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

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Yenilmez E., Öztürk A. A., Başaran E.

Letters in Drug Design and Discovery, vol.20, no.8, pp.1147-1157, 2023 (SCI-Expanded) identifier

  • Publication Type: Article / Article
  • Volume: 20 Issue: 8
  • Publication Date: 2023
  • Doi Number: 10.2174/1570180820666230207122755
  • Journal Name: Letters in Drug Design and Discovery
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Biotechnology Research Abstracts, Chemical Abstracts Core, EMBASE
  • Page Numbers: pp.1147-1157
  • Keywords: Benzydamine hydrochloride, cancer treatment, HPLC, hydroxypropyl methylcelulose, oral strip, wound healing
  • Anadolu University Affiliated: Yes


Background: Rapidly dissolving oral strips have many advantages, especialy in pediatric and geriatric use. Benzydamine hydrochloride is an active substance with local analgesic, anesthetic, antimi crobial and non-steroidal anti-inflammatory properties. Objective: The aim of the study was to formulate and characterize oraly dispersible benzydamine hydro chloride-loaded fast dissolving oral strips for the sufficient treatment of oral mucositis with high loading capacity as wel 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 benzy damine 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 successfuly loaded into the strips and the targeted system was successfuly performed. Benzydamine hydrochloride as oral strips can be a beter solution for the efficient treatment of oral mucositis for cancer patients during chemotherapy and radiotherapy stages.