Optimization of formulation and process variables using central composite design for the production of nevirapine spray dried solid dispersion

Abstract

The objective of the present investigation was to develop and optimize spray dried solid dispersion for dissolution enhancement of an anti-HIV drug, Nevirapine. The pareto chart of Plackett and Burman screening design revealed that drug: polymer ratio, concentration of silicon dioxide, and feed flow rate had a significant effect on production yield and drug release (Q60). These factors were further studied using central composite design to obtain optimized formulation. Optimized formulation was characterized by DSC, XRD, and SEM, and studied for drug release and accelerated stability. Spray dried solid dispersion formulated with drug: polymer ratio of 1:2, 2% w/w silicon dioxide and 1 mL/min flow rate gave the best result of 69.02% production yield and 80.46% drug release.