Potentially Incorrect Interpretation of In Vitro Dissolution Characteristics of Products – Glimepiride

Often I have written about the deficiencies (flaws) of the Paddle and Basket apparatuses in obtaining relevant and useful dissolution results. The underlying cause of these deficiencies is a poor stirring and mixing environment within dissolution vessels. However, as a long held tradition, these apparatuses are recommended and used for dissolution testing. As the apparatuses do not provide a relevant in vivo environment, obviously in vitro results would not be relevant to in vivo characteristics of drugs and their products. However, to maintain the status quo, the dissolution results obtained are rationalized as legitimate and useful. Considering practice of rationalization of dissolution results and noticing numerous queries in this regard about a drug glimepiride, I came across a publication (link) which may help in explaining the current dilemma of an analyst in dealing with in vitro drug dissolution testing. (please click here for complete post).

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