IMPLEMENTATION OF MIXING PROCESS PARAMETER ROSUVASTATIN CALCIUM ON SCALE UP IN PT B
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 Rosuva...
Saved in:
| Main Author: | |
|---|---|
| Format: | Theses |
| Language: | Indonesia |
| Online Access: | https://digilib.itb.ac.id/gdl/view/69291 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| Institution: | Institut Teknologi Bandung |
| Language: | Indonesia |
| Summary: | 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.
|
|---|