Long Term Stability Study of Miconazole Muco–Adhesive Tablets

Abstract

Stability is the ability of a drug substance or drug product to remainwithin established specifications to maintain its identity, strength, quality, andpurity throughout the retest or expiration dating periods. Physical, chemical dataare generated as a function of time and storage conditions. The purpose of thisstudy is design to evaluate of the stability life of Miconazole muco-adhesivetablets in experiential formula.Tablets used in the Stability study were prepared in three different batcheswith same preparing percentages. Long-term testing was cover a 180 daysduration for three different batches at the time of study. Prepared tablets werestoried under conditions of high relative humidity and temperatures that appliesparticularly to solid stability tests. The prepared samples were analyzedaccording USP 27 methods of analysis. Assays were performed by HPLC whilethe dissolution was performed by UV analysis.The assays, dissolutions and disintegration values predicated stableformula under long term stability study conditions. These results had shownnon-significant changes (p>0.05) for assay and disintegration over 3 years.This formula provided successful distribution of Miconazole in mucoadhesivetablet for mass production. This formula could be achieved for oraldisease with high efficiency.