3PC-005 Compounding imiquimod suppositories for condiloma acuminata

<h3>Background and Importance</h3> Condylomata acuminata (CA), or anogenital warts, are typically found on the penis, vulva, perianal skin and rectal mucosa. CA may also involve the cervix and urethral canal. Topical imiquimod 5% cream containing 12.5 mg per sachet is a first-line treatment option for external CA. However, its efficacy and safety can be compromised by the difficulty of administration in the anal canal. Some authors have published the efficacy and tolerability of imiquimod suppositories, but a standardised method to compound them remains unpublished. <h3>Aim and Objectives</h3> To review the scientific literature of imiquimod suppository compounding formulations and to compound suppositories of imiquimod 12.5 mg. <h3>Material and Methods</h3> A literature review was carried out in PubMed and Embase using ‘Imiquimod,’ ‘suppository,’ and ‘anal’ as keywords. Only clinical studies were analysed. Ingredients, equipment, method of preparation, quality control, packaging, and labelling were described. <h3>Results</h3> Imiquimod suppositories were used in four of the seven identified clinical studies. Three of them were observational studies, and one was a clinical trial. However, none explained how to compound imiquimod suppositories. Ingredients for 240 imiquimod 12.5 mg suppositories included: imiquimod 3g, massa esteranium 637g as suppository base (no calculations for dose replacement were needed). Equipment: analytical balance, beaker, porcelain mortar and pestle, suppository mould. Personal protective equipment: gloves, gown, eye protection, FFP2 mask. Environment: cleanroom, class one laminar flow hood. Method: 1) bring mould to room temperature. 2) Weigh imiquimod powder. 3) Melt suppository base using microwaves. 4) Disperse imiquimod in melted base using mortar and pestle. 5) Pour mixture into mould cavities (no lubricant needed). 6) Cool mould in refrigerator for 1 hour. 7) Remove excess material from mould top using a spatula. Quality control: weight variation +/- 5% and visual observation. Package in a tight, light-resistant container and label. Beyond use date: 6 months. <h3>Conclusion and Relevance</h3> Variability in imiquimod formulations likely caused contradictory results in the efficacy and tolerability of imiquimod suppositories for CA. Administering imiquimod suppositories following this preparation method may improve efficacy and safety in patients with CA who have difficulties or aversion to administering imiquimod cream in the anal canal. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest