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3PC-019 Development of a topical emulsion for the treatment of third-degree burn patient candidates for skin graft
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  1. E Castellana1,
  2. S Felloni1,
  3. M Scaldaferri1,
  4. R Viglianti1,
  5. B Bussolino2,
  6. F Cuzzi2,
  7. C Casalis2,
  8. D Risso2,
  9. MR Chiappetta1,
  10. F Cattel1
  1. 1Città della Salute e della Scienza, Hospital Pharmacy, Turin, Italy
  2. 2Città della Salute e della Scienza, Burn Unit, Turin, Italy

Abstract

Background and Importance A third-degree burn (TDB) destroys the epidermis and dermis presenting a high risk of infection. These lesions are treated with skin grafts (SK) in the absence of infection.

Aim and Objectives The hospital pharmacist was asked to develop a non-irritating, antibacterial, easily spreadable and removable topical emulsion formula specific to prepare the burned tissue for SK.

The aim is to describe effectiveness and tolerance of topical magistral formula emulsion.

Material and Methods A scientific literature search was conducted.

Galenic development and validation of the formula were described in the monograph ‘Semi-solid preparations for cutaneous application’ of the Official Pharmacopoeia of the Italian Republic.

The efficacy of the formulation was evaluated by the physician.

A retrospective observational analysis was performed. Patients with TDB who were eligible for SK in 2022–2023 are being evaluated. The variables collected were: duration of treatment, dosage, clinical response and adverse effects.

Results We have formulated Oil-in-water emulsions. The main components are:

  • C15–20–acid-PEG-8–ester-12%, hydrophilic-lipophilic balance 12, emulsifier, non-toxic for skin enzymes, suitable for the most sensitive skin, and the most histophilic of known emulsifiers.

  • Squalane-7%, a texturiser, creates a film that protects the skin by delaying the loss of trans- epidermal water and improves the spreadability of the product.

  • Sebopessina –2%, active principle for sebaceous secretion problems because burned skin has blisters.

  • Silicone oil improves –0.3% the application and absorption of creams. The favourable environment, created by occlusion-hydration, the formation of hypertrophic scars is prevented.

  • Cerium nitrate –2% combined with silver sulfadiazine-0.3% to provide broad antibacterial activity, forms a temporary barrier and promotes re-epithelialisation.

A shelf life of 30 days has been established, based on the critical skin lesion. Odour, colour and phase separation remained stable over the month. Spreadability and emulsion removal were excellent. Fifteen patients were treated; 100% responded well to treatment after an average of 2 weeks and a dosing frequency of 3 times a day. The physician confirmed good delimitation and absence of infections in the burnt areas that will receive the SK. No adverse reactions were reported.

Conclusion and Relevance The galenic emulsion described is a good therapeutic solution in patients with TDB who are candidates for SK.

Conflict of Interest No conflict of interest.

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