Abstract:
:This work describes a quality-by-design (QbD) approach to determine the optimal coating process conditions and robust process operating space for an immediate release aqueous film coating system (Opadry® 200). Critical quality attributes (CQAs) or associated performance indicators of the coated tablets were measured while coating process parameters such as percent solids of the coating dispersion, coating spray rate, inlet air temperature, airflow rate and pan speed were varied, using a design of experiment protocol. The optimized process parameters were then confirmed by independent coating trials. Disintegration time of coated tablets was not affected by the coating process conditions used in this study, while tablet appearance, as determined by measurement of tablet color, coating defects and gloss was determined to be a CQA. Tablet gloss increased when low spray rate and low percent solids were used, as well as with increased coating pan speed. The study used QbD principles and experimental design models to provide a basis to identify ranges of coating process conditions which afford acceptable product quality. High productivity, color uniformity, and very low defect levels were obtained with Opadry 200 even when using a broad range of coating process conditions.
journal_name
AAPS PharmSciTechjournal_title
AAPS PharmSciTechauthors
Teckoe J,Mascaro T,Farrell TP,Rajabi-Siahboomi ARdoi
10.1208/s12249-013-9935-3subject
Has Abstractpub_date
2013-06-01 00:00:00pages
531-40issue
2issn
1530-9932journal_volume
14pub_type
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journal_title:AAPS PharmSciTech
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journal_title:AAPS PharmSciTech
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journal_title:AAPS PharmSciTech
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