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Letters in Drug Design & Discovery

Editor-in-Chief

ISSN (Print): 1570-1808
ISSN (Online): 1875-628X

Research Article

Preparation and In vitro, Ex vivo Evaluation of Benzidamine Hydrochloride Loaded Fast Dissolving Oral Strip Formulations: Treatment of Oral Mucositis Due to Side Effects of Chemotherapy and Radiotherapy

Author(s): Evrim Yenilmez*, Ahmet Alper Öztürk and Ebru Başaran

Volume 20, Issue 8, 2023

Published on: 14 February, 2023

Page: [1147 - 1157] Pages: 11

DOI: 10.2174/1570180820666230207122755

open access plus

Abstract

Background: Rapidly dissolving oral strips have many advantages, especially in pediatric and geriatric use. Benzydamine hydrochloride is an active substance with local analgesic, anesthetic, antimicrobial and non-steroidal anti-inflammatory properties.

Objective: The aim of the study was to formulate and characterize orally dispersible benzydamine hydrochloride- loaded fast dissolving oral strips for the sufficient treatment of oral mucositis with high loading capacity as well as high patient compliance considering ease of use.

Methods: Oral strips were prepared by solvent casting method with many different polymer combinations and evaluated for different characteristics. In vitro and ex vivo characterizations were performed.

Results: In appearance oral strips were smooth and they were also uniform in thickness and weight. The release rates of the active agent from oral strips reached 100% within 25 minutes. The disintegration time was within the range of 15.5 ± 1.2 seconds. Due to ex vivo permeation studies steady-state flux of benzydamine hydrochloride in simulated saliva and pH 6.8 were found to be 27.1 μg cm−2 h−1 ± 1.4 and 26.2 μg cm−2 h−1 ± 1.7, respectively. No significant difference (p˃0.05) in permeability studies was observed using pH 6.8 phosphate buffer compared to simulated saliva.

Conclusion: Active agent was successfully loaded into the strips and the targeted system was successfully performed. Benzydamine hydrochloride as oral strips can be a better solution for the efficient treatment of oral mucositis for cancer patients during chemotherapy and radiotherapy stages.

Keywords: Benzydamine hydrochloride, oral strip, hydroxypropyl methylcellulose, wound healing, cancer treatment, HPLC.

Graphical Abstract
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