Formulation and Evaluation of Lamotrigine 25 Mg Immediate Release Tablet
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.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).