Optimization of Jiawei Qing'e Oral Fast Disintegrating Tablets Based on Response Surface-Central Composite Design / 中草药·英文版

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. © 2013 Tianjin Press of Chinese Herbal Medicines.