Comparison of Nitrazepam Tablets Release Profiles
Keywords:Nitrazepam, Tablets, Solubility, Chemistry, Pharmaceutical, Dissolution
The amount of bioavailable active substance is essential in demonstrating therapeutic drug efficacy. In vitro technique regarding the comparison of released quantity of active substance from drug can be a relevant anticipation test for in vivo drug characteristics. Comparison is usually conducted between test generic drug and a referent, innovative product (1). This comparative study shows the release of nitrazepam content from preparations Trazem® tablets 5 mg (Bosnalijek - test product) and Mogadon® tablets 5 mg (ICN Iberica S.A., Barcelona, Spain - referent product).
Based on the results obtained from the analysis, similarity factor f2 may be calculated. It is a parameter that, according to FDA guidelines (US Food and Drug Administration), measures similarity of dissolution profiles between two preparations. When two dissolution profiles are identical, f2 = 100. In case when f2 value ranges between 50 and 100, FDA defines that such two dissolution profiles may be considered similar (2).