IMPLEMENTATION OF MIXING PROCESS PARAMETER ROSUVASTATIN CALCIUM ON SCALE UP IN PT B

• Main Author: Febrianti, Istar
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/69291
• Institution: Institut Teknologi Bandung

Scale-up is generally defined as a procedure for applying the same process to obtain different output volumes. The homogeneity of the mixture is often a problem in the scale up process. As a result a smooth transition process cannot be achieved. This study aims to conduct a mixing study of Rosuvastatin Calcium on laboratory scale to obtain optimal mixing parameters then applied to the pilot scale by considering batch size and blender fill level. In this study, a mixing study was carried out with variations in mixing time of 16 minutes, 21 minutes and 26 minutes in batch size of 3 kg and a blender fill level was about 53%. All mixing time variation meet the acceptance criteria of blend uniformity test. All individuals are within ± 10% of the mean with the mean are within assay criteria (90.0 – 110.0%) with a relative standard deviation less than 5.0%. Relative standard deviation of each mixing time variation is 4.46%, 1.38% and 1.86%, respectively. Analysis of variance reveals that the difference in mixing time has an effect on blend uniformity. Mixing time of 21 minutes shows the smallest relative standard deviation so it was chosen as the optimal mixing. These parameters had been applied to a pilot scale with batch size 30 kg and a blender fill level blender of about 53%. Blend uniformity test meets the criteria with a relative standard deviation of 1.36%. Other tests on Rosuvastatin tablets were characterized including weight, hardness, and disintegration time. The result on laboratory and the pilot scale met the specifications. Comparative dissolution test shows test product Rosuvastatin tablet from laboratory and pilot scale was similar to the innovator in medium pH of 1.2; pH of 4.5 and pH of 6.8. Based on the resulted parameter, the mixing time of the laboratory scale can be applied to the pilot scale.