Design and development of quetiapine fumarate nanosuspension by media milling method

Introduction: The critical and complex properties of Biopharmaceutics Classification System Class II quetiapine fumarate active pharmaceutical ingredient molecules that complicate effective oral delivery of these active pharmaceutical ingredients include low aqueous solubility and reduced bioavailability. Objective: The objective of this investigation is to develop a nanosuspension formulation of quetiapine fumarate using media milling techniques to effectively reduce particle size and enhance dissolution rate. Method: Quetiapine fumarate Nano suspensions were prepared by the media milling method. The milling process was optimized by studying the effects of critical process parameters on the size of nanosuspension using a factorial design approach. The prepared nanosuspension is subjected to various characterization techniques such as Particle size, Zeta Potential, differential scanning calorimetry, X-ray powder diffraction, scanning electron microscopy, and in vitro dissolution rate assessment. Results: The obtained results demonstrate that the average particle size of the prepared nanosuspensions is 225 nm with a Polydispersity index of 0.530, while the average Zeta potential is -38.2 mv. The crystalline structure of quetiapine fumarate nano-suspension is evident from differential scanning calorimetry and X-ray powder diffraction. Conclusion: The dissolution rate of the nanosuspension is significantly faster than that of pure Quetiapine Fumarate, and the Cumulative drug release (%) of nanosuspension is higher than that of pure Quetiapine Fumarate , indicating that the use of nanotechnology can considerably enhance the dissolution rate.