Revisiting MSC expansion from critical quality attributes to critical culture process parameters

2017 ◽  
Vol 59 ◽  
pp. 231-243 ◽  
Author(s):  
Céline Martin ◽  
Éric Olmos ◽  
Marie-Laure Collignon ◽  
Natalia De Isla ◽  
Fabrice Blanchard ◽  
...  
Keyword(s):  
Process Parameters ◽  
Quality Attributes ◽  
Critical Quality Attributes ◽  
Culture Process

scholarly journals Design Space Approach in Optimization of Fluid Bed Granulation and Tablets Compression Process

2012 ◽  
Vol 2012 ◽  
pp. 1-10 ◽  
Author(s):  
Jelena Djuriš ◽  
Djordje Medarević ◽  
Marko Krstić ◽  
Ivana Vasiljević ◽  
Ivana Mašić ◽  
...  
Keyword(s):  
Process Parameters ◽  
Design Space ◽  
Quality Attributes ◽  
Dissolution Profile ◽  
Compression Force ◽  
Critical Quality Attributes ◽  
Fluid Bed ◽  
Fluid Bed Granulation ◽  
Atomization Pressure ◽  
Space Approach

The aim of this study was to optimize fluid bed granulation and tablets compression processes using design space approach. Type of diluent, binder concentration, temperature during mixing, granulation and drying, spray rate, and atomization pressure were recognized as critical formulation and process parameters. They were varied in the first set of experiments in order to estimate their influences on critical quality attributes, that is, granules characteristics (size distribution, flowability, bulk density, tapped density, Carr's index, Hausner's ratio, and moisture content) using Plackett-Burman experimental design. Type of diluent and atomization pressure were selected as the most important parameters. In the second set of experiments, design space for process parameters (atomization pressure and compression force) and its influence on tablets characteristics was developed. Percent of paracetamol released and tablets hardness were determined as critical quality attributes. Artificial neural networks (ANNs) were applied in order to determine design space. ANNs models showed that atomization pressure influences mostly on the dissolution profile, whereas compression force affects mainly the tablets hardness. Based on the obtained ANNs models, it is possible to predict tablet hardness and paracetamol release profile for any combination of analyzed factors.

Predicting the critical quality attributes of ibuprofen tablets via modelling of process parameters for roller compaction and tabletting

2019 ◽  
Vol 565 ◽  
pp. 209-218 ◽  
Author(s):  
Antonio Matji ◽  
Nicoletta Donato ◽  
Adrianna Gagol ◽  
Enrique Morales ◽  
Luis Carvajal ◽  
...  
Keyword(s):  
Process Parameters ◽  
Quality Attributes ◽  
Roller Compaction ◽  
Critical Quality Attributes

scholarly journals Comprehensive Study of Intermediate and Critical Quality Attributes for Process Control of High-Shear Wet Granulation Using Multivariate Analysis and the Quality by Design Approach

Pharmaceutics ◽  
2019 ◽  
Vol 11 (6) ◽  
pp. 252 ◽  
Author(s):  
Jong Kwon Han ◽  
Beom Soo Shin ◽  
Du Hyung Choi
Keyword(s):  
Multivariate Analysis ◽  
Process Parameters ◽  
Scale Up ◽  
Pilot Scale ◽  
Quality Attributes ◽  
Wet Granulation ◽  
High Shear ◽  
Critical Quality Attributes ◽  
High Shear Wet Granulation ◽  
The Relationship

A robust manufacturing process and the relationship between intermediate quality attributes (IQAs), critical quality attributes (CQAs), and critical process parameters (CPPs) for high-shear wet granulation was determined in this study. Based on quality by the design (QbD) approach, IQAs, CQAs, and CPPs of a telmisartan tablet prepared by high-shear wet granulation were determined and then analyzed with multivariate analysis (MVA) to evaluate mutual interactions between IQAs, CQAs, and CPPs. The effects of the CPPs on the IQAs and CQAs were quantitatively predicted with empirical models of best fit. The models were used to define operating space, and an evaluation of the risk of uncertainty in model prediction was performed using Monte Carlo simulation. MVA showed that granule size and granule hardness were significantly related to % dissolution. In addition, granule FE (Flow Energy) and Carr’s index had effects on tablet tensile strength. Using the manufacture of a clinical batch and robustness testing, a scale-up from lab to pilot scale was performed using geometric similarity, agitator torque profile, and agitator tip speed. The absolute biases and relative bias percentages of the IQAs and CQAs generated by the lab and pilot scale process exhibited small differences. Therefore, the results suggest that a risk reduction in the manufacturing process can be obtained with integrated process parameters as a result of the QbD approach, and the relationship between IQAs, CQAs, and CPPs can be used to predict CQAs for a control strategy and SUPAC (Scale-Up and Post-Approval Guidance).

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