The use of the SeDeM Diagram expert system to determine the suitability of diluents-disintegrants for direct compression and their use in formulation of ODT.
The new SeDeM Diagram expert system was used to analyze the suitability of 43 excipients for direct compression with disintegrant properties from eight chemical families. The SeDeM Diagram expert system is a new method for use in tablet preformulation and formulation studies. It provides the profile of a substance in powder form in terms of its suitability for direct compression. This study, which was based on the current concept of "Quality by Design ICH Q8", evaluated the pharmacotechnical properties of disintegrants in powder form and selected the candidates that were most suitable for direct compression and their use in formulation of orally disintegrating tablets (ODT). To achieve this, each disintegrant and its chemical families were individually analyzed. It was concluded that nine disintegrants had an SeDeM value with the index of good compression (IGC) over 5. Most of these disintegrants were from the microcellulose family. Other disintegrants had indexes that were close to 5. It is assumed that these excipients can be used in direct compression, when they are added to other excipients.
Aguilar-Díaz
Johnny Edward
JE
Pharmacy and Pharmaceutical Technology Department, University of Barcelona, Barcelona, Spain.
García-Montoya
Encarnación
E
Pérez-Lozano
Pilar
P
Suñe-Negre
José María
JM
Miñarro
Montserrat
M
Ticó
José Ramón
JR
D000284:Administration, Oral; D002482:Cellulose / Q000737:chemistry; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D005079:Excipients / Q000737:chemistry*; D011208:Powders; D013607:Tablets
D005079:Excipients; D011208:Powders; D013607:Tablets; D002482:Cellulose