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

Abstract

Background: SeDeM Expert System is an innovative tool which allows preformulation characterization of a powdered substance. This information is used to identify strengths and weaknesses for development of tablets by direct compression. Methods: Rheological studies have been carried out for the active pharmaceutical ingredient (API) carbamazepine following the new SeDeM Method and the SeDeM Diagram has been built. Furthermore, the main parameters such as Parametric Profile (IPP) and Good Compression Index (IGC) have been calculated. Results: The results obtained were graphically expressed in form of a SeDeM diagram and the values obtained for the Parametric profile (IPP) and the Good Compression Index (IGC) were 5,55 and 5,28 respectively. These values are considered as adequate for processing carbamazepine by direct compression. Conclusion: Carbamazepine has an appropriate ability to be processed through direct compression. Its profile can be improved adding a small amount of suitable excipients, as Flow Aid materials and Direct Compression fillers. These results provide information to build a database of pharmaceutical ingredients which allows checking the powder properties and enables the design of new formulations or improvement of the already existing in the market.