Title : Green technology approach for development of BCS Class II molecule nanoformulation
Fenofibrate (FNB), a BCS class II molecule is primarily used in hypercholesterolemia and hypertriglyceridemia. FNB presents a poor bioavailability of 36% due to its low solubility. To overcome the issue of solubility related poor efficacy; a nanosuspension based drug delivery system is proposed which results in a reduction of particle size; thereby facilitating enhancement in solubility and ultimately the bioavailability. The aim of the present study was the development of nanosuspension of fenofibrate using nano by design (NbD) approach. Stirred media milling and microfluidization techniques were compared for it efficiency to produce nanosuspension. The patient-centric quality target product profile (QTPP) and critical quality attributes (CQAs) were earmarked. Critical formulation parameters (CFPs) such as drug:stabilizer ratio and critical process parameter (CPPs) were identified as high impact parameters affecting particle size and polydispersity index (PDI) in risk assessment studies. The nanosuspension was further evaluated for dynamic light scattering(DLS), zeta potential, in-vitro release, in-vivo pharmacokinetic studies, intrinsic solubility, DSC, SEM, TEM, XRD, FTIR studies.
•The current research deals with the nanonization of the BCS class-II molecule using green technology approach which is the great learning for the audience.
•The present research deals with the semicontinous/continous process of nanoparticle generation using existing technologies, which would help to other researchers to explore the same technology for the other challenging molecules.
•The formulation development was carried out using quality by design (QbD) Approach which enables the efficient and accurate development of the formulation. QbD is the systemic approach to develop any formulation which will help the researchers in their own research areas.