Quality by Design for Development, Optimization and Characterization of Brucine Ethosomal Gel for Skin Cancer Delivery

Abstract

Natural products have been extensively used for treating a wide variety of disorders. In recent times, Brucine (BRU) as one of the natural medications extracted from seeds of nux vomica, was investigated for its anticancer activity. As far as we know, this is the first study on BRU anticancer activity against skin cancer. Thus, the rational of this work was implemented to develop, optimize and characterize the anticancer activity of BRU loaded ethosomal gel. Basically, thin film hydration method was used to formulate BRU ethosomal preparations, by means of Central composite design (CCD), which were operated to construct (32) factorial design. Two independent variables were designated (phospholipid percentage and ethanol percentage) with three responses (vesicular size, encapsulation efficiency and flux). Based on the desirability function, one formula was selected and incorporated into HPMC gel base to develop BRU loaded ethosomal gel. The fabricated gel was assessed for all physical characterization. In-vitro release investigation, ex-vivo permeation and MTT calorimetric assay were performed. BRU loaded ethosomal gel exhibited acceptable values for the characterization parameters which stand proper for topical application. In-vitro release investigation was efficiently prolonged for 6 h. The flux from BRU loaded ethosome was enhanced screening optimum SSTF value. Finally, in-vitro cytotoxicity study proved that BRU loaded ethosomal gel significantly improved the anticancer activity of the drug against A375 human melanoma cell lines. Substantially, the investigation proposed a strong motivation for further study of the lately developed BRU loaded ethosomal gel as a prospective therapeutic strategy for melanoma treatment.

Quality by Design for Optimizing a Novel Liposomal Jojoba Oil-Based Emulgel to Ameliorate the Anti-Inflammatory Effect of Brucine

“…Quality by design (QbD) is a systematic and organized technique for developing a unique product depending on pre-established factors and studying their influence on certain responses in order to attain the most optimized formula. It includes several tools, such as three-level full factorial, central composite design (CCD) and Box–Behnken design [ 28 ]. The most commonly used of them is Central Composite Design (CCD), which helps in selecting the optimized formula and in predicting the model relying on statistical analysis of variance (ANOVA) and definite equations [ 29 ].…”

Statistical Optimization and Evaluation of Ethosomal Miconazole Nitrate Suspension

“…The volume was made up to 10 ml with methanol. The resultant solution was suitably diluted with methanol and absorbance was measured at 272 nm [17].…”

“…The gel was filled in the wide mouth container in such a way that it should sufficiently allow to dip the spindle of the Viscometer. Samples of the gels were allowed to settle over 30 min at the constant temperature (25±/10 °C) before the measurements [17].…”

“…Lesser the less time is taken for the separation of two slides, the better the spreadability. It is determined by the formula given below [17].…”

Enhancement of Anti-Inflammatory Activity of Optimized Niosomal Colchicine Loaded into Jojoba Oil-Based Emulgel Using Response Surface Methodology

“…To ensure the quality of the formulation, an organized and systematic approach known as response surface methodology (RSM) should be applied. It depends on the influence of certain variables on observed responses to get the optimized formula with optimal features [ 26 ]. RSM has several mathematical designs; the most frequently used of them is Box Behnken Design (BBD).…”