{
  "abstract": "Background and Importance Losartan potassium (LP) is a selective angiotensin II receptor antagonist widely used for hypertension. Recently, it has attracted interest in ophthalmology due to its potential to reduce subretinal inflammation and protect the optic nerve in diseases such as glaucoma and age-related macular degeneration. Topical losartan 0.8 mg/mL has shown antifibrotic effects and favourable tolerability in preclinical and clinical studies. However, no commercial ophthalmic formulations are available. In hospital settings, LP eye drops are compounded extemporaneously but, without standardised stability or sterility data, they are often assigned short beyond-use dates. Given the strict requirements for ophthalmic preparations (pH, osmolality, clarity, and sterility) it is essential to have stability evidence to ensure safety.Aim and Objectives To evaluate the 30-day physicochemical and microbiological stability of preservative-free losartan potassium 0.8 mg/mL eye drops prepared with balanced salt solution (BSS), normal saline (NS), or glucose saline (GS), and stored in sterile bottles at different conditions: room temperature, refrigerated, and frozen.Material and Methods Triplicate formulations were prepared and stored at –20 °C, 4 °C, and 25 °C. Concentration of losartan was analysed on days 0, 7, 15, 22 and 30 by validated HPLC-DAD, supported by UV–visible spectrophotometry and high-resolution mass spectrometry (HRMS). Visual clarity, pH, osmolality, and refractive index were monitored. Sterility was assessed using the BACT/ALERT system on days 0, 10, 20 and 30. FTIR was used to investigate turbidity observed in GS samples.Results Formulations in BSS and NS retained ≥96% of initial losartan concentration under all conditions, with no degradation products detected by HRMS. pH (6.5–7.3), osmolality (~300 mOsm/kg), and refractive index remained stable, and no changes in clarity were observed. GS based formulations remained stable only when refrigerated or frozen; but at 25 °C, turbidity developed by day 15 and concentration dropped below 50% by day 20. FTIR suggested reversible losartan-glucose aggregation. All tested samples remained sterile throughout the days of the study.Conclusion and Relevance BSS and NS are suitable vehicles for extemporaneous losartan eye drops, supporting 30-day refrigerated or frozen storage. GS should be avoided at room temperature. These findings provide validated evidence to safely extend expiration dates and improve ophthalmic care delivery.Conflict of Interest No conflict of interest",
  "authors": [
    {
      "affiliations": [
        "Hospital Torrecárdenas, Farmacia Hospitalaria, Almeria, Spain"
      ],
      "name": "AM Garcia Aguilera"
    },
    {
      "affiliations": [
        "Hospital Torrecárdenas, Farmacia Hospitalaria, Almeria, Spain"
      ],
      "name": "E Romero Carreño"
    },
    {
      "affiliations": [
        "Hospital Torrecárdenas, Farmacia Hospitalaria, Almeria, Spain"
      ],
      "name": "R Gázquez Pérez"
    },
    {
      "affiliations": [
        "Hospital Torrecárdenas, Farmacia Hospitalaria, Almeria, Spain"
      ],
      "name": "MT Gómez Sanchez"
    },
    {
      "affiliations": [
        "Hospital Torrecárdenas, Farmacia Hospitalaria, Almeria, Spain"
      ],
      "name": "E Molina Cuadrado"
    },
    {
      "affiliations": [
        "Hospital Torrecárdenas, Farmacia Hospitalaria, Almeria, Spain"
      ],
      "name": "F Verdejo Reche"
    }
  ],
  "title": "3PC-025 Stability of preservative-free losartan potassium 0.8 mg/ml eye drops compounded in hospital pharmacy practice",
  "uid": "9fe1b832-d0dd-55fa-a47b-5cc3106f881e"
}