BR-102019008627-B1 - ARTIFICIAL TEARS NATURAL

Abstract

NATURAL ARTIFICIAL TEAR The present invention relates to the formulation of a natural artificial tear that has physical, chemical and biological properties very similar to human tears in all respects, for the treatment of dry eye, caused by various factors and affecting up to about 34% of the population, especially the elderly.

Inventors

• JONAS MARINHO DE ARAUJO FILHO

Assignees

• JONAS MARINHO DE ARAUJO FILHO

Dates

Publication Date

20260317

Application Date

20190429

Claims (3)

1. 1. “NATURAL ARTIFICIAL TEARS” characterized by consisting of the following ingredients by weight/% by weight: - 1.3 to 1.5% jojoba oil; - 0.2 to 0.4% linseed oil; - 1 to 2% amphoteric betaine; - 68 to 74% coconut water; - 25 to 29% okra mucin; - 1 to 1.5% honey; - Double distilled water qsp < 308 mOsm/L.
2. 2. “NATURAL ARTIFICIAL TEAR”, according to claim 1, characterized by the addition of a sufficient quantity of double-distilled water to the natural artificial tear to maintain the osmolarity below 308 mOsm/L.
3. 3. “NATURAL ARTIFICIAL TEAR”, according to claims 1 and 2, characterized by having an osmolarity of less than 308 mOsm/L and a pH of 7.0.

Description

FIELD OF THE INVENTION [01] The present invention relates to the formulation of a natural artificial tear, a product intended to replace human tears, for use in patients with dry eyes of any nature due to deficiency in the quantity or quality of tears and their constituents. [02] Tears or lacrimal fluid cover the anterior surface of the cornea and play fundamental roles in maintaining ocular surface homeostasis. BACKGROUND OF THE INVENTION [03] Tears hydrate and lubricate the mucous membranes that make up the ocular surface, provide nutrition to the avascular corneal epithelium, and provide a smooth optical surface essential for visual acuity. [04] Tears represent a biological fluid of immense complexity with a wide range of proteins, peptides, electrolytes, lipids and metabolites contributed by distinct sources. [05] Disturbances in this delicate balance can manifest in various eye conditions, such as dry eye syndrome and blepharitis. [06] Tears are not uniform in composition. [07] There are three layers in a tear. [08] The outer hydrophobic lipid layer protects tears from evaporation, formed by about 600 lipid species produced by the meibomian, zeiss and moll glands, containing saturated and unsaturated fats, hydrophilic and hydrophobic, corresponding to about 1.5% of the total volume of human tears. [09] The lipid layer has an outer layer or hydrophobic wax formed by nonpolar lipids and an inner layer formed by phospholipids, which joins with the aqueous layer. [010] Phospholipids are amphipathic molecules, that is, hydrophilic polar molecules in contact with the aqueous layer of the tear film and hydrophobic nonpolar molecules in contact with the nonpolar outer lipid layer (wax). [011] Human tears have a second, watery layer that spreads evenly over the eye and promotes osmoregulation (salt balance), nutrition, release of metabolites and helps prevent infection. [012] This aqueous layer makes up about 69.50% of human tears and is made up of water, electrolytes (sodium, chlorine, potassium, urea), vitamins, glucose and 1600 types of proteins, the main ones being antibodies, lysozyme, lipocalin and lacritin. [013] A third inner layer, highly hydrated mucosa, occupies about 29% of the total volume of human tears and lines the cornea. This layer, formed by mucins, is hydrophilic and ensures a smooth distribution of the aqueous layer over the entire surface of the cornea, keeping it hydrated. [014] Mucins are produced by goblet cells in the conjunctiva of the eye. [015] The mucin layer that joins the hydrophobic epithelial cells of the cornea with the hydrophilic mucin is formed by glycocalyx, rich in carbohydrates. [016] This is how the human tear is constituted, a biological fluid of immense complexity and of fundamental importance to the homeostasis of the ocular surface and maintenance of the optical transparency indispensable to vision. For better identification of the state of the art, we cite the patents. [017] Patent PI 1009281-1 deals with compositions for the prevention and treatment of eye pathologies, in particular inflammatory keratitis and conjunctivitis and dry eye syndrome, and the omega 3 and omega 6 components are contained in mixed fish and/or vegetable oils. [018] This patent application does not present a defined and claimed scope of protection that describes a descriptive and/or proportional formula of each constituent of the product, leaving inconsistencies in the formulation in the properties and therapeutic purpose. Evolution of the State of the Art [019] Natural artificial tears have physical, chemical and biological properties very similar to human tears, and are very useful in the treatment of dry eye, which is caused by various factors and causes many ocular signs and symptoms, affecting about 34% of the population, especially the elderly, and being the most prevalent ocular pathology. [020] Current ocular lubricants or artificial tears are constantly evolving. We have moved beyond the first generation with isotonic or hypotonic saline solutions, using benzalkonium chloride (BAK) as a preservative, products with a short duration of action, minimal viscoelastic action, and which caused eye irritation. [021] Next came the second generation, the most widely used and numerous group, with the arrival of natural or synthetic polymers, with mild preservatives or no preservatives. They offer hydration and viscosity, significantly relieving the signs and symptoms of dry eye. [022] Then came the third generation with the use of preservative-free sodium hyaluronate, a natural polymer that forms highly hydrating (97% water) and viscous gels, found in the eye (vitreous and aqueous), highly effective in reducing friction and preventing evaporation, further relieving the signs and symptoms of dry eye. [023] Next came the fourth generation with the use of lipid emulsions, aiming to acquire properties more similar to natural tears. [024] The fifth generation promises to have physical-chemical and