focused on optimizing tablet manufacturing processes, improving drug release profiles, and enhancing patient compliance through better dosage form design.

By utilizing Ibuprofen DC100, researchers can explore the benefits of direct compression, such as reduced production complexity and cost, while maintaining high-quality standards in tablet formulation. This aligns with the ongoing efforts in pharmaceutical sciences to develop more efficient and patient-friendly drug delivery systems.

Conclusion

This study established an in-line triangulation laser measurement as novel PAT for the prediction of SFribbon based on ER measurement. ERin−line values showed time and thus measurement spot dependency. However, the laser position does not influence the result of the prediction models for SFribbon. The ERin−line was approximately 5 % for all formulations using smooth rolls and a formulation dependent ERratio was found. […]

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Materials

Microcrystalline cellulose (MCC, Vivapur® 102, JRS Pharma, Germany), fine powder hydroxypropyl cellulose (HPC, NISSO HPC SSL SFP, Nippon Soda, Japan) and polyvinylpyrrolidone K 25 (PVP, Kollidon® 25, BASF, Germany) were selected as binders; dibasic calcium phosphate anhydrous (DCPA, DI-CAFOS® A60, Chemische Fabrik Budenheim KG, Germany) as filler and ibuprofen (IBU, Ibuprofen DC 100, IPC Process-Center GmbH & Co. KG, Germany) as active pharmaceutical ingredient. […]