bio-flexy film formulation for delivery of tiagabine via oro transsoft palatal route and its in-vitro stability study approach

The aim of research work was to formulate bio-flexy films using a novel biopolymer isolated from rosa polyantha petals containing tiagabine anticonvulsant drug. the soft palate drug delivery helps bypass first-pass metabolism in the liver and pre-systemic elimination in the gastrointestinal tract gets avoided. rosa polyantha biopolymer used as bio-excipient due to its biodegradability, biocompatibility, inbuilt filmability, mucoadhesivity, non-toxicity, non-reactiveness on soft palatal surface. bio-flexy 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) (frt1-frt6) were prepared and compared with nanosized tiagabine loaded sodium cmc standard flexy films (fet1-fet6). 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 bio-flexy films containing rosa polyantha biopolymer (frt1-frt6):0.027 mm±0.005 to 0.039±0.004 mm, folding endurance: 83- 130, 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: 90-1440 mins, mucoretentivity: 110-240 mins. based on all above mentioned evaluation parameters, frt5 (containing tiagabine: rosa polyantha biopolymer (1:6)) bio-flexy film having r2= 0.9295, higuchi matrix as best fit model, follows fickian diffusion (higuchi atrix) release mechanism, t50%:7 hrs., t80%: 30 hrs. was found to be best formulation. stability studies conducted as per ich guidelines revealed stable formulations at 40 ᵒc ± 2 ᵒc and ± 45± 5% rh, 25 ᵒc ± 2 ᵒc and 60 ± 5% rh and 2 ᵒc ± 5 ᵒc temperature and rh values in terms of invitro drug release, folding endurance, surface ph. significance: the purpose of this research work is to provide effective treatment of epilepsy for sustained action up to 48 hours in reduced drug dose, frequency and minimized side effects.