(344e) Large-Scale Experimental Comparison of Batch and Continuous Technologies for Pharmaceutical Tablet Manufacturing
- Conference: AIChE Annual Meeting
- Year: 2017
- Proceeding: 2017 Annual Meeting
- Group: Pharmaceutical Discovery, Development and Manufacturing Forum
- Time: Tuesday, October 31, 2017 - 1:58pm-2:20pm
The experimental result indicated that the product quality of all processes fulfilled the standard values which are often used in the industry. Granules made by fluidized bed granulation were porous, while granules made by high shear granulation and the continuous process were spherical. Although hardness of tablets made by the high shear granulation process was lower than that by the other two processes, there are no significant differences of dissolution profiles among the three processes. In the continuous process, product quality measured by mean particle diameter of granules was stable for the entire run time except for the initial nine minutes. Because of this reason, yield of the continuous process was lower than those of the other two processes, which indicates that stabilization would be one of the important challenges in continuous technology. In conclusion, the three investigated processes using continuous, fluidized bed, and high sheer granulation showed similarity in terms of product quality. However, intermediate products showed different quality characteristics such as size/shape, and especially in continuous technology, yield was found to be an improvement opportunity. The actual decisions should be based on various aspects such as quality, economy or safety, and thus, development of multiobjective design methodology is desired in future.