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In-situ fast-prepared mucoadhesive oral gel for palliative treatment of chemotherapy-induced mucositis: preparation, characterizations and pre-post study

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Abstract

Oral mucositis is a painful inflammation of mouth and throat mucosal tissues with or without lesions. Chemo and radiotherapy are the two main causes of oral mucositis which can limit nutritional intake of patients and interrupting the treatment. In this study we aimed to prepare the in-situ fast-prepared protective oromuco-adhesive hydrogel film to overcome the mucositis problems through human study in six chemotherapy patients with oral mucositis. The chosen G2 hydrogel formulation constructed of Carbopol-934 and high-Mw chitosan at weight ratio of 1:0.1 with acceptable gel appearance and proper biotribological properties such as mean mucoadhesive strength of 0.048 mJ/cm2 and mean residence time of 2.1 h, showed significant pain-reduction (p-value 0.043) and improvement of swallowng comfort in pre-post study. The hydrogel can be in-situ prepared fast and immediately used to form a protective physical barrier on mouth surface which can efficiently reduce the symptoms in patients with mucositis.

Graphical Abstract

The protective oromuco-adhesive hydrogel film constructed of Carbopol-934 and digested chitosan with 1:0.1 weigh ratio with acceptable gel appearance and proper biotribological properties which the pre-post study resulted pain-reduction and swallowing-comfort in chemotherapy patients with oral mucositis.

Highlights

  • Preparation of in-situ oromuco-adhesive hydrogel biofilm constructed of Carbopol-934 and chitosan.

  • Preparation of low, medium, and high molecular weight chitosan solutions by H2O2 digestion method.

  • Fabrication of different gel formulations based on fractional factorial design.

  • Pre-post study for the assessment of pain-reduction and swallowing-comfort in patients with mucositis.

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Acknowledgements

The authors would like to thank Prof. Soliman Mohammadi-Samani and Prof. Ali-mohammad Tamaddon for dedicating materials of this study, Mr. Mehdi Khayyat for his kind cooperation, and Dr. Fatemeh Sarvi for performing statistical analysis. We also acknowledge Dr. Mohammad Hashem Hashempur and ethical committee of Fasa university of medica sciences for their kind collaborations.

Author contributions

MH: methodology, investigation, visualization, writing original draft; MS: conceptualization, supervision, methodology, analysis, manuscript review and editing.

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Author notes

  1. Mana Heidari

    Present address: Razi Pharmed-Far’avaran pharmaceutical Inc., Shiraz, 41721, Iran

Authors and Affiliations

  1. School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, 71345, Iran

    Mana Heidari

  2. Cellular and Molecular Biology Research Center, Larestan University of Medical Sciences, Larestan, Iran

    Mohsen Salmanpour

Authors
  1. Mana Heidari
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Correspondence to Mohsen Salmanpour.

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The authors declare no competing interests.

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Informed consent was obtained from all individual participants included in the study

Ethical approval

The human study was approved by the Ethics Committee of Fasa University of Medical Sciences, Fasa, Iran; with approval number: IR.FUMS.REC.1440.121. The patients were included to study after training and signing informed consents which are available if necessary.

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Heidari, M., Salmanpour, M. In-situ fast-prepared mucoadhesive oral gel for palliative treatment of chemotherapy-induced mucositis: preparation, characterizations and pre-post study. J Sol-Gel Sci Technol 108, 352–360 (2023). https://doi.org/10.1007/s10971-023-06158-y

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  • DOI: https://doi.org/10.1007/s10971-023-06158-y

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