3PC-021 Formulation of voriconazole ovules and efficacy in vulvovaginal Ccandidiasis by candida glabrata: a case report

• Published in: European journal of hospital pharmacy. Science and practice Vol. 31; no. Suppl 1; p. A38
• Main Authors: López Gómez, A, Rodríguez-De Francisco, L, Carrascal-Mozo, C, Lora-Escobar, SJ, Suárez Casillas, P, Hevia-Álvarez, E, Quintero-García, JP, Rodríguez-Hernández, MJ
• Format: Journal Article
• Language: English
• Published: London British Medical Journal Publishing Group 20.03.2024; BMJ Publishing Group LTD
• Subjects: Conflicts of interest; Polyethylene glycol; Section 3: Production and compounding; Vagina
• DOI: 10.1136/ejhpharm-2024-eahp.78
• ISSN: 2047-9956

Background and Importance Candida glabrata is a vaginal coloniser causing vulvovaginal candidiasis (VVC), usually asymptomatic. Typical first-line therapies, boric acid or nystatin ovules, are not effective due to their inherent resistance. Flucytosine, amphotericin B or voriconazole would be the treatment of choice.Aim and ObjectivesTo formulate voriconazole ovules (VO) and describe our clinical experience in the treatment of VVC by C.glabrata. Material and MethodsThe patient was a 52-year-old woman with VVC by C.glabrata who presented vulvar pain, irritation, and burning. She was treated with oral fluconazole, oral voriconazole, topical amphotericin B, boric acid ovules and combined therapy by fluconazole-amphotericin B, but her symptoms did not resolve and the culture remained positive.A bibliographic search was carried out (Pharmacopoeia, UpToDate and PubMed) about VO formulation and its solubility in polyethylene glycol (PEG) was confirmed. Other magistral formulations of ovules containing PEG as an excipient were used as a reference for formulation design. Galenic validation included organoleptic controls and physical tests, mass uniformity and dissolution time.Finally, treatment efficacy was assessed by symptom resolution and negativisation of the vaginal exudate culture.ResultsModus operandi for 30 units VO 15 mg with an excess of 20%:Melt: 81.36 g PEG 400 and 54.72 g PEG 4.000.Crush 11 tablets of voriconazole 50 mg in a mortar and pestle. Work in biological safety cabinet type I if there is reproductive risk, otherwise Personal Protective Equipment (PPE).Add powder to the melted mass and homogenise.Pour mixture into 3 g ovule moulds and allow to cool.Unmould, package and label.Regarding galenic validation, the surface of VO was shiny, smooth and without cracks. All were within the weight range (±5) and took 34 minutes to dissolve. The given expiry date was 6 months.The patient started treatment with daily VO and after 3 months of treatment, complete resolution of symptoms and negative cultures were achieved. The frequency of administration increased to every 48 hours and then every 72 hours until 6 months of treatment, without reactivation of the infection.Conclusion and RelevanceThe magistral formulation was validated and proved to be effective in the treatment of VVC by C.glabrata. References and/or AcknowledgementsConflict of InterestNo conflict of interest.