Cream composition comprising Dead Sea Mud

Details Cream composition comprising Dead Sea Mud Cream composition comprising Dead Sea Mud

2001-10-15

2003-06-24

Dees, Jose′ G. (Department: 1616)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Cosmetic, antiperspirant, dentifrice

C424S600000, C514S844000, C514S847000, C514S861000, C514S863000, C514S864000, C514S865000, C514S938000

Reexamination Certificate

active

06582709

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to pharmaceutical and cosmetic cream compositions containing Dead Sea Mud for topical skin application. More specifically, the present invention relates to compositions for prevention and treatment of skin related disorders such as saborrehic dermatitis, xerosis, eczema, psoriasis and skin burns and for cosmetic use for retaining skin moisture and repairing of impaired skin.
BACKGROUND OF THE INVENTION
The skin is the largest organ in the body, serving as a protective barrier from the external environment. As such it is susceptible to various disorders and diseases caused by microorganisms, exposure to radiation, contact with irritating materials and loss of water.
Dead Sea mud and water are known for their therapeutic and cosmetic properties (for example see Ma'or Z. and Yehuda S. (1997)
International Journal of Cosmetic Science
19: 105-110). Various cosmetic products based on these properties exist in the market. For example, Japanese application JP 96011775 discloses a beauty plaster, comprising among other ingredients, natural salt and mud from the Dead Sea. PCT application No. PCT/IL98/00311 (applicant: Dead Sea Laboratories Ltd.) discloses a composition for skin care and protection comprising 10-15% of Dead Sea water.
Dead Sea mud is especially known for its therapeutic properties on psoriasis and other skin related disorders. Patients, suffering from various skin diseases come to the Dead Sea to have treatments with Dead Sea Mud, often upon their physician recommendation.
However, treatment with raw Dead Sea Mud has several drawbacks. It may be quite expensive and inconvenient for patients to travel to the Dead Sea for receiving treatment. The other possibility, delivering raw mud to the patient's home, is inconvenient due to the large amounts that must be applied for each treatment (10 Kg). Furthermore, the treatment with Dead Sea mud is quite messy and is limited to short time periods, since the mud cannot be left on the body for long periods of time due to inconvenience and aesthetic reasons.
It is the aim of the present invention to overcome the problems associated with treatments with Dead Sea water by providing an easy and pleasant to use creams that while having the therapeutic benefits of the Dead Sea mud do not suffer from the above mentioned disadvantages.
The incorporation of mud (in our case, Dead Sea mud) into a leave-on cream which should be evenly spreadable, aesthetic (i.e., unnoticeable), pleasant to use and absorbed easily to the skin, is not simple, because it involves a suspension of solid particles in an oil-in-water emulsion that contains electrolytes in a very high concentration. Such a combination has a high tendency to aggregate and to separate into phases. Still the cream must be stable and with a reasonable shelf life.
The present invention overcomes said difficulties by proper selection of stabilizers and other components, and provides a cream that has the benefits of treatment with Dead Sea mud, but non of the drawbacks. It is an easy and simple to use hypoallergenic cream that is absorbed into the skin and in contrast to the treatments used today, it may be in prolonged contact with the skin (i.e., leave-on cream), enhancing the beneficial effects of the Dead Sea mud. It is also stable, does not separate to phases, and has long shelf life.
In the context of the present invention the term “cosmetic cream” relates to an oil-in-water emulsion, suitable for applying to skin, of various viscosity ranges including milk, lotion, cream and ointment.
The term “pharmaceutical cream” relates to an oil-in-water emulsion of various viscosity including milk, lotion, cream and ointment for the use of treating (healing) and preventing or delaying skin disorders and diseases.
The term “leave on cream” (in contrary to “rinse off”) relates to a cream that may be in prolonged contact with the skin and can be applied to the skin without the need to wipe it off in any way.
SUMMARY OF THE INVENTION
The present invention relates to a pharmaceutical cream composition for topical application for the treatment of skin disorders and skin diseases, comprising 1-6 wt. % Dead Sea Mud as an active ingredient. Said composition is for use in treating skin disorders and skin diseases such as psoriasis, saborrehic dermatitis, xerosis, attopic dermatitis, eczema, diaper rush, skin burns of stage I and sensitive skin.
Said cream composition is also for use as a leave-on cosmetic cream for beautifying and enhancing the skin appearance.
In addition to Dead Sea Mud said composition comprises ingredients suitable for the preparation of cosmetic cream.
In a preferred embodiment, said ingredients are selected from Octyl Palmitate, Cetearyl Alcohol, Ceteareth-30, Hexadeacanol, Glyceryl Stearate, Glycerin, PEG-40 Stearate, Zinc Oxide, Propylene Glycol, Aloe Barbadensis Extract, Dimethicone, Sorbitan Tristearate, Allantoin, Methylparaben, Propylparben, Vitamin E (Tocopherol), Bronopol.
Said cream can further comprises up to 4 wt % Dead Sea water.
The present compositions can further contain a fragrance.
DETAILED DESCRIPTION OF THE INVENTION
The present invention relates to pharmaceutical cream composition for topical application for the treatment of skin disorders and skin diseases, comprising 1-6 wt. % Dead Sea Mud as an active ingredient. Said composition is also for use as a cosmetic leave-on composition for beautifying and enhancing the skin appearance.
Said composition is prepared by adding 1-6 wt. % Dead Sea Mud and optionally up to 4% Dead Sea water to cosmetic oil-in-water emulsion comprising of ingredients suitable for the preparation of a cosmetic cream such as ingredients selected from Octyl Palmitate, Cetearyl Alcohol (and) Ceteareth-30, Hexadeacanol, Glyceryl Stearate, Glycerin, PEG-40 Stearate, Zinc Oxide, Propylene Glycol (and) Aloe Barbadensis Extract, Dimethicone, Sorbitan Tristearate, Allontoin, Methylparaben, Propylparben, Vitamin E (Tocopherol), Bronopol and fragrance.
The present composition was found to be efficient in the treatment of the following skin disorders and diseases: Psoriasis, Saborrehic dermatitis, Xerosis (very dry skin), Attopic dermatitis, Eczema, Diaper rush, sensitive skin, and skin burns of stage I.
Dead Sea Mud (Silt) as defined in the present invention is (at 25° C.) stable black paste solid with specific density of 1.6-1.8 g/ml, pH=6.4-7.6, Water content of 30-40 %/w and less than 100 cfu/gr and non-pathogenic microbes. The chemical identity of Dead Sea mud is natural sediment, mixture of solid mineral clays with interstitial solution of inorganic salts and sulfide compounds originated from microbiological activity, with particle size 86-98% <0.005 mm, 2-9% 0.005-0.02 mm, 0-7% >0.02 mm.
The major constituents of the Dead Sea Mud are:
The solid phase which is 60-70% of the total weight consists of:
Water soluble: Halite (20-40%)
HCl soluble: Carbonates (30-40%): calcite, dolomite, aragonite
Non HCl-Soluble matter: Silicates (30-40%): quarts, montmorollonite, feldspar, kaolonite
In the liquid phase (30-40% dissolved as ions in water):
chloride (Cl
−
)148-190 g/l
sodium (Na
+
) 22-32 g/l
magnesium (Mg
2+
) 30-40 g/l
calcium (Ca
2+
) 10-15 g/l
potassium (K
+
) 6-8 g/l
Dead Sea Water, as defined in the present invention, comprises a clear colorless viscous liquid (at 25° C.) with a specific density of 1.2-1.36 g/ml, pH=4.5-5.5 (at 25° C.), less than 100 cfu/gr and non pathogenic microbes.
The major constituents of the Dead Sea Water are:
Calcium (Ca
−2
)
36000-40000
mg/l
Chloride (Cl
−
)
320000-370000
mg/l
Magnesium (Mg
+2
)
90000-95000
mg/l
Potassium (K
+
)
1300-1500
mg/l
Sodium (Na
+
)
1500-2500
mg/l
Bromide (Br
−
)
11000-12000
mg/l
Strontium (Sr
−2
)
750-850
mg/l
The preparation of creams according to the present invention involves the facilitation of non-ionic emulsifiers such as ethoxilated sorbitan esters, sorbitan esters, ethoxilated alcohols or fatty acids, alkyl glucosides, mono- and di-glyc

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