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.
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