| DOI: 10.29090/psa.2022.02.21.141 | Pharm Sci Asia 2022; 49(2), 180-192 |
Evaluation of formulation variables on azithromycin nanoparticles prepared by emulsification solvent diffusion method using quality by design approachNguyen-Thach Tung*, Canh-Hung Nguyen, Huu-Manh Nguyen
- Department of Pharmaceutics, Hanoi University of Pharmacy, Vietnam
The study aims to investigate the effect of formulation variables on the characteristics of azithromycin (AZI) nanoparticles using a quality by design approach. AZI nanoparticles were prepared by the emulsification solvent diffusion method. Two critical factors, the ratio of AZI: Eudragit EPO (X1) and volume of outer aqueous medium (X2), were chosen as independent variables for central composite design. The optimized formulation was further characterized by Fourier transform infrared spectroscopy, X-ray diffractometry, transmission electron microscopy, and dissolution test. The obtained results showed variability of mean particle size, entrapment efficacy, and zeta potential from 200 to 1232 nm, 10.78 to 75.9%, and 31 to 43 mV, respectively. The main coefficients indicated that the ratio of AZI: polymer (X1) possessed a synergistic effect on mean particle size (Y1), and volume of outer aqueous medium (X2) had an antagonistic effect on particle size. The interaction between the ratio of AZI: Eudragit EPO (X1) and volume of outer aqueous medium (X2) exhibited a significant antagonistic effect on entrapment efficacy (Y2) (p<0.05). AZI existed in an amorphous state in nanoparticles that were spherical and homogeneous in shape. The nanoparticles revealed the Korsmeyer-Peppas release model, from which AZI was released faster compared to raw material.
Keyword:
Azithromycin, Nanoparticles, Emulsification solvent diffusion, Quality-by-design
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