title: A new expert systems (SeDeM diagram) for control batch powder formulation and preformulation drug products.
abstract: The new SeDeM Method is proposed for testing the batch-to-batch reproducibility of the same active pharmaceutical ingredient (API) in powder form. The procedure describes the study of the galenic properties of substances in powder form in terms of the applicability of direct compression technology. Through experimental determination of the SeDeM Method parameters, and their subsequent mathematical treatment and graphical expression (SeDeM Diagram), three batches of the same API were analysed to determine whether it was suitable for direct compression. Batch-to-batch reproducibility of the results was verified. It was concluded that the SeDeM Method is suitable for testing batch-to-batch reproducibility of characteristics in powdered APIs substances. The results obtained confirm that the SeDeM Method is a useful, effective tool for drug-preformulation studies providing the pharmacotechnical data required when formulating a drug in tablet form. In addition, the results were effective for defining the most appropriate manufacturing technology.
authors.affiliation: Pharmacy and Pharmaceutical Technology Department, Pharmacy School, University of Barcelona, Barcelona, Spain.
authors.forename: Pilar
authors.initials: P
authors.lastname: Pérez
authors.forename: Josep M
authors.initials: JM
authors.lastname: Suñé-Negre
authors.forename: Montserrat
authors.initials: M
authors.lastname: Miñarro
authors.forename: Manel
authors.initials: M
authors.lastname: Roig
authors.forename: Roser
authors.initials: R
authors.lastname: Fuster
authors.forename: Encarna
authors.initials: E
authors.lastname: García-Montoya
authors.forename: Carmen
authors.initials: C
authors.lastname: Hernández
authors.forename: Ramón
authors.initials: R
authors.lastname: Ruhí
authors.forename: Josep R
authors.initials: JR
authors.lastname: Ticó
mesh_terms: D002626:Chemistry, Pharmaceutical; D019245:Compressive Strength; D005103:Expert Systems; D005944:Glucosamine / Q000737:chemistry / Q000592:standards; D008956:Models, Chemical; D011208:Powders; D011786:Quality Control; D015203:Reproducibility of Results; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000379:methods*
chemical_list: D011208:Powders; D013607:Tablets; D005944:Glucosamine