Formulation and Optimization of Microbeads Pharmaceutical Formulation Incorporating Black Cumin Seed Oil (BSO).

Nigella sativa L. (black cumin) is one of the most important spices used in the treatment of respiratory and allergy illnesses. Pharmaceutical formulation incorporated with black seed oil (BSO) can be a promising therapy to manage respiratory inflammation. The present study aims to formulate and optimize BSO encapsulated formulation (microbeads) using natural polymers and their combination for effective delivery. The methodology involves the use of natural biopolymers gellan gum, alginate, and anionic surfactants. Special emphasis was given to formulation variables and pharmacokinetic profiling for the optimization procedure. BSO-loaded beads were prepared by the ionic gelation method. In this method pre gelation liquid of sodium alginate (2-4% w/v) and gellan gum solution (2-6% w/v) was prepared. BSO in different concentrations (10%-50%) was then added to the polymer solution. BSO beads were formulated and characterized using different parameters. The effect of the independent variables on the response variables was studied by response surface plots and contour plots generated by the Design-Expert software. The desirability function was used to optimize the response variables. From the results, the best formulations (the most optimized formulations F 12 and F15) were chosen as they possessed most of the required physicochemical characteristics and sustained drug release properties. Entrapment efficiency and drug release of the optimized batch were found to be above 70%. The optimization, drug entrapment efficiency, and drug release behavior of BSO beads were also done by applying design expertise. It also exhibited sustained drug release in simulated pH. The in vitro release data fitted with higher values in the matrix model and the release was found to be Non-Fickian diffusion (anomalous transport) as the n value is between 0.5 to 1.0. Findings of this study enable the scale-up production of loading BSO and similar bioactive compounds in gellan gum and alginate beads. Hence, the designed system could be advantageous in terms of prolonged release with enhanced bioavailability for a promising therapy. [ABSTRACT FROM AUTHOR]