Please use this identifier to cite or link to this item:
10.3390/pharmaceutics15041236
Title: | High-Speed Tableting of High Drug-Loaded Tablets Prepared from Fluid-Bed Granulated Isoniazid |
Authors: | Mohylyuk, Valentyn Bandere, Dace Laboratory of Finished Dosage Forms Department of Pharmaceutical Chemistry |
Keywords: | isoniazid;tablets;high drug-loaded;granulation;wet granulation;fluid-bed granulation;high-speed tableting;Heckel plot;compressibility;tabletability;compactability;3.1 Basic medicine;1.1. Scientific article indexed in Web of Science and/or Scopus database |
Issue Date: | 13-Apr-2023 |
Citation: | Mohylyuk , V & Bandere , D 2023 , ' High-Speed Tableting of High Drug-Loaded Tablets Prepared from Fluid-Bed Granulated Isoniazid ' , Pharmaceutics , vol. 15 , no. 4 , 1236 . https://doi.org/10.3390/pharmaceutics15041236 |
Abstract: | The aim of this feasibility study was to investigate the possibility of producing industrialscale relevant, robust, high drug-loaded (90.9%, w/w) 100 mg dose immediate-release tablets of isoniazid and simultaneously meet the biowaiver requirements. With an understanding of the reallife constrictions on formulation scientists during product development for the generic industry, this study was done considering a common set of excipients and manufacturing operations, as well as paying special attention to the industrial-scale high-speed tableting process as one of the most critical manufacturing operations. The isoniazid substance was not applicable for the direct compression method. Thus, the selection of granulation method was logically justified, and it was fluid-bed granulated with an aqueous solution of Kollidon® 25, mixed with excipients, and tableted with a rotary tablet press (Korsch XL 100) at 80 rpm (80% of the maximum speed) in the compaction pressure range 170–549 MPa monitoring of ejection/removal forces, tablet weight uniformity, thickness, and hardness. Adjusting the main compression force, the Heckel plot, manufacturability, tabletability, compactability, and compressibility profiles were analysed to choose the main compression force that resulted in the desirable tensile strength, friability, disintegration, and dissolution profile. The study showed that highly robust drug-loaded isoniazid tablets with biowaiver requirements compliance can be prepared with a common set of excipients and manufacturing equipment/operations incl. the industrial-scale high-speed tableting process. |
Description: | Publisher Copyright: © 2023 by the authors. |
DOI: | 10.3390/pharmaceutics15041236 |
ISSN: | 1999-4923 |
Appears in Collections: | Research outputs from Pure / Zinātniskās darbības rezultāti no ZDIS Pure |
Files in This Item:
File | Size | Format | |
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High_Speed_Tableting_of_High_Drug_Loaded_Tablets.pdf | 5.27 MB | Adobe PDF | View/Open |
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