TY - JOUR
T1 - Rapid automated process development of a continuous capsule-filling process
AU - Wagner, Bernhard
AU - Brinz, Thomas
AU - Otterbach, Stephanie
AU - Khinast, Johannes
PY - 2018/7/30
Y1 - 2018/7/30
N2 - This paper introduces a rapid automated process-development approach for a continuous capsule-filling process. In our proposed method, both the material attributes and the critical process parameters were varied to understand and to optimize the overall process. Using our approach a statistical process model can be generated with unprecedented speed (2 days), which is the prerequisite for effectively developing and operating continuous process platforms. In a first set of experiments a process model was developed using different mixture compositions of ascorbic acid, lactose and magnesium stearate while changing simultaneously the critical process parameters of the capsule filler (speed, pressure, immersion depth and powder bed height). Targets of the model were the mean fill weight and the relative standard deviation of the produced capsules. In a second experimental set the model was tested, i.e., the goal was to predict the behavior of the system at different set points in order to predict weight and relative standard deviation for predefined targets. Predictions were very good, thus validating our approach. The combination of the rapid automated process development approach and the continuous capsule-filling process resulted in a new strategy for the development and manufacture of pharmaceutical dosage forms.
AB - This paper introduces a rapid automated process-development approach for a continuous capsule-filling process. In our proposed method, both the material attributes and the critical process parameters were varied to understand and to optimize the overall process. Using our approach a statistical process model can be generated with unprecedented speed (2 days), which is the prerequisite for effectively developing and operating continuous process platforms. In a first set of experiments a process model was developed using different mixture compositions of ascorbic acid, lactose and magnesium stearate while changing simultaneously the critical process parameters of the capsule filler (speed, pressure, immersion depth and powder bed height). Targets of the model were the mean fill weight and the relative standard deviation of the produced capsules. In a second experimental set the model was tested, i.e., the goal was to predict the behavior of the system at different set points in order to predict weight and relative standard deviation for predefined targets. Predictions were very good, thus validating our approach. The combination of the rapid automated process development approach and the continuous capsule-filling process resulted in a new strategy for the development and manufacture of pharmaceutical dosage forms.
KW - Automated capsule filling
KW - Continuous capsule filling
KW - Design of experiments
KW - Optimized process
KW - Process modeling
KW - Rapid automated process development
UR - http://www.scopus.com/inward/record.url?scp=85047077061&partnerID=8YFLogxK
U2 - 10.1016/j.ijpharm.2018.05.009
DO - 10.1016/j.ijpharm.2018.05.009
M3 - Article
C2 - 29738798
AN - SCOPUS:85047077061
SN - 0378-5173
VL - 546
SP - 154
EP - 165
JO - International Journal of Pharmaceutics
JF - International Journal of Pharmaceutics
IS - 1-2
ER -