STATISTICALLY OPTIMIZATION AND FORMULATION DEVELOPMENT OF BROMOFENAC SODIUM OPHTHALMIC DRUG DELIVERY SYSTEM
Keywords:
Optimization, gelling agent, viscosity, Megabrom, pHAbstract
The purpose of this work was to develop and optimise the Bromofenac sodium temperature sensitive ocular in-situ gel using a 32 complete factorial design. Two factors were evaluated at three levels each, and experimental trials were carried out using various combinations and central point values. As independent variables, the concentrations of gelling agent (X1) and viscosity enhancer (X2) were chosen. To improve the response data, dependant factors such as gelling capacity (Y1), viscosity (Y2), and 100 percent drug release (Y3) were used. The Design Expert software was used to do analysis of variance (ANOVA), 3D surface plots, counter plots, optimization, and desirability. The comparative investigations used a commercially available medication (Megabrom) with a better formulation (F5). All of the formulations were clear, transparent, and yellow. When compared to the ocular pH of 7.4, the pH of the formulations ranges from 7.01 to 7.34, which is an acceptable range. All of the formulations had a gelation temperature of 37°C-43.5°C, and the drug content ranged from 95.13 to 98.55 percent. The pseudo plastic behaviour is observed in all formulations (shear thinning systems). The improved recipe had a higher desirability concern (1), indicating that it was a good formulation. The model’s predictability and validity were demonstrated when the experimental values matched the expected values.
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