A quality-by-design study to develop Nifedipine nanosuspension: examining the relative impact of formulation variables, wet media milling process parameters and excipient variability on drug product quality attributes

2018 ◽  
Vol 44 (12) ◽  
pp. 1942-1952 ◽  
Author(s):  
Pooja J. Patel ◽  
Bhavin Y. Gajera ◽  
Rutesh H. Dave
Keyword(s):  
Product Quality ◽  
Process Parameters ◽  
Quality By Design ◽  
Drug Product ◽  
Milling Process ◽  
Relative Impact ◽  
Design Study ◽  
Media Milling ◽  
Excipient Variability ◽  
Formulation Variables

scholarly journals Design Space and QbD Approach for Production of Drug Nanocrystals by Wet Media Milling Techniques

Pharmaceutics ◽  
2018 ◽  
Vol 10 (3) ◽  
pp. 104 ◽  
Author(s):  
Leena Peltonen
Keyword(s):  
Process Parameters ◽  
Design Space ◽  
Milling Process ◽  
Production Chain ◽  
Media Milling ◽  
Process Understanding ◽  
Poorly Soluble ◽  
Critical Process Parameters ◽  
Input Variables ◽  
Definition Of

Drug nanocrystals are nanosized solid drug particles, the most important application of which is the improvement of solubility properties of poorly soluble drug materials. Drug nanocrystals can be produced by many different techniques, but the mostly used are different kinds of media milling techniques; in milling, particle size of bulk sized drug material is decreased, with the aid of milling beads, to nanometer scale. Utilization of Quality by Design, QbD, approach in nanomilling improves the process-understanding of the system, and recently, the number of studies using the QbD approach in nanomilling has increased. In the QbD approach, the quality is built into the products and processes throughout the whole production chain. Definition of Critical Quality Attributes, CQAs, determines the targeted final product properties. CQAs are confirmed by setting Critical Process Parameters, CPPs, which include both process parameters but also input variables, like stabilizer amount or the solid state form of the drug. Finally, Design Space determines the limits in which CPPs should be in order to reach CQAs. This review discusses the milling process and process variables, CPPs, their impact on product properties, CQAs and challenges of the QbD approach in nanomilling studies.

An Analysis on Technology and Product Quality Effect of II-Powdery Emulsion Explosives

2011 ◽  
Vol 84-85 ◽  
pp. 652-656
Author(s):  
Jun Guo ◽  
De Qing Gan ◽  
Jing Tan
Keyword(s):  
Production Process ◽  
Product Quality ◽  
Process Parameters ◽  
Raw Materials ◽  
Milling Process ◽  
Detonation Parameter ◽  
Effect Factors ◽  
Emulsion Explosives

This paper discusses the effect factors and proposals between milling process of Ⅱ-powdery emulsion explosives and raw materials, production process parameters. The effect from percentage of the additive M on dispensability and detonation parameter of explosive can be analyzed through the experiments.

TOPSIS based selection of optimal end milling process parameters

2020 ◽  
Author(s):  
A. Singh ◽  
I. Shivakoti ◽  
Z. Mustafa ◽  
R. Phipon ◽  
A. Sharma
Keyword(s):  
Process Parameters ◽  
End Milling ◽  
Milling Process ◽  
End Milling Process ◽  
Selection Of

The Impact of Ball Milling Process Parameters on the Preparation of Nano Silicon Powder

2021 ◽  
Vol 217 (1) ◽  
pp. 255-264
Author(s):  
Xiaomeng Zhu ◽  
Xiaolan Cai ◽  
Shuang Zhang ◽  
Lei Wang ◽  
Xudong Cui
Keyword(s):  
Ball Milling ◽  
Process Parameters ◽  
Silicon Powder ◽  
Milling Process ◽  
Ball Milling Process ◽  
Nano Silicon ◽  
The Impact

scholarly journals Optimization of injection molding process for car fender in consideration of energy efficiency and product quality

2014 ◽  
Vol 1 (4) ◽  
pp. 256-265 ◽  
Author(s):  
Hong Seok Park ◽  
Trung Thanh Nguyen
Keyword(s):  
Energy Efficiency ◽  
Energy Consumption ◽  
Injection Molding ◽  
Product Quality ◽  
Process Parameters ◽  
Optimization Problems ◽  
Computational Cost ◽  
Injection Molding Process ◽  
Molding Process ◽  
Nsga Ii

Abstract Energy efficiency is an essential consideration in sustainable manufacturing. This study presents the car fender-based injection molding process optimization that aims to resolve the trade-off between energy consumption and product quality at the same time in which process parameters are optimized variables. The process is specially optimized by applying response surface methodology and using nondominated sorting genetic algorithm II (NSGA II) in order to resolve multi-object optimization problems. To reduce computational cost and time in the problem-solving procedure, the combination of CAE-integration tools is employed. Based on the Pareto diagram, an appropriate solution is derived out to obtain optimal parameters. The optimization results show that the proposed approach can help effectively engineers in identifying optimal process parameters and achieving competitive advantages of energy consumption and product quality. In addition, the engineering analysis that can be employed to conduct holistic optimization of the injection molding process in order to increase energy efficiency and product quality was also mentioned in this paper.

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