GD - Online Press Releases 1998
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2nd Annual Meeting of the Gesellschaft für Dermopharmazie [GD] (Society for Dermopharmacy) in Wiesbaden on 6 May 1998

GD Press releases 1 to 5/1998 concerning the 2nd Annual Meeting of the Gesellschaft für Dermopharmazie

In brief
Complete replacement of animal experiments?
Vitamin E - most important protecting vitamin of skin
Care lotions for dry skin - which requirements do they have to meet?
Solid lipid nano particles: the new generation of liposomes

Press release 1/1998

In brief

Cosmetics without animal experiments

Members of animal protection groups have been demanding for a long time that animal experiments should be given up in the development of cosmetical products. From 30 June 2000 on this wish could become true: from this date on no cosmetical products should be placed on the market the elements of which have been tested in animal experiments. This has been stipulated by directives decided by the EC commission. However, in the meantime substitutional methods have to be developed and these new methods as well as already existing methods have to be approved on an international level. Professor Dr. med. Horst Spielmann, head of the Zentralstelle zur Erfassung und Bewertung von Ersatz- und Ergänzungsmethoden zum Tierversuch (Central Office for the Registration and Assessment of Replacement- and Supplementation-Methods of Animal Experiments) [ZEBET] at the Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin (Federal Institute for Sanitary Consumer Protection and Veterinary Medicine) [BgVV] in Berlin explained the possibility of a renunciation of animal experiments until the deadline in the year 2000 on the occasion of the 2nd Annual Meeting of the Gesellschaft für Dermopharmazie. A realistic way of proceedings seems to be a gradual opting out of animal experiments. Step by step alternative methods would have to be introduced. The physician presented several promising methods in Wiesbaden. Thus he explained for example that it is possible to obtain reliable data from human skin of operation material. Due to the fact that the share of the experiments for cosmetics in the EC is only three per cent, the prospects to reduce the suffering of animals considerably are rather insignificant.

Body care lotions for dry skin

Many people use body care lotions as a remedy for dry skin. There is a heavy demand for such products in pharmacies. The reason is probably that customers expect to get here qualified advice. However, the judgement of the products is sometimes difficult because quite often sufficient information relating to the product properties is not available. For this reason the department Dermocosmetics of the Gesellschaft für Dermopharmazie (GD) intends to define guidelines which lay down the requirements cosmetic products have to meet from a professional view. This has been announced at the 2nd Annual Meeting of the Gesellschaft für Dermopharmazie in Wiesbaden. First of all the guidelines for body care lotions for dry skin sold in the market will be established. There is an urgent need to stipulate the demands because these products are applied by numerous persons on large parts of the skin and over a long period of time. By defining minimal standards, the department will ensure a higher degree of transparency within the cosmetic market.

Significance of Vitamin E in Skin

Human skin is exposed to a high measure of stress. Especially environmental factors as UV-rays and ozone can harm the largest human organ. Among the most important protecting substances, human skin is provided with, is vitamin E. Dr. Jens J. Thiele, Institut für Physiologische Chemie (Institute for Physiological Chemistry) of the Heinrich-Heine-University in Düsseldorf has investigated the significance of vitamin E in the stratum corneum epidermis and the way it spreads in skin in several studies. He presented his investigation results at the 2nd Annual Meeting of the Gesellschaft für Dermopharmazie. Thiele was able to verify in his studies that skin suffering from a lack of vitamin E reacts in a more intense way when exposed to environmental stress as for instance UV-rays and ozone.


Solid lipid nano particles: the new generation of liposomes

News from cosmetical research: the name of the new generation of liposomes is Lipopearls. They are ultra-fine particles of solid lipids disposing of a good tolerability. Lipopearls form a protective film on skin, the moisture care of skin rises, conditioning substances from the particles are passed on in a controlled manner to the skin. Professor Dr. Rainer H. Müller, Institut für Pharmazeutische Technologie der FU Berlin (Institute for Pharmaceutical Technology of the Free University Berlin) presented the advantages of the lipid nano particles and explained two technical possibilities to produce the new active substance vehicle.

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Press release 2/1998

Complete replacement of animal experiments in the cosmetic field?

Starting from 30 June 2000 definitely no cosmetic products are to be sold the contents of which have been subject to test in animal experiments. This has been decided by the directives of the EC committee on 17 April 1997. Until the coming into force of this prohibition, substitutional methods have to be developed and validated on an international level together with the already existing methods. At present it cannot be assessed whether or not a replacement can be found for all safety-toxicological tests until this deadline. Professor Dr. med. Horst Spielmann, head of the Zentralstelle zur Erfassung und Bewertung von Ersatz- und Ergänzungsmethoden zum Tierversuch [ZEBET] (Central Office for Registration and Assessment of Replacement- and Supplementation Methods for Animal Experiments) at the Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin [BgVV] (Federal Institute for Sanitary Consumer Protection and Veterinary Medicine) in Berlin discussed the possibilities until the year 2000 at the 2nd Annual Meeting of the Society for Dermopharmacy.


He explained that since it is not realistic to dispense with animal experiments as of immediately, the Europäische Verband der Kosmetikindustrie [COLIPA] (European Federation of the Cosmetic Industry) and the EU Validierungszentrum für Alternativmethoden [ECVAM] (EC Validation Center of Alternative Methods) suggest to opt out gradually. Accordingly, cosmetic finished products are not to be tested in animal experiments effective immediately. In Germany this prohibition has been realized since 1987 whereas other European countries as England, France and Austria still have carried out animal experiments until quite recently. According to this sequence plan it will be possible to test skin penetration, skin irritation, corrosivity and phototoxicity of new content substances until the year 1999 by using alternative methods. According to Spielmann, the test of eye irritation caused by content substances cannot be realized without using the Draize-test at rabbit eyes before 2000.

The physician presented numerous promising in-vitro theories which still have to be agreed to by the corresponding international committees first. Thus mice fibrocytes are used very successfully for testing the phototoxic properties of chemical substances. When using human skin from operation material, as was to be expected, even more reliable data regarding the skin penetration of content substances can be achieved compared with the very hairy animal skin. The Draize-test at the rabbit eye could be replaced by special tests (HET-CAM-test) at hatched hen's eggs in the future.

For other tests for example, when examining a content substance regarding sensitisation properties or toxicity, experts only see minor prospects for the replacement of animal experiments by in-vitro-tests.

In conclusion however, Spielmann made clear to the audience that the suffering by animals will not be considerably reduced by the new directives due to the fact that the part of tests for cosmetics in the EC amounting to three per cent only plays an insignificant part in the totality of all animal experiments.

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Press release 3/1998

Vitamin E - most important protective vitamin of skin

The effect of topical applied tocopherol for the protection from light-induced skin damages could already be shown in many studies. The significance of vitamin E in the horny layer of the epidermis, the stratum corneum, however, and how it spreads in human skin, could now be proven for the first time. Dr. Jens J. Thiele, Institut für Physiologische Chemie (Institute for Physiological Chemistry) at the Heinrich-Heine-University in Düsseldorf informed about his latest examinations relating to the protective effect of alpha-tocopherol against UV-light and ozone-induced oxidative stress in skin at the 2nd Annual Meeting of the Gesellschaft für Dermopharmazie in Wiesbaden.

His studies prove that vitamin E is the most important antioxidant for the entire skin network, but in particular for the stratum corneum. The horny layer because of its border position between environment and human body is subject to detrimental environmental factors to an extreme degree. This dermal layer is a two-compartment system of protein-rich, anuclear structural cells, the corneocytes, embedded in a matrix from multiple lipid-double layers, the lipid bi-layers. These epidermal lipids perform the function of a dehydration- and penetration barrier for the entering of foreign substances into skin. As the lipid layer mainly consists of cholesterol, free fatty acids and ceramides, this structure is especially susceptible to oxidative detriments. Composition and structure of this layer, however, are extremely important for its barrier function.

Thiele was able to prove by his studies that skin reacts in a more intense way to oxidative stress by UV-radiation, ozone and chemicals if there is a lack of vitamin E. He designated the vitamin as a very sensitive biomarker for this type of environmental strain. Besides, his studies demonstrated that alpha-tocopherol is transported from deeper skin layers to the skin surface by means of a mechanism mediated by the sebaceous glands.

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Press release 4/1998

Care lotions for dry skin. Which requirements do they have to meet?

The department Dermocosmetics of the Gesellschaft für Dermopharmazie (GD) intends to define guidelines which lay down the requirements for cosmetical products from a competent point of view. As a first product segment body lotions for dry skin will be treated. Due to the fact that these preparations are used by a large number of persons extensively and mostly on a long-term basis, the department holds the opinion that a benefit-risk evaluation is of utmost importance. The elaborated standards are to facilitate consultation in pharmacies, explained professor Rolf Daniels, Institut für Pharmazeutische Technologie der TU Braunschweig (Institute for Pharmaceutical Technology of the Technical University) at the GD's 2nd Annual Meeting in Wiesbaden on 6 May.

There is a large number of inquiries for body lotions for dry-sensitive and possibly also pre-damaged skin in pharmacies. The reason for this is probably that the consumer expects here a high level of consultation competence. However, at present the assessment of products is difficult because information about the product properties is not available at a sufficient extent.

It is true that the products claim effects as providing the skin with fat and moisture or giving the skin protection. However, the specification of the efficacy proof which the cosmetic decree calls for is seldom shown; as a rule it is indicated by addenda as "tested clinically" or "examined dermatologically". In order to obtain a positive benefit-risk assessment, the tolerability has to be tested by using appropriate methods in addition. Information as to type and extent of the examinations carried out, however, are not easily available. In this context the department intends to establish more transparency by defining minimal standards. In the future corresponding guidelines will be drawn up also for additional cosmetic product groups.

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Press release 5/1998

Solid lipid nano particles: the new generation of liposomes

After liposomes and niosomes, solid lipid nano particles (Solid Lipid Nano particles - SLN) are the new generation of nano particular active substance vehicles. The particles registered under the trademark Lipopearls have a size of approx. 80 to maximal 1000 nanometer. They consist of a solid lipid which has been stabilized in an aqueous dispersion with a surfactant or polymer.

Professor Dr. Rainer H. Müller, Institut für Pharmazeutische Technologie der FU Berlin (Institute for Pharmaceutical Technology of the FU Berlin) introduced the two technical possibilities to produce the new active substance vehicles at the 2nd Annual Meeting of the Gesellschaft für Dermopharmazie: the hot-homogenisation and the cold-homogenisation which is especially applicable for active substances sensitive to temperature

For the hot-homogenisation the active substance is dissolved in melted lipids and the solution is poured into a hot surfactant solution. A crude emulsion is produced by means of an agitator. This emulsion is subsequently homogenized in three stages under high pressure. After the cooling off process, solid lipid nano particles develop.

For the cold-homogenisation, the lipid-active substance melting is cooled off and ground to micro particles which are then suspended in a cold surfactant solution. This suspension is afterwards homogenised in the solid state whereas the cavitation power tear the micro particles to lipid nano particles.

The SLN combine the advantages of emulsions, liposomes and solid polymer nano particles: they can be manufactured in large-scale production, are of minor toxicity, protect the active substance from decomposition and allow at the same time a controlled active substance release. They form a film on skin and improve the penetration of active substances by means of the occlusive effect. Furthermore, they can be easily processed in creams: they are simply stirred into creams or lotions or a part of water can be replaced by the SLN dispersion in the production process.

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For further information please contact:

Gesellschaft für Dermopharmazie
65760 Eschborn
Tel: +49-6196-928-328
FAX: +49-6196-928-329
Internet: info@dermopharmazie.de

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