Smart Mucoadhesive Film Former from Seeds of Arachis Hypogea and Its In-Built Properties for Pharmaceutical Applications

S. Varshney, N. S. Satheesh Madhav
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Abstract

Aim: Isolation of novel biopolymer from Arachis hypogea seeds to be used as bio-excipient in formulation of nanosized Topiramate loaded bio-flexy films for epilepsy treatment. Method: Formulations containing nanosized Topiramate: Arachis hypogea biopolymer (in ratios of 1:0.5, 1:1; 1:3, 1:5, 1:6, 1:10) (FAO1-FAO6) were prepared by solvent casting method. Results: Arachis Hypogea Biopolymer showed percentage yield of 20% ±0.01. The biopolymer was brown in color, odourless, partially soluble in water. Its colour changing point was found to be 210ºC±2. It was tested positive for proteins and carbohydrates, amino acids were not present. Evaluation parameters of nanosized Topiramate loaded bio-flexy films containing Arachis hypogea biopolymer (FAO1-FAO6) revealed Thickness: 0.022 mm±0.004 to 0.044±0.003 mm, Folding Endurance: 140-169, Surface pH: 7.01±0.03 to 7.01±0.02, Weight Uniformity: 0.006±0.04 to 0.036±0.02, Drug Content Uniformity: 85.4%±0.68 to 93.4%±0.50, Swelling Percentage: 73%±0.6 to 89%±0.4, Percentage Moisture Uptake (PTU): 1.8%±0.10 to 2.4%±0.08, Mucoadhesion time: 45-150 minutes, Mucoretention time: 75-210 minutes. The drug release pattern for formulations FAO1-FAO6 containing Arachis hypogea biopolymer based on the T50% and T80% was found to be FAO2 (1:1) > FAO5 (1:6) > FAO6 (1:10) > FAO1 (1:0.5)> FAO4 (1:5) > FAO3 (1:3). Conclusion: Based on all above-mentioned evaluation parameters, FAO2 (containing Topiramate: Arachis hypogea biopolymer (1:1)) Bio-flexy film having R2 =0.9215, Higuchi Matrix as best fit model, follows Fickian Diffusion (Higuchi Matrix) release mechanism, T50%: 44.52 hrs., T80%: 46.14 hrs. using BITS Software. Stability study revealed stable formulations. Isolated Arachis hypogea biopolymer showed in-built filmability, mucoadhesivity properties, was non-reactive and suitable for Soft Palatal Drug Delivery.
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花生种子的智能粘接成膜剂及其在制药应用中的内在特性
目的:从花生种子中分离新型生物聚合物,并将其作为生物赋形剂用于制备纳米托吡酯生物柔韧膜治疗癫痫。方法:含有纳米托吡酯的配方:花生米生物聚合物(比例为1:0.5,1:1;采用溶剂铸造法制备了1:3,1:5,1:6,1:10)(FAO1-FAO6)。结果:花生米生物聚合物的产率为20%±0.01。该生物聚合物呈褐色,无味,部分溶于水。其变色点为210℃±2℃。蛋白质和碳水化合物检测呈阳性,氨基酸不存在。含花生生物聚合物(FAO1-FAO6)的纳米托吡酯负载生物弹性膜的评价参数为:厚度:0.022 mm±0.004 ~ 0.044±0.003 mm,折叠耐久度:140 ~ 169,表面pH: 7.01±0.03 ~ 7.01±0.02,重量均匀度:0.006±0.04 ~ 0.036±0.02,药物含量均匀度:85.4%±0.68 ~ 93.4%±0.50,溶胀率:73%±0.6 ~ 89%±0.4,吸湿率(PTU): 1.8%±0.10 ~ 2.4%±0.08,黏附时间:45 ~ 150 min,粘留时间:75 - 210分钟。以T50%和T80%为基准,含有花生生物聚合物的fa01 - fa06的药物释放规律为fa02 (1:1) > FAO5 (1:6) > FAO6 (1:10) > fa01 (1:0.5)> FAO4 (1:5) > FAO3(1:3)。结论:综合上述评价参数,FAO2(含托吡酯:花生壳生物聚合物(1:1))生物柔性膜R2 =0.9215,以Higuchi Matrix为最佳拟合模型,符合Fickian Diffusion (Higuchi Matrix)释放机制,T50%: 44.52 h。, 80%: 46.14小时。使用BITS软件。稳定性研究揭示了稳定的配方。分离得到的花生生物聚合物具有内在的成膜性和黏附性,无反应性,适合软腭给药。
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