Abstract
The objective of these studies is to verify and validate the improvement in the inter-tablet coating uniformity for an industrially commercialized coated tablet, without involving changes in the approved registration dossier. Using the CPP (critical process parameters) determined from previous retrospective statistical analysis, the recommended working ranges are identified. Retrospective analysis showed that the design of experiments (DoE) provided an improved process variable configuration. Therefore, it is decided to study two critical parameters: Product temperature and drum speed, with an additional 22 experimental design. The quality results of the samples analyzed show that the aesthetic defects of the batches made with the new working ranges have been reduced. These results have also been corroborated with the 42 industrial batches manufactured with the new ranges. With the optimized parameters, tablets have been coated and the suitability of the model determined. The results demonstrated the overall reliability and effectiveness of the proposed Quality by Design approach and provides a useful tool to help optimize the industrial coating process. This study confirms that it is possible to optimize and validate the manufacturing process of an existing commercial product by means of a DoE with retrospective data. Therefore, no variation in the dossier is required.
Highlights
One of the questions that is often asked by the pharmaceutical industry is how it can improve the quality of its commercial products.GMP (Good Manufacturing Practices) and ICH Q10 talk about the continuous improvement and implementation that are expected throughout the product lifecycle to facilitate innovation and continual improvement in the pharmaceutical industry.One of the reasons for not considering improving the industrial processes of commercialized products is the registration dossier approved by the authorities.The optimization of tablet-coating processes generally warrants extensive experimental research
Retrospective analysis showed that the design of experiments (DoE) provided an improved process variable configuration
Critical process parameters of the coating phase of a commercial product could be identified with a retrospective analysis of commercial batches
Summary
One of the questions that is often asked by the pharmaceutical industry is how it can improve the quality of its commercial products.GMP (Good Manufacturing Practices) and ICH Q10 talk about the continuous improvement and implementation that are expected throughout the product lifecycle to facilitate innovation and continual improvement in the pharmaceutical industry.One of the reasons for not considering improving the industrial processes of commercialized products is the registration dossier approved by the authorities.The optimization of tablet-coating processes generally warrants extensive experimental research. It is not necessary to go back to the galenic development phase in order to optimize commercial processes, as improvements could be proposed based on historical data from the industrial batches already manufactured. With a central composite design considering independent and dependent variables, a model could be obtained to achieve an optimized response characteristic for the three surface defects. Such surface defects can be classified into the following three groups: Erosion, white spots, and poor coating uniformity. The practicality of this study is very interesting as it facilitates a design space with minimal investment in experiments as the actual production batch data are processed statistically
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