Design Space Approach for the Optimization of Green Fluidized Bed Granulation Process in the Granulation of a Poorly Water-Soluble Fenofibrate Using Design of Experiment
In the pharmaceutical industry, the systematic optimization of process variables using a quality-by-design (QbD) approach is highly precise, economic and ensures product quality. The current research presents the implementation of a design-of-experiment (DoE) driven QbD approach for the optimization...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-07-01
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| Series: | Pharmaceutics |
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| Online Access: | https://www.mdpi.com/1999-4923/14/7/1471 |
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| author | Mohamed H. Fayed Ahmed Alalaiwe Ziyad S. Almalki Doaa A. Helal |
| author_facet | Mohamed H. Fayed Ahmed Alalaiwe Ziyad S. Almalki Doaa A. Helal |
| author_sort | Mohamed H. Fayed |
| collection | DOAJ |
| description | In the pharmaceutical industry, the systematic optimization of process variables using a quality-by-design (QbD) approach is highly precise, economic and ensures product quality. The current research presents the implementation of a design-of-experiment (DoE) driven QbD approach for the optimization of key process variables of the green fluidized bed granulation (GFBG) process. A 3<sup>2</sup> full-factorial design was performed to explore the effect of water amount (X<sub>1</sub>; 1–6% <i>w</i>/<i>w</i>) and spray rate (X<sub>2</sub>; 2–8 g/min) as key process variables on critical quality attributes (CQAs) of granules and tablets. Regression analysis have demonstrated that changing the levels of X<sub>1</sub> and X<sub>2</sub> significantly affect (<i>p</i> ≤ 0.05) the CQAs of granules and tablets. Particularly, X<sub>1</sub> was found to have the pronounced effect on the CQAs. The GFBG process was optimized, and a design space (DS) was built using numerical optimization. It was found that X<sub>1</sub> and X<sub>2</sub> at high (5.69% <i>w</i>/<i>w</i>) and low (2 g/min) levels, respectively, demonstrated the optimum operating conditions. By optimizing X<sub>1</sub> and X<sub>2</sub>, GFBG could enhance the disintegration and dissolution of tablets containing a poorly water-soluble drug. The prediction error values of dependent responses were less than 5% that confirm validity, robustness and accuracy of the generated DS in optimization of GFBG. |
| first_indexed | 2024-03-09T13:10:34Z |
| format | Article |
| id | doaj.art-5e0f9b5842034115971cc02224857eea |
| institution | Directory Open Access Journal |
| issn | 1999-4923 |
| language | English |
| last_indexed | 2024-03-09T13:10:34Z |
| publishDate | 2022-07-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj.art-5e0f9b5842034115971cc02224857eea2023-11-30T21:42:18ZengMDPI AGPharmaceutics1999-49232022-07-01147147110.3390/pharmaceutics14071471Design Space Approach for the Optimization of Green Fluidized Bed Granulation Process in the Granulation of a Poorly Water-Soluble Fenofibrate Using Design of ExperimentMohamed H. Fayed0Ahmed Alalaiwe1Ziyad S. Almalki2Doaa A. Helal3Department of Pharmaceutics, Faculty of Pharmacy, Fayoum University, Fayoum 63514, EgyptDepartment of Pharmaceutics, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Al-Kharj 11942, Saudi ArabiaDepartment of Clinical Pharmacy, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Al-Kharj 11942, Saudi ArabiaDepartment of Pharmaceutics, Faculty of Pharmacy, Fayoum University, Fayoum 63514, EgyptIn the pharmaceutical industry, the systematic optimization of process variables using a quality-by-design (QbD) approach is highly precise, economic and ensures product quality. The current research presents the implementation of a design-of-experiment (DoE) driven QbD approach for the optimization of key process variables of the green fluidized bed granulation (GFBG) process. A 3<sup>2</sup> full-factorial design was performed to explore the effect of water amount (X<sub>1</sub>; 1–6% <i>w</i>/<i>w</i>) and spray rate (X<sub>2</sub>; 2–8 g/min) as key process variables on critical quality attributes (CQAs) of granules and tablets. Regression analysis have demonstrated that changing the levels of X<sub>1</sub> and X<sub>2</sub> significantly affect (<i>p</i> ≤ 0.05) the CQAs of granules and tablets. Particularly, X<sub>1</sub> was found to have the pronounced effect on the CQAs. The GFBG process was optimized, and a design space (DS) was built using numerical optimization. It was found that X<sub>1</sub> and X<sub>2</sub> at high (5.69% <i>w</i>/<i>w</i>) and low (2 g/min) levels, respectively, demonstrated the optimum operating conditions. By optimizing X<sub>1</sub> and X<sub>2</sub>, GFBG could enhance the disintegration and dissolution of tablets containing a poorly water-soluble drug. The prediction error values of dependent responses were less than 5% that confirm validity, robustness and accuracy of the generated DS in optimization of GFBG.https://www.mdpi.com/1999-4923/14/7/1471green fluidized bed granulationdesign spacequality-by-designdesign-of-experimentgranules and tablets |
| spellingShingle | Mohamed H. Fayed Ahmed Alalaiwe Ziyad S. Almalki Doaa A. Helal Design Space Approach for the Optimization of Green Fluidized Bed Granulation Process in the Granulation of a Poorly Water-Soluble Fenofibrate Using Design of Experiment Pharmaceutics green fluidized bed granulation design space quality-by-design design-of-experiment granules and tablets |
| title | Design Space Approach for the Optimization of Green Fluidized Bed Granulation Process in the Granulation of a Poorly Water-Soluble Fenofibrate Using Design of Experiment |
| title_full | Design Space Approach for the Optimization of Green Fluidized Bed Granulation Process in the Granulation of a Poorly Water-Soluble Fenofibrate Using Design of Experiment |
| title_fullStr | Design Space Approach for the Optimization of Green Fluidized Bed Granulation Process in the Granulation of a Poorly Water-Soluble Fenofibrate Using Design of Experiment |
| title_full_unstemmed | Design Space Approach for the Optimization of Green Fluidized Bed Granulation Process in the Granulation of a Poorly Water-Soluble Fenofibrate Using Design of Experiment |
| title_short | Design Space Approach for the Optimization of Green Fluidized Bed Granulation Process in the Granulation of a Poorly Water-Soluble Fenofibrate Using Design of Experiment |
| title_sort | design space approach for the optimization of green fluidized bed granulation process in the granulation of a poorly water soluble fenofibrate using design of experiment |
| topic | green fluidized bed granulation design space quality-by-design design-of-experiment granules and tablets |
| url | https://www.mdpi.com/1999-4923/14/7/1471 |
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