PROCESS VALIDATION OF VALACYCLOVIR TABLETS BY OPTIMISING PROCESS PARAMETERS
Journal Title: International Journal of Pharmaceutical Development & Technology - Year 2012, Vol 1, Issue 1
Abstract
In the present study, Valacyclovir tablets were formulated using different formulation parameters and their effects on the dissolution rate of these tablets were evaluated. The binding agent used in this study was Povidone. Tablets were prepared by wet granulation method and were evaluated for various parameters like weight variation, hardness, friability, disintegration time, drug content and in vitro dissolution studies. This Process validation report for Valacyclovir Hydrochloride Tablets 500mg & 1gram common blend is based on the observations/data collected during manufacturing of three consecutive batches, which were manufactured as per Batch Manufacturing record for Export Market at Aurobindo Pharma Ltd. Unit-VII, Jadcherla. Samples were collected and analysed as per Process validation protocol. The data & test results of blend at various in-process phases were complied with the specified limits and final blend sample analysis results found to be complying within specifications. This study and results obtained assures that the manufacturing process is reproducible, yielding consistent product, which meets specification.
Authors and Affiliations
D. VENKATESH , N. SRIRAM , VINAY UMESH RAO , UMESH S. H.
Keywords
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- EP ID EP137041
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