PT98757A - PROCESS FOR THE PREPARATION OF A PHARMACEUTICAL COMPOSITION FOR THE TREATMENT OF PSORIASIS CONTAINING GAMA-LINOLIC ACID AS ACTIVE INGREDIENT - Google Patents

Description

The invention relates to compositions suitable for the topical treatment of psoriasis as well as processes for the preparation of said compositions.

The compositions according to the invention contain the extracts from different parts of the maize plant (Zea mays) together with gamma-linolenic acid as the active ingredient.

The different clinical and laboratory investigations have clearly revealed that psoriasis is not usually induced by a single cause, but rather by the complex resulting from different mechanisms that are related to each other casually. The incidence of psoriasis is different but occurs worldwide, with both men and women being affected and the number of patients being in the range of 0.3-4.8% of the total population. The disease can occur at any age, but it most often affects people in the 10-30 age bracket. Psoriasis belongs to the group of papulosquamous diseases that may be characterized by silver-scaled scales, considerable scaling and anarchic cell division (karyokinesis). At the beginning papules 3-5 mm in diameter appear and covered with parakeratosis that can gradually collect or increase in size thus forming plaques with a diameter of several centimeters. Investigations into cell kinetics prove that epidermal cell reproduction is done very quickly. Typically the cell cycle time is about 311 hours, while the same is shortened to 36 hours in the case of patients with psoriasis. The clinical picture usually reveals a progression at the edges and a central improvement. Very characteristic is the occurrence in the elbow, the knee and the scalp. 3 Psoriasis is a hereditary deficiency of epidermal regulation as well as haemostasis disorder due to which it is necessary to face both local and systemic effect in relation to various clinical forms of psoriasis. The role of heredity in the formation of psoriasis is now generally recognized and is thought to be related to the psoriatic gene Cw6. Several authors have different opinions on the mode and process of heredity but in general the hereditary process called polygenic, multifactorial is accepted. The heredity factor can be supported for example by the following observations: - incidence in mass in certor geographic territories - incidence in families is more frequent, - also be proven by genetic investigations.

The local disturbance of the relevant biochemical regulation is also related to complex pathogenic factors. Injury of the cAMP dysteme may cause disturbance of the epidermal self-regulation, and thus for example after administration of lithium (which decreases the level of cAMP) the psoriasis intensity decreases, whereas the enzyme inhibitors (for example 'fosfordieste-rase-PDE ) by decomposing the cAMP system (for example Theophylline) advantageously influence the disease. The immune system, the arachidonic acid system as well as the metabolism of the polyamine and the various proteinases may also have a significant role in triggering the disease since these systems differentially influence the metabolism of the cyclic nucleotides. 4

Particularly discussed is the system function of arachidonic acid as drugs that increase the level of free arachidonic acid (for example non-steroidal antiphlogistics) worsen psoriasis.

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It has also been proved by various clinical and biological tests that in the case of psoriasis the level of free arachidonic acid and its derivatives (12-hydroxyheicosatetraenoic acid, 12-ETE) is increased in the epidermal layer of the skin.

The characteristic types of psoriasis are as follows: 1) guttate psoriasis: disseminated phenomenon having a diameter of 0.5-1.5 cm present throughout the skin. 2) Plate shape: the appearance is similar to that of the type mentioned previously but the phenomena are prolonged and accompanied with inflammation. 3) Palmar-plantar psoriasis: a thickened, flaky, less inflamed change that may have cracks at the edges and sterile blisters may appear. 4) Psoriasis of the scalp: moderately inflamed, intensely scaly phenomena possibly occurring throughout the scalp without any hair loss.

The complicated forms of psoriasis are as follows: 1) Erythrodermic psoriasis: Inflammatory and scaly symptoms appear throughout the skin, with the plaques and papules being fully assembled. 2) Pustular psoriasis: it is usually located in the palm and the plant, it spreads sometimes on the whole surface of the skin. It is a very serious, fatal disease. 3) Arthropathic psoriasis: besides the characteristic symptoms of the skin, arthritis also develops, mainly (and initially) in one hand.

To the best of our knowledge, every

I types of psoriasis are treated symptomatically. Local treatment has different objectives: a) suppression of inflammatory reactions; b) removal of accumulated scales; c) decreased epithelial cell activity; and d) prevention of associated infection of the skin surface.

In uncomplicated cases these requirements may be met partially with local treatment and in cases partially complicated with local treatment and partially with internal treatment performed simultaneously.

According to the technique the following substances have been suggested for local treatment.

Mineral tar and tar of vegetable origin have been the best known and most widely used ingredients being applied in a concentration of 3-10% in the form of ointments, dyes and bath compositions. Nowadays the use of these materials is avoided due to its carcinogenic side effects. Phototherapy has also long been known to have been observed that sunlight is very useful in treating most types of psoriasis. This therapy may be used alone or in combination with photosensitizing drugs.

The different baths represent a very important additional treatment for all types of psoriasis. Depending on the composition of medicinal water, the removal of the scales may be achieved in part and in part a decrease in inflammatory symptoms. t

Formerly ditranol, the synthetic version of plant-derived chrysaro-bin has also been used for the treatment of psoriasis but due to its defined irritative side effect and pigmentation properties is no longer applied.

The most effective antiphlogistic and proliferation inhibiting materials are corticosteroids (for example Dermovate = 21-chloro-9-fluoro-11betal7-dihydroxy-16β-methylpregn-1,4-diene-3,20-dione; Diproderm = 9-fluoro-11β, 17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate, Diploren) which may be used for the treatment of all types of psoriasis.

These drugs have a symptomatic effect and within a relatively short period of time after treatment discontinuation occurs; however prolonged use may lead to atrophy of the connective tissues, and a certain habituation to these drugs may also be observed. Thus, for prolonged treatments only steroids with fewer side effects (eg Hydrocortisone, Prednisolone) are appropriate. Systemic corticosteroid treatment can only be considered in complicated cases, but only for short periods of time.

For now the agents most frequently used for systemic treatments - exclusively in severe cases - are the aromatic derivatives of vitamin A, the so-called retinoids (eg Tigason = etretinate). These drugs, however, can only be applied very carefully since they cause serious side effects (for example increased serum lipids, hypertension, teratogenesis). f

Accordingly, psoriasis treatment has not yet been sufficiently resolved. All known compositions have side effects, and the fact that only a few topical compositions are known to prove that good results can be achieved with the orally administered compositions. The aim of our invention was to provide a topical composition for the treatment of psoriasis.

Another object of our invention has been to provide a composition without any detrimental side effect (eg, carcinogenic, teratogenic, bone marrow-damaging, producing adrenal dysfunction, etc.) without any pigmentation, dehydration, atrophy , generalized infection on the affected skin surface and its application is not limited by intercourse with other drugs.

Surprisingly it has been found that a composition comprising the pharmacologically acceptable aqueous and / or organic solvent, preferably ethanolic extract from harvests of young maize and / or young corn beards and / or young nodular corn stalk and / or ear of corn young corn and gamma-linolenic acid can be used for the treatment of psoriasis without any side effects. It is known from HUP No. 195915 (USP No. 4,950,481) that the aqueous and / or ethanolic extract from harvests of young maize and / or young corn beards and / or young nodular corn stalk and / or of young corn ear has a sedative and regenerative effect on the skin. The aqueous and / or ethanolic extract comprises the following active ingredients: - carbohydrates (mono- and oligosaccharides, polysaccharides), - fats, oils, fatty acids (phospholipids, glycolipids, galactolipids), - proteins, amino acids , - phenolic materials (flavonoids, coumarins, phenyltropanes and phenolic materials), - terpenes (sesquiterpenes, triterpenes, tetraterpenes), - vitamins, volatile oils.

Of the components indicated above those that have antiphlogistic effect are polysaccharides and flavonoids. Phospholipids are emulsifiers and are often used in cosmetic compositions as additives. Gamma-linolenic acid is an essential amino acid and " Body-friend " (histotropical), has no harmful side effect. Oenothera oil containing gamma-linolenic acid has been successfully used mainly for the treatment of different complicated and uncomplicated cardiovascular diseases. It was able to decrease the aggregation of thrombocytes, to normalize lipid levels, however in popular therapeutics it has also been used as antispasmodic and antiphlogistic agent.

Surprisingly the corn extract used hitherto in cosmetic compositions and exhibiting a mild antiphlogistic effect together with gamma-linoleic acid is effective in the treatment of uncomplicated psoriasis and after treatment the patients become asymptomatic. As the composition contains only natural ingredients it has no side effects. The active ingredients of the composition according to the invention separately are not capable of ensuring the desired effect, only being effective against psoriasis if used in common.

Accordingly the invention relates to pharmaceutical compositions suitable for the topical treatment of psoriasis comprising a pharmaceutically acceptable aqueous and / or organic solvent, preferably ethanolic extract from young maize and / or young corn and / or stem bean young nodal corn and / or young corn cob and gamma-linolenic acid as the active ingredient in admixture with one or more solid and / or liquid carriers and / or other additives. The concentration of the active ingredient preferably ranges from 15-75%.

A further object of the invention is a process for the preparation of a pharmaceutical composition suitable for topical treatment of psoriasis wherein the pharmaceutically acceptable aqueous and / or organic solvent, preferably ethanolic extract from harvests of young maize and / or young maize beards and / or young nodal corn stalk and / or young corn cob and gamma-linolenic acid as the active ingredient are mixed with one or more solid and / or liquid carriers and / or additives and the mixture thus obtained is formed into cream , emulsion or solution suitable for topical use. 10

The corn extract used in the composition according to the invention can be prepared in a manner known per se, for example the method described in U.S. Patent No. 4,590,481 may be used.

The extract may be prepared for example by extraction of optionally dried plant portions with a 2-30-fold higher amount - calculated for the dry mass of the plant - of water or aqueous solution of a cosmetically acceptable organic solvent at a temperature between 15 and 95 ° C and separation of the solid phase φ (portions of the plant) from the liquid phase.

Alternatively, the extract may also be obtained as follows: portions of the plant are crushed and soaked in the solvents referred to above. The infusion time may vary over a wide range, preferably between 5 and 48 hours. On an industrial scale extraction is preferred as it can be carried out in a shorter period of time (for example 30-60 minutes).

After extraction or infusion the product obtained may be sterilized by heating in one or more times, preferably three times at 80 ° C and heating it at this temperature for a short period of time.

For extraction, water or the aqueous solution of a pharmaceutically acceptable organic solvent miscible with water is generally used.

The pharmaceutical compositions according to the invention contain the active ingredient and one or more pharmaceutically acceptable carrier (s) and / or additive (s).

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The compositions according to the invention may contain as solid carrier for example talc, zinc oxide, bentonite, kaolin, colloidal silica, titanium dioxide, corn starch, potato starch. Solid emulsifying agents, for example fats, fatty alcohols, fatty acid, fatty acid esters, waxes may also be used as solid carriers.

The compositions according to the invention may contain as liquid carriers one or more pharmaceutically acceptable liquid non-irritating skin solvent (s), for example ethanol or animal or vegetable oil. The composition according to the invention may contain as carrier and emulsifier, respectively, fats, oils, waxes, fatty acids and their esters and glycerides generally used in the cosmetic industry.

The fatty acids may be linear or branched having 12-18 carbon atoms, may be saturated or unsaturated and may also be substituted with one or more hydroxy group (s). Suitable fatty acids are selected from the group consisting of undecenoic acid, laurylic acid, caprylic acid, myristic acid, palmitic acid, isopalmylic acid, stearic acid, isostearic acid, hydroxy stearic acid, oleic acid, hydroxy oleic acid, behenic acid , lanolinic acid, arachidonic acid, octyldecanoic acid, pentadecaic acid or mixtures thereof. Suitable fatty acid esters are selected from the group consisting of isopropyl myristate, butyl myristate, octyldodecyl myristate, isocetyl myristate, cetyl myristate, ethyl palmitate, isopropyl palmitate, hexadecyl stearate, isopropyl isostearate, isostearate of isostearyl, diisopropyl sebacate, cetyl ricinoleate, propylene glycol dipelargonate, 2-ethylhexyl isonate, hexyl laurate, 2-ethylhexyl stearate, fatty alcohol lactate having 12-16 carbon atoms, salicylate triglycerides of octanoic and decanoic acid and the mixture thereof.

As the fatty alcohol, for example alcohols having 14-22 carbon atoms, for example behenyl alcohol, myristyl alcohol, arachidyl alcohol, stearyl alcohol, isostearyl alcohol, cetyl alcohol, cetyl stearyl alcohol, isocetyl alcohol, oleyl alcohol , lauryl alcohol.

As liquid carrier various oils or oil blends commonly applied in the cosmetic industry may also be used. The oils act as stabilizing agent in the emulsions and ensure a cosmetically suitable viscosity for the emulsion. Suitable oils are selected from the group consisting of aliphatic hydrocarbons (for example liquid paraffin, petroleum jelly, ceresin, etc.), vegetable oils and fats (for example olive oil, almond oil, wheat germ oil, corn, cottonseed oil, grape seed oil, jojoba oil, avocado oil, pepper oil, palm oil, cocoa butter, etc.), animal fats and oils (for example liver oil cod, whale oil, butyram, etc.).

The compositions according to the invention may contain as other additives for example one or more hygroscopic material (materials), solubilizing and stabilizing agent, preservative, disinfectant, skin sedative, skin protector, epithelial regenerator, replenishment agent fat in the skin, light protective materials and flavorings, vitamins, etc.

As hygroscopic materials may be used, for example, glycerol, sorbitol, propylene glycol.

As the solubilizing material, for example butylhydroxyanisole, butylhydroxytoluene, ethylene-diamine-tetraacetic acid, nor-dihydroguaiaretic acid may be used.

A preservative may be used, for example methyl paraben, p-hydroxybenzoic acid and its esters, chloromethyl-isothiazoline, methyl isothiazoline, phenoxethole, hexetidine, chlorhexidi-n-gluconate, imidazolidinyl urea. If desired, formaldehyde and other similar preservatives may also be used. As tonic and disinfectants may be used for example menthol, camphor, lactic acid, citric acid, ethanol.

As the regenerating material of the epithelium, for example, allantoin, panthenol, calcium pantothenate can be used.

As the skin's sedative material there may be used, for example, chamomile extract, azulene, bisabolole.

As protective and skin fat replacement material, for example, cholesterol, propane-3-carboxymethyl betaine, 1- (alkylamino) -3- (dimethylamino) propane-3-N-oxide, propane-3- (carboxymethyl) -betaine, alkyl-dimethylaminoxide, cocoa-acid mono-and di-ethanolamide.

As the light-protecting material (sunscreen) there may be used, for example, octyl dimethyl-PABA,

2-hydroxy-4-methoxybenzophenone, 2- (ethylhexyl) -3- (4-methoxyphenyl) -2-propenoate, 1- (4-methoxyphenyl) -3- (4- butyl-phenyl) -propane-1,3-dione, urocainic acid, esculin.

As a vitamin one may be used, for example, vitamin A, B, B1, C, E, F, Η, P.

As flavoring material, for example, perfume oil can be used which ensures a pleasant and attractive smell for the composition. The composition according to the invention may be formulated into different forms suitable for topical treatment, for example cream, ointment, emulsion, solution, tonic, gel, etc. may be prepared.

The creams and ointments according to the invention contain 30-70% by weight corn extract and 0.05-3% by weight gamma-linolenic acid as the active ingredient.

The emulsions according to the invention contain 15-30% by weight corn extract and 0.05-3% by weight gamma-linolenic acid as the active ingredient.

The solutions according to the invention preferably contain 30-50% by weight corn extract and 0.05-3% by weight gamma-linolenic acid as the active ingredient. w The amount of water and aqueous solvent used in the compositions depends on the consistency of the desired end product. The water used is preferably deionized water and the amount thereof is generally 27-75% by weight calculated for the total amount of the composition. The cream and ointment compositions generally contain at least 20% by weight but at most 60% by weight of water, the water content of the emulsion preferably varying between 50-70% by weight and that of the solutions preferably between 40-70 % by weight.

The following non-limiting Examples have compositions of the invention.

The corn extracts used in Examples 1, 2 and 3 were prepared according to Example 1 of HU P No. 195,915 (using water as the extraction solvent), the corn extract used in Example 6 was prepared according to Example 6 of the said patent specification (using ethanol as solvent) and the corn extract used in Examples 4, 5 and 7 was prepared according to Example 3 of the same patent specification.

The corn extracts used in Examples 1-5 were prepared from harvests, hypophiles, ear, beards and nodular stems of the young corn plant, for the preparation of maize extracts used in Examples 6 and 7 hypophiluses and harvests of corn were used. corn plant, and hypophiles, ear and beard, respectively.

The products specified with trade marks contain the following compounds:

Hostacerin WO: fatty acid polyglycerol ester (Hoechst AG, DE)

Lanette N: blend of sodium-cetyl stearyl sulphate and cetyl stearyl alcohol (Henkel, DE) BRIJ71: ethoxylated stearyl alcohol (JCI, USA) BRIJ721: ethoxylated stearyl alcohol) JCI, USA)

Chromophor W07: hydrogenated peppermint oil (BASF, DE) Genagol AMS: detergent and surfactant (Hoechst, DE) HOe S 3495: fatty acid (Hoechst, DE) ethoxylated polyglycerol ester Example 1 Cream for day 1 Composition quantities (g) Maize extract 45.0 Gamma linolic acid 0.10 Cetyl alcohol 7.65 Stearin 2.35 Pepper oil 4.00 Vaseline oil 6.00 Corn germ oil 5.00 Sodium lauryl sulphate 1.00 Glycerol 5 00 Cholesterol 1.00 Vitamin A 0.05

Vitamin E 0.10

Material preservation, flavoring 0.20 Deionized water ad 100.00 Example 2 Night cream Composition quantities (g) Corn Extract 60.0 Gamma linolenic acid 0.12 Hostacerin WO 10.00 Light Vaseline 5.00 Lanette N 2.00 Avocado oil 10.00 Vaseline oil 4.00 Wheat germ oil < J1 oo 17

Example 2 continued Composition Cholesterol Glycerol

Vitamin A ,

Vitamin E

Material preservation, Deionized water amounts 3.00 0.10 0.05 0.05 flavoring 0.02 ad 100.00 (g)

Example 3

Body lotion

Composition

Corn Extract Linoleic Acid Cetyl Alcohol Pepper Oil Maize Germ Oil Vaseline Oil BRIJ 72 BRIJ 721

Sorbitol

Glycerol

Vitamin A

Vitamin E

Preservation material, Deionized water amounts (g) 40.00 '0.10 1.50 1.50 3.00 1.00 2.50 1.60 5.00 6.00 0.05 0.05 flavoring 0.20 ad 100.00) 18

quantities (g) 15.00 0.15 5.00 4.00 3.00

Example 4 Emulsion Composition Corn Extract Linolenic Acid t

Chremophor WO 7 Avocado oil Corn germ oil

Example 4 continued

Composition Vaseline oil Cetyl alcohol

Propylene glycol

Vitamin A

Vitamin E

Preservation material, Deionized water amounts (g) 14.00 1.00 4.00 0.05 0.07 flavoring 0.20 100.00

Example 5 Solution for medical treatment Composition Corn Extract Gamma-linolenic acid Isopropyl alcohol Menthol Canfora

Sarboxethene lactone

Propylene glycol

Vitamin

Preservation material, Deionized water amounts (g) 35.00 0.08 5.00 0.03 0.02 2.00 10.00 0.10 flavoring 0.20 ad 100.00

Example 6

Solution Composition quantities (g) Maize extract 30.00 Gamma linolenic acid 0.10 Isopropyl alcohol 5.00 Ethane1.00 Menthol 0.05 Lactic acid 1.00 Sorbitanide lactone 0.50 Propylene glycol 10.00 Example 6 continued

Composition quantities (g)

Preservation material, flavoring 0.20

Deionized water ad 100.00 Example 7 Shampoo Composition quantities (g) Maize extract 75.00 Gamma linolenic acid 0.08 Sodium lauryl sulfate 10.00 Genagol AMS 5.00 Hoe S 3495 1.00 Panthenol 2.00 Propane- 3-carboxymethyl betaine 5.00 Methyl-p-hydroxybenzoate 0.20 Flavoring material 0.50 Deionized water ad 100.00 The effect of the composition according to the invention has been proved by the following clinical tests.

Experiment 1 The composition according to Example 1 was tested in 11 female patients aged 21-68 years and in 10 male patients aged 33-73 years. Patients had suffered from psoriasis on average for 12 years. The cream was applied to the surface of the injured skin 3 times a day and the treatment was maintained for 3 weeks. The results obtained are summarized in Table 1. The abbreviations used have the following meanings: number of patients suffering from the indicated type of psoriasis Cl = considerable improvement SI = slight improvement D = deterioration

Table 1

Type of psoriasis N Cl SI D Dissemination in plaques 11 7 1 3 Psoriatic erythroderma 2 1 1 - Dissemination guttata 2 1 1 - Seborrheic type 1 1 - Palmoplantar type Localized psoriasis 4 4 - to members 1 1 - - Total 21 15 3 3 It is concluded from the previous Table that the condition of 71% of patients improved considerably, with a slight improvement of 15% and deterioration of 14%. Particularly good results have been obtained with regard to seborrheic and palmoplantar type psoriasis as well as psoriasis localized to the limbs.

Comparative experience 2

For comparison, the composition according to Example 1 but containing 45.0 g of wheat germ oil instead of 45 g of maize extract was tested in 10 male patients aged 32 to 70 years and in 10 female patients between the ages of 20 and 65 years. Patients had suffered from psoriasis on average for 11 years. The cream was applied to the affected surface 3 times a day and the treatment was maintained for 3 weeks. The results obtained are summarized in Table 2.

Table 2

Type of psoriasis N Cl SI D Dissemination on plaque 8 1 4 3 Psoriatic erythroderma 2 - 1 1 Dissemination guttata 2 - 1 1 Seborrheic type 3 1 1 1 Type Palmoplantar Psoriasis localized 1 1 to limbs 4 1 1 2 Total 20 3 9 8

Looking at the previous table it appears that the number of patients showing a considerable improvement has decreased (to 15%), the number of patients with a slight improvement has increased (to 45%) and the number of patients with deterioration of the condition has increased to 40% . A considerable improvement was only achieved in the case of a patient suffering from disseminated plaque, psoriasis of the seborrheic type and psoriasis localized to the limbs, due to the sedative effect on the skin of the cream only a slight improvement was achieved. 22

According to the above it can be stated that gamma linolenic acid without corn extract is not suitable for the treatment of psoriasis.

Comparative experience 3

For yet another comparison the composition according to Example 1 but containing 0.01 g of wheat germ oil instead of 0.1 g of gamma linolenic acid was tested in 13 male patients aged 28 to 60 years and in 7 female patients between the ages of 22 and 67 years. Patients had suffered from psoriasis on average for 11 years. The cream was applied to the surface of the injured skin 3 times a day. The treatment was maintained for 3 weeks. The results obtained are summarized in Table 3.

Table 3

Type of psoriasis N Ci Si D Dissemination of plaque 10 3 4 3 Erythroderma psoriatica 3 - 2 • 1 Dissemination guttata 1 - - 1 Seborrheic type 2 - 1 1 Palmoplantar type Localized psoriasis 2 - 1 1 to members 2 - 1 1 Total 20 3 9 8

Looking at the previous table it becomes clear that the number of patients showing a considerable improvement (up to 15%) decreased, the number of patients showing slight improvement increased (up to 45%) and deterioration was established in 40% of patients. Significant improvement was only achieved in the case of plaque dissemination, in other cases the slight improvement was probably due to the moderate antiphlogistic effect of corn extract. The foregoing table clearly indicates that the antiphlogistic effect of maize extract acting alone is not capable of reducing the occurrence of symptoms of different types of psoriasis in that the gamma-linolenic acid-containing composition has less activity than the composition according to Example 1.

Experiment 4 The composition according to Example 6 was tested in 16 male patients between the ages of 30 and 60 years and in 13 female patients between the ages of 22 and 60 years. Patients had suffered from psoriasis of the scalp, on average for 10 years. The solution was applied 3 times a day and the treatment was maintained for 3 weeks. The results obtained are summarized in Table 4.

Table 4

Intensity of Before After symptoms treatment Mean Moderate Mean Moderate Paraqueratosis 9 20 5 '0 Infiltration 9 20 7 0 Burning 3 20 2 0 Itching 7 20 5 3 24

The Table clearly indicates that the solution according to Example 6 eliminated moderate parakeratosis, infiltration, burning and itching in all 20 patients. This means that in the case of moderate symptoms an efficiency of 100% has been achieved. r

In the case of mean parakeratosis and infiltration, an efficiency of 100% was achieved in 4 and 2 patients, respectively, among 9 patients, however in the case of medium ardor the symptoms were totally eliminated in 1 patient of 3 patients. the treatment of patients suffering from an extremely severe change has not been fully realized seen according to clinical experience these cases can only be made asymptomatic - for a short period of time - by means of systemic treatment.

Claims (2)

1. A process for the preparation of pharmaceutical compositions suitable for the topical treatment of psoriasis comprising the admixture of a pharmaceutically acceptable aqueous and / or organic solvent, preferably ethanolic extract from young maize and / or bean crops young corn and / or young nodular corn stalk and / or young corn cob and gamma-linolenic acid as active ingredient mixed with one or more solid and / or liquid carriers and / or other additives and conversion of the thus obtained mixture in a form suitable for topical application, preferably in a cream, emulsion or solution. 2a. A process according to Claim 1, characterized in that it comprises the use of a pharmaceutically acceptable aqueous and / or organic solvent, preferably preferably ethanolic extract from harvests of young maize and / or young maize beards and / or Young nodal corn stalk and / or young corn spike and gamma-linolenic acid in an amount of 15-75% by weight calculated for the total amount of the composition and in a weight ratio of (100: 1) to (950: 1 ) as an active ingredient. 3a. A process as claimed in any one of claims 1-2, characterized in that it comprises the use of the aqueous extract from harvests of young maize and / or young maize beards and / or young nodular maize stalks and / or young corn cob. 4a. A process according to any one of claims 1-2, comprising the use of 30-70% by weight of maize extract and 0.05-3% by weight of gamma-linoleic acid as the active ingredient. A process according to any one of Claims 1-2, characterized in that it comprises the use of 15-30% by weight of corn extract and 0.05-3% by weight of gamma-linolenic acid as an ingredient active. 6ã. A process according to any one of Claims 1-2, characterized in that it comprises the use of 30-50% by weight of maize extract and 0.05-3% by weight of gamma-linolenic acid as the active ingredient. 7 ^. A process according to any one of Claims 1-6, characterized in that it comprises the use of fats, oils, fatty alcohols, fatty acid esters and / or their natural or synthetic derivatives as carrier and / or emulsifying agent. 8ã. A process according to Claim 7, characterized in that it comprises the use of cetyl alcohol, cetylsilyl alcohol, fatty acid polyglycerol ester, sodium cetyl stearyl sulfate, stearin, castor oil, avocado oil, wheat germ oil, petrolatum oil, wheat germ oil and / or light petrolatum as carrier. 9a. Process according to any one of Claims 1-8, characterized in that it comprises the use of one or more emulsifying, dissolving, hygroscopic, skin and epithelial regenerating agents, flavorings, disinfectant, preservatives and / or vitamins and other additives. 27 10a. A process according to claim 9, which comprises the use of sodium lauryl sulfate, sodium lauryl ether sulphate, ethoxylated stearyl alcohol, hydrogenated castor oil and / or ethoxylated fatty acid polyglycerol ester, as the emulsifying and solubilizing agent, respectively. III. A process according to Claim 9, characterized in that it comprises the use of glycerol, sorbitol and / or propylene-lycol as a hygroscopic material. A process according to Claim 9, characterized in that it comprises the use of cholesterol, panthenol and / or propane-3-carboxymethyl betaine as a skin and epithelial regenerating material. 13 â. A process according to Claim 9, characterized in that it comprises the use of vitamin A, E and / or B1 as a vitamin. 14a. A process according to Claim 9, characterized in that it comprises the use of menthol, camphor and / or lactic acid as a disinfectant. Lisbon, August 23, 1991 J. PEREIRA DA CRUZ Official Agent for Industrial Property RUA V1CTOR COROON, 10 · A 3. · 1200 LISBOA