QbD in Pharma Development World Congress Amit Murani Wins Budding QbD Scientist Award 2015

Amit Murani Wins Budding QbD Scientist Award 2015

Qbd Based Development of Fenofibrate Nanosuspension: A Non-Infringing Approach



Mirani A, Gite S, Patravale V
Department of Pharmaceutical Science & Technology, Institute of Chemical Technology, Mumbai, India

Fenofibrate (FNB), a BCS class II molecule mainly used in hypercholesterolemia and hypertriglyceridemia. FNB represents poor bioavailability of 36% due to its low solubility. To overcome this solubility related poor efficacy; nanocarrier mainly Nanosuspension based drug delivery system is proposed which results the reduction in particle size thereby facilitate increase solubility and ultimately the bioavailability. The aim of the present study is Quality by Design (QbD) development of Fenofibrate Nanosuspension using planetary ball mill as non-infringing approach. The patient-centric quality target product profile (QTPP) and critical quality attributes (CQAs) were earmarked. Critical formulation parameter (CFP’s) such as drug:polymer ratio and Critical process parameters (CPP’s) i.e. milling speed were identified as high impact particle size and polydispersibility index in risk assessment studies. A 32 Full Factorial Design (FFD) was employed for optimization using drug: polymer ratio (X1) and milling speed (X2), evaluating CQAs like particle size and polydispersity index as response variable. The design space was generated using mathematical models, and the optimum formulation was located using desirability parameters, followed by its validation. In nutshell, FNB nanosuspension prepared using Quality by Design approach showed effective prognostic ability to provide quality product using planetary ball mill as novel green technology.