Objective: The present study reports the use of MicrofluidizerTM technology to form a stable
nanosuspension of atovaquone (ATQ) using quality by design (QbD) approach.
Methods: The patient-centric quality target product profile and critical quality attributes (CQAs) were
identified. A Box-Behnken design was employed for the optimization of dependent variables, while
CQAs like particle size and PDI were evaluated as response variables. Effective optimization of ATQ
nanosuspension preparation using Microfluidizer processor as a novel green technology was achieved
using QbD approach.
Result: The prepared nanosuspension had a mean particle size of 865 nm ± 5%, PDI of 0.261 ± 3%, and
zeta potential of -1.79 ± 5 mV. The characterization of the prepared nanosuspension by SEM, DSC, and
XRD revealed its nano-crystalline nature whereas FTIR spectroscopic analysis confirmed the absence
of any physicochemical interaction because of process parameters between the drug and excipients.
Conclusion: In vitro dissolution studies of the nanosuspension using USP-IV exhibited a 100% cumulative
drug release over 90 minutes, which is significantly better than that of ATQ pure API. In vivo
pharmacokinetic studies revealed bioequivalence of ATQ nanosuspensions by Microfluidizer homogenization
process to the marketed formulation1.