Background and Importance Cutaneous hyperpigmentation due to iron extravasation is a described adverse effect of its intravenous administration.

Aim and Objectives To describe the components and method of preparation of a 0.5% deferoxamine emulsion for the treatment of hyperpigmentation caused by iron extravasation. To describe the efficacy and tolerance of the pharmaceutical compound on a hospitalised patient.

Material and Methods Literature research was carried out in different databases to determine the clinical evidence and experience. (Google Scholar, PubMed, SEFH formulary, Acofarma website).

In order to assess efficacy and tolerance, direct observation of the stain was performed twice a week for 30 days. Possible colour change, and skin irritation were compared with photographs and interviewing the patient.

Results Composition: deferoxamine 0.5g (commercially available lyophilised powder), propylene glycol 20g; NeoPCL self-emulsifier O/W 25g and purified water in sufficient quantity for 100g. In contrast to the available evidence, Beeler base was not used. Instead, NeoPCL was chosen, which allowed the formation of an aqueous external phase emulsion, not very oily, dense, but easy to apply topically.

Methodology

• Deferoxamine-liophilised was reconstituted with purified water.

• Water, propylene glycol and NeoPCL were weighed separately and placed in a waterbath at 60°C.

• NeoPCL was stirred to facilitate the fusion and propylene glycol was gradually added while stirring to form the oleo-aqueous emulsion.

• Deferoxamine solution was added over the previous mixture, stirring constantly until obtaining the oleo-aqueous emulsion.

• It was stirred for 2–3 minutes with an emulsifier.

MethodologyThe final appearance of PhC was a homogeneous white emulsion with no lumps and no characteristic odour. According to the local Guide of Good Practices, a 30-day expiration period was assigned as well as storage conditions of room temperature and proception from light. Galenic validation was performed, and the emulsion did not lose the characteristics described.

Fifteen days after the extravasation, the emulsion was applied every 12 hours for four weeks. A slight improvement was observed. However, there was complete tolerance to emulsion with no adverse reactions reported.

Conclusion and Relevance The development of the emulsion with a self-emulsifying O/W base ensured that the emulsion remained stable throughout the shelf life.

The results did not match with those described in the literature. Time was a limiting factor to have observed better results.

Conflict of Interest No conflict of interest.