Development and Evaluation of Lacosamide Orally Disintegrating Tablets Using Qbd Approach

Abstract

Purpose The main purpose for the development of Lacosamide orally disintegrating tablet was to ease the administration of drug, especially in geriatric and pediatric patients. The development and evaluation of Lacosamide ODT was performed using QbD approach. Quality by Design (QbD) is a key tool used by current pharmaceutical industries, so as to make the whole process simple, short and less costly. This project encompasses of all the key elements of QbD: Defining QTPP, by identifying CQA, Defining Design Space, Identifying Risk and Assessing Control Strategy. Objective The main objective of this research work was to design and formulate orally disintegrating tablets (ODTs) of Lacosamide by using quality by design (QbD) approach. The quality target product profile (QTPP) of Lacosamide ODT was identified. Initial risk assessment was performed by determining Critical Quality Attributes (CQAs) through the Ishikawa (fishbone) diagram. A 32 Full Factorial Design was used in order to study the effect of various critical factors like the Critical Material Attributes (CMAs) & Critical Process Parameters (CPPs) of ODTs. After the determination of Critical Quality Attributes (CQAs), the independent factors were identified. The independent factors that are responsible for the development of Lacosamide ODT are the concentration of Mannitol (X1) and concentration of Crospovidone (X2). Both the factors were operated at three different levels. The dependent variables (responses) were the disintegration time and drug dissolution. The optimized batch was prepared by QbD approach and was analyzed by in-vitro studies. After that, it was finalized based on the results. Thus, in this study, a high degree of assurance has been provided for the consistency and efficiency of Lacosamide ODT.