Application of a Statistical Approach to the Process Development of Futibatinib by Employing Quality-by-Design Principles. Part 2: Development of Design Space for Impurities Using the Response Surface Methodology

2022 ◽  
Author(s):  
Yasunori Abe ◽  
Kosuke Emori
Keyword(s):  
Response Surface Methodology ◽  
Response Surface ◽  
Quality By Design ◽  
Statistical Approach ◽  
Design Space ◽  
Process Development ◽  
Design Principles

Employment of Quality by Design approach via Response Surface Methodology to Optimize and Develop Modified Release formulation of Hydrochlorothiazide

2020 ◽  
Vol 16 ◽  
Author(s):  
Vikas D Singhai ◽  
Rahul Maheshwari ◽  
Swapnil Sharma ◽  
Sarvesh Paliwal
Keyword(s):  
Response Surface Methodology ◽  
Response Surface ◽  
Quality By Design ◽  
Management Tool ◽  
Contour Plot ◽  
P Value ◽  
Average Weight ◽  
Content Uniformity ◽  
Modified Release ◽  
Release Formulation

Background: Heart attack predominantly occurs during the last phase of sleep and early morning hours, causing millions of death worldwide. Hydrochlorothiazide (HCTZ) is recommended drug for the prevention of heart disease but its long action (>4 h) dosage form is lacking in the commercial market and development of extended-release formulation may have industrial significance. Regulatory agencies emphasize Quality by Design based approach for product development to entrust quality in the product. Objective: Aim of the current research was to develop a quality product profile of HCTZ modified-release tablets (MRT; ~14 h) by applying Response Surface Methodology using computational QbD approach. Methods: Three independent factors were identified by qualitative and quantitative risk assessment. Statistical terms like p-value, lack of fit, sum of square, R-squared value, model F value and linear equations were determined. Graphical tools like normal plot of residual, residual vs predicted plot and box cox plot were used to verify model selection. Graphical relationship among the critical, independent variables was represented using the Contour plot and 3-D surface plot. Design space was identified by designing overlay plot using response surface design. Results: Excellent correlation was observed between actual and predicted values. Similarity Factor (F2) of reproducible trials was 78 and 79 and content uniformity was 100.9% and 100.4%. Average weight, hardness, thickness, diameter and friability were within acceptable limits. Conclusions: QbD approach along with quality risk management tool provided an efficient and effective paradigm to build quality MRT of HCTZ.

Manufacturing Task Process Characterization Utilizing Response Surface Methodology

2012 ◽  
Vol 3 (2) ◽  
pp. 62-77
Author(s):  
Janet H. Sanders ◽  
Silvanus J. Udoka
Keyword(s):  
Response Surface Methodology ◽  
Response Surface ◽  
Process Development ◽  
High Strength ◽  
Business Culture ◽  
Process Characterization ◽  
Novel Approach ◽  
High Strength Fiber ◽  
Rapid Deployment ◽  
Operating Window

To meet today’s business culture of rapid deployment of new products and processes, engineering and manufacturing personnel must utilize efficient means for process development. This paper discusses a novel approach to characterize a task driven manufacturing process. The approach utilized Response Surface Methodology (RSM) to investigate, identify, and prioritize the key process drivers and subsequently develop quantifiable methods for setting the operating levels for the process drivers to determine if the current levels of these key process drivers result in a process response value that is near optimum. The approach identifies the improved response region, generates a mathematical model of the process and specifies an operating window that would yield consistent results for each of the process drivers. A High Strength Fiber Splicing process was used to demonstrate this approach. This study led to the identification of the region that improved the process yield from 65% to 85%.

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