WO2004009101A1 - Gel composition comprising sea salts - Google Patents

Gel composition comprising sea salts Download PDF

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Publication number
WO2004009101A1
WO2004009101A1 PCT/HU2003/000059 HU0300059W WO2004009101A1 WO 2004009101 A1 WO2004009101 A1 WO 2004009101A1 HU 0300059 W HU0300059 W HU 0300059W WO 2004009101 A1 WO2004009101 A1 WO 2004009101A1
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Prior art keywords
weight
pharmaceutical composition
gel
composition according
dead sea
Prior art date
Application number
PCT/HU2003/000059
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French (fr)
Inventor
János SHOMER
Original Assignee
Shomer Janos
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shomer Janos filed Critical Shomer Janos
Priority to AU2003246980A priority Critical patent/AU2003246980A1/en
Publication of WO2004009101A1 publication Critical patent/WO2004009101A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/02—Medicinal preparations containing materials or reaction products thereof with undetermined constitution from inanimate materials
    • A61K35/08—Mineral waters; Sea water
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/04—Antipruritics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics

Definitions

  • the subject of the invention is a pharmaceutical composition in the form of a gel which comprises a sea salt, preferebly a Dead Sea salt. It is known that bathing in the Dead Sea has beneficial effects to the skin at patients suffering from different skin disorders.
  • the unique climatic conditions and the ingredients of the water ensure that the condition of patients suffering from psoriasis, pruritus and several other skin disorders significatntly improves after a stay at the Dead Sea [see ⁇ rdecireiche Behand- lung der Psoriasis thropica am Toten Meer", Med. Report, 6, 2-3 (1992)].
  • Dead Sea Located more than 400 meters below the sea level, Dead Sea is the lowest point on the surface of the Earth.
  • the humid air almost completely filters out the UV-B range of the solar UN radiation, and only the beneficial and safe UN-A radiation can reach the Dead Sea level.
  • the sea water is relatively rich in rare elements, and this fact probably contributes to the beneficial effects of the Dead Sea water.
  • a cure at the Dead Sea improves the condition of patients suffering from the following disorders: atopic dermatitis, psoriasis, pruritus, several skin irritations, so as allergic irritations and vitiligo [see Seidl N. Hirstakieva and E. Harari: Klimatherapie der Nitiligo am Toten Meer, Der yer Dermatologe, 2, 144-159 (1949)].
  • ingredients of the gel especially by the presence of starch and wax-like ingredients, so as white vaseline (vaseline alba) or paraffin oil.
  • the subject of the invention is a gel form composition
  • sea salts preferably Dead Sea salts.
  • the disadvantages of the known treatments with solid salts, saline solu- tions and muds may be avoided since considerably smaller quantities are necessary.
  • the salts can be absorbed in the epidermis just as good as from the sea water.
  • the gel composition ensures sufficient salt concentration and a long-keeping contact with the skin. So the advantage of the composition is that it is easy to handle and bigger topical concentrations can be achieved for a longer time.
  • the composition of the invention may comprise any of the sea salts, but Dead Sea salts are preferred. Sea salts usually also comprise rare elements. By using the composition of the invention these elements can also be absorbed in the skin.
  • composition of the invention may preferably comprise starch of different origin, so as corn-starch, cassava, rice, shorgum or potato starch. Corn-starch is preferred. If desired, the composition of the invention may also comprise other ingredients having pharmaceutical additional activity which can be also absorbed to the skin.
  • composition of the invention may be used for the treatment of the same skin diseases or disorders as a Dead Sea stay.
  • Said diseases include obstinate psoriasis, pruritus, atopic dermatitis, several skin irritations e.g. allergic irritations, vitiligo, reumathoid artritis and osteo-arthiritis.
  • composition of the invention may comprise any sea salts, however, Dead Sea salts are preferred.
  • composition of the invention has good stability. On room-temperature its consis- tence does not change within 6 months and even within 12 months.
  • a further advantage of the composition is that it moisurizes the skin. It is due to the fact that the composition comprises a large amount of water and it remains on the skin for a relatively long time.
  • the effects of the composition of the invention may be enhanced when a thin foil is placed on the treated surface of the skin.
  • the foil may be a polymer foil, polyethylene foils are preferred.
  • the corners of the foil may be fastened to the skin.
  • a foil may be used especially to those compositions whose viscosity is sufficiently large to adhere the foil. Covered by a foil, the water content of the gel evaporates later, so the gel remains on the moisturized surface of the skin for a longer time, i.e. it dries later. Therefore the effect of the gel lasts longer. In this way the salt remains on the skin surface up to 10 hours, which time is significantly longer than a duration of a bath in the sea.
  • the effects of the gel may be enhanced by UV radiation whose wavelength lies in the range of the solar UN radiation at the Dead Sea. So the effects of the salts and the UN radiation together are closely similar to the effects of a Dead Sea bath.
  • composition of the invention preferably comprises 2 to 40 % by weight salt, 8 to 15 % by weight starch, 0,6 to 1,0 % by weight polysorbate, 0,6 to 1,0 by weight paraffin oil, 1 to 3 % cetylalcohol and 3 to 6 % vaseline alba and deionized water.
  • Polysorbate is poly- oxyethylene fatty acid ester, obtained by esterification of sorbitol.
  • composition of the invention optionally comprises 1 to 5 % by weight, preferably 0,5 to 2 % by weight Rosmarinus Officialis, which can enhance the pharmaceutical effects of the salts.
  • Rosmarinus Officialis Rosmarinus Officialis
  • it can be added to the paraffine oil in an amount of 1 to 5 % by weight, more preferably in an amount of 1 to 2 % by weight.
  • a gel of example 3 comprising corn starch was prepared according to the following procedure: Water was heated to 75-80 °C in a double wall flask. The mixture was continuously stirred and corn-starch was added in the necessary amount. Under continuos stirring it was allowed to cool to 75 °C, and at this temperature paraffin oil, cetylalcohol and vaseline alba was added. The mixture was allowed to cool to a temperature of 35 °C then stirring was stopped.
  • the consistency of the resulting jelly-like substance was proper.
  • the gel showed no changes after 12 months storing.
  • compositions of examples 2 to 4 can also be prepared by the same procedure. Pharmacological studies
  • composition was prepared according to example 5. It was tested on four patients who suffered from serious pruritus. The patients did not receive steroid or antihistamine treatment. All the three patients were treated with the gel twice a day for three weeks. The gel was left on the patients' skin until drying.
  • D) 2 patients two women, 69 and 21 years old, respectively were treated with the composition, who suffered from pruritus as a consequence of allergic urticaria. Their complaints reduced significantly.

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  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Chemical & Material Sciences (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The subject of the invention is a gel composition which comprises sea salts, preferably Dead Sea salt. The gel of the invention is useful for treating several skin disorders, especially psoriasis. Remaining on the skin for a long time the gel makes possible the convenient use of sea salts. Its further advantage is that relatively small amounts are necessary to a treatment.

Description

GEL COMPOSITION COMPRISING SEA SALTS
The subject of the invention is a pharmaceutical composition in the form of a gel which comprises a sea salt, preferebly a Dead Sea salt. It is known that bathing in the Dead Sea has beneficial effects to the skin at patients suffering from different skin disorders. The unique climatic conditions and the ingredients of the water ensure that the condition of patients suffering from psoriasis, pruritus and several other skin disorders significatntly improves after a stay at the Dead Sea [see Εrfolgreiche Behand- lung der Psoriasis thropica am Toten Meer", Med. Report, 6, 2-3 (1992)]. Located more than 400 meters below the sea level, Dead Sea is the lowest point on the surface of the Earth. The humid air almost completely filters out the UV-B range of the solar UN radiation, and only the beneficial and safe UN-A radiation can reach the Dead Sea level. The sea water is relatively rich in rare elements, and this fact probably contributes to the beneficial effects of the Dead Sea water. A cure at the Dead Sea improves the condition of patients suffering from the following disorders: atopic dermatitis, psoriasis, pruritus, several skin irritations, so as allergic irritations and vitiligo [see Seidl N. Hirstakieva and E. Harari: Klimatherapie der Nitiligo am Toten Meer, Der deutsche Dermatologe, 2, 144-159 (1949)].
Several attempts were carried out with Dead Sea salt treatments, but they were not suc- cessful because it is difficult to handle the salt and further, a large amount of salt is necessary to a sole treatment [see Shani J., Even-Pazz Z., Avrah WW. et al: Topical replacement therapy of psoriasis by Dead Sea salts; Dermatosen 39, 49-53. Treatments were made with muds comprising Dead Sea salts, however, their are difficult to use and the results were not satisfying. The saline content of Dead Sea water is 30 to 32% by weight. A solution comprising 30% Dead Sea salt were even prepared [see Cheesbough MJ., "Treatment of Psoriasis with 30%
Dead Sea lotion", J. Dermatol. Treat, 3, 201-203 (1992)]. The use of the solid salts has the disadvantage that a large amount of salt is necessary to a sole treatment, e.g. about 30 to 90 kg in a bath-tube. Delivery of the salt is pricey and difficult, so it is almost impossible to carry out such a treatment. Using the gel form compositions of the invention the above disclosed disadvantages may be eliminated since the gel may be topically used in a thin layer, and if desired, only on a small surface of the skin. For a treatment with the gel composition, only a thousandth of the amount is necessary than to a bath. In the present description, "gel" means a jelly-like substance. According to the state of the art gel form pharmaceutical compositions comprising sea salts, especially Dead Sea salts are not known.
We have surprisingly found that with a gel form composition comprising sea salts the same effects can be achieved as with the sea water or with a bath in the sea or in a bath-tube where the necessary amount of the salt is considerably smaller.
These effects can be ensured by the ingredients of the gel, especially by the presence of starch and wax-like ingredients, so as white vaseline (vaseline alba) or paraffin oil.
So the subject of the invention is a gel form composition comprising sea salts, preferably Dead Sea salts. The disadvantages of the known treatments with solid salts, saline solu- tions and muds may be avoided since considerably smaller quantities are necessary. From the composition of the invention the salts can be absorbed in the epidermis just as good as from the sea water. The gel composition ensures sufficient salt concentration and a long-keeping contact with the skin. So the advantage of the composition is that it is easy to handle and bigger topical concentrations can be achieved for a longer time. The composition of the invention may comprise any of the sea salts, but Dead Sea salts are preferred. Sea salts usually also comprise rare elements. By using the composition of the invention these elements can also be absorbed in the skin.
The composition of the invention may preferably comprise starch of different origin, so as corn-starch, cassava, rice, shorgum or potato starch. Corn-starch is preferred. If desired, the composition of the invention may also comprise other ingredients having pharmaceutical additional activity which can be also absorbed to the skin.
The composition of the invention may be used for the treatment of the same skin diseases or disorders as a Dead Sea stay. Said diseases include obstinate psoriasis, pruritus, atopic dermatitis, several skin irritations e.g. allergic irritations, vitiligo, reumathoid artritis and osteo-arthiritis.
Several other salts are known which have pharmaceutical activity. These salts may also be included by the gel composition of the invention. The composition of the invention may comprise any sea salts, however, Dead Sea salts are preferred.
The composition of the invention has good stability. On room-temperature its consis- tence does not change within 6 months and even within 12 months.
A further advantage of the composition is that it moisurizes the skin. It is due to the fact that the composition comprises a large amount of water and it remains on the skin for a relatively long time. The effects of the composition of the invention may be enhanced when a thin foil is placed on the treated surface of the skin. The foil may be a polymer foil, polyethylene foils are preferred. The corners of the foil may be fastened to the skin. A foil may be used especially to those compositions whose viscosity is sufficiently large to adhere the foil. Covered by a foil, the water content of the gel evaporates later, so the gel remains on the moisturized surface of the skin for a longer time, i.e. it dries later. Therefore the effect of the gel lasts longer. In this way the salt remains on the skin surface up to 10 hours, which time is significantly longer than a duration of a bath in the sea.
The effects of the gel may be enhanced by UV radiation whose wavelength lies in the range of the solar UN radiation at the Dead Sea. So the effects of the salts and the UN radiation together are closely similar to the effects of a Dead Sea bath.
The composition of the invention preferably comprises 2 to 40 % by weight salt, 8 to 15 % by weight starch, 0,6 to 1,0 % by weight polysorbate, 0,6 to 1,0 by weight paraffin oil, 1 to 3 % cetylalcohol and 3 to 6 % vaseline alba and deionized water. Polysorbate is poly- oxyethylene fatty acid ester, obtained by esterification of sorbitol.
The composition of the invention optionally comprises 1 to 5 % by weight, preferably 0,5 to 2 % by weight Rosmarinus Officialis, which can enhance the pharmaceutical effects of the salts. Preferably it can be added to the paraffine oil in an amount of 1 to 5 % by weight, more preferably in an amount of 1 to 2 % by weight. In the following examples we can show some embodiments of the invention without the intention of limitation. Example 1
Example 2
Figure imgf000005_0001
Example 5
Preparation of a gel composition according to the invention
A gel of example 3 comprising corn starch was prepared according to the following procedure: Water was heated to 75-80 °C in a double wall flask. The mixture was continuously stirred and corn-starch was added in the necessary amount. Under continuos stirring it was allowed to cool to 75 °C, and at this temperature paraffin oil, cetylalcohol and vaseline alba was added. The mixture was allowed to cool to a temperature of 35 °C then stirring was stopped.
The consistency of the resulting jelly-like substance was proper. The gel showed no changes after 12 months storing.
The compositions of examples 2 to 4 can also be prepared by the same procedure. Pharmacological studies
We have studied the effects of the gel composition of example 3.
A) The composition was prepared according to example 5. It was tested on four patients who suffered from serious pruritus. The patients did not receive steroid or antihistamine treatment. All the three patients were treated with the gel twice a day for three weeks. The gel was left on the patients' skin until drying.
After 15 to 20 minutes the complaints of the patients were significantly ameliorated, later the complaints ceased. No side effects were shown. B) A patient suffering from chronic pruritus for four years was former treated with about forty different preparations, among them with steroids, without any results. Most of the patient's body was scraped. He was treated with the gel and after that his symptoms were reduced. After a 6 weeks long treatment the patient was asymptotic, he did not suffered from pruritus, the red knots disappeared. After further 6 months no recession was shown, the pa- tient's skin remained clear.
C) 3 patients (80, 89 and 93 years old, respectively) were treated. They suffered from pruritus.. After 8 weeks treatment with the composition of the invention the patinents' complaints completly disappeared. No side effects were shown during and after the treament.
D) 2 patients (two women, 69 and 21 years old, respectively) were treated with the composition, who suffered from pruritus as a consequence of allergic urticaria. Their complaints reduced significantly. E) 1 patient (a 31 years old man) was treated who suffered from Hogkin disease and as a consequence he suffered from pruritus. After the treatment his symptoms reduced significantly.
F) 1 patient suffering from pruritus s. materia, 2 patients suffering from nodular prurigo and a patient suffering from Lichen simplex chr. Nidal, respectively, were treated.
They did not receive any other active agent. The gel was used twice a day. All the four patients' complaints reduced significantly and no side effects were shown.

Claims

1. A gel form pharmaceutical composition comprising sea salts.
2. A pharmaceutical composition according to claim 1 characterized by that the sea salt is Dead Sea salt and it further comprises starch.
3. Pharmaceutical composition according to claim 2 characterized by that it comprises 5 to 25 % by weight Dead Sea salt.
4. Pharmaceutical composition according to claim 3 characterized by that it comprises 10 to 15 % by weight Dead Sea salt.
5. Pharmaceutical composition according to claim 2 characterized by that it comprises paraffin oil and/or vaseline and optionally Rosmarinus Officialis, polysorbate, paraffin oil, cetylalcohol, white vaseline and the rest is deionized water.
6. Pharmaceutical composition according to claim 2 characterized by that it comprises 2 to 25 % by weight Dead Sea salt, 8 to 15 % by weight starch, 0,6 to 1 % by weight polysor- bate, 0,6 to 1 % by weight paraffin oil, 1 to 3 % by weight cetylalcohol, 3 to 6 % by weight white vaselin, 1 to 2 % by weight Rosmarinus Officialis, and the rest is deionized water.
7. Pharmaceutical composition according to claim 6 characterized by that it comprises 5 to 20 % by weight Dead Sea salt, 11 to 12 % by weight starch, 0,80 to 0,85 % by weight polysorbate, 0,80 to 0,85 % by weight paraffin oil, 1,5 to 1,85 % by weight cetylalcohol and the rest is deionized water.
8. Pharmaceutical composition according to claim 7 characterized by that it comprises 10 to 15 % by weight Dead Sea salt.
9. Pharmaceutical composition according to claim 2 characterized by that the starch is corn-starch.
10. Pharmaceutical composition according to claim 2 characterized by that it comprises
1 to 5 % by weight Rosmarinus Officialis.
PCT/HU2003/000059 2002-07-19 2003-07-18 Gel composition comprising sea salts WO2004009101A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2003246980A AU2003246980A1 (en) 2002-07-19 2003-07-18 Gel composition comprising sea salts

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
HU0202391A HUP0202391A2 (en) 2002-07-19 2002-07-19 Sea salt in form gel
HUP0202391 2002-07-19

Publications (1)

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WO2004009101A1 true WO2004009101A1 (en) 2004-01-29

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006112690A1 (en) * 2005-04-22 2006-10-26 R & H Minerals B.V. Mineral salt gel compositions
WO2014015881A3 (en) * 2012-07-25 2014-11-13 Kimovi Aps A cosmetic or medical composition with kigelia africana

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2533437A1 (en) * 1982-09-28 1984-03-30 Hecmati Michel Dentifrice composition containing exclusively natural products and which has the appearance of a black gel or paste
JPH05117158A (en) * 1991-10-22 1993-05-14 Sasaki Kagaku Yakuhin Kk External preparation composition for skin
WO1998025586A1 (en) * 1996-12-10 1998-06-18 Patricia Dupuy Preparation for dermatological use
WO1998052515A1 (en) * 1997-05-20 1998-11-26 Kahale, Nadim Prevention/retardation of hair growth
WO1999033443A1 (en) * 1997-12-28 1999-07-08 Dead Sea Laboratories Ltd. A gel composition for skin care and protection and a method for preparation thereof
WO2001085103A1 (en) * 2000-05-08 2001-11-15 Karl Laden Anhydrous skin cleansers

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2533437A1 (en) * 1982-09-28 1984-03-30 Hecmati Michel Dentifrice composition containing exclusively natural products and which has the appearance of a black gel or paste
JPH05117158A (en) * 1991-10-22 1993-05-14 Sasaki Kagaku Yakuhin Kk External preparation composition for skin
WO1998025586A1 (en) * 1996-12-10 1998-06-18 Patricia Dupuy Preparation for dermatological use
WO1998052515A1 (en) * 1997-05-20 1998-11-26 Kahale, Nadim Prevention/retardation of hair growth
WO1999033443A1 (en) * 1997-12-28 1999-07-08 Dead Sea Laboratories Ltd. A gel composition for skin care and protection and a method for preparation thereof
WO2001085103A1 (en) * 2000-05-08 2001-11-15 Karl Laden Anhydrous skin cleansers

Non-Patent Citations (6)

* Cited by examiner, † Cited by third party
Title
"Dead Sea Products: coming to life", EUROPEAN COSMETIC MARKETS, vol. 17, no. 9, 1 September 2000 (2000-09-01), pages 341 *
CHEESBROUGH MJ: "TREATMENT OF PSORIASIS WITH 30% DEAD SEA SALT LOTION", JOURNAL OF DERMATOLOGICAL TREATMENT, BASINGSTOKE, GB, vol. 3, no. 4, 1992, pages 201 - 203, XP000943997, ISSN: 0954-6634 *
DATABASE NLDB [online] XP002257164, retrieved from STN Database accession no. 2000:265190 *
DATABASE WPI Section Ch Week 199049, Derwent World Patents Index; Class B06, AN 1990-364041, XP002257166 *
DATABASE WPI Section Ch Week 199324, Derwent World Patents Index; Class D21, AN 1993-191439, XP002257165 *
MA'OR, Z, YEHUDA S, VOSS, W: "Skin smoothing effects of dead sea minerals: comparative profilometric evaluation of skin surface", INTERNATIONAL JOURNAL OF COSMETIC SCIENCE, vol. 19, 1997, pages 105 - 110, XP002257163 *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006112690A1 (en) * 2005-04-22 2006-10-26 R & H Minerals B.V. Mineral salt gel compositions
JP2008538558A (en) * 2005-04-22 2008-10-30 アール アンド エイチ ミネラルズ ビー．ブイ． Inorganic salt gel composition
WO2014015881A3 (en) * 2012-07-25 2014-11-13 Kimovi Aps A cosmetic or medical composition with kigelia africana

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AU2003246980A1 (en) 2004-02-09
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