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Indian Journal of Pharmaceutical Education and ResearchNOW IN
Article

Development and Evaluation of Unidirectional Mucoadhesive Bio-Flexy Films Loaded with Nanosized Topiramate using a Novel Biopolymer from Glycine max

Sugandha Varshney1★, N V Satheesh Madhav2★ Corresponding author

  1. 1Kingston Imperial Institute of Technology and Sciences, Dehradun, Uttarakhand, INDIA.
  2. 2Formulation Research Development, Vital Therapeutics and Formulations, Pvt. Ltd., Telangana, 500003, INDIA.

CORRESPONDENCE

Sugandha Varshney

Kingston Imperial Institute of Technology and Sciences, Dehradun, Uttarakhand, INDIA.

sugandhavarshney19.12.86@gmail.com

Received: 03-08-2019; Revised: 09-11-2019; Accepted: 26-02-2020.

Volume 54, Issue 3 · pp. 618–629 · PUBLISHED 2020 · DOI: 10.5530/ijper.54.3.111

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ABSTRACT

Aim: Formulation and evaluation of nanosized Topiramate loaded bio-flexy films using novel biopolymer isolated from Glycine max seeds for epilepsy treatment. Methods: Formulations containing nanosized Topiramate: Glycine max biopolymer (in ratios of 1:0.5, 1:1; 1:3, 1:5, 1:6, 1:10) (FGO1-FGO6) were prepared by solvent casting method. Results: Glycine max biopolymer showed percentage yield: 81.06%±0.01, light yellow, odorless, soluble in chloroform, water and color changing point: 218°C±2. Topiramate loaded bio-flexy films containing Glycine max biopolymer (FGO1-FGO6) revealed Thickness: 0.019 mm±0.012 to 0.037 mm±0.010, Surface pH:7.01±0.03 to 7.01±0.02, ex-vivo Mucoadhesion Time: 30-120 mins, ex vivo Mucoretention Time:90-210 mins, Weight Uniformity: 0.078±0.05 to 0.083±0.04, Drug Content Uniformity:72.7%±0.50 to 82.84%±0.48, Folding Endurance: 117-173, Swelling Percentage: 62%±0.6 to 74%±0.4, Percentage Moisture Uptake (PTU): 2.0%±0.13 to 2.8%±0.12. The drug release pattern based on the T50% and T80% was found to be FGO2 (1:1) > FGO6 (1:10) > FGO1 (1:0.5) > FGO4 (1:5)> FGO5 (1:6) > FGO3 (1:3). Conclusion: Based on all the evaluation parameters, FGO2 (containing Topiramate: Glycine max biopolymer (1:1)) Bio-flexy film having R2=0.9139, Higuchi Matrix as best fit model, follows Fickian Diffusion (Higuchi Matrix) release mechanism, T50%: 25 hr., T80%: 27 hr. Prepared formulations were suitable for Soft Palatal Delivery.

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    Varshney, S., & Madhav, N. V. S. (2020). Development and Evaluation of Unidirectional Mucoadhesive Bio-Flexy Films Loaded with Nanosized Topiramate using a Novel Biopolymer from Glycine max. Indian Journal of Pharmaceutical Education and Research, 54(3), 618–629. https://doi.org/10.5530/ijper.54.3.111