The aim of this work is to identify the best combination between process characteristics and product quality in the final stage of the development as a valid support of the following process validation. We determined the relationships between compression force and mechanical and biopharmaceutical properties of tablets prepared, by changing the weight in the range of the pharmacopeia limits under the same working conditions, there by reproducing the usual variability in tablet manufacturing

G. Dondi

M. L. Binda

P. Colombo

U. Conte

A NEW APPROACH TO TABLETTING VALIDATION

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