Quality by Design Approach for Formulation and Optimization of Microparticles Based Inhalable Phytopharmaceuticals of Trigonella Foenum-Graecum and Alpinia Galanga

Chronic obstructive pulmonary disease has been the most widespread worldwide health problem that has influenced millions of people worldwide. The freeze-dried inhalable microparticles (FDIMs) of Trigonella foenum-graecum and Alpinia galanga extracts were synthesized by simple emulsification solvent evaporation technique using polyvinyl pyrrolidone K30 (PVP K30) and polyethylene glycol 6000 (PEG 6000) and were optimized using Box-Behnken design (BBD). Mannitol was utilized for surface modification of FDIM for enhancing their aerodynamic characteristics. The independent parameters which were utilized in the optimization strategy were herbal extract: polymer (w/w, X1) mannitol (% w/v, X2) and surfactant (% v/v, X3). The studied response variables were mean diameter (mu m) (Y1) and bulk density (g/cc) (Y2). The present study concluded that optimized FD1Ms could be successfully manufactured using herbal extract: polymer (1:2 w/w), mannitol (4.616 % w/v) and surfactant (1.5 % v/v) which had 0.977 desirability functions. The predicted values of response parameters of optimized FDIMs were found at 1.326 mu m mean diameter and 0.244 g/cc bulk density. The percentage relative error between actual and model-predicted values of mean diameter and bulk density for optimized FDIM was found 4.09 and 2.45%, respectively (< 5%), which authenticated the articulacy of the optimization approach.

Automated summary

This study successfully synthesized freeze-dried inhalable microparticles of herbal extracts using emulsification solvent evaporation technique and optimized the particles' properties using Box-Behnken design. The optimized microparticles demonstrated suitable diameter and bulk density, validating the efficacy of the optimization approach.