Analysing the Release Parameters and Characterisation of Mucoadhesive Non-Selective Beta Blocker Sustained-Release Buccal Films
Abstract
Timolol Maleate is a non-selective beta-adrenergic blocker, widely used in the treatment of hypertension, however it suffers from limitations such as the need for frequent dosing and extensive first-pass metabolism. This study aims to formulate and evaluate a sustained-release mucoadhesive buccal film containing Timolol Maleate intends to address the existing issues associated with oral administration of this drug. The films were prepared by solvent casting method involving multiple mucoadhesive polymers. These films were evaluated for their physicochemical and mechanical properties to ensure the integrity of the films during handling and drug release profile was examined using in vitro drug release and ex vivo drug permeation studies. The findings confirmed that the formulation followed Hixson-Crowell release kinetics and achieved a cumulative drug release of approximately 74% over 8 hours. The drug-excipient compatibility was confirmed by FTIR analysis and the thermal behaviour of the drug-loaded films was characterised using DSC, demonstrating a broad endothermic transition with a reduced peak at 211.64°C (onset at 181.42°C); these tests were performed in conjugation with SEM analysis for visualization of surface morphology of the film. Stability studies conducted in accordance with ICH Q1A(R2) guidelines for a period of three months confirmed that there were no significant changes in the physicochemical properties and drug content of the films. Hence, the data supports the potential development of timolol maleate buccal films as a replacement for oral therapy as the films may offer better patient compliance and bioavailability.
Keywords: Timolol Maleate, Buccal Films, Mucoadhesive Polymers, Hypertension
Keywords:
Timolol Maleate,, Buccal Films, Mucoadhesive Polymers, HypertensionDOI
https://doi.org/10.22270/jddt.v16i5.7735References
1) Walse PV, Thoke ST, Jadhao UT, Rathod DA, Dhembre GD, Kauthekar VR, et al. Formulation and evaluation of mucoadhesive buccal tablets of carvedilol. Journal of Drug Delivery and Therapeutics. 2024 Nov 15;14(11):24-30. https://doi.org/10.22270/jddt.v14i11.6876
2) Katzung BG, Trevor AJ. Basic and Clinical Pharmacology 15e. McGraw Hill Professional; 2020.
3) Burnier M, Egan BM. Adherence in Hypertension. Circulation Research. 2019 Mar 29;124(7):1124-40. https://doi.org/10.37349/emed.2025.1001298
4) World Health Organization. (2023). Global report on hypertension: The race against a silent killer. Geneva, Switzerland: World Health Organization. Available at: https://www.who.int/publications/i/item/9789240081062.
5) Shojaei AH. Buccal mucosa as a route for systemic drug delivery: a review. J Pharm Pharmaceut Sci. 1998;1(1):15-30. Available at: https://sites.ualberta.ca/~csps/JPPS1(1)/A.Shojaei/Shojaei.pdf
6) Patel VF, Liu F, Brown MB. Advances in oral transmucosal drug delivery. Journal of Controlled Release. 2011 Jul;153(2):106-16. https://doi.org/10.1016/j.jconrel.2011.01.027 PMid:21300115
7) Umarani N, Meghana SK, Vaishnavi G, Swathi D, Prakash KA, Reddy NR. Formulation and evaluation of mucoadhesive buccal patches of timolol maleate. Int J Adv Res Med Pharm Sci. 2021;6(6):10-15. Available from: http://www.ijarmps.org/vol-6-2021/
8) Indian Pharmacopoeia Commission. Indian Pharmacopoeia 2020. Vol. I-III. Ghaziabad: Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare; 2020.
9) Pasi SP, Archana PO, Bhavana ED, Maheshwari RA, Mounika ER, Manisha AE. Formulation and evaluation of mucoadhesive buccal patches of timolol maleate. Int J Adv Res Med Pharm Sci. 2022;6:e06439. Available at: http://www.ijarmps.org/wp-content/uploads/v6.i6.3.formulation-and-evaluation-of-mucoadhesive-buccal-patches-of-timolol-maleate.pdf
10) Divya V, Vallur G, Kumar GV. Formulation and evaluation of buccal patches of timolol maleate. Int J Pharm Res Technol. 2023;13(2):46-51. Doi: 10.31838/ijprt/13.02.06.
11) Hassan AA, Kristó K, Ibrahim YH, Regdon G Jr, Sovány T. Quality by design-guided systematic development and optimization of mucoadhesive buccal films. Pharmaceutics. 2023;15(10):2375. https://doi.org/10.3390/pharmaceutics15102375 PMid:37896135 PMCid:PMC10610159
12) Sharma K, Khan AD, Sachdeva M. Development and characterization of mucoadhesive buccal patch of timolol maleate. J Appl Pharm Sci Res. 2018;1(1):8-15. https://doi.org/10.31069/japsr.v1i01.13057
13) Devdatt J, Nagesh C, Hiroji M, Chandrashekhar S, Patel N. Formulation and evaluation of buccal films of timolol maleate. Res J Pharm Dosage Forms Technol. 2012;4(3):iv.
14) Nair AB, Kumria R, Harsha S, Attimarad M, Al-Dhubiab BE, Alhaider IA. In vitro techniques to evaluate buccal films. J Control Release. 2013;166(1):10-21. https://doi.org/10.1016/j.jconrel.2012.11.019 PMid:23219961
15) Shivane P, Solanki D. Formulation and evaluation of mucoadhesive buccal patch of timolol maleate. 2017 [cited 2026 Apr 19]. Available at: https://www.researchgate.net/publication/350653970
16) Hanif M, Zaman M, Chaurasiya V. Polymers used in buccal film: a review. Des Monomers Polym. 2015;18(2):105-111. https://doi.org/10.1080/15685551.2014.971389
17) Gaikwad SS, Thombre SK, Kale YK, Gondkar SB, Darekar AB. Design and in vitro characterization of buccoadhesive tablets of timolol maleate. Drug Development and Industrial Pharmacy. 2014 Mar 5;40(5):680-90. PMid:24592893 https://doi.org/10.3109/03639045.2014.892955
18) Saleem MA, Malvania D, Patel J, Murali YD, Naheed M. Preparation and evaluation of timolol maleate matrix tablet using hydrogel forming polysaccharides. Int J Pharm Sci Res. 2012;3(8):2786-2794. https://doi.org/10.13040/IJPSR.0975-8232.3(8).2786-94
Published
Abstract Display: 0 
PDF Downloads: 0 PDF Downloads: 0 How to Cite
Issue
Section
Copyright (c) 2026 Shubhangi Yashwant Aher
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
How to Cite
.