Abstract
Dry eye disease (DED) is a high prevalent multifactorial disease characterized by a lack of homeostasis of the tear film which causes ocular surface inflammation, soreness, and visual disturbance. Conventional ophthalmic treatments present limitations such as low bioavailability and side effects. Lactoferrin (LF) constitutes a promising therapeutic tool, but its poor aqueous stability and high nasolacrimal duct drainage hinder its potential efficacy. In this study, we incorporate lactoferrin into hyaluronic acid coated liposomes by the lipid film method, followed by high pressure homogenization. Pharmacokinetic and pharmacodynamic profiles were evaluated in vitro and ex vivo. Cytotoxicity and ocular tolerance were assayed both in vitro and in vivo using New Zealand rabbits, as well as dry eye and anti-inflammatory treatments. LF loaded liposomes showed an average size of 90 nm, monomodal population, positive surface charge and a high molecular weight protein encapsulation of 53%. Biopharmaceutical behaviour was enhanced by the nanocarrier, and any cytotoxic effect was studied in human corneal epithelial cells. Developed liposomes revealed the ability to reverse dry eye symptoms and possess anti-inflammatory efficacy, without inducing ocular irritation. Hence, lactoferrin loaded liposomes could offer an innovative nanotechnological tool as suitable approach in the treatment of DED.
Highlights
Dry eye disease (DED) or keratoconjunctivitis sicca is considered a chronic multifactorial pathology of the ocular surface characterized by a loss of homeostasis of the tear film, associated with characteristic ocular symptoms, such as tear film instability and hyperosmolarity, ocular surface inflammation and damage
This study has focused on the incorporation of a high molecular weight protein within a lipidic nanocarrier
Aiming to achieve the optimal formulation, the effect of independent variables such as concentrations of bovine LF (bLF), lipoid S75 and P80 on the physicochemical properties of the liposomes was evaluated by 23 factorial design
Summary
Dry eye disease (DED) or keratoconjunctivitis sicca is considered a chronic multifactorial pathology of the ocular surface characterized by a loss of homeostasis of the tear film, associated with characteristic ocular symptoms, such as tear film instability and hyperosmolarity, ocular surface inflammation and damage. Pharmaceutics 2021, 13, 1698 of contact lenses, certain environmental conditions as elevated pollution or low humidity, and the excessive smartphone and computer use has led to an increase in DED incidence especially among the younger population [4] This osmotic and cellular stress at the ocular surface leads to irritation, ocular surface inflammation, soreness, blurred vision, and visual disturbance, resulting in a considerable decline in quality of life [3]. The elevated tear osmolarity, oxidative and mechanical stressassociated trigger a pro-inflammatory environment [5] It is characterized by a broad release of pro-inflammatory mediators, cytokines, chemokines, and immune cells, leading to the extracellular matrix degradation and disruption of tight junctions between corneal epithelial cells. Generating a self-inflammatory feedback loop that affects ocular function and integrity [4]
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