Process Validation of Sevelamer Hydrochloride Film Coated Tablet

Abstract

All the three batches resulted in granules with desired flow and compaction which is evident from the data of compressed tablets. At compression stage Weight parameters and Speed parameters evaluated and found within Specified limit as well as, The Statistical analysis process performance is high capable, Data is normal and Z bench value also give assurance that process remains in state of control (Process validation state) during manufacturing of Sevelamer Hydrochloride film coated tablets, 800 mg. Coating process proven as validated from the weight build up data of tablets as validation data provided for after 50% coating, 75% coating and 100% coating and found in accordance with process validation protocol. Finished product result was evidence of Weight gain while the inspection activity as this material is in very high hygroscopic in nature. However results found within specified limit.