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The Thai Journal of Pharmaceutical Sciences

Abstract

As validation is an integral part of current good manufacturing practice, nowadays, it is practiced in all pharmaceutical industries to assure that the manufacturing process is in control and products of high quality are obtained. Building of quality needs attention in the manufacturing process, from the raw materials to finalized product. The current research work is to perform prospective process validation for the manufacture of ketoprofen fast dissolving tablets (FDT) of 50 mg dose. Various trials and challenge studies were done to finalize critical process parameters. Three consecutive batches of ketoprofen FDT with the same batch size, procedure, equipment, and validation criteria were done and critical process parameters were monitored in each stage such as sifting, mixing, and compression. In-process quality control tests were performed for each batch. Friability, disintegration, dissolution, uniformity of dispersion, and assay were the major evaluation parameters considered. An average disintegration time was found to be 18–19 s and 97% of dissolution within 30 min, drug content ranging from 98.4% to 99.5% was achieved. All results complied with acceptance criteria. Evaluation results of all three batches were within acceptance criteria. The results concluded that current process validation was reproducible meeting all predetermined process variables.

Publisher

Faculty of Pharmaceutical Sciences, Chulalongkorn University

First Page

215

Last Page

220

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