A comprehensive review of formulation strategies, statistical designs and regulatory considerations in the QbD roadmap in nanotechnology

Abstract

Nanotechnology has greatly enhanced the delivery of pharmaceutical drugs by improving solubility, stability, bioavailability and therapeutic effectiveness. However, the creation of nanoformulations is still problematic as even little differences in composition or production circumstances may greatly alter the quality of the output. Quality by Design (QbD) and Design of Experiments (DoE) have become obligatory approaches for the production of robust, repeatable nanoformulations [1–3]. This study addresses the use of QbD and DoE to the major nano-drug delivery platforms including polymeric nanoparticles, liposomes, solid lipid nanoparticles, nanoemulsions, nanosuspensions, dendrimers and polymeric micelles. 1. Critical review of main QbD components (QTPP, CQAs, CMAs, CPPs) 2. Risk assessment techniques 3. Experimental design approaches 4. Process Analytical Technology (PAT) 5. Present- day regulatory requirements from FDA, EMA and ICH The integration of QbD and DoE is emphasized as critical to provide consistent product quality, regulatory approval and effective lab-to-market translation of nanomedicines.