DD234611B1 - OINTMENT BASE AND SKIN CARE IN THE FORM OF A LIPID IN WATER EMULSION - Google Patents

Description

Field of application of the invention

The invention relates to a new ointment base of the type W, which can be used as a skin care product or in which dermatologically active ingredients can be incorporated. Field of application of the invention is the pharmaceutical industry and medicine.

Characteristic of the known technical solutions

The normal functional state of the epidermis of human skin is essentially determined by the intensity and timing of the proliferation, differentiation, maturation and keratinization of the epidermis cells and by the relationship of these processes to one another. External or internal skin effects may affect one or more of these parameters, which in turn may retroactively affect the course of other processes in the skin. The result of these processes, depending on the presence or absence of the basic disposition of the skin, are various skin diseases such as desiccation dermatoses, aging skin, various forms of eczema, psoriasis, ichthyosis, and the like. a. m.

The starting point for any successful external therapy of these diseases is the selection of an optimal basis, the most suitable vehicle. For each active substance, a corresponding vehicle must be selected in the respective desired pharmaceutical form. The following requirements must be met for these vehicles:

- no irritative effects on the skin

- lack of sensitization properties

- favorable liberation of the active substance

- Favorable influence on the functional structure of the skin according to the particular disease

- Support of the respective penetration kinetics of the drug

The ointment base is not only to be selected as a carrier for drugs, but it also affects the skin itself because of their physicochemical properties. This is especially true in the prophylaxis and metaphylaxis of many skin diseases. So z. B. psoriatiker a corresponding, the normal functional structure of the skin supportive, drug-free skincare in the eruption-free interval or a therapy-supporting Externum after or before the various forms of phototherapy.

The attending physician relies on individual formulations to be prepared by the pharmacist, which seldom meet all the above-mentioned requirements. On the other hand, the interaction of skin condition, vehicle and drug under the influence of numerous auxiliaries is a problem of dermatopharmacology manageable only for the specialist. In addition, in selecting an appropriate basis in external therapy, the skin type, the degree of manifestation of the disease and the morphology of the disease must be taken into account, so that different bases must be applied.

In summary, it can be stated that at present there are no ointment bases or skincare products satisfying these requirements.

Object of the invention

The object of the invention is to develop a skin care product adapted to the basic type of skin which supports the normal functional structure of the skin.

Explanation of the essence of the invention

The invention has for its object to develop a skin care product or an ointment base type W with penetration-promoting properties, which can serve as a vehicle for different drugs.

According to the invention, the new ointment base type W in the form of a lipid in water emulsion from 1 to 10 '% with 5 to 20% urea-occupied polysaccharide, 1 to 5% glycerol triacetate, 2 to 10% propylene glycol, glycerol stearate, stearyl alcohol and emulsifying alcohols, preferably Romulgin ASS, as well as 50 to 80% water. This composition is well adapted to the basic skin types and is galenically and chemically stable.

The microbiological purity of this emulsion type is preferably achieved by addition of methyl hydroxybenzoate and propyl hydroxybenzoate.

In this vehicle, drugs, preferably corticosteroids, dithranol, antimycotics, sunscreens or antiviral substances and necessary stabilizers and excipients may be incorporated.

The application of the low-fat ointment base type W is usually carried out in seborrheic skin types (about 50% of the population).

embodiment

The invention will be explained in more detail below using an example:

According to the invention, a urea phase is first prepared by urea dissolved in water and stirred with a polysaccharide, preferably corn starch, to a thin suspension, which is then dried at 60 to 80 ° C. A water phase is prepared by dissolving triacetin, propylene glycol and methyl hydroxybenzoate in water at a maximum of 80 ° to 90 ° C. In a melt phase, glycerol stearate, stearyl alcohol, romulgin ASS and propyl hydroxybenzoate in the melt kettle are stirred continuously at a maximum of 70.degree mixed to clear liquid melt. The mixture of the individual phases takes place in a Frymaf plant by initially introducing the melt phase and mixing the urea phase with constant stirring. Subsequently, the emulsion is formed by adding the water phase with intensive stirring (homogenizing) for 10 to 20 minutes. The emulsion is then cooled to about 37 ° C. with constant stirring until the system has been emptied.

As an example of a composition of the ointment base of the W type can be listed: Triacetin 3.50

Propylene glycol 3.50

Glycerol stearate 3.00

Stearyl alcohol 2.50

Romulgin ASS 6,00

Urea 10.00

Cornstarch 4.00

Methyl hydroxybenzoate 0.12

Propyl hydroxybenzoate 0.08

Water 67.30

100.00

The galenic stability of the ointment base according to the invention proved to be sufficient in the cold, heat, swing and centrifuge tests usually used for stability reports.

For chemical stability, the following urea concentrations could be found with respect to the urea content of the example given above:

After storage for 1 year at room · at + 40 ° C

temperature

Ointment base W type 9.78% 9.23%

A comparatively very good skin compatibility results from the epidermal reaction after short-term and long-term contact with the ointment base type W in animal experiments (guinea pig ear) after biometric and 'H-Thymidinautoradiographischen investigations.

Contact duration AF PI DNS-SI

1 week 1.19 1.13 1.05

4 weeks 0.93 0.99 0.73

(AF = acanthosis factor, Pl = papillomatosis index, ONS-SI = DNA synthesis index)

Claims (2)

1. ointment base for dermatologically active ingredients and skin care products in the form of a lipid-in-water emulsion, characterized in that they from 1 to 10% with 5 to 20% urea-occupied polysaccharide, 1 to 5% glycerol triacetate, 2 to 10% propylene glycol, glycerol stearate , Stearylalkohol and emulsifying alcohols, preferably Romulgin ASA, and 50 to 80% water. 2. ointment base and skin care agent according to claim 1, characterized in that for the microbiological purity of the emulsions preferably 0.01 to 1% Methylhydroxybenzoat and Propylhydroxybenzoateingearbeiting.