Topical medicament for the treatment of psoriasis

Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Recombinant or stably-transformed bacterium encoding one or...

Reexamination Certificate

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C560S066000, C560S252000, C560S254000, C560S255000

Reexamination Certificate

active

06383499

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to a topical medicament for treating psoriasis.
BACKGROUND OF THE INVENTION
Psoriasis is a common chronic skin disease whose cause is unknown. It is characterized by persistent patches of redness covered with scales. The disease is, in part, determined by a genetically dominant trait. While it is absent at birth, it can begin at any age from childhood to extreme old age. Psoriasis does not, however, appear to be a communicable disease and there are no known causative factors for it in the environment.
In the involved patches, the cells of the epidermis grow and multiply many times faster than normal. The agents currently used for treatment of psoriasis include ultraviolet light, coal tar, ammoniated mercury, anthralin, and topical corticosteroids. Methotrexate has been used to treat psoriasis by systemic administration, but such treatment method is accompanied by all the side effects commonly encountered with its use for other conditions. Antimetabolite drugs such as aminopterin, thioguanine, and azaribine have also been used in treating this disease. Systemic corticosteroids or anti-malarial drugs such as chloroquine may aggravate psoriasis by mechanisms that are not understood. A low relative humidity also aggravates the disease, probably by allowing desiccation of the skin and irritation.
Improvements in the treatment of psoriasis continue to be sought. A topical medicament which is both (1) highly effective in treating the skin lesions which characterize psoriasis and is (2) based upon natural ingredients would be highly desirable.
SUMMARY OF THE INVENTION
The present invention provides a topical medicament for the treatment of psoriasis comprising as primary ingredients one or more of the following: cod liver oil, castor oil, peanut oil, olive oil, virgin wax, lanolin, metallic iodine, camphor, chlorophyll and benzoic acid. The medicament further comprises an exciplent that is medically suitable for topical application to the skin.
Additional features and advantages of the invention will be set forth in the description which follows and will be apparent from the description or may be learned by practice of the invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Reference will now be made in detail to the presently preferred embodiments of the invention. The present invention provides a topical medicament, useful for the local treatment of the cutaneous manifestations of psoriasis, comprising a mixture of one or more of natural oils, metallic iodine, camphor, benzoic acid, virgin wax and other natural substances that act as emollients and that possess keratoplastic and keratolytic properties.
In a preferred embodiment, the present invention provides a topical medicament for the treatment of psoriasis comprising cod liver oil, castor oil, peanut oil, olive oil, virgin wax, lanolin, metallic iodine, camphor, chlorophyll, benzoic acid, and an excipient which is suitable for topical application to the skin and which, preferably, provides emollient properties. The topical medicament of the invention advantageously functions to remove the corneal layer of the epidermis, diminish the thickness of hyperkeratotic lesions, decreases inflammation and burning, and reduce capillary dilation and intercellular edema. As a result, the symptoms of psoriatic skin lesions are seen to be diminished, and the skin is allowed to recover its normal characteristics.
Metallic iodine, camphor, and benzoic acid can be characterized as inorganic antiseptics. Metallic iodine is an antiseptic agent for local (topical) use, and may be obtained from a variety of well-known sources such as igneous rock and sea water. It exhibits germicidal action in general, and fungicidal action in particular. Its germicidal action results from its combination with bacterial proteins, causing precipitation. Its action is very fast, taking place in about 10 seconds, but it combines with and is inactivated by organic substances. For example, when brought into contact with serum, blood or tissue matter, metallic iodine precipitates proteins and is partially transformed to inactive iodides. Therefore, metallic iodine has weak antiseptic action on wounds.
Moreover, at low concentrations, metallic iodine is non-toxic to tissues.
Cod liver oil is the oil obtained from the fresh livers of
Gadus morrhua
and other species of Gadidae.
The oil is extracted from the liver using steam, which breaks down the cellular membranes. Once obtained it is frozen and filtered to separate the stearin. Cod liver oil contains predominantly glycorides With non-saturated fatty acids that together comprise morrhuic acid. It also contains cholesterol, but the most important constituents are vitamins A and D, i.e., retinol and cholecalciferol or vitamin D
3
.
Castor oil is the cold-drawn oil of the seeds, stripped of the episperm, of
Ricinus comunis
and other members of its family Euphorbisceae. It is a slightly yellow to colorless thick, viscous liquid with mild odor or odorless and subtle taste. The term peanut oil as used herein refers to the oil obtained from one or more varieties of
Arachis hypogaea.
Camphor belongs to the category of analeptics and is recognized as a topical anti-infective and anti-pruritic agent. Camphor is also known as 2-bornanone, a dextrogyrous ketone (C
6
H
6
CO) obtained from the camphor tree,
Cinnamomum camphora T. Nees
and Ebermeier (Lauraceae). It is purified by sublimation (natural camphor) or produced synthetically (synthetic camphor) and contains no less than 96% C
10
H
16
O.
Chlorophyll is the green pigment found in plants, trees, and algae which contains chlorophyll A and B in an approximate ratio of 3:1. Chlorophyll A (C
55
H
72
MgN
4
O
5
, R═CH
3
) and B (C
55
H
70
MgN
4
O
6
, R═CHO) are present in waxen blue-black microcrystals.
Benzoic acid is a keratolytic agent (i.e., an agent capable of reducing the normal thickness of the stratum corneum of the skin) found in various plants in free form and in combination, especially in resins and balsams. In high concentrations benzoic acid causes inflammation with erythema, some exudation and intraepidermic edema (Malpighi stratum) with epithelial break-up, followed by sloughing of the stratum corneum and peeling or exfoliation. In addition, there is a direct action on the keratin, with disintegration of the molecule. “Virgin wax” is the product of fusion and purification of the honeycomb of the
Apis mellifera
(Apidae) bee after the honey has been separated.
The excipients used in the topical medicament of the present invention can vary widely and are comprised primarily of emollients. Emollients are Iipids or substances with a similar consistency which, when applied to the skin, protect and soften the skin, making it more supple. Emollients are used primarily as the excipients and bases of ointments and other dermatological preparations. A simple classification of emollients is as follows:
Emollients
1)
Oil-based
Hydrocarbons
Eg:
Petroleum
as
Animal fats
Jelly
ointments
Vegetable
eg:
Castor oil
oils
Peanut oil
Waxes
2)
Absorbent
Cholesterol
eg:
sperm oil
bases
Lanolin
Cetyl alcohol
Stearyl
alcohol
3)
Emulsive
Sulfated
bases
alcohols
Synthetic
surface-
active agents
Acid soaps
4)
Water-
Basic soaps
eg:
Stearic acid
soluble
eg. Glycerine
bases
1) Oil-based: Oil-based emollients include fats. These products are anhydrous, do not absorb water and are insoluble in it, and are non-washable. Oil-based emollients include: a) hydrocarbons or mineral fats obtained by the distillation of petroleum (petroleum jelly); b) vegetable oils and liquid triglycerides; c) animal fats or solid natural triglycerides; and d) waxes or solid ethers of fatty acids and organic alcohols.
2) Absorbent bases: These bases are anhydrous and insoluble in water, and are hydrophilic. They typically form water-like emulsions in oil and, thus, can incorporate substances in aqueous solutions. In addition, they are largely non-washable. Absorbent bases include: a) Lanolin or wool fats that are obtained from sheep's wool and made up o

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