Evaluation of emulgel formulations contain diclofenac sodium via quality by design approach

OpenAlex · English

Emulgel is considered as emulsions, either oil-in-water or water-in-oil type, that is formed via blending with a gelling agent. Their common usage as pharmaceutical dosage form results from the broad utilization of emulsion systems, particularly for dermatological formulations. Quality by Design (QbD) is a scientific, holistic, risk-based, systematic, and proactive approach that starts with predefined objectives and assertiveness on product quality, procedure understanding, and process control. In this study, the QbD approach was implemented in the production of emulgel containing diclofenac sodium and the goal was to build quality into the product from the inception of formulation development. The hydrogel phase and oil phase of emulgel were prepared separately, then mixed. Emulgels were evaluated for their macroscopic, and microscopic examination, pH, electrical conductivity measurements, and viscosity. The optimum formulation was found by using the ANN Modelling program. According to macroscopic evaluation the optimum emulgel was an opaque white color, and homogeneous with no phase separation or grittiness. The viscosity of the optimum formula is 4600, pH value is 6.7, electrical conductivity is 120 S-1, and particle diameter was also 0,989 m. Results showed the optimized formula has the required properties. ANN modeling technique has been used to develop a pharmaceutical formulation via determining multivariate relations between independent parameters and quality properties affected by these parameters. Although artificial intelligence programs are not enough to build and develop formulations by itself, they play a significant role in formulation development.