3PC-030 Design and development of a magistral formulation of mouthwash for the treatment of mucositis: a case report

<h3>Background and Importance</h3> Oral mucositis is an inflammatory condition from cancer therapies, which causes pain, infection and ulceration. Standard treatment with mouthwashes and systemic analgesics is not always effective, leading to the use of more personalised therapeutic options, such as the design of a magistral formulation (MF). <h3>Aim and Objectives</h3> To formulate a mouthwash by galenic validation and describe its use in the treatment of mucositis. <h3>Material and Methods</h3> A 17-year-old patient with severe spinal cord aplasia developed grade four of mucositis, with severe pain and oral aphthous ulcers. After the failure of conventional treatments, such as oral viscous lidocaine and chlorhexidine, a MF was formulated and designed through a literature review (pharmacopoeia, Pubmed). Galenic validation included organoleptic (smell, colour), chemical (ph measurement) and microbiological controls. <h3>Results</h3> The components of the MF aimed to reduce pain (lidocaine), irritation (dexchlorpheniramine), inflammation (triamcinolone), prevent superinfections (nystatin) and regulate mucosal pH (sodium bicarbonate). The excipients used were Tween 80, glycerine, and 1% carboxymethylcellulose. Preparation of 250 mL: Mix triamcinolone acetonide (0.125 g) and nystatin (460 mg); add Tween 80 (3 drops), glycerine (25 mL), and 1% carboxymethylcellulose (40 mL), homogenising after each addition. In a separate container, mix lidocaine (5 g) and sodium bicarbonate (2.5 g); add glycerine (25 mL), dexchlorpheniramine solution 0,4 mg/ml (40 mL) and 1% carboxymethylcellulose (40 mL), homogenising after each addition. Combine in a beaker, and adjust the volume to 250 mL with 1% carboxymethylcellulose, then homogenise. Galenic validation of the MF was carried out for one month. In the second week, the pH remained stable at 8, with no crystals or colour variations. In the third week, the pH increased to 9 and small crystals appeared. Despite this, the microbiological control was negative. With these data, a shelf life of 14 days was established for the MF, stored in a topaz glass container and kept in a refrigerator at 2–8°C. After 1 month of treatment with a dosage regimen of 10 ml three times a day, the patient experienced a significant improvement in oral aphthous ulcers and pain, avoiding the use of morphics and improving oral tolerance. <h3>Conclusion and Relevance</h3> The MF was validated and proved effective for the treatment of mucositis. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest