Development of a New Punch Head Shape to Replicate Scale-Up Issues on a Laboratory Tablet Press III: Replicating Sticking Phenomenon Using the SAS Punch and Evaluation by Checking the Tablet Surface Using 3-D Laser Scanning Microscope
| Autor: | Jumpei Uchiyama, Keisuke Yamato, Shigeru Aoki, Manabu Ito |
|---|---|
| Rok vydání: | 2018 |
| Předmět: |
Materials science
Surface Properties Process analytical technology Drug Compounding Pharmaceutical Science 02 engineering and technology 030226 pharmacology & pharmacy Head shape Excipients 03 medical and health sciences chemistry.chemical_compound Tableting 0302 clinical medicine Laser scanning microscope Pressure Magnesium stearate Composite material Microscopy Confocal Adhesiveness Equipment Design 021001 nanoscience & nanotechnology Compression (physics) chemistry SCALE-UP 0210 nano-technology Compression time Stearic Acids Tablets |
| Zdroj: | Journal of pharmaceutical sciences. 107(8) |
| ISSN: | 1520-6017 |
| Popis: | Sticking is a common observation in the scale-up stage on the punch tip using a commercial tableting machine. The difference in the total compression time between a laboratory tableting machine and a commercial one is considered one of the main root causes of scale-up issues in the tableting processes. The proposed "Size Adjusted for Scale-up punch" can be used to adjust the consolidation and dwell times for commercial tableting machine. As a result, the sticking phenomenon is able to be replicated at the pilot scale stage. As reported in this article, the quantification of sticking was done using a 3-D laser scanning microscope to check the tablet surface. It was shown that the sticking area decreased with the addition of magnesium stearate in the formulation, but the sticking depth was not affected by the additional amount of magnesium stearate. It is proposed that the use of a 3-D laser scanning microscope can be applied to evaluate sticking as a process analytical technology tool, and so sticking can be monitored continuously without stopping the machine. |
| Databáze: | OpenAIRE |
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