SeDeM Diagram: A New Expert System for the Formulation of Drugs in Solid Form

Abstract

The SeDeM expert system is a methodology which is applied in preformulation and formulation studies of medicines specifically in solid dosage forms. This system informs on the physical profile of powdered substances (APIs and excipients) used to formulate drugs (Sune et al, 2005; Garcia et al, 2010; Aguilar et al, 2009). By determining whether powders (API or excipient) are suitable for direct compression, the SeDeM profile will inform about the advantages and gaps of those powdered substance to be used in direct compression, so the system informs on whether the direct compression method is appropriate (e.g.. wet granulation should be applied before compression). The characterization of powdered substances by SeDeM facilitates the identification of the characteristics that require amendment in order to obtain tablets by direct compression. This system thus provides information that will ensure the robust design of the formulation in the final product. This new method is based on the selection and application of several parameters that the formulation must fulfill to ensure a successful tablet elaborated by direct compression. The following criteria are applied: a. The formulation must be representative and appropriate for the requirements of compression technology. b. The execution of the experimental methodology and calculus must be readily applicable.