Alcohol-free Benzydamine mouth gel

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Alcohol-free Benzydamine mouth gel recommendations and experiences in oral mucositis

D. Keiner, D. Stephan, L. Krüger
SRH Zentralklinikum Suhl, Zentralapotheke, Suhl, Germany

Background: Chemotherapy- and radiotherapy-induced oral mucositis (OM)represents a therapeutic challenge frequently encountered in cancer patients. More than 40 different substances were evaluated in terms of prevention and treatment of mucositis. The implementation of an alcohol-free benzydamine mouth wash in pharmaceutical care is discussed. Benzydamine is one option supported by an evidence base.

Material and Methods: A mouth gel with 0.15% benzydamine hydrochloride has been developed, which is in line with recommended requirements alcohol-free preparation, no growth factor, easy to use oral, pleasant taste and consistency, moderate price) and has been analyzed concerning its safety and effectiveness, using both subjective and objective measures.

Results: Its lead compound alcohol mouth gel contains benzydamine HCl, sodium hydrogen carbonate, saccharine sodium, polysorbate, polyvidone, glycerol and hydroxyethyl cellulose. The evaluation of OM by longitudinal survey in the Head and Neck Clinic (n=10;20 % female, 48-65 y) was recorded before cytotoxic therapy (T0) and at day 7 (T1). The Brief Pain Inventory pain intensity score decreased(T0:12.6 + 4.1; T1: 9.4 + 3.0). The pain during a 24-hour recall period was reduced by 36.5 + 9.4 %. Patients reported less use of analgesic medications (non-opioid medications). The mouth gel was applied undiluted on average 4 times per day (Min: 3, Max: 5). Patients developed mostly OM-degree 1 (WHO, 80%).

Conclusion: Health-related quality of life is improved by reducing pain. This new
intervention for the prevention and treatment of OM could ultimately lead to reduced patient suffering and improve cancer treatment outcome. The 0.15% alcohol-free benzydamine mouth wash can beproduced easily from any pharmacy.

References: 16th Congress of EAHP. 30 March - 01 April 2011. Viena. Austria