Home | Articles
Published on:August 2020
Indian Journal of Pharmaceutical Education and Research, 2020; 54(3):618-629
Original Article | doi:10.5530/ijper.54.3.111

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


Authors and affiliation (s):

Sugandha Varshney1,*, N V Satheesh Madhav2

1Kingston Imperial Institute of Technology and Sciences, Dehradun, Uttarakhand, INDIA.

2Formulation Research Development, Vital Therapeutics and Formulations, Pvt. Ltd., Telangana, 500003, INDIA.

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.

Key words: Unidirectional, Mucoadhesive, Bio-flexy films, Nanosized Topiramate, Soft Palate, Glycine max biopolymer.

 




 

Impact Factor

IJPER - An Official Publication of Association of Pharmaceutical Teachers of India is pleased to announce continued growth in the Latest Release of Journal Citation Reports (source: Web of Science Data).

 

Impact Factor® as reported in the 2023 Journal Citation Reports® (Clarivate Analytics, 2023): 0.8

The Official Journal of Association of Pharmaceutical Teachers of India (APTI)
(Registered under Registration of Societies Act XXI of 1860 No. 122 of 1966-1967, Lucknow)

Indian Journal of Pharmaceutical Education and Research (IJPER) [ISSN-0019-5464] is the official journal of Association of Pharmaceutical Teachers of India (APTI) and is being published since 1967.

DOI HISTORY

IJPER uses reference linking service using Digital Object Identifiers (DOI) by Crossref. Articles from the year 2013 are being assigned DOIs for its permanent URLs