WO1994005272A1 - Compositions destinees au traitement de l'epiderme, contenant du dimethylsulfone et du dimethylsulfoxyde - Google Patents

Compositions destinees au traitement de l'epiderme, contenant du dimethylsulfone et du dimethylsulfoxyde Download PDF

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Publication number
WO1994005272A1
WO1994005272A1 PCT/GB1993/001876 GB9301876W WO9405272A1 WO 1994005272 A1 WO1994005272 A1 WO 1994005272A1 GB 9301876 W GB9301876 W GB 9301876W WO 9405272 A1 WO9405272 A1 WO 9405272A1
Authority
WO
WIPO (PCT)
Prior art keywords
dimethylsulphoxide
methylsulphonylmethane
composition
skin
treatment
Prior art date
Application number
PCT/GB1993/001876
Other languages
English (en)
Inventor
Aws Shakir Mustafa Salim
Original Assignee
Aws Shakir Mustafa Salim
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
Priority claimed from GB929218773A external-priority patent/GB9218773D0/en
Priority claimed from GB939310611A external-priority patent/GB9310611D0/en
Application filed by Aws Shakir Mustafa Salim filed Critical Aws Shakir Mustafa Salim
Priority to AU49747/93A priority Critical patent/AU4974793A/en
Publication of WO1994005272A1 publication Critical patent/WO1994005272A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/095—Sulfur, selenium, or tellurium compounds, e.g. thiols
    • A61K31/10—Sulfides; Sulfoxides; Sulfones

Definitions

  • the present invention relates to a pharmaceutical synergistic composition for the treatment of dermatological disorders and for improving the condition of the skin, which composition comprises methylsulphonylmethane with dimethylsulphoxide.
  • the skin Due to its susceptibility to environmental pollutants, irritants and noxious agents and due to its large surface area, the skin is a common site for a wide variety of diseases and disorders be they degenerative, inflammatory, endocrinal, metabolic or neoplastic. While there is a large number of dermatological agents on the market, these do little to combat the mediators of skin injury or diseases, or to enhance the repair of skin in the aftermath of injury or diseases, or to sustain the integrity of skin against recurrence of such disorders or protect against their development. Moreover, many of the therapeutic modalities currently available have limitations pertaining to patient selection or application.
  • the present invention provides a composition comprising methyl sulphonylmethane and dimethylsulphoxide.
  • the present invention provides a composition comprising methyl sulphonylmethane and dimethylsulphoxide for use in the preparation of a medicament for the treatment of dermatological disorders and for improving the condition of the skin of a human.
  • methyl sulphonylmethane reverses the degenerative and ageing processes occurring in the skin, affords therapy against a wide variety of diseases be they inflammatory, metabolic, endocrinal or traumatic such as wounds and ulcers, and protects the skin against the recurrence of these diseases and disorders by sustaining its physiochemical properties thereby increasing its resistance; it was particularly suprising to discover that the addition of dimethylsulphoxide augments and enhances these therapeutic advantages in a synergistic manner. This action refers to the sum of the individual efficacy of the ingredients being less than that of their composition. It was also observed that the composition has the advantageous property of adhesion to the skin thereby affording prolonged contact with the treatment area and an enhanced therapeutic delivery. In vivo and in vitro experiments demonstrated that the compositions of the present invention exhibit the following actions:
  • cytoprotection which refers to sustaining the physio-chemical properties of biological tissues, thus increasing their resistance to noxious stimuli.
  • biosynthesis and donation of a methyl group and sulphur which effect enhanced repair and healing.
  • compositions of the present invention onto the skin improves its condition in a number of ways including:
  • the improvement in skin condition can also include maintenance of its vitality, smoothness, firmness and texture.
  • vasodilator substance such as menthol in order to further increase the effectiveness of the composition in the skin.
  • enhanced therapeutic gains have been noted with the incorporation of vitamins A and E in compositions of the present invention.
  • the present invention provides a pharmaceutical composition
  • a pharmaceutical composition comprising methylsulphonylmethane with dimethylsulphoxide in intimate admixture with a physiologically acceptable carrier for use in improving the condition of the skin.
  • this invention provides a topical formulation comprising methylsulphonylmethane with dimethylsulphoxide in intimate admixture with a pharmaceutically acceptable vehicle.
  • a pharmaceutically acceptable vehicle should not be deleterious to biological tissues or incompatible with any of the ingredients of the formulation. Since some individuals have more sensitive skin than others, alternative vehicles to those used normally may have to be tried.
  • Suitable vehicles are well known in the art and are presented in all its standard publications such as the British National Formulary and British Pharmacopoeia. They include ointment and cream bases, lotions, pastes, jellies, sprays, aerosols and bath oils. Ointments and creams may contain oleaginous absorption colloidal clays, thickening agents such as gum tragacanth or sodium alginate and other pharmaceutically acceptable accessory ingredients such as humectants, preservatives, buffers and antioxidants which have utility in such formulations. In general cream formulations are preferred as being most acceptable to the majority of users.
  • a particularly convenient base is one utilizing cetomacrogol, comprising for example 30% w/v cetomacr ⁇ gol emulsifying ointment (30% w/v cetomacrogol emulsifying wax, 20% w/v liquid paraffin wax, 50% w/v white soft paraffin) in freshly boiled and cooled purified water with for example 0.1% w/v chlorocresol or 0.08% w/v propyl hydroxybenzoate, 0.15% w/v methyl hydroxybenzoate and 1.5% w/v benzyl alcohol.
  • the topical formulations of the invention contain at least 0.5% w/w of each of its ingredients, preferably from 1 to 20% w/w and most preferably from 1 to 10% w/w, e.g. 5% methyl sulphonylmethane and dimethylsulphoxide. Where menthol is included, this is generally used in an amount of from 1 to 20% w/w and most preferably from 1 to 5% w/w.
  • the invention being presented can be administered orally or parenterally in a suitable vehicle, in particular by intravenous injection.
  • ingredients of the invention and any accompanying material may be presented as a draught in water or in a syrup, in capsules, sachets, boluses or tablets, as an aqueous or oleaginous solution or suspension or in suspension in a syrup, such suspensions optionally including suspending agents or as an oil-in-water or water-in-oil emulsion.
  • compositions of the invention can be taken in an alcoholic drink be that a spirit, wine or beer.
  • the non-alcoholic forms of these drinks may also serve as vehicles for the oral consumption of the invention.
  • compositions of the present invention may be presented in fruit juices, mineral waters be they carbonated or not, and to all forms of soft drinks.
  • compositions of the invention can be directly delivered to the lung via smoke and in this respect, they can be added as a powder or solution to tobacco leaves or to the tobacco of cigarettes, cigars and pipes.
  • the compositions of the invention may also be included as a solution or powder in cigarette filters or small delivery compartments incorporated in the cigarette. This compartment may also contain the composition of the invention in granules which evaporate upon contact with the smoke thereby delivering their active ingredients to be carried by the smoke.
  • flavouring sweetening, preserving, thickening or emulsifying agents may be included in the formulation.
  • Tablets may contain the ingredients of the invention and any accompanying material as a powder or granules optionally mixed with binders, lubricants, inert diluents or surface-active or dispersing agents.
  • compositions of this invention and any accompanying material may be presented in sterile solutions or suspensions in aqueous or oleaginous vehicles, which may also contain preservatives, antioxidants and material for rendering the solution or suspension isotonic with the recipient's blood.
  • Such formulations may conveniently be presented in unit-dose or multi-dose sealed containers.
  • the compositions of this invention are preferably presented in solution, suspension, or emulsion at a concentration of from 0.5% to 20% w/v, more preferably 2 to 5% w/v in unit multidose form.
  • each unit dose preferably contains from 100 to 500mg of each of its active ingredients.
  • This dosage may be given once or more daily, preferably at intervals of from 2 to 8 hours, most preferably every 6 hours.
  • the active ingredients of the compositions of the invention are administered in a slow release or a sustained release vehicle, various suitable vehicles of this type being known in the art.
  • composition For topical therapy the composition is applied onto the skin from 1 to 3 times a day whereby it is spread over the whole area to be treated and massaged in for about 3 to 5 minutes. It is advisable to leave the evening application overnight if repair of any skin damage is to be realised. It is not necessary to wash away the previous application in order to apply a fresh one. However this may be simply done using warm water alone.
  • Example 2 Use of the Topical Cream
  • Example 1 The creams mentioned in Example 1 can be applied several times a day and the evening application may be left overnight and washed away the following morning using warm water with or without soap. Treatment may be for a few days or months depending on each case.
  • the formula is applied once daily onto the parts of the skin to be protected, e.g. face and limbs, prior to exposure to environmental irritants or sunlight.
  • application is governed by the nature of the disorder to be treated, e.g. dermatitis 5-10 days (unless caused by varicose veins when treatment is extended to 4 weeks) , wound healing 2-3 weeks, varicose ulceration 12-16 weeks. In these cases, the application is 2 to 3 times daily, most preferably at 8 hourly intervals. Maintenance therapy after successful treatment, or to sustain the condition of skin, may require a once daily application to a particular part of the skin for months, years or even indefinitely.
  • MSM methylsulphonylmethane
  • DMSO dimethylsulphoxide
  • each of MSM and DMSO exhibit cytoprotection against tissue injury and interact with each other in this respect synergistically.
  • the mechanism of this action is believed to be scavenging oxygen-derived free radicals which mediate tissue damage.
  • DMSO DMSO prepared in double distilled water.
  • Ten animals from each group were killed by ether overdose six hours after each of the second and third instillations, their gastric acid secretion collected and analysed for the H + output as stated above and their stomachs pinned out and examined to assess the integrity of the mucosa and to determine the presence or absence of injury, The following observations were made:
  • Example l.B The sunscreening effect of the formulation listed under Example l.B and its ability to protect patients against skin burns, erythema, itching and scaling following a few hours' exposure to the sun was examined.
  • Complete protection (100%) was afforded by active therapy against all the adverse effects produced by exposure to the sunlight. This protection extended to prevention of skin burns or irritation. Controls had no protection at all.
  • Example l.A The therapeutic effect of the formulation listed under Example l.A in the treatment of contact dermatitis was examined. Treatment was applied twice every day for 5 days. There were 14 controls (9 men and 5 women, age range 20 to 36 years, mean 25) and 17 treatment cases (10 men and 7 women, age range 19 to 40 years, mean
  • Hyperkeratosis is a proliferative skin disorder which represents hyperplasia of the epidermis and may have a malignant potential.
  • the condition affects the exposed parts of the skin of middle aged people, particularly the face and upper limbs.
  • Treatment of these lesions by the twice daily application of the formulation described in Example l.C for four weeks 24 cases, 10 women and 14 men with an age range of 54 to 71 years, mean 64) caused complete shedding of the lesions and their replacement by normal skin in all cases. No response was noted in any of the control cases (25 patients, 12 women and 13 men with an age range of 55 to 69 years, mean 62) . It is, thus, construed that the formulation used stimulates repair of skin lesions.
  • Example l.B The therapeutic efficacy of the formulation described in Example l.B in controlling the symptoms caused by skin burns resulting from exposure to the sun and in treating this condition was examined by its application onto the affected parts of skin every 8 hours for 10 days.
  • Within 24 hours of treatment all the symptoms of the burns (hyperaesthesia, itching, pain) were completely controlled in all members of the active therapy group, but in none of the controls.
  • the burnt skin had been shed off and a return to normal skin was achieved by the 10th day of treatment in all cases.
  • Example l.C. The efficacy of the formulation described in Example l.C. in maintaining the skin smoothness and avoiding its roughening and/or fissuring was examined in a group of women who were already using some form of beauty cream to this end and who had no previous history of any skin diseases. All the cases entered into the study abstained from using their original cream and were then randomized to the control or active therapy group and instructed to use their respective cream whether for the hands and/or face once daily before retiring to bed and to leave it overnight for 2 months. There were 24 cases in the active therapy group (age range 18 to 29 years, mean 24) and 26 cases in the control group (age range 19 to 31 years, mean 25) .
  • the ulcer was dressed by open-weave Terylene and cotton gauze.
  • the skin surrounding the ulcer was treated with propylene glycol monostearate then a below knee graduated compression bandage as described above was applied over the dressing. This procedure was repeated every day for 7 days then weekly until the ulceration had healed or until the end point of the study at 3 months.
  • Patients were advised to sleep with the foot of the bed raised, to avoid long periods of standing without exercising the calf pump, to walk whenever possible and to elevate the leg when sitting.
  • Active treatment produced complete healing of the ulceration in 33 patients (89%) and in 24 controls (69%) thereby reflecting actual stimulation of varicose ulcer healing by the formulation used.
  • MSM methylsulphonylmethane
  • DMSO dimethylsulphoxide
  • Example 1 In groups of ten healthy male volunteers of ages ranging between 19 to 36 years, 5 grams of each of the formulations described in Example 1 was applied onto the face, neck and shoulders once in the morning, once in the morning and again in the evening, or once every eight hours. Treatment lasted for ten days and the applications were spread over the skin of the face, neck and shoulders, gently rubbed in for a few minutes then left for at least 3 hours before being washed away with warm water.
  • Example 1 All the therapeutic regimens were comfortably tolerated without any apparent allergic or adverse reactions. In addition, no toxicity was produced by the treatment used. It is, therefore, concluded that the formulations described in Example 1 are safe for use in man within the recommended dosage ranges.
  • methylsuphonylmethane and dimethylsulphoxide are advantageously used in equal amounts, by weight, in the synergistic compositions of the invention, other ratios may also be used.' Generally there is used a ration of from 10:1 to 1:10, preferably from 5:1 to 1:5, most preferably about 1:1, by weight.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La présente invention se rapporte à des compositions synergiques comprenant du méthylsulfonylméthane et du diméthylsulfoxyde, et sensiblement dépourvues d'urée, ainsi qu'à leur utilisation dans des formulations et des méthodes thérapeutiques et prophylactiques destinées aux affections dermatologiques, et à l'amélioration de l'état de l'épiderme.
PCT/GB1993/001876 1992-09-04 1993-09-03 Compositions destinees au traitement de l'epiderme, contenant du dimethylsulfone et du dimethylsulfoxyde WO1994005272A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU49747/93A AU4974793A (en) 1992-09-04 1993-09-03 Skin treatment compositions containing dimethylsulphone and dimethylsulphoxide

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
GB9218773.1 1992-09-04
GB929218773A GB9218773D0 (en) 1992-09-04 1992-09-04 Skin treatment
GB939310611A GB9310611D0 (en) 1993-05-22 1993-05-22 Skin treatment
GB9310611.0 1993-05-22

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WO1994005272A1 true WO1994005272A1 (fr) 1994-03-17

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Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004105741A1 (fr) * 2003-05-30 2004-12-09 Gianfranco De Paoli Ambrosi Compositions cosmetiques et/ou pharmaceutiques a base de sulphone de dimethyle destinees au traitement et a la prevention d'irritations, d'inflammations et d'erythemes cutanes
WO2005115546A2 (fr) * 2004-05-24 2005-12-08 General Topics S.R.L. Composition pharmaceutique et/ou cosmetique pour traiter la couperose
JP2008291032A (ja) * 2008-06-04 2008-12-04 Paoli Ambrosi Gianfranco De ケミカルピーリングのための処方
US20100063152A1 (en) * 2008-03-11 2010-03-11 Rajiv Bhushan Method and Topical Formulation for Treating Localized Edema
US8217085B2 (en) 2009-10-30 2012-07-10 Biogenic Innovations, Llc Methylsulfonylmethane (MSM) for treatment of drug resistant microorganisms
US8546373B2 (en) 2009-10-30 2013-10-01 Biogenic Innovations, Llc Methods of sensitizing drug resistant microorganisms using methylsulfonylmethane (MSM)
ITBS20120093A1 (it) * 2012-06-04 2013-12-05 Paoli Ambrosi Gianfranco De Composizione cosmetica e/o farmaceutica per il trattamento dell'infiammazione della cute e delle sindromi correlate
EP2937074A1 (fr) * 2014-04-25 2015-10-28 Petra Reinacher Préparation pouvant être utilisée localement à base de méthylsulfonylméthane destiné à l'amélioration de la cicatrisation
US9186472B2 (en) 2005-09-12 2015-11-17 Abela Pharmaceuticals, Inc. Devices for removal of dimethyl sulfoxide (DMSO) or related compounds or associated odors and methods of using same
US9186297B2 (en) 2005-09-12 2015-11-17 Abela Pharmaceuticals, Inc. Materials for facilitating administration of dimethyl sulfoxide (DMSO) and related compounds
US9427419B2 (en) 2005-09-12 2016-08-30 Abela Pharmaceuticals, Inc. Compositions comprising dimethyl sulfoxide (DMSO)

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2057875A (en) * 1979-08-30 1981-04-08 Herschler R J Dimethyl sulphoxide compositions

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2057875A (en) * 1979-08-30 1981-04-08 Herschler R J Dimethyl sulphoxide compositions

Cited By (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2003238687B8 (en) * 2003-05-30 2009-08-06 Gianfranco De Paoli Ambrosi Cosmetic and/or pharmaceutical compositions comprising dimthylsulphone for the cure and prevention of irritation, inflammation and cutaneous erythema
JP2006525951A (ja) * 2003-05-30 2006-11-16 デ・パオリ・アムブロスィ、ジアンフランコ 刺激、炎症および皮膚紅斑の治療および予防のための化粧品および／または薬学的組成物
WO2004105741A1 (fr) * 2003-05-30 2004-12-09 Gianfranco De Paoli Ambrosi Compositions cosmetiques et/ou pharmaceutiques a base de sulphone de dimethyle destinees au traitement et a la prevention d'irritations, d'inflammations et d'erythemes cutanes
AU2003238687B2 (en) * 2003-05-30 2009-07-02 Gianfranco De Paoli Ambrosi Cosmetic and/or pharmaceutical compositions comprising dimthylsulphone for the cure and prevention of irritation, inflammation and cutaneous erythema
WO2005115546A2 (fr) * 2004-05-24 2005-12-08 General Topics S.R.L. Composition pharmaceutique et/ou cosmetique pour traiter la couperose
WO2005115546A3 (fr) * 2004-05-24 2006-03-16 Gen Topics Srl Composition pharmaceutique et/ou cosmetique pour traiter la couperose
US9186297B2 (en) 2005-09-12 2015-11-17 Abela Pharmaceuticals, Inc. Materials for facilitating administration of dimethyl sulfoxide (DMSO) and related compounds
US9186472B2 (en) 2005-09-12 2015-11-17 Abela Pharmaceuticals, Inc. Devices for removal of dimethyl sulfoxide (DMSO) or related compounds or associated odors and methods of using same
US9427419B2 (en) 2005-09-12 2016-08-30 Abela Pharmaceuticals, Inc. Compositions comprising dimethyl sulfoxide (DMSO)
US9616127B2 (en) * 2008-03-11 2017-04-11 Livionex Inc. Method and topical formulation for treating localized edema
US20100063152A1 (en) * 2008-03-11 2010-03-11 Rajiv Bhushan Method and Topical Formulation for Treating Localized Edema
JP2008291032A (ja) * 2008-06-04 2008-12-04 Paoli Ambrosi Gianfranco De ケミカルピーリングのための処方
US8841100B2 (en) 2009-10-30 2014-09-23 Biogenic Innovations, Llc Use of methylsulfonylmethane (MSM) to modulate microbial activity
US8546373B2 (en) 2009-10-30 2013-10-01 Biogenic Innovations, Llc Methods of sensitizing drug resistant microorganisms using methylsulfonylmethane (MSM)
US9487749B2 (en) 2009-10-30 2016-11-08 Biogenic Innovations, Llc Use of methylsulfonylmethane (MSM) to modulate microbial activity
US8217085B2 (en) 2009-10-30 2012-07-10 Biogenic Innovations, Llc Methylsulfonylmethane (MSM) for treatment of drug resistant microorganisms
US9839609B2 (en) 2009-10-30 2017-12-12 Abela Pharmaceuticals, Inc. Dimethyl sulfoxide (DMSO) and methylsulfonylmethane (MSM) formulations to treat osteoarthritis
US9855212B2 (en) 2009-10-30 2018-01-02 Abela Pharmaceuticals, Inc. Dimethyl sulfoxide (DMSO) or DMSO and methylsulfonylmethane (MSM) formulations to treat infectious diseases
US10596109B2 (en) 2009-10-30 2020-03-24 Abela Pharmaceuticals, Inc. Dimethyl sulfoxide (DMSO) or DMSO and methylsulfonylmethane (MSM) formulations to treat infectious diseases
WO2013182998A3 (fr) * 2012-06-04 2014-07-10 General Topics S.R.L. Composition cosmétique et/ou pharmaceutique pour le traitement de l'inflammation cutanée et de syndromes afférents
ITBS20120093A1 (it) * 2012-06-04 2013-12-05 Paoli Ambrosi Gianfranco De Composizione cosmetica e/o farmaceutica per il trattamento dell'infiammazione della cute e delle sindromi correlate
EA025135B1 (ru) * 2012-06-04 2016-11-30 Дженераль Топикс С.Р.Л. Косметическая и/или фармацевтическая композиция для лечения воспаления кожи и связанных синдромов
EP2937074A1 (fr) * 2014-04-25 2015-10-28 Petra Reinacher Préparation pouvant être utilisée localement à base de méthylsulfonylméthane destiné à l'amélioration de la cicatrisation

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