Predicting orally disintegrating tablets formulations of ibuprophen tablets: An application of the new SeDeM-ODT expert system

This article provides a new innovative tool for pharmaceutical preformulation to predict whether a disintegrant excipient or mixture of powder containing API + excipients is suitable to obtain a bucodispersible tablet by direct compression or not.This innovative tool is the new model SeDeM-ODT that provides the Index of Good Compressibility and Bucodispersibility (IGCB index), which is based on the previous SeDeM expert system that indicates the aptitude of a powder to be compressed. The IGCB index is composed of six main factors (from 15 pharmaceutical raw parameters), which indicate whether a mixture of powder has the aptitude to be compressed by direct compression and at the same time indicates whether these tablets are suitable to be used as a bucodispersible tablet (disintegration time lower than 3 min).

The proposed method involves in the first place the SeDeM characterization of the API to be formulated, and then the 5 SeDeM indexes are reviewed to determine which of them needs to be improved. From the excipients database are selected those excipients that theoretically show high rates and may improve the low level of the API’s indexes. Then the SeDeM software is applied and several formulae are proposed to be produced in the laboratory. The good prediction is validated by formulating and implementing quality controls of the ODT tablets formulated.Figure optionsDownload high-quality image (78 K)Download as PowerPoint slide