Drug – bio-affecting and body treating compositions – Extract – body fluid – or cellular material of undetermined... – Separated animal oil or solidified form thereof derived from...
Reexamination Certificate
2000-11-29
2003-01-14
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Extract, body fluid, or cellular material of undetermined...
Separated animal oil or solidified form thereof derived from...
C424S682000, C424S697000, C514S558000, C514S912000, C514S915000, C514S725000
Reexamination Certificate
active
06506412
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention concerns generally the treatment of disease, and more particularly the treatment of human glandular function disorders involving oil and mucus secreting glands and/or tear secreting (lacrimal) glands leading to dryness in the eyes, mouth or other areas.
Dry-eye syndrome is a common condition affecting approximately one in five Americans. It is characterized by symptoms including dry, irritated eyes, excessively watery eyes, burning and stinging, a foreign body sensation, and blurred vision. Despite the diverse causes of dry eye syndrome, in all dry eye conditions the ocular surface epithelium undergoes squamous metaplasia, manifested by loss of goblet cells, mucin deficiency and keratinization. These changes result in tear film instability, which leads to the clinical symptoms of dry eye syndrome.
Human tears are produced by the lacrimal glands. Tears are distributed by blinking, undergo evaporation from the ocular surface, and drain through the nasal lacrimal duct. An abnormality in any of these processes can cause dry eye. For example, Sjogren's Syndrome is caused by damage to the lacrimal gland, which disables the reflex aqueous tear production process. Meibomian gland dysfunction, or MGD, alters the oily layer in tears, causing increased evaporation. The tears comprise three layers, only one of which is the aqueous saline layer. A layer of mucin, a slimy substance produced by the goblet cells, coats the corneal epithelium. The aqueous tear layer, produced by the lacrimal gland and approximately 0.9% saline, floats on the mucin layer. Outside the aqueous tear layer is an oil layer which protects the tears, this oil being produced by glands located in the eyelid. This oil is actually an aqueous-lipid mixture, a thin, fine film which floats on top of the tears and limits evaporation.
Essential fatty acids (EFAs) are critical to optimum ocular functioning. EFAs cannot be synthesized by the human body and thus must be obtained from the diet. The omega-6 essential fatty acid, linoleic acid, is of particular importance to dry eye syndrome. The body converts linoleic acid into prostaglandin E1 (PGE1) in the following step-wise sequence: linoleic acid, gamma-linolenic acid (GLA), dihomo-gamma-linolenic acid, prostaglandin E1. It is important that omega-3 fatty acids be in balance with the omega-6 fatty acids.
Enzymatic conversion of linoleic acid to PGE1 may be impaired by a wide variety of factors, including an insufficiency or imbalance of fatty acid precursors; a deficiency of nutrient conversion factors; aging; viral infections; consumption of foods rich in trans-fatty acids and saturated fats; and alcohol. Thus, a direct source of GLA must be provided in many circumstances in order to form prostaglandin E1 for proper tear production.
Horrobin and others have suggested that an effective approach to the treatment of dry eye disorders may be to address the biochemical basis of an intact tear film. See Horrobin D. F., Campbell A., McEwen C. G.: Treatment of the Sicca Syndrome and the Sjogren's Syndrome with E.F.A., Pyroxidine and Vitamin C. Prog Lipid Res 8(4): 253-4, 1981; and Oxholm, P., Manthorpe R., Prause J. U., Horrobin D.: Patients with Primary Sjogrn's Syndrome Treated for 2 Months With Evening Primrose Oil. Scand J Rheumatology 1986: 103-108. In this work the authors evaluated the use of supplemental intake of the essential fatty acids, linoleic and gamma-linolenic acids, vitamin B6, and vitamin C to treat dry eye. These nutrients are necessary components of the pathway for biosynthesis of PGE1, which is necessary for aqueous tear secretion by the lacrimal gland. See also Horrobin Patents U.S. Pat. Nos. 4,388,324 and Re31,386, and U.S. Pat. Nos. 3,993,775, 4,977,187, 5,677,335 and 6,060,486.
However, the work of Horrobin et al., while it may have been effective to increase aqueous tear secretion via the lacrimal gland, did not address all issues regarding dry eye syndrome. In many patients with dry eye syndrome, the function of the lacrimal glands is normal, with adequate aqueous tear production; it is one of the other tear layers described above which is inadequate. Enhancement of the function of these other glands, or supplying the deficiencies exhibited by the glands, was not adequately addressed in the prior studies.
Most previous treatments for dry eye syndrome have involved the topical application of eye drops, which can be required very frequently in some patients. However, in addition to the Horrobin patents referenced above, Urashima U.S. Pat. No. 6,060,486 and Robertson U.S. Pat. No. 5,677,335 (listed above) are directed to oral approaches to the treatment of dry eye syndrome.
SUMMARY OF THE INVENTION
The treatment embodied in the present invention addresses all of the underlying cellular factors that may produce dry eye syndrome (or other glandular-related dryness), including deficiency of omega-3 EFAs and prostaglandin E1 (PGE1), ocular deficiency of vitamin A, and abnormal levels of mucus, glycoproteins produced by conjunctival goblet cells. The orally-administered preparation comprises a unique combination of biologically active ingredients. The preparation does not merely treat symptoms of dry eye, as do prior topical lubricating products or hypotonic solutions and mucolytic agents that can decrease symptoms of excess mucin strands, or other additives that can help lower tension at the water-oil interfaces and mimic some actions of mucin network. The treatment according to the invention addresses the underlying causes of dry eye syndrome, rather than providing temporary palliative measures. The invention addresses the biochemical basis of an intact tear film, treating the causative factors of dry eye syndrome and supporting the body's natural tear formation.
In one preferred embodiment of the preparation and treatment according to the invention, the preparation includes blackcurrant seed oil, as a source of both omega-3 and omega-6 fatty acids; pyridoxal 5-phosphate, the active form of vitamin B6; ascorbic acid and ascorbil palmitate (vitamin C); vitamin A; mucin; and magnesium, preferably in the form of magnesium sulfate. The preparation preferably also includes cod liver oil, as an additional source of omega-3 essential fatty acids.
One important aspect of the formulation of the invention, for effective treatment, is the provision of the omega-3 fatty acids from both plant and fish sources, due to the synergistic combination of the two types of fatty acids from these difference sources.
These and other objects, advantages and features of the invention will be apparent from the following description of a preferred embodiments.
DESCRIPTION OF PREFERRED EMBODIMENTS
In a preferred embodiment of a preparation for treating dry eye syndrome, and also for treating dryness in the mouth, female vaginal dryness or other glandular-related dryness, the preparation of the invention includes the following components:
Vitamin A (from retinyl palmitate)
1040 IU (or a range of
about 200 to 5000 IU)
Vitamin C (from calcium ascorbate)
90 mg (or at least about
50 mg)
Vitamin B6 (from pyridoxal 5-phosphate)
6.3 mg (or a range of
about 2.0 to 20 mg)
Magnesium (from magnesium sulfate)
20 mg (or a range of
about 10 to 50 mg)
Black Currant Seed Oil (or other
750 mg (or at least about
plant source providing gamma
300 mg)
linolenic acid (GLA))
Mucin
150 mg (or a range of
about 100 to 300 mg)
Cod Liver Oil
1.6 mg (or a range of
(or other cold water fish oil)
about 0.5 to 3.0 mg)
This preparation preferably is administered to a patient twice daily, advantageously taken with meals (it should be understood that the word “preparation” or “formulation” as used herein is intended to refer collectively to these substances and amounts whether taken separately by a patient or whether included in a single capsule or other ingestible medium).
The above is a preferred form of the treatment of the invention, but variations are possible. The above formulation addresses not only the adequate production of aqueous tears, the middle laye
Kaufman Richard
Thornton Spencer P.
Troyer Ellen M.
Whiting K. Steven
Freiburger Thomas M.
ScienceBased Health
Tate Christopher R.
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