Design and evaluation of pharmaceutical availability, stability and quality of modified viscosity eye drops with choline salicylate

• Published in: European journal of pharmaceutical sciences 2021-04, Vol.159, p.105725-105725, Article 105725
• Main Authors: Wróblewska, Katarzyna B., Plewa, Szymon, Długaszewska, Jolanta, Froelich, Anna, Muszalska-Kolos, Izabela
• Format: Article
• Language: English
• Subjects: Choline salicylate; Chromatographic purity; Eye drops; Stability; Test of permeation
• ISSN: 0928-0987; 1879-0720
• DOI: 10.1016/j.ejps.2021.105725

These studies investigate the possibility of developing and using choline salicylate (CS) in ophthalmic therapy in the form of eye drops with increased viscosity. A 0.5% addition of hydroxypropyl methylcellulose (HPMC) was used as the viscosity increasing agent. The ability of CS to cross a hydrophilic membrane (regenerated cellulose membrane) was assessed by determining a rate constant consistent with zero order kinetics. In studies on a porcine cornea, the ability of CS to penetrate into the structure of the cornea was confirmed by determining the content of CS in the cornea after 5 minutes and 3 hours exposure to eye drops. The quality parameters of eye drops were assessed: pH, viscosity, osmolarity and microbiological purity. Stability tests were also performed on eye drops stored in unit minims packaging and in multi-dose bottle packaging. The following storage conditions were adopted: 40°C/75% RH, 25°C/60% RH, 2-8°C. The sensitivity of CS to light was also confirmed. The UV and HPLC-UV methods were used to assess the CS content, while the HPLC-UV and HPLC-MS/MS methods were used to assess the chromatographic purity. [Display omitted]