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 & DISCOVERY, vol.20, no.8, pp.1147-1157, 2023 (SCI-Expanded) identifier identifier

  • Publication Type: Article / Article
  • Volume: 20 Issue: 8
  • Publication Date: 2023
  • Doi Number: 10.2174/1570180820666230207122755
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Biotechnology Research Abstracts, Chemical Abstracts Core
  • 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, 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 & PLUSMN; 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 & mu;g cm(-2) h(-1) & PLUSMN; 1.4 and 26.2 & mu;g cm(-2) h(-1) & PLUSMN; 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.