Evaluation and Characterization of Stabilized Drug, Formulated as Oro Dispersible Tablet Using Advanced Method
Mo’men Safari *
Research and Development Department, Hikma Pharmaceuticals, Egypt.
Hammam A. Mowafy
Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Al- Azhar University, Egypt.
Ahmed M. Samy
Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Al- Azhar University, Egypt.
*Author to whom correspondence should be addressed.
Abstract
In a challenge to prepare a stable Oro-dispersible tablet (ODT) of Desloratadine, using dry resin was incorporated into a fast-disintegrating matrix to prepare an optimized ODT that achieved the desired criteria of stabilization and patient acceptance. In this study, the critical process parameters (CPPs) and critical material attributes (CMAs) were determined via risk assessment methods within the framework of Quality by Design (QbD). The results showed that resin (Amberlite IRP64®) can be used as a dry stabilizer and the selected variables in the optimization phase have a strong influence on the blend flowability, disintegration time, and wetting time of the ODTs. Furthermore, by comparing the optimized formula with the marketed one, the optimized formula showed a significantly lower disintegration, lower wetting time, and an almost similar dissolution profile.
Keywords: Oral disintegrating tablets, desloratadine, quality by design, risk assessment, FMEA