Effects of process parameters on tablet critical quality attributes in continuous direct compression: a case study of integrating data-driven statistical models and mechanistic compaction models

2020 ◽  
Vol 25 (10) ◽  
pp. 1204-1215 ◽  
Author(s):  
Zhuangrong Huang ◽  
Shaun C. Galbraith ◽  
Bumjoon Cha ◽  
Huolong Liu ◽  
Seoyoung Park ◽  
...  
Keyword(s):  
Process Parameters ◽  
Statistical Models ◽  
Quality Attributes ◽  
Data Driven ◽  
Direct Compression ◽  
Critical Quality Attributes

The influence of direct compression powder blend transfer method from the container to the tablet press on product critical quality attributes: a case study

2017 ◽  
Vol 43 (6) ◽  
pp. 911-916 ◽  
Author(s):  
Michał Teżyk ◽  
Emilia Jakubowska ◽  
Kasylda Milczewska ◽  
Bartłomiej Milanowski ◽  
Adam Voelkel ◽  
...  
Keyword(s):  
Quality Attributes ◽  
Direct Compression ◽  
Critical Quality Attributes ◽  
Powder Blend ◽  
Tablet Press ◽  
Transfer Method

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.

Determination of Critical Quality Attributes for a Biotherapeutic in the QbD Paradigm: GCSF as a Case Study

2017 ◽  
Vol 19 (6) ◽  
pp. 1826-1841 ◽  
Author(s):  
Sumit K. Singh ◽  
Deepak Kumar ◽  
Anurag S. Rathore
Keyword(s):  
Quality Attributes ◽  
Critical Quality Attributes

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

Assessing Consumer Emotional Responses in the Presence and Absence of Critical Quality Attributes: A Case Study with Chicken Eggs

2015 ◽  
Vol 80 (7) ◽  
pp. S1574-S1582 ◽  
Author(s):  
Wisdom Wardy ◽  
Amporn Sae-Eaw ◽  
Sujinda Sriwattana ◽  
Hong Kyoon No ◽  
Witoon Prinyawiwatkul
Keyword(s):  
Emotional Responses ◽  
Quality Attributes ◽  
Critical Quality Attributes ◽  
Presence And Absence ◽  
Chicken Eggs
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