High-Speed Tableting of High Drug-Loaded Tablets Prepared from Fluid-Bed Granulated Isoniazid
The aim of this feasibility study was to investigate the possibility of producing industrial-scale relevant, robust, high drug-loaded (90.9%, <i>w</i>/<i>w</i>) 100 mg dose immediate-release tablets of isoniazid and simultaneously meet the biowaiver requirements. With an unde...
| Main Authors: | , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2023-04-01
|
| Series: | Pharmaceutics |
| Subjects: | |
| Online Access: | https://www.mdpi.com/1999-4923/15/4/1236 |
| _version_ | 1797603883052171264 |
|---|---|
| author | Valentyn Mohylyuk Dace Bandere |
| author_facet | Valentyn Mohylyuk Dace Bandere |
| author_sort | Valentyn Mohylyuk |
| collection | DOAJ |
| description | The aim of this feasibility study was to investigate the possibility of producing industrial-scale relevant, robust, high drug-loaded (90.9%, <i>w</i>/<i>w</i>) 100 mg dose immediate-release tablets of isoniazid and simultaneously meet the biowaiver requirements. With an understanding of the real-life 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<sup>®</sup> 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. |
| first_indexed | 2024-03-11T04:38:17Z |
| format | Article |
| id | doaj.art-77570a89844748f0b8860b023a94d5ce |
| institution | Directory Open Access Journal |
| issn | 1999-4923 |
| language | English |
| last_indexed | 2024-03-11T04:38:17Z |
| publishDate | 2023-04-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj.art-77570a89844748f0b8860b023a94d5ce2023-11-17T20:54:39ZengMDPI AGPharmaceutics1999-49232023-04-01154123610.3390/pharmaceutics15041236High-Speed Tableting of High Drug-Loaded Tablets Prepared from Fluid-Bed Granulated IsoniazidValentyn Mohylyuk0Dace Bandere1Laboratory of Finished Dosage Forms, Faculty of Pharmacy, Riga Stradiņš University, LV-1007 Riga, LatviaDepartment of Pharmaceutical Chemistry, Faculty of Pharmacy, Riga Stradiņš University, LV-1007 Riga, LatviaThe aim of this feasibility study was to investigate the possibility of producing industrial-scale relevant, robust, high drug-loaded (90.9%, <i>w</i>/<i>w</i>) 100 mg dose immediate-release tablets of isoniazid and simultaneously meet the biowaiver requirements. With an understanding of the real-life 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<sup>®</sup> 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.https://www.mdpi.com/1999-4923/15/4/1236isoniazidtabletshigh drug-loadedgranulationwet granulationfluid-bed granulation |
| spellingShingle | Valentyn Mohylyuk Dace Bandere High-Speed Tableting of High Drug-Loaded Tablets Prepared from Fluid-Bed Granulated Isoniazid Pharmaceutics isoniazid tablets high drug-loaded granulation wet granulation fluid-bed granulation |
| title | High-Speed Tableting of High Drug-Loaded Tablets Prepared from Fluid-Bed Granulated Isoniazid |
| title_full | High-Speed Tableting of High Drug-Loaded Tablets Prepared from Fluid-Bed Granulated Isoniazid |
| title_fullStr | High-Speed Tableting of High Drug-Loaded Tablets Prepared from Fluid-Bed Granulated Isoniazid |
| title_full_unstemmed | High-Speed Tableting of High Drug-Loaded Tablets Prepared from Fluid-Bed Granulated Isoniazid |
| title_short | High-Speed Tableting of High Drug-Loaded Tablets Prepared from Fluid-Bed Granulated Isoniazid |
| title_sort | high speed tableting of high drug loaded tablets prepared from fluid bed granulated isoniazid |
| topic | isoniazid tablets high drug-loaded granulation wet granulation fluid-bed granulation |
| url | https://www.mdpi.com/1999-4923/15/4/1236 |
| work_keys_str_mv | AT valentynmohylyuk highspeedtabletingofhighdrugloadedtabletspreparedfromfluidbedgranulatedisoniazid AT dacebandere highspeedtabletingofhighdrugloadedtabletspreparedfromfluidbedgranulatedisoniazid |