OPTIMIZATION OF ALBENDAZOLE 400 MG TABLET COMPRESSION PROCESS USING DESIGN OF EXPERIMENT (DOE) APPROACH
Objective: The present study aims to model and optimize the compression process of the Albendazole 400 mg tablets of a pharmaceutical industry production line with the purpose of increasing the production speed (tablets/hour) while maintaining quality requirements.
Methods: Study was conducted using the Design of Experiments (DoE) methodology for the purpose of identify and correlate the critical parameters during the process that affect the maintenance of the compression speed. In order to support the experiments, was tested disintegration time, average hardness, hardness variation, average weight and friability.
Results: Was obtained that quality attributes of disintegration and friability did not generate a significant model, but it has been established correlations between Fill-O-Matic speed and main compression force in the responses of weight variation, hardness and mean hardness. It was found that the main compression force between 6 to 9 kN, the pre-compression force of 1,965 to 5,615 kN and the speed of 55 RPM for Fill-O-Matic speed are responsible for ensuring that all quality attributes analyzed remain within the expected specification.
Conclusion: It was possible to apply the Design of Experiment (DoE) methodology in the compression process of the drug Albendazole 400 mg and to evaluate the impact of the parameters of this step on the formation of the tablet to significantly increasing the productivity of this product. The Fill-O-Matic speed parameter was the main control factor discovered in this study to maintain the quality attributes.
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