Smart Approach for Preparing Nanosized Topiramate Loaded BioFlexy Films Using Film Former from Piper Nigrum and Screening its InVitro Performance

Purpose: To formulate nanosized bio-flexy films using a novel biopolymer isolated from Piper nigrum seeds containing Topiramate for epilepsy treatment. Soft palate drug delivery bypasses first-pass metabolism in gastrointestinal tract. Piper nigrum biopolymer possessed biodegradability, biocompatibility, non-toxicity, inertness, non-reactiveness on soft palatal surface, cost effectivity. Topiramate, anticonvulsant drug, augments the activity of neurotransmitter gammaamino butyrate (GABA). Thus, to minimize drug dose, frequency and side effects like suicidal thoughts and sudden unexpected death, this attempt of Bio-flexy films formulations was made. Methods: Bio-flexy films were prepared by solvent casting technique. Varying ratios of topiramate: Piper nigrum biopolymer were chosen for preparing formulations (FNO1-FNO5) and compared with Sodium carboxyl methyl cellulose standard films and evaluated. Results: The percentage yield of Piper nigrum biopolymer was found to be 2.2%±0.02. Shear Stress study of Piper nigrum biopolymer showed promising mucoadhesivity than standard Sodium Carboxyl Methyl standard polymer. Thickness of formulations (FNO1-FNO5): 0.029±0.003 mm to 0.039±0.002 mm, Folding Endurance: 91-124, Surface pH: 7.02±0.02 to 7.02±0.01, Weight Uniformity: 0.016±0.08 to 0.030±0.07, Drug Content Uniformity: 89.7%±0.72 to 95.4%±0.54, Swelling Percentage: 66%±0.5 to 72%±0.4, Tensile Strength: 88.54 gm±2.5 to 102.05 gm±2.4, Percentage Moisture Uptake (PTU): 2.2%±0.13 to 2.4%±0.12, more mucoretentive on Capra aegagrus intestinal mucosa than standard Sodium Carboxyl Methyl Cellulose films. Conclusion: Formulation FNO4 (containing Topiramate: Piper nigrum biopolymer (1:6)) flexy film having R2=0.9892, Peppas Korsemeyer as best fit model, follows Fick an Diffusion (Higuchi Matrix) release mechanism, T50%: 6 hrs, T80%: 28 hrs, was selected as Best bio-flexy film.