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Optimization of Process Parameters for a Quasi-Continuous Tablet Coating System Using Design of Experiments

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Abstract

The aim of this study was to identify and optimize the critical process parameters of the newly developed Supercell quasi-continuous coater for optimal tablet coat quality. Design of experiments, aided by multivariate analysis techniques, was used to quantify the effects of various coating process conditions and their interactions on the quality of film-coated tablets. The process parameters varied included batch size, inlet temperature, atomizing pressure, plenum pressure, spray rate and coating level. An initial screening stage was carried out using a 26−1(IV) fractional factorial design. Following these preliminary experiments, optimization study was carried out using the Box–Behnken design. Main response variables measured included drug-loading efficiency, coat thickness variation, and the extent of tablet damage. Apparent optimum conditions were determined by using response surface plots. The process parameters exerted various effects on the different response variables. Hence, trade-offs between individual optima were necessary to obtain the best compromised set of conditions. The adequacy of the optimized process conditions in meeting the combined goals for all responses was indicated by the composite desirability value. By using response surface methodology and optimization, coating conditions which produced coated tablets of high drug-loading efficiency, low incidences of tablet damage and low coat thickness variation were defined. Optimal conditions were found to vary over a large spectrum when different responses were considered. Changes in processing parameters across the design space did not result in drastic changes to coat quality, thereby demonstrating robustness in the Supercell coating process.

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ACKNOWLEDGMENTS

The authors wish to express their gratitude to GEA Pharma Systems, UK, for providing the Supercell coater used in this study. CAMO Softwares, Norway, is also acknowledged for providing The Unscrambler software used for multivariate analysis. Lastly, the authors would like to thank National University of Singapore for the facilities and funding given to this research (Grant No.: R148-000-008-001).

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  1. GEA-NUS Pharmaceutical Processing Research Laboratory, Department of Pharmacy, Faculty of Science, National University of Singapore, 18 Science Drive 4, Singapore, 117543, Singapore

    Christine Cahyadi, Paul Wan Sia Heng & Lai Wah Chan

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  1. Christine Cahyadi
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  2. Paul Wan Sia Heng
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  3. Lai Wah Chan
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Correspondence to Lai Wah Chan.

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Cahyadi, C., Heng, P.W.S. & Chan, L.W. Optimization of Process Parameters for a Quasi-Continuous Tablet Coating System Using Design of Experiments. AAPS PharmSciTech 12, 119–131 (2011). https://doi.org/10.1208/s12249-010-9567-9

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