Application of Central Composite Design for Statistical Optimization of Trigonella foenum-graecum Phytosome-Based Cream

Rheumatoid arthritis is an autoimmune disease which could lead to severe joint damage and disability. Various strategies for treatment of rheumatoid arthritis produce serious adverse effects which require continuous monitoring. Consequently, herbal treatments are considered safer alternative to manage rheumatoid arthritis. In this investigation, Trigonella foenum-graecum ether extracts containing linolenic acid for anti-inflammatory and anti-arthritic activity was produced. Furthermore, Trigonella foenum-graecum ether extract phytosomes (TFG-PH) were developed by thin-film hydration technique using L-α-Phosphatidylcholine and cholesterol followed by optimization using central composite design to determine optimized composition and processing conditions for optimized TFG-PH. Quadratic equation was developed for % entrapment efficiency (Y1) and % yield (Y2) to evaluate the effect of independent variables on response parameters. Y1 = 69.75 + 9.21 X1 + 0.5191 X2 + 1.61 X3 + 1.19 X1X2 + 0.5488 X1X3- 1.06 X2X3 - 3.56 X1² -0.7654 X2² - 2.39 X3²; Y2 = 61.52 + 8.99 X1 + 1.32 X2 + 1.56 X3 + 1.42 X1X2 + 0.47 X1X3 - 0.4025 X2X3 - 4.29 X1² -1.10X2² - 2.39 X3². It was found that, % entrapment efficiency and yield rapidly increased with increase in phosphatidylcholine concentration. The desirability function was explored using Design-Expert software (Trial Version 11.1.2.0, Stat-Ease Inc., MN) to achieve optimized TFG-PH on set paradigm of maximizing entrapment efficiency (% w/v) and yield (% w/v). The composition and processing conditions for optimized TFG-PH as explored using Design-Expert software (Trial Version 11.1.2.0, Stat-Ease Inc., MN) was phosphatidylcholine (X1 = 1.31% w/v), cholesterol (X2 = 6.218% w/v) and rotation speed (X3 = 94.5 rpm). Desirability function for optimized TFG-PH was found 0.918 which will produce entrapment efficiency and yield of 72.18% w/v and 64.89% w/v, respectively. Furthermore, optimized TFG-PH-based transparent, homogeneous, moisturizing, non-greasy, spreadable and stable cream was manufactured which could generate superior therapeutic effect owing to enhanced permeability and skin retention potential of phytosomes without producing any adverse effect.