Dissolution Method Development for Poorly …

1w h e re,V= Dissolution medium vo l u m eCS= Sat u rated solubility of the co m pound inthe mediumSink = Sink condition facto rTo increase the maximum dissolvable dose,o n eneeds to increase the Dissolution media vo l u m e,change the media to increase the sat u ration solu-b i l i ty of the co m po u n d, or re d u ce the dissolutionsink re q u i re m e nt Vo l u m eTh e re are seve ral ways to increase the dissolutionmedia vo l u m e. Using 4-liter vessels is re l at i ve l yu n co m m o n ,but they are available from ve n d o r offers a po te ntial 4-fold enhance m e nt inmaximum dissolvable dose over the standard 1-lite rve s s e l flow - t h rough apparatus (USP 4) allows flowrates exceeding 50 ml/min (3 L/hr).

pH If the co m p ound is ionizable,adjusting the pH of the dissolution media is a ve r y effe ct i v e way to i n c r ease solubility.Examples of solubility as a func-

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