Batch vs. continuous direct compression - a comparison of material processability and final tablet quality.

Autor: Bekaert B; Laboratory of Pharmaceutical Technology, Department of Pharmaceutics, Ghent University, Ottergemsesteenweg 460, B-9000 Ghent, Belgium., Janssen PHM; Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, Antonius Deusinglaan 1, 9713 AV Groningen, the Netherlands.; DFE Pharma, Klever Strasse 187, 47568 Goch, Germany., Fathollahi S; DFE Pharma, Klever Strasse 187, 47568 Goch, Germany., Vanderroost D; GEA Process Engineering, Keerbaan 70, B-2160 Wommelgem, Belgium., Roelofs T; DFE Pharma, Klever Strasse 187, 47568 Goch, Germany., Dickhoff BHJ; DFE Pharma, Klever Strasse 187, 47568 Goch, Germany., Vervaet C; Laboratory of Pharmaceutical Technology, Department of Pharmaceutics, Ghent University, Ottergemsesteenweg 460, B-9000 Ghent, Belgium., Vanhoorne V; Laboratory of Pharmaceutical Technology, Department of Pharmaceutics, Ghent University, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.
Jazyk: angličtina
Zdroj: International journal of pharmaceutics: X [Int J Pharm X] 2023 Dec 21; Vol. 7, pp. 100226. Date of Electronic Publication: 2023 Dec 21 (Print Publication: 2024).
DOI: 10.1016/j.ijpx.2023.100226
Abstrakt: In this study, an in-depth comparison was made between batch and continuous direct compression using similar compression set-ups. The overall material processability and final tablet quality were compared and evaluated. Correlations between material properties, process parameters and final tablet properties were made via multivariate data analyses. In total, 10 low-dosed (1% w /w) and 10 high-dosed (40% w/w) formulations were processed, using a total of 10 different fillers/filler combinations. The trials indicated that the impact of filler type, drug load or process settings was similar for batch and continuous direct compression. The main differentiator between batch and continuous was the flow dynamics in the operating system, where properties related to flow, compressibility and permeability played a crucial role. The less consistent flow throughout a batch process resulted in a significantly higher variability within the tablet press (σ CF ) and for the tablet quality responses (σ Mass , σ TS ). However, the better controlled blending procedure prior to batch processing was reflected in a more consistent API concentration variability. Overall, the comparison showed the benefits of selecting appropriate excipients and process settings to achieve a specific outcome, keeping in mind some key differentiators between both processes.
Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(© 2023 The Authors.)
Databáze: MEDLINE
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