WO1996005805A1 - Composition pour le traitement des ampoules cutanees - Google Patents

Composition pour le traitement des ampoules cutanees Download PDF

Info

Publication number
WO1996005805A1
WO1996005805A1 PCT/SE1994/000782 SE9400782W WO9605805A1 WO 1996005805 A1 WO1996005805 A1 WO 1996005805A1 SE 9400782 W SE9400782 W SE 9400782W WO 9605805 A1 WO9605805 A1 WO 9605805A1
Authority
WO
WIPO (PCT)
Prior art keywords
blisters
composition according
primary aliphatic
weight
aliphatic alcohol
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/SE1994/000782
Other languages
English (en)
Inventor
Carl Kamme
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
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 to SE9300663D priority Critical patent/SE9300663L/xx
Priority to SE9300663A priority patent/SE501801C2/sv
Priority claimed from SE9300663A external-priority patent/SE501801C2/sv
Application filed by Individual filed Critical Individual
Priority to PCT/SE1994/000782 priority patent/WO1996005805A1/fr
Priority to AU78254/94A priority patent/AU7825494A/en
Publication of WO1996005805A1 publication Critical patent/WO1996005805A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/34—Alcohols
    • A61K8/342—Alcohols having more than seven atoms in an unbroken chain
    • 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
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/39—Derivatives containing from 2 to 10 oxyalkylene groups
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A61Q19/004—Aftersun preparations

Definitions

  • the present invention relates to a cream composition for treatment of or prophylaxis against skin blisters, such as blisters due to sun-bathing or solar dermatitis (polymorphic light-induced dermatitis) or blisters at or around the lips in connexion with infection by Herpes simplex virus.
  • Skin blisters are a widespread affection. They may arise from irritation of the skin by radiation, heat or mechanical or chemical agents, e.g. , after taking a sun- bath. However, they are often caused by an infection such as a latent infection by Herpes simplex virus with recurrent outbursts in form of small blisters on or adjacent to the lips. These episodes do not require medical treatment but always cause distress. After a few days the blisters will heal, followed by a shorter or longer asymptomatic period. The blisters come with itch and are often touched by hand consciously or unconsciously, from which secondary infections may result.
  • the known antiviral agents acyklovir and pho ⁇ phono formic acid have insignificant effect in topical treatment.
  • Acyclovir shows effect in various kinds of herpes infections if given in tablet form or administered intravenously.
  • Cream compositions for treatment of Herpes simplex episodes based on these agents have been developed.
  • Acyklovir eye ointment 3 % shows effect in Herpes simplex keratitis, that is, eye infection caused by Herpes simplex virus.
  • a cream containing 5 % by weight of acyklovir does not show significant prophylactic effect against cold sores caused by Herpes simplex virus (Dermatologica 172 (1986) 104-107) .
  • the effect of the known cream is assumed to be due to the local action of the medicine on herpes virus inhibiting its reproduction and thereby alleviating the symptoms.
  • the cream is important for the cream to be applied as soon as possible after the patient becomes aware of a coming active episode and, preferably, also as an maintenance prophylactic measure.
  • a drawback is the toxicity of the pharmacologically active compound. Because the cream is applied on the lips there is risk for unintended oral intake, especially in children.
  • the purpose with the present invention is to provide a cream for treatment of skin blisters of the kind mentioned above, which excludes the possibility of oral intake of toxic agents and which is effective even if administered when blisters already have developed.
  • a cream composition comprising at least one member from each of straight chain primary aliphatic alcohol, branched chain primary aliphatic alcohol and polyglycol ether of primary aliphatic alcohol, and which does not contain pharmacologically active agents, such as agents against Herpes simplex virus, in doses therapeutically effective in man.
  • pharmacologically active agents does not relate to agents that have been cleared by registration authorities for formulation of creams, salves, lotions and similar pharmaceutical compositions, that is, pharmaceutical excipients, including preservatives for such compositions.
  • straight chain aliphatic primary alcohol is a C 12 -C 22 alcohol
  • branched chain aliphatic primary alcohol is a C 12 -C 24 alcohol
  • polyglycol ether of straight chain aliphatic primary alcohol is a polyglycol ether of a C 12 -C 22 alcohol.
  • composition according to the invention comprises from 1.0 to 9.0 % by weight, more preferred from 3.5 - 7.0 % by weight, most preferred from 4.5 - 6.5 % by weight of C 12 -C 22 straight chain primary aliphatic alcohol. It is also particularly preferred for the composition according to the invention to comprise from 0.5 to 5.5 % by weight, more preferred from 1.5 - 4.0 % by weight, most preferred from 2.5 - 3.5 by weight of C 12 -C 24 branched chain primary aliphatic alcohol.
  • composition according to the invention comprises from 0.4 to 5.0 % by weight, more preferred from 1.0 - 3.5 % by weight, most preferred about 2 % by weight of polyglycol ether of C-,-,-C 22 straight chain primary aliphatic alcohol.
  • the composition comprises consistency-controlling agent in an amount of between 3 and 15 % by weight, said consistency - controlling agent comprising one or several agents selected from the group consisting of mineral oil, silicone oil and paraffin wax.
  • the composition according to the invention preferably comprises between 0 and 2.5 % by weight of mineral oil, between 0 and 2.0 % of silicone oil and between 0 and 12 % of paraffin wax.
  • Strongly hydrophobic agents i.a., certain consistency- controlling agents such as fats of vegetable or animal origin, for example, lanolin or coconut oil, and, to a minor extent, hydrocarbons or hydrocarbon fractions, such as vaselinum album or vaselinum oil, when present in larger amounts reduce or entirely eliminate the effect of the cream according to the invention, whereby the overall content of these agents seems to be decisive.
  • a more pronounced reduction in activity can be observed if saturated carbohydrate fractions with a molecular weight between about 150 to about 250, such as, e.g., vaselinum oil, are added to the composition according to the invention than on addition of corresponding fractions with higher molecular weight, such as, for example, paraffin wax.
  • Reduced effect of a composition according to the invention has been observed in the presence of fats in suntan creams and other cosmetic salves, oils, creams, lotions, etc. on the treated area.
  • the cream affects the membrane function of the skin preventing the accumulation of liquid in the blisters or, rather, preventing the development of blisters by accumulation of liquid in the deeper layers of the skin or by effecting resorption of liquid that already has accumulated, that is, in the first case, by impeding the development of blisters and, in the second case, by making existent blisters shrink and vanish without formation of a crust. It is thus preferred for the composition according to the invention to be essentially free from fats of animal or vegetable origin.
  • compositions according to the invention are preferred to add to the composition according to the invention, as required by the circumstances, pharmaceutical excipients, such as preservatives, preferably methyl paraban, propyl paraban or a mixture thereof, in a total amount between 0 and 0.8 % by weight, preferably between 0.05 and 0.3 % by weight, the composition further optionally containing one or several agents selected from the group consisting of colouring agents, perfumes, one or several pH-stabilizing agents, preferably selected from the group consisting of citric acid, tartaric acid, lactic acid and betaine lactate, emulsifiers, preferably sodium lauryl sulfate and sorbitan esters of higher fatty alcohols, agents for skin care, preferably carbamide, local anaesthetics, UV-filtering agents and agents effective against other infections than by Herpes simplex, particularly antibiotics and steroids.
  • pharmaceutical excipients such as preservatives, preferably methyl paraban, propyl paraban or a mixture thereof, in
  • the symptom-treating effect according to the invention can be combined with an antiviral effect by the composition additionally containing antiviral agents that are effective against Herpes simplex virus in therapeutically effective dosages in man, particularly foscarnet or acyklovir or a mixture thereof.
  • antiviral agents that are effective against Herpes simplex virus in therapeutically effective dosages in man, particularly foscarnet or acyklovir or a mixture thereof.
  • other antiviral agents may be used for this purpose, especially compounds of the nucleoside type.
  • composition according to the invention has great value for the topical treatment of manifestations of infections by Herpes simplex virus in man and of skin blisters of other origin. It is also preferred to make up the composition according to the invention for this specific purpose, that is, to bring it into a form suited for practical use, therein included an appropriate package, such as a tube, a single dose package in plastic material or metal foil or a cream jar.
  • an appropriate package such as a tube, a single dose package in plastic material or metal foil or a cream jar.
  • the cream composition according to the invention is on par with some of the most lenient products for skin care on the market.
  • the invention also discloses a process for manufacture of a cream composition intended for prophylaxis against or treatment of skin blisters caused by radiation, heat or chemical or mechanical agents or caused by infections, particularly infection by Herpes simplex virus, comprising emulsifying in water one or several agents selected from the group consisting of straight chain primary aliphatic alcohol, branched primary aliphatic alcohol and polyglycol ether of primary aliphatic alcohol, preferably by selection of at least one agent for each member of the group, in absence of pharmacologically active agents in concentrations that are therapeutically active in man, particularly agents with antiviral activity. It is preferred for the process according to the invention to comprise addition of consistency-providing agents.
  • the process according to the invention may comprise addition of pharmaceutical excipients, such as preservatives, preferably methyl paraban, propyl paraban or a mixture thereof.
  • pharmaceutical excipients such as preservatives, preferably methyl paraban, propyl paraban or a mixture thereof.
  • the process according to the invention may also comprise the addition of colouring agents, perfumes, pH-stabilizing agents, emulsifiers, agents for skin care, UV-filtering agents, local anaesthetics, and agents against infections other than by Herpes simplex, particularly antibiotics and steroids.
  • antiviral agents such as foscarnet or acyclovir may be added to the composition according to the invention.
  • composition according to the invention may be used for the manufacture of a medicament for topical treatment of blisters due to herpes simplex labialis infection in man or for the manufacture of a medicament for topical treatment of skin blisters in man due to physical or chemical irritation of the skin, such as blisters formed in solar dermatitis or sunburn blisters.
  • the invention will now be explained in greater detail by reference to several preferred but not limiting embodiments.
  • a cream was prepared from 80 g of cetyl alcohol, 30 g of 2-octyl dodecanol, 30 g of cetostearyl alcohol polyglycol ether, 20 g of vaselinum oil, 10 g of silicone oil, 55 g of paraffin wax, 3 g of methyl paraben, 3 g of propyl paraben and 755 ml of water. An opaque white cream was obtained.
  • Example 3 By the procedure of Example 1 the following cream compositions were prepared: Example 3 4 5 6 7 8
  • 2-octyl dodecanol 30 30 10 55 30 cetostearyl alcohol polyglycol ether 20 20 20 35 50 50 50 vaselinum oil 20 10 10 5 10 10 silicone oil 10 20 10 2.5 2.5 2.5 paraffin wax 55 55 30 30 55 55 methyl paraben + propyl paraben 1: 1 3 3 3 3 3 3 rest water *) cetostearyl alcohol
  • a cream with the composition according to Example 1 was prepared as described but with additional substances added, and with corresponding reduction in water content:

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Birds (AREA)
  • Emergency Medicine (AREA)
  • Dermatology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Preparation (AREA)

Abstract

Composition en crème pour le traitement ou la prophylaxie des ampoules cutanées, telles que les ampoules qui apparaissent après les coups de soleil, dans la dermite solaire ou dans le cadre d'une infection par le virus de l'herpès. La préparation comprend respectivement un membre des familles des alcools aliphatiques primaires à chaîne droite, de préférence les alcools à chaîne droite C12-C22, des alcools aliphatiques primaires à chaîne ramifiée, de préférence les alcools à chaîne ramifiée C12-C24, et des éthers polyglycoliques d'alcools aliphatiques primaires, de préférence d'alcools primaires C12-C22. La composition est dépourvue d'agents pharmacologiquement actifs à des doses ayant une action thérapeutique chez l'homme. Des méthodes de traitement, un procédé de fabrication de la composition et l'utilisation de la composition pour la fabrication d'un médicament sont également décrits.
PCT/SE1994/000782 1993-02-26 1994-08-25 Composition pour le traitement des ampoules cutanees Ceased WO1996005805A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
SE9300663D SE9300663L (sv) 1993-02-26 1993-02-26 Kräm mot munsår
SE9300663A SE501801C2 (sv) 1993-02-26 1993-02-26 Kräm mot munsår
PCT/SE1994/000782 WO1996005805A1 (fr) 1993-02-26 1994-08-25 Composition pour le traitement des ampoules cutanees
AU78254/94A AU7825494A (en) 1993-02-26 1994-08-25 Composition for treatment of skin blisters

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE9300663A SE501801C2 (sv) 1993-02-26 1993-02-26 Kräm mot munsår
PCT/SE1994/000782 WO1996005805A1 (fr) 1993-02-26 1994-08-25 Composition pour le traitement des ampoules cutanees

Publications (1)

Publication Number Publication Date
WO1996005805A1 true WO1996005805A1 (fr) 1996-02-29

Family

ID=26661666

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/SE1994/000782 Ceased WO1996005805A1 (fr) 1993-02-26 1994-08-25 Composition pour le traitement des ampoules cutanees

Country Status (1)

Country Link
WO (1) WO1996005805A1 (fr)

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0055029A2 (fr) * 1980-12-09 1982-06-30 Kowa Company, Ltd. Préparations pour le traitement de dermatoses

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0055029A2 (fr) * 1980-12-09 1982-06-30 Kowa Company, Ltd. Préparations pour le traitement de dermatoses

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