In present work, concurrent process validation of Pantoprazole Sodium 40 mg delayed release tablets was carried out to monitor process parameters in current production batches. The process validation was divided into two major steps, first one is process validation of dosage form before coating and second one is after coating. In-process quality monitoring of all critical processing steps was done for three production batches, before coating and after coating. 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 limit of 100%-104% at the dry mixing stage. LOD for the dried granules after wet granulation was within 1-4% RSD. Assay after lubrication was within the specified limit at different corners in the blender, indicating blend uniformity. Physical parameters like average weight of core tablet was found to be 180.95%-182.25%, thickness was found to be between 3.25 cm-3.60 cm, hardness was found to be 5.08kg/cm2-5.65kg/cm2, %friability was between 0.117%-0.134%. disintegration time was 181sec -202 sec, assay of core tablets 99.54%-100.13 % for all the three batches of compressed tablets. Two coatings were applied on the core tablets, base coating and enteric coating. Base coating using OPADRY polymer and enteric coating using ACRYL EZE polymer. Temperature monitoring was done throughout the coating process. After coating percentage weight build up was within 10%-12%. Finished product assay was between 99.56%-100.23%. No dissolution of active occurred in acidic medium up to 2 hours, drug release in buffered medium was within the limit of 96%-100% within 30 min. Average weight of coated tablet was between 200.52mg-202.37mg. Diameter of coated tablets was 9.1mm- 9.19mm. Thickness was 3.97cm-3.99 cm. Uniformity of dosage forms for 10 dosage unit is between 98.91%- 99.05%, which is within the acceptance limit of = 15 %. Blister strip packing was carried out for the tablets. During 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. Thus process validation of pantoprazole tablets was successfully completed and found within the specifications.
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