Design of Experiments for Wet Granulation of Valsartan and Pravastatin Fixed-Dose Combination Tablet

Kim, Kang-Min; Kim, Geun-Tae; Kang, Jae-Seon

doi:10.14233/ajchem.2016.20115

Cited by 2 publications

(2 citation statements)

References 12 publications

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“…LOD was measured by halogen moisture analyzer (HG63, Mettler-Toledo GmbH, Greifensee, Switzerland), using 5 g of each wet granules at 105°C for 15 min [10].…”

Section: Lodmentioning

confidence: 99%

A Study of Fluid Bed Granulation of Pravastatin Tablet Using Design of Experiments

Kim

Pyo

2018

Asian J Pharm Clin Res

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Objective: The objective of this study was to reduce size and weight of pravastatin tablet through quality by design approach; potential factors (spray rate, atomizing pressure, and inlet temperature) which could influence on the production process for critical process parameters of wet granulation using fluid-bed granulator were examined.Methods: The manufacturing process of the reduced weight and size formulation pravastatin tablet involves wet granulation, drying, granulate screening, blending, and tableting. Design of experiments study for wet granulation of the reduced weight/size pravastatin tablet was produced on 11 combinations of three factors (spray rate, atomizing pressure, and inlet temperature), which were chosen through initial risk assessment. The process of wet granulation was rated by measuring four responses: loss on drying (LOD) (%), bulk density (g/ml), product temperature (°C), and dissolution similarity (f2).Results: It was measured that LOD varied from 1.46 to 3.24%, bulk density from 0.34 to 0.51 g/ml, product temperature from 40.12 to 51.69°C, and dissolution (f2) of pravastatin from 52.14 to 58.91. Control strategy for wet granulation production of the reduced weight and size pravastatin tablet by our results demonstrated that the most optimized condition of three factors for wet granulation is spray rate (3–5 g/min), atomizing pressure (about 1 bar), and inlet temperature (65–90°C), respectively. Updated risk assessment and justification by all experimental data safely existed within the range of acceptance criteria were presented.Conclusion: It can be concluded that the ideal ranges of three factors (spray rate, atomizing pressure, and inlet temperature) in wet granulation were successfully identified.

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“…LOD was measured by halogen moisture analyzer (HG63, Mettler-Toledo GmbH, Greifensee, Switzerland), using 5 g of each wet granules at 105°C for 15 min [10].…”

Section: Lodmentioning

confidence: 99%

A Study of Fluid Bed Granulation of Pravastatin Tablet Using Design of Experiments

Kim

Pyo

2018

Asian J Pharm Clin Res

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“…In previous the DoE approach for wet granulation and tablet compression (0.85 kg lab-scale), granulating water (60 g), granulating time (8 min), and agitator speed (200 rpm) for wet granulation and main compression force (12 kN), press speed (20 rpm), and feeder speed (20 rpm) for tablet compression were optimal for the tablet having good blend uniformity, uniformity of dosage unit, and assay, etc. 13,14 The DoE study for coating process was performed to identify the range of coating conditions using spray rate, pan speed, and inlet temperature.…”

Section: Preliminary Study Evaluationmentioning

confidence: 99%

Design of Experiments for Coating Process of Valsartan and Pravastatin Fixed-dose Combination Tablet

Kim¹,

Kang²

2017

IJPER

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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 67 o C) 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.

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Design of Experiments for Wet Granulation of Valsartan and Pravastatin Fixed-Dose Combination Tablet

Cited by 2 publications

References 12 publications

A Study of Fluid Bed Granulation of Pravastatin Tablet Using Design of Experiments

A Study of Fluid Bed Granulation of Pravastatin Tablet Using Design of Experiments

Design of Experiments for Coating Process of Valsartan and Pravastatin Fixed-dose Combination Tablet

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