Long Term Stability Study of Miconazole Muco–Adhesive Tablets

H. Abed, Hayder; J. Alsaree, Omar; G. Sajet, Hayat

	Long Term Stability Study of Miconazole Muco–Adhesive Tablets
Al-Mustansiriyah Journal for Pharmaceutical Sciences
Article 1, Volume 7, Issue 1, 2010, Pages 123-129
Authors
Hayder H. Abed; Omar J. Alsaree; Hayat G. Sajet
Abstract
Stability is the ability of a drug substance or drug product to remain within established specifications to maintain its identity, strength, quality, and purity throughout the retest or expiration dating periods. Physical, chemical data are generated as a function of time and storage conditions. The purpose of this study is design to evaluate of the stability life of Miconazole muco-adhesive tablets in experiential formula.Tablets used in the Stability study were prepared in three different batches with same preparing percentages. Long-term testing was cover a 180 days duration for three different batches at the time of study. Prepared tablets were storied under conditions of high relative humidity and temperatures that applies particularly to solid stability tests. The prepared samples were analyzed according USP 27 methods of analysis. Assays were performed by HPLC while the dissolution was performed by UV analysis. The assays, dissolutions and disintegration values predicated stable formula under long term stability study conditions. These results had shown non-significant changes (p>0.05) for assay and disintegration over 3 years. This formula provided successful distribution of Miconazole in mucoadhesive tablet for mass production. This formula could be achieved for oral disease with high efficiency.

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