RT Journal Article
T1 Limitations and Challenges in the Stability of Cysteamine Eye Drop Compounded Formulations
A1 Martín Sabroso, Cristina
A1 Alonso González, Mario
A1 Fernández Carballido, Ana María
A1 Aparicio Blanco, Juan
A1 Córdoba Díaz, Damián
A1 Navarro García, Federico
A1 Córdoba Díaz, Manuel
A1 Torres Suárez, Ana Isabel
AB Accumulation of cystine crystals in the cornea of patients suffering from cystinosis is considered pathognomonic and can lead to severe ocular complications. Cysteamine eye drop compounded formulations, commonly prepared by hospital pharmacy services, are meant to diminish the build-up of corneal cystine crystals. The objective of this work was to analyze whether the shelf life proposed for six formulations prepared following different protocols used in hospital pharmacies is adequate to guarantee the quality and efficacy of cysteamine eye drops. The long-term and in-use stabilities of these preparations were studied using different parameters: content of cysteamine and its main degradation product cystamine; appearance, color and odor; pH and viscosity; and microbiological analysis. The results obtained show that degradation of cysteamine was between 20% and 50% after one month of storage in the long-term stability study and between 35% and 60% in the in-use study. These data confirm that cysteamine is a very unstable molecule in aqueous solution, the presence of oxygen being the main degradation factor. Saturation with nitrogen gas of the solutions offers a means of reducing cysteamine degradation. Overall, all the formulae studied presented high instability at the end of their shelf life, suggesting that their clinical efficacy might be dramatically compromised.
PB MDPI
SN 1424-8247
YR 2022
FD 2022-12-21
LK https://hdl.handle.net/20.500.14352/72770
UL https://hdl.handle.net/20.500.14352/72770
LA eng
NO Recordati Rare Diseases Spain through the university enterprise collaboration number UCM: 564-2019-A-2020
DS Docta Complutense
RD 5 abr 2025