{
  "abstract": "Background and Importance Acetylcysteine is used in ophthalmology in eye drop formulations as in Spain there are no marked drugs available. These are considered high risk formulations and the available stability information is limited.Aim and Objectives To determine the physicochemical stability of two acetylcysteine 10% eye drop formulations prepared in two hospitals.Material and Methods Acetylcysteine 10% eye drop formulation at Complejo Hospitalario Universitario Insular Materno Infantil (Eye Drop–M), 6 mL: Flumil 100 mg/mL injectable solution 600 mg/6 mL. Sterile amber glass. Expiration: 9 days.Acetylcysteine 10% eye drop formulation at Complejo Hospitalario Universitario Nuestra Señora de la Candelaria (Eye Drop–M), 7.5 mL: Flumil 5 g/25 mL, 3.75 mL, and artificial tears (BSS ) q.s. to 7.5 mL. Sterile eye dropper. Expiration: 14 days.Both hospitals provided six samples. Stability was assessed under storage at 5 °C, protected from light. Chemical stability was determined by ultra-high performance liquid chromatography (Acquity, Waters Corporation, ): stationary phase Acquity UPLC BEH column (C18, 2.1 × 100 mm, 1.7 μm), mobile phase 0.1 M phosphate buffer adjusted to pH 3.0 with phosphoric acid, flow rate 0.5 mL/min, injection volume 10 μL, detection wavelength 214 nm and run time 10 minutes. Acetylcysteine content was analysed in three unopened samples on days 0, 21, and 30, and in three opened samples on days 0, 2, 4, 7, 9, 11, 21, and 30. Results were expressed as a percentage of declared value. pH was measured using a Crison GLP21 pH metre on days 0 and 30 in both opened and unopened samples.Results Acetylcysteine concentrations remained above 90% up to day 30 in Eye Drop-C and up to day 11 in Eye Drop-M. No relevant pH variations were observed (Eye Drop-M: day 0 pH 6.51, day 30 pH 6.42; Eye Drop-C: day 0 pH 6.16, day 30 pH 6.07).Conclusion and Relevance Eye Drop-C maintained its stability for 30 days, extending its original expiration date. Eye Drop-M showed an increase in stability from 9 to 11 days. Microbiological stability studies will be conducted to ensure their long-term safety and efficacy.Conflict of Interest No conflict of interest",
  "authors": [
    {
      "affiliations": [
        "Complejo Hospitalario Universitario Insular Materno Infantil De Las Palmas De Gran Canaria, Hospital Pharmacy, Las Palmas De Gran Canaria, Spain"
      ],
      "name": "E Gandullo Sanchez"
    },
    {
      "affiliations": [
        "Complejo Hospitalario Universitario Insular Materno Infantil De Las Palmas De Gran Canaria, Hospital Pharmacy, Las Palmas De Gran Canaria, Spain"
      ],
      "name": "CL Crespo Martinez"
    },
    {
      "affiliations": [
        "Universidad De La Laguna, Department of Chemical Engineering and Pharmaceutical Technology, San Cristóbal De La Laguna, Spain"
      ],
      "name": "A Hernández Figueroa"
    },
    {
      "affiliations": [
        "Universidad De La Laguna, Department of Chemical Engineering and Pharmaceutical Technology, San Cristóbal De La Laguna, Spain"
      ],
      "name": "J Suárez González"
    },
    {
      "affiliations": [
        "Universidad De La Laguna, Department of Chemical Engineering and Pharmaceutical Technology, San Cristóbal De La Laguna, Spain"
      ],
      "name": "AM Santoveña Estévez"
    },
    {
      "affiliations": [
        "Complejo Hospitalario Universitario Nuestra Señora De La Candelaria, Hospital Pharmacy, Santa Cruz De Tenerife, Spain"
      ],
      "name": "N Roman Gonzalez"
    }
  ],
  "title": "3PC-020 Physico-chemical stability study of two acetylcysteine 10% eye drop formulations",
  "uid": "ecaf667c-5cc6-531f-90ab-0e841fb58c85"
}