Development and Characterization of Terminalia arjuna Phospholipid Complex and Its Tablet Formulation by Qbd Approach

Abstract

Phytosomes are a newly introduced novel drug delivery system and novel botanical formulation to induce lipophilic molecular complexes to enhance absorption and bioavailability of phytoconstituents. Terminali aarjuna phospholipid complex and it’s tablet formulations targeted for cardiovascular systems was prepared. Our study aims is for improving the cardioprotective activity by formulating Terminalia arjuna phospholipid complex tablet by using solvent evaporation method. and characterized by various parameters like solubility studies, particle size determination, infrared absorption (FTIR), Scanning electron microscopy (SEM), entrapment efficiency etc. as well as by applying QbD approach various general characteristics such as entrapment efficiency etc were also done. A QbD- based approach using a Box-Behnken design was done to obtain a response surface design expert software 9.0.5 to systematically study the combined influence of the formulation and process variables such as the phospholipids-drug ratio(X1, w/w), the reaction temperature(X2, °C), and the reaction time (X3, hrs) on a critical quality attributes (CQAs) of the product i.e., the entrapment efficiency. Using this design, the experimental trials were carried out at all 15 possible combinations. The preliminary investigation of the influence of factors revealed that all the tested variables, i.e., the phospholipids to drug ratio, the reaction temperature and the reaction time had a significant influence on the entrapment efficiency of the prepared phytosomes. The study revealed that the entrapment efficiency of Terminalia arjuna Phytosomes was found to be 83.0-97.9 %w/w.