Optimization of Jiawei Qing'e Oral Fast Disintegrating Tablets Based on Response Surface-Central Composite Design

Abstract

Abstract Objective To apply the response surface-central composite design to developing and optimizing the oral fast disintegrating tablets (ODT) formulation for Jiawei Qing'e, a kind of prescription of Chinese herbal medicine. Methods The bitterness of Jiawei Qing'e was masked using Eudragit E-100 by solvent evaporation technique. Response surface approach was applied to investigating the interaction of formulation parameters in optimizing the formulation. The independent variables were Eudragit E-100/drug ratio (X1), amount of disintegrants (X2), and the amount of diluents (X3). The disintegration time (Y1), hardness (Y2), and weight variations of the tablets were characterized. Results The models predicted levels of X1 = 4.63%, X2 = 5.25%, and X3 = 34.33%, for the optimal formulation having a hardness of 3.0 kg with the disintegration time of 30 s within experimental region. The observed response of Y1 = 26.5 s and Y2 = 3.14 kg reasonably agreed with the predicted response. Conclusion Response surface methodology shows the good predictability and reliability in optimizing the formulation. The optimized ODT of Jiawei Qing'e has acceptable taste, rapid disintegrating ability, and good mechanical strength.