Bioflexy film formulation for delivery of tiagabine via oro transsoft palatal route and its invitro stability study approach

The aim of research work was to formulate bioflexy films using a novel biopolymer isolated from Rosa polyanthapetals containing tiagabine as a model drug. The soft palate drug delivery helps bypass firstpass metabolism in the liver and presystemic elimination in the gastrointestinal tract gets avoided. Tiagabine, anticonvulsant drug possesses t1/2:79 hours (low); protein binding: 96%; water solubility: 22mg/L enhances acts as selective GABA reuptake inhibitor. Side effects include abdominal pain, pharyngitis, suicidal thoughts and sudden unexpected death. Rosa polyantha biopolymer used as bioexcipient due to its biodegradability, biocompatibility, nontoxicity, nonreactiveness on soft palatal surface. Physicochemical characterization of biopolymer displayed inbuilt filmability, mucoadhesivity properties. Bioflexy films were prepared by solvent casting technique. Formulations containing different ratios of nanosized Tiagabine: Rosa polyantha biopolymer (1:0.5, 1:1; 1:3, 1:5, 1:6, 1:10) (FRT1FRT6) were prepared and compared with nanosized Tiagabine loaded Sodium CMC standard flexy films (FET1FET6). The percentage yield of Rosa polyantha biopolymer was found to be 2.24±0.01%. Evaluation parameters for formulations revealed Thickness of nanosized Tiagabine loaded bioflexy films containing Rosa polyantha biopolymer (FRT1FRT6): 0.027 mm±0.005 to 0.039±0.004 mm, Folding Endurance: 83130, Surface pH: 7.00±0.04 to 7.00±0.01, Weight Uniformity: 0.008±0.05 to 0.044±0.03, Drug Content Uniformity: 85.6%±0.48 to 94.8%±0.37, Swelling Percentage: 66%±0.2 to 75%±0.1, Percentage Moisture Uptake (PTU): 2.5%±0.14 to 3.8%±0.10. Mucoadhesivity: 901440 mins, Mucoretentivity: 110240 mins. Drug release pattern for formulations FRT1FRT6 containing Rosa polyantha biopolymer based on the T50% and T80% was found to be FRT5 (1:6) gt; FRT4 (1:5) gt; FRT6 (1:10) gt; FRT1 (1:0.5) gt; FRT3 (1:3) gt; FRT2 (1:1). Based on all above mentioned evaluation parameters, FRT5 (containing Tiagabine: Rosa polyantha biopolymer (1:6)) bioflexy film having R2= 0.9295, Higuchi Matrix as best fit model, follows Fickian Diffusion (Higuchi Matrix) release mechanism, T50%: 7hrs., T80%: 30 hrs. using BITS Software 1.12 was found to be Best formulation.