Fernández-Ferreiro Anxo, Luaces-Rodríguez Andrea, Díaz-Tomé Victoria, Gil-Martínez María, Rodríguez Ares María Teresa, Touriño Peralba Rosario, Blanco-Méndez José, González-Barcia Miguel, Otero-Espinar Francisco Javier, Lamas María Jesús
Servicio de Farmacia, Xerencia Xestión Integrada Santiago de Compostela (SERGAS) Grupo Farmacología Clínica, Instituto de Investigación Sanitaria, Santiago de Compostela (IDIS-ISCIII) Departamento de Farmacología, Farmacia y Tecnología Farmacéutica, Facultad de Farmacia, Universidad de Santiago de Compostela (USC).
Grupo Farmacología Clínica, Instituto de Investigación Sanitaria, Santiago de Compostela (IDIS-ISCIII) Departamento de Farmacología, Farmacia y Tecnología Farmacéutica, Facultad de Farmacia, Universidad de Santiago de Compostela (USC).
Farm Hosp. 2017 Nov 1;41(6):678-687. doi: 10.7399/fh.10834.
Ocular cystinosis is a rare disease characterised by the deposit of cystine crystals on the corneal surface, which hinder patients' eyesight. Oral cysteamine is given as cysteamine; however, it does not reach the cornea due to the lack of corneal vascularization making necessary its administration by the topical ocular route. The aim of the present study is to determine the stability of an ophthalmic hydrogel of cysteamine, which can be potentially prepared at hospital pharmacy departments, under different preservation conditions during a follow-up of 30 days. Different physical and chemical parameters were evaluated: osmolality, pH and cysteamine concentration, which has been measured by a method of ultra performance liquid chromatography-tandem mass spectrometer (UPLC-MS/MS). Descriptive assays were also performed, such as transparency measurement and microbiological assays in order to verify its sterility. The obtained results allow us to conclude that the cysteamine hydrogel is stable during 30 days, being recommendable its preservation in refrigerated conditions.
眼胱氨酸病是一种罕见疾病，其特征是胱氨酸晶体沉积在角膜表面，这会妨碍患者视力。口服半胱胺是以半胱胺形式给药；然而，由于角膜缺乏血管化，它无法到达角膜，因此需要通过眼部局部给药途径。本研究的目的是确定一种可在医院药房潜在制备的半胱胺眼用水凝胶在30天随访期间不同保存条件下的稳定性。评估了不同的物理和化学参数：渗透压、pH值和半胱胺浓度，后者通过超高效液相色谱-串联质谱仪（UPLC-MS/MS）方法进行测定。还进行了描述性试验，如透明度测量和微生物学试验以验证其无菌性。所得结果使我们能够得出结论，半胱胺水凝胶在30天内是稳定的，建议在冷藏条件下保存。
