Development and Characterization of Oral Spray for Stomatitis Containing Irsogladine Maleate

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  • Kawano Yayoi
    Faculty of Pharmaceutical Science, Tokyo University of Science
  • Imamura Ayano
    Faculty of Pharmaceutical Science, Tokyo University of Science
  • Nakamura Tomoe
    Faculty of Pharmaceutical Science, Tokyo University of Science
  • Akaishi Mio
    Faculty of Pharmaceutical Sciences, Toho University
  • Satoh Mitsutoshi
    Faculty of Pharmaceutical Sciences, Toho University Faculty of Pharmaceutical Sciences, Meiji Pharmaceutical University
  • Hanawa Takehisa
    Faculty of Pharmaceutical Science, Tokyo University of Science

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<p>The stomatitis caused by anticancer agents and radiation therapy deteriorates patient QOL, potentially causing eating disorders as a result of pain. Although gargling and ointments can be used in the treatment of stomatitis, patients must spit out mouthwash after use, while ointment application requires a finger to be inserted into the oral cavity. In contrast, sprays eliminate these potential compliance problems. Therefore, we developed a stomatitis spray that remains on the oral mucosa. It has been reported that irsogladine maleate (IM) is effective against stomatitis via oral administration. IM is water insoluble; thus, it was dissolved with various cyclodextrins (CDs). Furthermore, we examined combination with gum ghatti (GG), a mucoadhesive polymer. The interaction between mucin and GG was examined by Quartz Crystal Microbalance with Dissipation monitoring. We found that GG exhibited mucoadhesion. Furthermore, we examined the healing effects of IM on stomatitis in a stomatitis model hamster. We found that stomatitis healed after direct application of IM. However, the model used in this experiment is not based on stomatitis caused by anticancer agents. Further study is therefore necessary.</p>

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