Application of the SeDeM Diagram and a new mathematical equation in the design of direct compression tablet formulation.
Application of the new SeDeM Method is proposed for the study of the galenic properties of excipients in terms of the applicability of direct-compression technology. Through experimental studies of the parameters of the SeDeM Method and their subsequent mathematical treatment and graphical expression (SeDeM Diagram), six different DC diluents were analysed to determine whether they were suitable for direct compression (DC). Based on the properties of these diluents, a mathematical equation was established to identify the best DC diluent and the optimum amount to be used when defining a suitable formula for direct compression, depending on the SeDeM properties of the active pharmaceutical ingredient (API) to be used. The results obtained confirm that the SeDeM Method is an appropriate system, effective tool for determining a viable formulation for tablets prepared by direct compression, and can thus be used as the basis for the relevant pharmaceutical development.
Suñé-Negre
Josep M
JM
Pharmacy and Pharmaceutical Technology Department, University of Barcelona, Barcelona, Spain.
Pérez-Lozano
Pilar
P
Miñarro
Montserrat
M
Roig
Manel
M
Fuster
Roser
R
Hernández
Carmen
C
Ruhí
Ramon
R
García-Montoya
Encarna
E
Ticó
Josep R
JR
D000465:Algorithms; D002626:Chemistry, Pharmaceutical / Q000706:statistics & numerical data*; D004339:Drug Compounding / Q000706:statistics & numerical data*; D004355:Drug Stability; D005079:Excipients; D066298:In Vitro Techniques; D008153:Lubrication; D010316:Particle Size; D011208:Powders; D013607:Tablets
D005079:Excipients; D011208:Powders; D013607:Tablets