{
  "abstract": "Background and Importance Myopia causes blurred distance vision due to improper image focus. Low-dose atropine 0.1–0.5 mg/ml is widely used to prevent myopia progression in children with minimal side effects. In Estonia, only 1 mg/ml drops are available, which must be diluted. This limits the shelf life to 7 days. A stability study was conducted to extend usability.Aim and Objectives The aim of the study was to evaluate the physicochemical and microbiological stability of 0.1 mg/ml atropine eye drops prepared extemporaneously in a hospital pharmacy. The study included a 14-week closed-container stability assessment and a 4-week in use stability evaluation.Material and Methods Quantification of atropine sulfate and related impurities using the HPLC method (EP 11.0)Sterility testing in accordance with EP 11.0Visual evaluation of solution colour and clarity, along with measurements of pH and osmolality (via the freezing point depression methodResults Atropine sulfate 0.1 mg/ml eye drops remained sterile throughout both the 14-week stability study and the 4-week in use study.Abstract 3PC-005 Tabel 1Average concentration of atropine sulfate (mg/ml)Batch 4-week in use study 14-week stability study Day 0 Day 28 Day 0 Day 98 I 0.102 ± 0.0013 0.098 ± 0.0009 0.101 ± 0.0002 0.105 ±0.0033 II 0.102 ± 0.0006 0.098 ± 0.0008 0.101 ± 0.004 0.105±0.0014 Abstract 3PC-005 Tabel 2Average pH of atropine sulfate eye drops during stability studiesBatch 4-week in use study 14-week stability study Day 0 Day 28 Day 0 Day 98 I 5.44 ± 0.025 5.20 ± 0.010 5.47 ± 0.199 5.14 ± 0.038 II 5.38 ± 0.020 5.17 ± 0.021 5.57 ± 0.060 5.16 ± 0.012 Abstract 3PC-005 Tabel 3Average osmolality of atropine sulfate eye dropsBatch 4-week in use (mosm/kgH2O) 14-week stability (mosm/kgH2O) Day 0 Day 28 Day 0 Day 98 I 288 ± 0.00 287 ± 1.41 290 ± 0.00 291 ± 1.41 II 289 ± 1.41 289.5 ± 0.71 289 ± 2.83 289 ± 1.41 Conclusion and Relevance Hospital pharmacy–prepared atropine sulfate 0.1 mg/ml eye drops remained sterile throughout a 14-week closed-container stability study and a 4-week in-use period. Stability data from the lowest tested concentration 0.1 mg/ml support extrapolation to 0.5 mg/ml, indicating that an extended shelf life may enhance patient convenience and cost-effectiveness.Conflict of Interest No conflict of interest",
  "authors": [
    {
      "affiliations": [
        "Tartu University Hospital, Pharmacy Administration, Tartu, Estonia"
      ],
      "name": "K Olado"
    },
    {
      "affiliations": [
        "Tartu University Hospital, Pharmacy Administration, Tartu, Estonia"
      ],
      "name": "K Teder"
    },
    {
      "affiliations": [
        "Tartu University Hospital, Eye Clinic, Tartu, Estonia"
      ],
      "name": "M Pauklin"
    },
    {
      "affiliations": [
        "University of Tartu, Institute of Pharmacy, Tartu, Estonia"
      ],
      "name": "I Laidmäe"
    },
    {
      "affiliations": [
        "University of Tartu, Institute of Pharmacy, Tartu, Estonia"
      ],
      "name": "L Preem"
    },
    {
      "affiliations": [
        "University of Tartu, Institute of Pharmacy, Tartu, Estonia"
      ],
      "name": "A Meos"
    }
  ],
  "title": "3PC-005 Stability testing of low-concentration atropine formulations for ophthalmic use",
  "uid": "f38c18fa-245d-569d-92a8-a14a2ddd5c9a"
}