Quality by Design: Comparison of Design Space construction methods in the case of Design of Experiments

Application of Quality by Design Approach in Uv-Vis Spectroscopy Method Development for Simultaneous Estimation of Saxagliptin HCL and Metformin HCL in Active Pharmaceutical Ingredient

“…The method of ruggedness were determined by carrying out the method by the three different analyst and taking the absorbance and results are reported in terms of mean of percentage relative standard deviation [3][4][5][6][7][8][9][10].…”

“…The method of accuracy was carried out by recovery study from API at three different level such as 80%, 100% 120%. Percentage recovery should be within 98%-102% [4,[11][12][13][14][15].…”

“…Determination of wavelength of maximum absorption Standard working solution (10μg/ml) of Saxagliptin and Metformin was scanned from 200-400 nm in the UV spectrophotometer for the selection of analytical wavelength.Saxagliptin showed maximum absorbance (λmax) at 204.5 nm and Metformin showed maximum absorbance (λmax) at 232.5 nm (Figure3). Hence these two wavelengths selected as an analytical wavelengths[2,3].Implementation of AQbD approach in the development of the analytical methodFor the development of AQbD approach, the Ishikawa diagram was used to study the relationship between different variable input parameters and the characteristics of method performance of the spectrophotometric analytical methods (Figure4)[2,4].…”

Model-assisted DoE software: optimization of growth and biocatalysis in Saccharomyces cerevisiae bioprocesses

“…Although DoE can be used to identify correlations between process parameters and their influence on the final productivity, the complex bioprocess is reduced to a few key numbers (e.g., final product concentration), and the dynamics of growth and metabolism are not sufficiently taken into account [ 1 , 13 , 14 ]. In addition, the heuristic conception of a DoE by choosing the limits of the parameter space poses a particular challenge [ 15 – 17 ]. Thus, there is a high risk that the experiments carried out were wrongly chosen and have only insufficient validity, which results in further costs and time delays [ 1 , 18 ].…”

Granulation of teawaste and limestone using sodium-based lignosulfonate and DEM simulation of powder mixing

“…A clear understanding of how changes in the formulation or process variables affect the final product quality is very important in order to reduce waste produced during the process. Design of Experiment and multivariate analysis has been used in the past to establish the design space in which the granulation process would result in the production of a product with desired attributes and develop correlations between the product attributes and input variables [9][10][11][12][13][14]. The pharmaceutical industry has adopted the concept of Quality by Design has been used to produced solid dosage forms with desired functionality [9,[13][14][15][16][17][18] .…”