Volume 16

October-December 2024

Fast-Acting Oral Disintegrating Film for the Delivery of Teneligliptin Hydrobromide Hydrate

Shrishail M Ghurghure, Attar M Kais Sameer, Sumit S Umbardand

Abstract: 
The current research work was aimed at optimizing and developing a fast-acting oral disintegrating film of teneligliptin hydrobromide hydrate so as to control the blood sugar level. Solvent casting was used to create the oral disintegrating film containing teneligliptin hydrobromide hydrate. Using a magnetic stirrer, the polymers necessary to prepare ODF were dissolved in an aqueous solution. Teneligliptin was dissolved in the polymer-containing aqueous solution mentioned above, and the mixture was then stirred with a magnetic stirrer. The previously mentioned polymeric solution was then combined with the remaining ingredients and stirred using a magnetic stirrer. Teneligliptin ODF formulations all showed outstanding folding endurance, suggesting that the formulation is robust enough to tolerate handling and transportation. The findings demonstrate the improved physical and chemical characteristics of the oral disintegrating film formulation, along with its good disintegration. The batch of teneligliptin hydrobromide hydrate ODF TF3 that has been optimized displays a pH of 5.8, an oral disintegration time of 45 S, and good folding endurance. The optimized batch’s medication content was discovered to be 96.3%. Every formulation batch has a moisture content that never varies more than 1.5%. This study’s findings show that teneligliptin’s ODF can be created with the intention of improving therapeutic efficacy, increasing bioavailability, and improving patient compliance. Evaluations of the films’ thickness, weight homogeneity, drug content, folding durability, in-vitro release, and disintegration time revealed that they were satisfactory.

Keywords: Disintegrating property, Insulin secretion, Oral disintegrating film, Teneligliptin hydrobromide hydrate.

References:
[1] Muhammad I, Rabel Subahdar Q, Qadir M, Jabeen F, Khan A. Orally disintegrating films: A modern expansion in drug delivery system. Saudi Pharmaceutical Journal (2016) 24,537-546.

[2] Dixit R.P, Puthli S.P. Oral strip technology: Overview and future Potential. Journal ofControlledRelease2009 June24;139:94-107.

[3] Vishwakarma P, Deshkar P, Lal N, Dhudekar S. Orally Disintegrating Strips (ODS)Convenience of Liquid Dosage Form and Dose Accuracy of Solid Dosage Form. American Journal of Pharmacy and Health Research2015;12 (5):1-26.

[4] AcharyaP, Baral R, Manandhar S, Shahi P, Gurung B, Lamichhane A, et al. Formulation and In-Vitro Characterization of Fluxetine Hydrochloride Loaded Fast Dissolving Oral Film using HPMC15CPS and HPMCK4M. Journal of pharmaceutics and drug development 2021 May;8(1):1-19.

[5] Ravi K, Chandrakala V, Srinivasan S, Kaviya. Formulation and Evaluation of Mouth Dissolving Film of Ondonsetron Hydrochloride by using Superdisintegrant. International Journal of Pharmaceutical Research and Applications. 2021 Nov 22;6(6):472-485.

[6] Tizkam H, Osma Q, Ghazy E. Formulation and Evaluation of Metoclopramide Fast Dissolving Film. Systamatic Reviews in pharmacy 2020 December; 11 (12):1641-1646.

[7] Arwa I, Ibrahim M, Hassan A. Optimization and evaluation of venalafaxine hydrochloride fast dissolving oral films. Saudi Pharmaceutical Journal. 2020(28):1374-1382.

[8] Amar S, Bhavana N, Sankeerth P.T, Nandhini P, Nadendla R. Formulation and Evaluation of Loperamide Oral Films. International Journal of Scientific & Engineering Research 2017 October; 8(10):370-378.

[9] SultanaF, Arafat M, Pathan S. Preparation and evaluation of Fast Dissolving Oral Thin Film of Caffeine. International Journal of Pharmacy and Biological Sciences 2013 Jan-Mar;3(1):153-161.

[10] Pingale P, Shinkar D, Boraste S, Amrutkar S. Formulation, Evaluation and Characterization of Mouth Dissolving Film of Cisapride. Current Trends in Biotechnology and Pharmacy 2022 Oct;16 (4):490-500.

[11] Semalty A, Semalty M, Nautiyal U. Formulation and Evaluation of Mucoadhesive Buccal Films of Enalapril Maleate. Indian Journal of Pharmaceutical sciences 2010October;571-575.

[12] Dasari N, Nandhini S, Sudhakar M. Design and evaluation of fast dissolving oral films of Zolpidem by solvent casting method. AsianJ.Pharm.Res.2016;6(2):67-71.

[13] Ramana V, Chandra Sekhar S.S, Reddy A, Reddy M, Rama Rao N. Formulation and Optimization of Zolmitriptan Oral Fast Dissolving Films. International Journal of Chem Tech Research2018;11 (9):96-107.

[14] Mahaparale S, Wagh B. Formulation and Evaluation of Mouth dissolving film ofGlycopyrrolate.InternationalJournalofcreativeResearchThoughts2021Sept;9(9):509-516.

[15] Ramya Deepthi P, Kumar Satish. Formulation and Evaluation of Amlodipine Besylate Oral thin films. International Journal of Pharmaceutical Sciences and Research 2015Sept.04;7 (1):199-205.

[16] Bala R, Pawar P, Khanna S, Arora S. Orally dissolving strips: A new approach to oral drug delivery system. International Journal of Pharmaceutical Investigation. 2013 April:3(2):67-76.

[17] L. Bantosova and J. Bajgar; Transdermal drug delivery in-vitro using diffusion cell, Current medicinal chemistry. (2012). Page no 4671-4677.

[18] Indian Pharmacopoeia 2022, Government of India, Ministry of Health & family welfare, Published by the Indian Pharmacopeia Commission, Ghaziabad. Volume-3, Page no-33.