Long-term stability study of chlorhexidine gluconate mouth wash in experimental formula

Hayder Hamed Abed B.Sc. M.Sc. Ph.D, Dr.

	Long-term stability study of chlorhexidine gluconate mouth wash in experimental formula
MUSTANSIRIA DENTAL JOURNAL
Article 1, Volume 4, Issue 2, 2007, Pages 136-143
Author
Dr. Hayder Hamed Abed B.Sc. M.Sc. Ph.D
Abstract
Chlorhexidine is a bisbiguanide antiseptic and disinfectant that is bactericidal or bacteriostatic against a wide range of Gram-positive and Gram-negative bacteria. Stability study is the capacity 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 designed to evaluation the stability life of chlorhexidine gluconate mouth wash in experimental formula. Stability information from long-term testing was designed according to the European agency for evaluation of medicinal products storage conditions of high relative temperature and humidity. The prepared samples were analyzed according to united state pharmacopoeia -27. Assays were performed by high performance liquid chromatography analysis. Ascorbic acid, sodium citrate with organic solvents and antitoxins has been used to provide efficient, simple mixing method for chlorhexidine gluconate mouth wash. The assays and level of related substances predicated stable formula under long term stability study conditions. These results had shown non-significant changes (p>0.05). This formula provided successful distribution and stability of chlorhexidine gluconate in mouth wash solution and this formula is also suitable for mass production and stable products for more than 3 years.
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