RT Journal Article
T1 Cysteamine Eye Drops in Hyaluronic Acid Packaged in Innovative Single-Dose Systems, Part II: Long-Term Stability and Clinical Ocular Biopermanence
A1 Schmidt, Anja
A1 Castro Balado, Ana
A1 Giráldez Fernández, María Jesús
A1 Cuartero Martí­nez, Andrea
A1 González Barcia, Miguel
A1 Otero Espinar, Francisco Javier
A1 Fernández Ferreiro, Anxo
A1 Pena Verdeal, Hugo
A1 Hermelo Vidal, Gonzalo
A1 Montero, Belén
A1 Hernández Blanco, Manuela
A1 Zarra Ferro, Irene
A1 Mondelo-García, Cristina
A1 Yebra-Pimentel Vilar, Eva
K1 Cysteamine
K1 Cystinosis
K1 Eye drops
K1 Ophthalmic administration
AB Background: Cystinosis is a rare genetic disorder characterized by the accumulation of cystine crystals in several tissues and organs causing, among others, severe eye symptoms. The high instability of cysteamine eye drops makes it difficult to develop formulations with an acceptable shelf life to be prepared in hospital pharmacy departments. Previously, a new compounded formulation of cysteamine eye drops in hyaluronic acid (HA) packaged in innovative single-dose systems was developed.Methods: Long-term stability at -20 °C of this formulation was studied considering the content of cysteamine, pH, osmolality, viscosity, and microbiological analysis. The oxygen permeability of single-dose containers was also studied and an ocular biopermanence study was conducted in healthy volunteers measuring lacrimal stability and volume parameters.Results: Data confirm that cysteamine concentration remained above 90% for 120 days, all parameters remaining within the accepted range for ophthalmic formulations. The permeability of the containers was reduced over time, while ocular biopermanence was maintained despite the freezing process and storage time.Conclusions: 0.55% cysteamine hydrochloride formulation in HA and packaged in single-dose containers preserved at -20 °C is stable for 120 days protected from light, presenting high potential for its translation into clinical practice when commercial presentations are not available
PB MDPI
SN 1999-4923
YR 2023
FD 2023-11
LK http://hdl.handle.net/10347/32052
UL http://hdl.handle.net/10347/32052
LA eng
NO Castro-Balado, A.;Cuartero-Martínez, A.; PenaVerdeal, H.; Hermelo-Vidal, G.;Schmidt, A.; Montero, B.;Hernández-Blanco, M.; Zarra-Ferro,I.; González-Barcia, M.; MondeloGarcía, C.; et al. Cysteamine EyeDrops in Hyaluronic Acid Packagedin Innovative Single-Dose Systems,Part II: Long-Term Stability andClinical Ocular Biopermanence.Pharmaceutics 2023, 15, 2589.https://doi.org/10.3390/pharmaceutics15112589
NO FEFH 18-19/Fundación Española de Farmacia HospitalariaJR18/00014/Instituto de Salud Carlos IIIJR20/00026/Instituto de Salud Carlos IIICM21/00114/Instituto de Salud Carlos IIIAsociación La Lucha de Iker/Asociación La Lucha de Iker
DS Minerva
RD 28 abr 2026