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WO1998017265A1 - Composition pharmaceutique contenant de la tromethamine pour le traitement topique de l'acne simple - Google Patents

Composition pharmaceutique contenant de la tromethamine pour le traitement topique de l'acne simple Download PDF

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Publication number
WO1998017265A1
WO1998017265A1 PCT/IT1997/000239 IT9700239W WO9817265A1 WO 1998017265 A1 WO1998017265 A1 WO 1998017265A1 IT 9700239 W IT9700239 W IT 9700239W WO 9817265 A1 WO9817265 A1 WO 9817265A1
Authority
WO
WIPO (PCT)
Prior art keywords
tromethamine
realization
composition according
grams
stearyl
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/IT1997/000239
Other languages
English (en)
Inventor
Achille Sandoli
Adele Fantola
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
Application filed by Individual filed Critical Individual
Publication of WO1998017265A1 publication Critical patent/WO1998017265A1/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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines

Definitions

  • the present invention concerns a pharmaceutical composition containing tromethamine for the topical treatment of acne vulgaris.
  • Tromethamine behaves as a weak base characterized by a significant buffer action.
  • a 0.3 molar solution (3.6% solution - 36 g/litre) is iso-osmolar with human plasma and has a pH of about 8.
  • tromethamine has been employed in the synthesis of surface-active agents and of vulcanisation accelerators. In cosmetics, it is used as an emulsifying agent for creams and lotions. In medical therapy tromethamine is used in the treatment of metabolic, respiratory, diabetic and post-operative acidosis; in acidosis during the cardiopulmonary bypass, in heart failure and shock. In all these therapeutic uses, tromethamine is employed in the form of a 0.3 molar watery solution.
  • Acne vulgaris is one of the most common dermatological affection that strikes 25% of the youth between 12 and 20 years in variable measure. As in its most serious forms, which are not infrequent, acne vulgaris may cause disfiguring scars, it is in fact a disease with large psychical implications that may result in social maladjustment and self-isolation.
  • the topical therapy is based on the use of compounds against seborrhoea compositions with keratolytic action (benzoyl peroxide) , with a basis of retinoic acid, estrogens and topical corticosteroids .
  • Topical preparations against seborrhoea in general are available in a huge variety of lotions, creams, powders containing sulphur, salicylic acid and resorcinol.
  • the majority of these products are irritant when applied onto the skin, and the best results are obtained when they are used with they produce a non- damaging exsiccation and an exfoliation of the affected skin.
  • a too limited use offers a very limited advantage, while an excessive use may be the cause of further lesions and pain. All these products might induce further seborrhoea.
  • Benzoyl peroxide acts as an exfoliating and a keratolytic agent. Therapeutic results are not obtained before 5-6 weeks. This treatment may produce skin irritation at various degrees and eczema.
  • Retinoic acids acts against the creation of comedones.
  • the greatest handicap of this product is its irritating action that, during the first month of treatment or even further, may cause a deterioration of the lesions, with erythema and desquamation, and such collateral effects might lead to a suspension of the therapy.
  • the effectiveness of the treatment with chemotherapeutic agents and antibiotics is debatable, as there might occur photo- sensitization and modification of the bacterial flora.
  • the hormonic therapy has several drawbacks. First of all, male patients are excluded from the treatment; secondly, therapeutic effects are detectable only after months; finally, the best results are obtained using preparations with a higher level of estrogens, which yet present the greatest risks of thrombosis and embolism. Usually the hormonic therapy is employed in young female patients with acne clearly becoming acute in pre-menstrual periods.
  • the present invention derives from the discovery that tromethamine and its pharmacologically acceptable salts, such as acetate, carbonate, citrate, phosphate, succinate and sulfate, administered in topical applications, are extremely effective anti-acne agents, not presenting the considerable side effects of known medicines .
  • a pharmaceutical composition according to above scientific and experimental discovery comprising tromethamine and/or its pharmacologically acceptable salts in preparations for topical use such as creams, emulsions, solutions, lotions, in spray containers and similar.
  • compositions are given per 100 g of their formulation.
  • Spray composition tromethamine gr. 3.60 citric acid " 0.65 cetyl-stearyl-ethoxylate alcohol " 2.00 water " 83.70 freon 12 - Freon 114 (15/85) " 10.00
  • Cream composition tromethamine gr. 3.60 citric acid " 0.65 silicon oil “ 0.15 soya lecithin “ 1.00 sodium stearyl lactilate “ 1.50 cetyl-stearyl-ethoxylate alcohol “ 14.00 propylene glycol “ 4.00 glycerin “ 2.00 nipasept " 0.15 water " 73.00
  • 0.3 molar watery solutions may also be used.
  • composition according to the present invention has been tested, using a 3.6% tromethamine solution (thamesol of Baxter hydroxymethyl - aminomethane 0.3 M - Acetic acid 0.1
  • the clinical varieties treated were mixed forms of acne microcystica-comedonica and papulo-pustulosa, with a wide range of seriousness and extension of skin lesions.
  • the medication On the dry face, the medication is applied and the skin is gently rubbed with wads watered with abundant tromethamine solution on all the points concerned.
  • the application for a few minutes of a pledget soaked with solution has proved to be effective; the skin may dry at ambient air.
  • the skin shows a definitely less greasy appearance; its surface is smoother and more regular; its colour is clearer and more uniform.
  • the results further improve with a total "restitutio ad integrum" of the dermal tissue.
  • tromethamine and its pharmacologically acceptable salts perform a progressive and constant therapeutical action in the topical treatment of acne vulgaris .
  • the first event is shown by a rapid halt to the evolution of cutaneous lesions, followed by a constant regression, up to the complete remission, of the objective symptomatology. Such an effect is most evident towards the inflammatory component.
  • the rectification of the abnormally lowered pH may determine the inhibition of those enzymatic activities (in particular, phospholipases) with an optimum in acid media (pH 5-6) , which give rise to the liberation of free fat acids.

Landscapes

  • 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)
  • Medicinal Preparation (AREA)
  • Cosmetics (AREA)

Abstract

Cette composition pharmaceutique de trométhamine permet le traitement topique de l'acné simple grâce à la réalisation de crèmes, de laits, de lotions et similaires, contenant de 1 à 10 grammes de trométhamine par 100 grammes de produit.
PCT/IT1997/000239 1996-10-17 1997-10-06 Composition pharmaceutique contenant de la tromethamine pour le traitement topique de l'acne simple Ceased WO1998017265A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITCA96A000022 1996-10-17
ITCA960022 IT1288708B1 (it) 1996-10-17 1996-10-17 Composizione farmaceutica comprendente trometamina per il trattamento per via topica dell'acne vulgaris.

Publications (1)

Publication Number Publication Date
WO1998017265A1 true WO1998017265A1 (fr) 1998-04-30

Family

ID=11347108

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IT1997/000239 Ceased WO1998017265A1 (fr) 1996-10-17 1997-10-06 Composition pharmaceutique contenant de la tromethamine pour le traitement topique de l'acne simple

Country Status (2)

Country Link
IT (1) IT1288708B1 (fr)
WO (1) WO1998017265A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2018177778A (ja) * 2017-04-10 2018-11-15 花王株式会社 皮膚洗浄剤組成物
CN110494120A (zh) * 2017-04-10 2019-11-22 花王株式会社 去除角栓的方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994021271A1 (fr) * 1993-03-19 1994-09-29 Cellegy Pharmaceuticals, Inc. Procedes et compositions pour induire une separation de phase des deux couches lipidiques de l'epithelium
US5352389A (en) * 1991-07-08 1994-10-04 Crinos Industria Farmacobiologica Spa Composition for the cleaning of the skin, scalp and hair
WO1995000176A1 (fr) * 1993-06-18 1995-01-05 Allergan, Inc. Compositions pour le traitement des complications oculaires associees a l'hypoxie
WO1995033489A1 (fr) * 1994-06-07 1995-12-14 Allergan Composition de gel stable pour le traitement topique de maladies de la peau
WO1996014055A1 (fr) * 1994-11-04 1996-05-17 The Procter & Gamble Company Hydrolyse acide ou basique d'emulsions tamponnees contenant des composes actifs

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5352389A (en) * 1991-07-08 1994-10-04 Crinos Industria Farmacobiologica Spa Composition for the cleaning of the skin, scalp and hair
WO1994021271A1 (fr) * 1993-03-19 1994-09-29 Cellegy Pharmaceuticals, Inc. Procedes et compositions pour induire une separation de phase des deux couches lipidiques de l'epithelium
WO1995000176A1 (fr) * 1993-06-18 1995-01-05 Allergan, Inc. Compositions pour le traitement des complications oculaires associees a l'hypoxie
WO1995033489A1 (fr) * 1994-06-07 1995-12-14 Allergan Composition de gel stable pour le traitement topique de maladies de la peau
WO1996014055A1 (fr) * 1994-11-04 1996-05-17 The Procter & Gamble Company Hydrolyse acide ou basique d'emulsions tamponnees contenant des composes actifs

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2018177778A (ja) * 2017-04-10 2018-11-15 花王株式会社 皮膚洗浄剤組成物
CN110494120A (zh) * 2017-04-10 2019-11-22 花王株式会社 去除角栓的方法
EP3610848A4 (fr) * 2017-04-10 2021-01-06 Kao Corporation Composition d'agent nettoyant pour la peau
EP3610849A4 (fr) * 2017-04-10 2021-01-13 Kao Corporation Procédé d'élimination des points noirs
US11406576B2 (en) 2017-04-10 2022-08-09 Kao Corporation Method for removing keratotic plugs
US11975086B2 (en) 2017-04-10 2024-05-07 Kao Corporation Method for removing keratotic plugs

Also Published As

Publication number Publication date
IT1288708B1 (it) 1998-09-23
ITCA960022A1 (it) 1998-04-17

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