Formulation and Evaluation of Lamotrigine 25 Mg Immediate Release Tablet

  • Ashwini Gunjal
  • Monali Tajane
  • Reshma Londhe

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.

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1.
Gunjal A, Tajane M, Londhe R. Formulation and Evaluation of Lamotrigine 25 Mg Immediate Release Tablet. JDDT [Internet]. 13Aug.2019 [cited 14Jun.2021];9(4-s):295-7. Available from: https://jddtonline.info/index.php/jddt/article/view/3321