Aim of work: The purpose of this study was to prepare the ranges of critical process parameters (CPP) (spray rate, pan speed, and inlet temperature) in the coating process of valsartan and pravastatin fixed-dose combination (FDC) tablets using design of experiment (DoE). A central composite face-centered DoE with three center points was employed in this study. Method: Valsartan and pravastatin FDC tablets were manufactured by wet granulation, drying, sieving, blending, tableting and coating. For the coating process, 3-factorial (spray rate, pan speed and inlet temperature), 4-level (defect, coating efficiency, disintegration time and dissolution), and 1-center (n=3) points as critical quality attributes (CQAs) were applied for the DoE batch using Design Expert Software. Results: Spray rate and inlet temperature were an important factor in the defect and coating efficiency results (p<0.05). The results indicated that spray rate (4.1 g/min), pan speed (from 18 to 23 rpm), and inlet temperature (from 63 to 67oC) for coating process were optimal for valsartan and pravastatin FDC tablets. Conclusion: These studies illustrated that coating process spaces can be defined that CQAs based on levels of risk (defects, coating efficiency, disintegration and dissolution). It can be concluded that the wide process ranges of operation leading to high quality (low defect and coating efficiency) for the CPPs of coating process were successfully observed by the DoE approach.
Key words: Valsartan, Pravastatin, Quality by design, Design of experiment, Coating.
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