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• W2952398688 abstract "This work aimed at establishing a framework to screen and understand the product variability deeming from factors that affect the quality features of cream formulations. As per Quality by Design – based approach, cream quality target profile and critical quality attributes were identified, and a risk assessment analysis was conducted to qualitatively detect the most critical variables for cream design and development. A Plackett-Burman design was used to screen out unimportant factors, avoiding collecting large amounts of data. Accordingly, 2 designs of experiments (DoE-1 and DoE-2) were performed, and the effects of independent variables on the cream formulations responses were estimated. At different factor combinations, significant variability was observed in droplet size, consistency, hardness, compressibility, and adhesiveness with values ranging from 2.6 ± 0.9 to 10 ± 6 μm, 7.93 ± 0.05 to 13.53 ± 0.14 mm, 27.6 ± 0.3 to 58.4 ± 1.1 g, 38 ± 6 to 447 ± 37 g.s, and 25.7 ± 2.1 to 286 ± 33 g.s, respectively. The statistical analysis allowed determining the most influent factors. This study revealed the potential of Quality by Design methodology in understanding product variability, recognizing the most critical independent variables for the final product quality. This systematic approach in the pharmaceutical field will yield more robust products and processes, provisioning time and cost effective developments." @default.
• W2952398688 created "2019-06-27" @default.
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• W2952398688 date "2019-10-01" @default.
• W2952398688 modified "2023-09-23" @default.
• W2952398688 title "Developing Cream Formulations: Renewed Interest in an Old Problem" @default.
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• W2952398688 doi "https://doi.org/10.1016/j.xphs.2019.06.006" @default.
• W2952398688 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/31216450" @default.
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