SMART APPROACH FOR PREPARING NANOSIZED LOADED TIAGABINE USING A BIO-FLEXY FILM FORMER FROM GREEN BRINJAL POLYMER AND ITS IN-VITRO PERFORMANCE
Sugandha Varshney* and N.V. Satheesh Madhav
ABSTRACT
The research work aimed to formulate bio-flexy films loaded with nanosized tiagabine using a novel biopolymer isolated from Solanum melongena pulp. Tiagabine, anticonvulsant drug possesses t1/2:7-9 hours (low); protein binding: 96%; water solubility: 22mg/L, acts as selective GABA reuptake inhibitor. Side effects include abdominal pain, pharyngitis, suicidal thoughts and sudden unexpected death. Biopolymer isolated from Solanum melongena was used to prepare bio-flexy films because of its biodegradability, biocompatibility, non-toxic, non-irritant nature and non-reactive on soft palatal surface. Physicochemical characterization of biopolymer displayed inbuilt properties of filmability, mucoadhesivity. Bio-flexy films were prepared by solvent casting technique. Drug to polymer ratio was chosen at five levels for Solanum melongena FSM1-FSM5 containing varying ratios of biopolymer from 1%-10% and 1% of nanosized tiagabine and compared with Sodium CMC standard films. Bio-flexy films were evaluated for thickness, surface pH, weight uniformity, folding endurance, in-vitro release and stability studies. The percentage yield of Solanum melongena biopolymer was found to be 2.24±0.01%. Thickness of formulated bio-flexy films was ranging from 0.019 mm to 0.076 mm, folding endurance: 86-114, surface pH: 7.01±0.02 to 7.01±0.01, weight uniformity: 0.001±0.02 to 0.032±0.01. Based on all above mentioned evaluation parameters, FSM3 (containing Tiagabine: Solanum melongena biopolymer (1:5)) having R2=0.9770, peppas korsmeyer as best fit model, follows Fickian diffusion (Higuchi matrix) release mechanism using BITS Software 1.12.Stability study revealed 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.
Keywords: Bio-flexy films, nanosized tiagabine, Solanum melongena biopolymer, soft palatal delivery.
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