Preparation and evaluation of softgel shell by Box-Behnken design-response surface method [Box-Behnken设计-效应面法优化胶皮处方及胶皮的性能研究]

作者：Ai J.-J.; Deng P.; Hu P.-Y.; Li D.-X.^*; Zhang G.-S.

来源：中国新药杂志, 2020, 29(2): 192-198.

• Box-Behnken design
• Dissolution rate
• Mechanical properties
• Response surface method
• Softgel shell
• Water adsorption isotherm
• Water vapor permeance

Objective: To optimize the softgel shell prescription and investigate its properties by Box-Behnken design-response surface method. Methods: The dosages of glycerin, sorbitol, polyethylene glycol 400 (PEG400) and gelatin were taken as the investigation factors, and the dissolution rate of the softgel shell was used as an indicator. The Box-Behnken design-response surface methodology was used to optimize the formulation of softgel shell. The water vapor permeability, water adsorption isotherm, and mechanical properties were evaluated. Results: The optimal formulation of softgel shell was gelatin:glycerol:sorbitol:PEG400=1.00:0.67:1.00:0.11, and the dissolution rate was 4 923.27 mg?(min?cm2)-1. The evaluation of the softgel shell properties showed that the water vapor permeance was 4.381 g?mm?(kPa?h?m2)-1, equilibrium water content was low in the environment with relative humidity Aw<0.60, the tensile strength was (9.60±0.04) MPa, and the elongation was (106.67±0.26)%. Conclusion: It is feasible and effective to optimize the formulation of softgel shell by using the Box-Behnken design-response surface method.