期刊
INTERNATIONAL JOURNAL OF PHARMACEUTICS
卷 576, 期 -, 页码 -出版社
ELSEVIER
DOI: 10.1016/j.ijpharm.2019.118979
关键词
Dry eye disease; Nanoemulsion; NSAID; Chitosan; Lecithin
资金
- project entitled Topical nanodelivery systems - University of Zagreb [Z169]
- project Modelling of the Pharmaceutical Spray Drying Process of the Emulsions in Laboratory and Pilot Scale
- PLIVA Croatia Ltd.
- Spanish Government [RTI2018-094071-B-C21]
- Croatian Science Foundation (programme Young researchers' career development project-training of new doctoral students)
- Regional JCyL Scholarship/European Social Fund Program [ORDEN EDU/128/2015]
Inflammation plays a key role in dry eye disease (DED) affecting millions of people worldwide. Non-steroidal anti-inflammatory drugs (NSAIDs) can be used topically to act on the inflammatory component of DED, but their limited aqueous solubility raises formulation issues. The aim of this study was development and optimization of functional cationic nanoemulsions (NEs) for DED treatment, as a formulation approach to circumvent solubility problems, prolong drug residence at the ocular surface and stabilize the tear film. Ibuprofen was employed as the model NSAID, chitosan as the cationic agent, and lecithin as the anionic surfactant enabling chitosan incorporation. Moreover, lecithin is a mixture of phospholipids including phosphatidylcholine and phosphatidy-lethanolamine, two constituents of the natural tear film important for its stability. NEs were characterized in terms of droplet size, polydispersity index, zeta-potential, pH, viscosity, osmolarity, surface tension, entrapment efficiency, stability, sterilizability and in vitro release. NEs mucoadhesive properties were tested rheologically after mixing with mucin dispersion. Biocompatibility was assessed employing 3D HCE-T cell-based model and ex vivo model using porcine corneas. The results of our study pointed out the NE formulation with 0.05% (w/w) chitosan as the lead formulation with physicochemical properties adequate for ophthalmic application, mucoadhesive character and excellent biocompatibility.
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