3PC-015 Development and preparation of a gel for urethral administration of 5-fluorouracil and lidocaine for the treatment of condyloma acuminatum

<h3>Background and Importance</h3> Condyloma acuminatum are warts in the genital and perianal regions caused by human papillomavirus (HPV), with 9–17% of men with external warts also having intraurethral warts. Though benign, these warts have a potential for malignancy. Treatment options include topical therapies, ablative treatments like surgical excision, and systemic immunotherapy. The lack of suitable therapies in the Portuguese market, prompted the Urology Department to request our collaboration to develop a local alternative with 5-fluorouracil (5-FU) and lidocaine. <h3>Aim and Objectives</h3> Pharmaceutical development and preparation of a compounded medication (CM) containing 5-FU and lidocaine to treat condyloma acuminatum intraurethral warts. Quality control of the prepared pharmaceutical form. <h3>Material and Methods</h3> Pharmaceutical development began with a literature review of the pharmacological and physicochemical properties of the active pharmaceutical ingredient (API). Based on this information, a procedure was defined, and an operating procedure was elaborated. A test formula was prepared, and its stability concerning appearance and pH was studied over 10 days. <h3>Results</h3> 5-FU is an antimetabolite, used either alone or in combination for the local treatment of condyloma acuminatum, being generally well tolerated. There is emerging evidence that lidocaine, an anaesthetic, may also have antitumor properties, potentially impacting disease progression and enhancing the effects of 5-FU. Literature regarding the combination of these API in extemporaneously prepared non-sterile ointments exists. A gel containing 11 ml with 2.5% 5-FU and 1% lidocaine was prepared in a sterile environment, suitable for cytotoxic drug preparation, using a closed system. It was stored between 2 and 8°C, and its appearance and pH were evaluated over 10 days. As no changes were observed, a beyond use date of 10 days was assigned according to the United States Pharmacopeia guidelines. After approval, the CM was available to use in the institution. The administration was well tolerated by the patient, with no significant complications. <h3>Conclusion and Relevance</h3> This pharmaceutical intervention provided a personalised therapeutic solution in the absence of commercially available treatments. The method used allows for the safe preparation of the CM, ensuring its quality, particularly in terms of sterility. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest