The aim of this work was to exercise concurrent process validation of Modafinil 200 mg Tablets. All the instruments were qualified as per standard operating procedures. In-process quality monitoring of all critical processing steps like granulation, compression, and packaging was done for three production batches. End product testing of current production batches was done to provide documented evidence that manufacturing process is in state of control. Assay for drug content was within the acceptable limit for the samples which were collected after dry mixing and lubrication stage, indicating blend uniformity. LOD for the granules after dry mixing and lubrication was within 0.8-2.5%. Physical parameters like average weight of tablet was found to be 448.0 to 451.0mg, thickness was between 3.8 mm-3.9mm, hardness was within the acceptable limit, disintegration time was 1min-2min, assay of tablets was within 90.0%-110.0% for all the three batches of compressed tablets. Dissolution occurred in 0.1N HCL for up to 30min. at 50 rpm, drug release was within the limit of NLT 75% in 30min. During blister packing operation each pack size was checked for physical appearance and sealing quality and found satisfactory. All the tests were found to have satisfactory results and there was no significant variation between batch to batch. Thus process validation of Modafinil 200mg uncoated tablets was successfully completed and found within the specifications.
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