Comparison of the performance of two grades of metformin hydrochloride elaboration by means of the SeDeM system, compressibility, compactability, and process capability indices

Quality by design, applied to the development of a pharmaceutical drug, demands scientific methodologies, representing source information that will allow for complete understanding production process and materials used its manufacturing. Although SeDeM system is tool enables rational product, result does not assure an assessed material or mixture be successful in terms compression, hence, further research necessary on these features. The objective this study was assess compare two grades metformin hydrochloride elaboration: crystalline direct compression using PXRD, expert system, Heckel Ryshkewitch-Duckworth models, as well control tools such charts capability indices characterize predict performance process. assessment identified spite dealing with different technical specific critical quality attributes each one, PXRD analysis showed we dealt same structure, while profiles obtained have very close values, main differences were observed when subjecting them conditions simulate compaction model, which 46-times higher mechanical resistance compared one. statistical revealed only could elaborate tablets whose weight variation always maintained within specification limits.