Formulation development and optimization of a novel Cremophore EL-based nanoemulsion using ultrasound cavitation

Abstract

In the present study, response surface methodology (RSM) based on central composite design (CCD) was employed to investigate the influence of main emulsion composition variables, namely drug loading, oil content, emulsifier content as well as the effect of the ultrasonic operating parameters such as pre-mixing time, ultrasonic amplitude, and irradiation time on the properties of aspirin-loaded nanoemulsions. The two main emulsion properties studied as response variables were: mean droplet size and polydispersity index. The ultimate goal of the present work was to determine the optimum level of the six independent variables in which an optimal aspirin nanoemulsion with desirable properties could be produced. The response surface analysis results clearly showed that the variability of two responses could be depicted as a linear function of the content of main emulsion compositions and ultrasonic processing variables. In the present investigation, it is evidently shown that ultrasound cavitation is a powerful yet promising approach in the controlled production of aspirin nanoemulsions with smaller average droplet size in a range of 200-300 nm and with a polydispersity index (PDI) of about 0.30. This study proved that the use of low frequency ultrasound is of considerable importance in the controlled production of pharmaceutical nanoemulsions in the drug delivery system.

Formulation development and optimization of palm kernel oil esters-based nanoemulsions containing sodium diclofenac

“…29 A larger F-value and a smaller P-value for each term in the models would demonstrate the effect of the higher degree of significance on the dependent factors. 3 The coefficient estimates and respective P-values shown in Table 3 the O/S ratio had the most significant effect (P.0.05) on the variability of both responses that followed by water content. All quadratic terms had significant effects on the particle size.…”

“…The existence of some free emulsifier in the micellar form plays a basic role in preventing coalescence after emulsification and storage, which results in improved emulsion stabilization. 3 The increase in viscosity of the continuous phase is the other factor that could improve the stability of the emulsion by restraining the Brownian movement of the droplets in the disperse phase. 3 Despite of the low viscosity of the optimized nanoemulsion (as a desired condition for optimization of formulation), the result of particle size and surface charge measurements indicated that the optimized nanoemulsion presented good physical stability throughout the 90 days of the storage period.…”

“…3 The increase in viscosity of the continuous phase is the other factor that could improve the stability of the emulsion by restraining the Brownian movement of the droplets in the disperse phase. 3 Despite of the low viscosity of the optimized nanoemulsion (as a desired condition for optimization of formulation), the result of particle size and surface charge measurements indicated that the optimized nanoemulsion presented good physical stability throughout the 90 days of the storage period. In essence, it is hypothesized that the oil-water interfaces that are formed are in a stable state against coalescence, which is achieved through surfactant adsorption.…”

Continuous manufacturing of carboxyamidotriazoleencapsulated nanoemulsions using adaptive focused acoustics: Potential green technology for the pharmaceutical industry

“…Ultrasound is generated by ultrasonicators, which is then delivered through a large bath of water or tip of the instrument. It has been reported that hydrophobic drugs were successfully encapsulated through ultrasonic emulsification [14,[30][31][32] . Preparation conditions and instrument settings can be manipulated to yield nanoemulsions with different sizes.…”

“…Ultrasonic emulsification earns its merit as an energy-saving method, compared to other high-energy methods. It requires 18 times less power for drug encapsulation than the microfluidization into the same size nanoemulsions [15,30] . However, current instrumentation and methods require improvements.…”