Formulation and Evaluation of Lamotrigine 25 Mg Immediate Release Tablet

Abstract

In the present quality assurance research work Lamotrigine  Immediate Release tablet25mg  has been undertaken in accordance with Quality By Design guidelines. Quality by design a common understanding of the concept of ICH guideline Q8, Q9 & Q10 is now a day treaded as an essential tool in the process of formulation development. The development of Target Product Profile & Critical Quality Attributes were done after dew consideration of risk assessment before finalization of these attributes. As Lamotrigine is poorly soluble (BCS class-II) it may effect bioavailability, Hence, Solid dispersion approach was taken as risk assessment measure. Product design space & process parameters were finalized on the basis of critical material attributes. Control strategies for continuous monitoring & updating of the process requirements were also highlighted. In the present research work critical process parameters were validated. The critical process parameter impacts on Quality. The Quality By Design principle & tools demonstrated in present research work will be useful in creating & developing control strategies in similar formulation & process development.   

Keywords: QbD, Solid dispersion, ICH Guidelines.