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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