A new expert systems (SeDeM Diagram) for control batch powder formulation and preformulation drug products

Characterisation of the Ability of Carbamazepine for Processing It through Direct Compression Applying the New Expert System SeDeM

“…The tapped density was obtained according to Equation 2. ρ tapped =m⁄V tapped (2) Where ρ tapped is the tapped density (g/mL), m is mass (g) and ρ tapped is the volume after tapping (mL).…”

“…Rheological studies have been carried out for the API following the new SeDeM Method [1,2]. Whenever possible, the methods indicated in pharmacopeias were applied.…”

“…Whenever possible, the methods indicated in pharmacopeias were applied. If not available, a system based on usual practice in Pharmaceutical Technology was employed, adapted specifically for the SeDeM Diagram [2].…”

“…Preformulation studies are essential to estimate the ability of active ingredients or excipients to be processed through direct compression. In this sense, Suñé Negre et al [1] at the University of Barcelona, Spain, have developed a new expert system called SeDeM, that supposes an interesting approach to the rational design of a formulation that will be adequate for direct compression [2].…”

“…The SeDeM method can be applied to active ingredients as well as to pharmaceutical excipients, providing information about their suitability for direct compression [1][2][3]. This system allows detecting the powder properties that need to be improved in order to facilitate the design of pharmaceutical formulations [4][5][6][7].…”