QUALITY BY DESIGN BASED DEVELOPMENT OF LUMATEPERONE TRANSDERMAL PATCH

Objective: The current study is oriented on the design and development of a Transdermal Patch for Lumateperone, a BCS Class I drug, utilizing the Quality by Design (QbD) principle.Methodology: The study was aimed to demonstrate the QbD approach's feasibility and effectiveness by integrating the product and determining the targeted sustain release profile.The Quality Target Product Profile was defined, CQAs were identified, and risk assessments was carried out by using various tools such as Ishikawa diagram, risk estimation matrix and Failure modes and effects analysis.Each factor's Risk Priority Number was determined separately.Main effect screening design was used, with independent variables Eudragit RL-100/RS-100 and Tween 80 as material attributes that influence responses such as thickness, folding endurance and drug content.The optimized formulation was checked for the in vitro skin permeability and skin irritation test.Results: The results of the main effect screening design of 12 formulations revealed that the combined action of all variables had a substantial impact on CQAs and could predict the optimal formulation with maximum global desirability of 0.6231.Statistically significant models were observed for thickness(mm) (R2=0.98),folding endurance (R2=0.87),and drug content (%) (R2=0.98).