Development and evaluation of Bio-Flexy films using a novel biopolymer from loaded with nanosized tiagabine

Background
Tiagabine, an anticonvulsant drug, has : 7–9 h (low); protein binding: 96%; water solubility: 22 mg/l; it also acts as a selective GABA reuptake inhibitor. Side effects include abdominal pain, pharyngitis, suicidal thoughts, and sudden unexpected death.
Aim
The aim of this work was to formulate nanosized Bio-Flexy films using a novel biopolymer isolated from fruit pulp containing tiagabine as a model drug. The soft palate drug delivery helps bypass first-pass metabolism in the liver and presystemic elimination in the gastrointestinal tract is avoided.
Materials and methods
Bio-Flexy films were prepared using the solvent casting technique. The drug to polymer ratio was chosen at five levels for FPA1–FPA5 with varying ratios of biopolymer from 1 to 10 and 1% of nanosized tiagabine and compared with sodium carboxyl methyl cellulose standard films. Bio-Flexy films were evaluated for thickness, surface pH, weight uniformity, folding endurance, in-vitro release, and stability studies.
Results
The percentage yield of the biopolymer was found to be 0.972±0.008%. The thickness of the formulated Bio-Flexy films ranged from 0.041 to 0.091 mm, the folding endurance was 65–95, the surface pH was 7.01±0.02 to 7.01±0.01, and weight uniformity was 0.001±0.02 to 0.032±0.01.
Conclusion
On the basis of all the above-mentioned evaluation parameters, formulation FPA3 [containing Tiagabine: biopolymer (1:5)] was selected as the best film as results of an in-vitro release study showed prolonged durationof 48 h in prolonged manner. The best film showed =0.969 release pattern by Peppas–Korsmeyer, as the Best Fit model, followed by anomalous transport release mechanism, which was confirmed by using BITS Software 1.12. Stability study showed stable Bio-Flexy films with no significant change in physical appearance and stable pH. Prepared formulations of tiagabine-loaded Bio-Flexy films are suitable for soft palatal delivery.