Preformulation studies for direct compression suitability of cefuroxime axetil and paracetamol: A graphical representation using SeDeM diagram

摘要

The direct compression suitability of active pharmaceutical ingredients could be studied by SeDeM diagram method. Cefuroxime axetil (CfA) and paracetamol (PCM) were employed for SeDeM studies as these powders are well-characterized and known to be particularly difficult with respect to flowability and compactibility. Twelve different selected pharmacotechnical parameters were determined experimentally and were treated mathematically for being expressed in graphic representation as SeDeM diagram. Parameter index, parameter profile index and good compression index were calculated for both the selected drugs. Good compression index was found to be 2.19 and 1.36 for CfA and PCM, respectively, indicating poor direct compression characteristics of the selected drugs. The results from this SeDeM diagram method are in line with the previously reported studies where it was established as a reliable method for preformulation studies and as a quality control tool for studying batch-to-batch reproducibility of API's. Furthermore, it once again established the notion that blending poorly compressible drugs with suitable ingredients followed by SeDeM studies could be used as method for identifying best excipient and calculating maximum amount of excipient required for direct compression of API.