Challenges encountered in the transfer of atorvastatin tablet manufacturing - commercial batch-based production as a basis for small-scale continuous tablet manufacturing tests
Jazyk angličtina Země Nizozemsko Médium print-electronic
Typ dokumentu časopisecké články
PubMed
37832703
DOI
10.1016/j.ijpharm.2023.123509
PII: S0378-5173(23)00930-4
Knihovny.cz E-zdroje
- Klíčová slova
- Dry granulation, Oral solid dosage form, Pharmaceutical continuous manufacturing, Tableting, Twin screw feeding,
- MeSH
- atorvastatin MeSH
- farmaceutická technologie * metody MeSH
- prášky, zásypy, pudry chemie MeSH
- příprava léků metody MeSH
- tablety chemie MeSH
- tlak MeSH
- velikost částic MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- atorvastatin MeSH
- prášky, zásypy, pudry MeSH
- tablety MeSH
As is the case with batch-based tableting processes, continuous tablet manufacturing can be conducted by direct compression or with a granulation step such as dry or wet granulation included in the production procedure. In this work, continuous manufacturing tests were performed with a commercial tablet formulation, while maintaining its original material composition. Challenges were encountered with the feeding performance of the API during initial tests which required designing different powder pre-blend compositions. After the pre-blend optimization phase, granules were prepared with a roller compactor. Tableting was conducted with the granules and an additional brief continuous direct compression run was completed with some ungranulated mixture. The tablets were assessed with off-line tests, applying the quality requirements demanded for the batch-manufactured product. Chemical maps were obtained by Raman mapping and elemental maps by scanning electron microscopy with energy-dispersive X-ray spectroscopy. Large variations in both tablet weights and breaking forces were observed in all tested samples, resulting in significant quality complications. It was suspected that the API tended to adhere to the process equipment, accounting for the low API content in the powder mixture and tablets. These results suggest that this API or the tablet composition was unsuitable for manufacturing in a continuous line; further testing could be continued with different materials and changes in the process.
Department of Technical Physics University of Eastern Finland Kuopio Finland
School of Pharmacy PromisLab University of Eastern Finland Kuopio Finland
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