CA1324960C - Procedure for obtaining the preparation for the treatment of the disease psoriasis drug for the treatment of psoriasis and its application - Google Patents
Procedure for obtaining the preparation for the treatment of the disease psoriasis drug for the treatment of psoriasis and its applicationInfo
- Publication number
- CA1324960C CA1324960C CA 565548 CA565548A CA1324960C CA 1324960 C CA1324960 C CA 1324960C CA 565548 CA565548 CA 565548 CA 565548 A CA565548 A CA 565548A CA 1324960 C CA1324960 C CA 1324960C
- Authority
- CA
- Canada
- Prior art keywords
- ointment
- process according
- vitamin
- psoriasis
- oil
- 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.)
- Expired - Fee Related
Links
- 238000000034 method Methods 0.000 title claims abstract description 23
- 201000004681 Psoriasis Diseases 0.000 title claims abstract description 18
- 238000002360 preparation method Methods 0.000 title claims abstract description 15
- 239000003814 drug Substances 0.000 title description 4
- 229940079593 drug Drugs 0.000 title description 4
- 201000010099 disease Diseases 0.000 title description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 title description 2
- 239000003246 corticosteroid Substances 0.000 claims abstract description 20
- 229960001334 corticosteroids Drugs 0.000 claims abstract description 17
- 239000003242 anti bacterial agent Substances 0.000 claims abstract description 7
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 7
- 239000002674 ointment Substances 0.000 claims description 40
- VYGQUTWHTHXGQB-FFHKNEKCSA-N Retinol Palmitate Chemical compound CCCCCCCCCCCCCCCC(=O)OC\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C VYGQUTWHTHXGQB-FFHKNEKCSA-N 0.000 claims description 22
- YGSDEFSMJLZEOE-UHFFFAOYSA-N salicylic acid Chemical compound OC(=O)C1=CC=CC=C1O YGSDEFSMJLZEOE-UHFFFAOYSA-N 0.000 claims description 20
- CEAZRRDELHUEMR-URQXQFDESA-N Gentamicin Chemical compound O1[C@H](C(C)NC)CC[C@@H](N)[C@H]1O[C@H]1[C@H](O)[C@@H](O[C@@H]2[C@@H]([C@@H](NC)[C@@](C)(O)CO2)O)[C@H](N)C[C@@H]1N CEAZRRDELHUEMR-URQXQFDESA-N 0.000 claims description 17
- 229930182566 Gentamicin Natural products 0.000 claims description 17
- 239000000203 mixture Substances 0.000 claims description 15
- 239000007764 o/w emulsion Substances 0.000 claims description 13
- 238000001816 cooling Methods 0.000 claims description 12
- VYGQUTWHTHXGQB-UHFFFAOYSA-N Retinol hexadecanoate Natural products CCCCCCCCCCCCCCCC(=O)OCC=C(C)C=CC=C(C)C=CC1=C(C)CCCC1(C)C VYGQUTWHTHXGQB-UHFFFAOYSA-N 0.000 claims description 11
- 229940108325 retinyl palmitate Drugs 0.000 claims description 11
- 235000019172 retinyl palmitate Nutrition 0.000 claims description 11
- 239000011769 retinyl palmitate Substances 0.000 claims description 11
- 238000003756 stirring Methods 0.000 claims description 11
- QAOWNCQODCNURD-UHFFFAOYSA-L Sulfate Chemical compound [O-]S([O-])(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-L 0.000 claims description 10
- FJKROLUGYXJWQN-UHFFFAOYSA-N papa-hydroxy-benzoic acid Natural products OC(=O)C1=CC=C(O)C=C1 FJKROLUGYXJWQN-UHFFFAOYSA-N 0.000 claims description 10
- 229960004889 salicylic acid Drugs 0.000 claims description 10
- SNPLKNRPJHDVJA-UHFFFAOYSA-N dl-panthenol Chemical compound OCC(C)(C)C(O)C(=O)NCCCO SNPLKNRPJHDVJA-UHFFFAOYSA-N 0.000 claims description 8
- 229940088594 vitamin Drugs 0.000 claims description 8
- 229930003231 vitamin Natural products 0.000 claims description 8
- 235000013343 vitamin Nutrition 0.000 claims description 8
- 239000011782 vitamin Substances 0.000 claims description 8
- 150000003722 vitamin derivatives Chemical class 0.000 claims description 7
- 230000003115 biocidal effect Effects 0.000 claims description 6
- 238000002844 melting Methods 0.000 claims description 6
- 230000008018 melting Effects 0.000 claims description 6
- 230000002045 lasting effect Effects 0.000 claims description 4
- 239000004519 grease Substances 0.000 claims description 3
- 150000003431 steroids Chemical class 0.000 claims description 3
- 230000001954 sterilising effect Effects 0.000 claims description 2
- 239000004480 active ingredient Substances 0.000 abstract description 4
- 239000000839 emulsion Substances 0.000 abstract description 4
- 229940088710 antibiotic agent Drugs 0.000 abstract description 3
- 239000003795 chemical substances by application Substances 0.000 abstract description 3
- 150000003873 salicylate salts Chemical class 0.000 abstract description 3
- 208000017520 skin disease Diseases 0.000 abstract description 3
- 210000000056 organ Anatomy 0.000 abstract description 2
- 239000004615 ingredient Substances 0.000 abstract 1
- 235000005911 diet Nutrition 0.000 description 2
- 238000000265 homogenisation Methods 0.000 description 2
- 230000009291 secondary effect Effects 0.000 description 2
- LINZZISWCNKFEM-UHFFFAOYSA-N 3,3-dimethylbutanamide Chemical compound CC(C)(C)CC(N)=O LINZZISWCNKFEM-UHFFFAOYSA-N 0.000 description 1
- 201000004624 Dermatitis Diseases 0.000 description 1
- 206010039509 Scab Diseases 0.000 description 1
- 206010040893 Skin necrosis Diseases 0.000 description 1
- 210000004100 adrenal gland Anatomy 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 239000003054 catalyst Substances 0.000 description 1
- 229960003950 combination of corticosteroids Drugs 0.000 description 1
- 230000037213 diet Effects 0.000 description 1
- 230000000378 dietary effect Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 210000000750 endocrine system Anatomy 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000006386 neutralization reaction Methods 0.000 description 1
- 210000005259 peripheral blood Anatomy 0.000 description 1
- 239000011886 peripheral blood Substances 0.000 description 1
- 239000000419 plant extract Substances 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 230000003236 psychic effect Effects 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 230000003637 steroidlike Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 229910021653 sulphate ion Inorganic materials 0.000 description 1
- 230000001629 suppression Effects 0.000 description 1
- 230000003639 vasoconstrictive effect Effects 0.000 description 1
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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
-
- 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
- A61K31/60—Salicylic acid; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Molecular Biology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
ABSTRACT OF THE DISCLOSURE
The invention relates to a preparation for the treatment of the skin disease called psoriasis. According to the invention, there is provided a medicinal agent based on two corticosteroids, salicylates and antibiotics which clear the skin from psoriasis effectively, in a rapid manner and without endangering the integrity of healthy organs and skin regions. The relapses are practically non-existent. The process according to the invention consists in the prepara-tion of an emulsion consisting of previously sterilized oil phase and water, to which are then added solutions of the active ingredients in such a way that all the phases are completed according to the order of ingredient stability at specified temperatures.
The invention relates to a preparation for the treatment of the skin disease called psoriasis. According to the invention, there is provided a medicinal agent based on two corticosteroids, salicylates and antibiotics which clear the skin from psoriasis effectively, in a rapid manner and without endangering the integrity of healthy organs and skin regions. The relapses are practically non-existent. The process according to the invention consists in the prepara-tion of an emulsion consisting of previously sterilized oil phase and water, to which are then added solutions of the active ingredients in such a way that all the phases are completed according to the order of ingredient stability at specified temperatures.
Description
' 1 324960 The present invention relates to a medical ointment which is useful for the treatment of the skin disease called PSORIASIS. The invention also relates to a method for the preparation of such medical ointment.
It is well known that skin diseases are as old as the human ~ace and that people have been trying to find curative agents for these diseases ever since the advent of man. Plant extracts as well as drugs of both organic and non-organic origin have been used extensively. Nowadays, there are about 2000 preparations used all over the world for the treatment of psoriasis most of which are based on the use of corticosteroids, combinations of corticosteroids or combinations of antibiotics and salicylates.
The main disadvantages of the preparations mentioned above a~e secondary effects after local application of corticosteroids, such as skin ~ecrosis, steroidal dermatitis and, in some cases, secondary effects on the adrenal gland (e.g. suppression).
It is an object of the present invention to over-come the above disadvantages, and more particularly, the activity of the steroids on the endocrine system.
It is another object of the present invention to provide a medicinal agent based on - corticosteroids, salicylates and antibiotics, using catalyst belonging to the group of highly purified proteins, which would clear the skin from psoriasis effectively, the most quickly and without endangering the integrity of healthy organs and skin regions and the reiapses approximate to zero point.
` According to the invention, there is provided a process for makiny a preparation useful for the treatment of psoriasis which comprises 1 3~4960 a. adding an oil phase to de~lineralized water while constantly stirring to obtain an oil in water emulsion, b. successively adding solutions of at least two corticosteroids effective in the treatment of psoriasis, to said oil in water emulsion, c. adding salicylic acid or a derivative to mixture obtained in b., d. homogenizing and cooling mixture obtained in c.
to provide a medicinal ointment.
In accordance with a preferred embodiment of the invention, the oil phase is prepared by melting an ointment grease vehicle, permanently homogenizing it at a temperature of about 150C, Gooling it to about 85C - 90C while stirring, the melting, homogenizing and cooling lasting about 20 minutes.
Pre~erably, the oil phase is added to previously sterilized water for about 10 minutes and the oil in water emulsion is sterilized for about 30 minutes, followed by cooling to about 60C. Normally, there is added about 7 weight percent of salicylic acid or derivative thereof to the mixture obtained in step b.
The two preferred corticosteroids successively added to the oil in water emulsion comprise 9-fluoro-11-17,21-trihydroxy-16-methyl pregna-1,4-dien-3,2~-dion-17,21-dipropionate and 6,9-difluoro-11,16,17,21-tetrahydroxy-pregna-1,4-dien-3,20,21-acetate-16,17-acetonide, and they are usually added in a 1:1 weight ratio.
An antibiotic such as a gentamycin, preferably gentamycin sul~ate, may also be added to the mixture obtained in step c. before proceeding to step d.
The process according to the invention may also involve adding a vitamin to the mixture obtained in step c.
before proceeding to step d. The vitamin may comprise vitamin A palmitate.
According to the invention, 2,4-dihydroxy-N-(3-hydroxy-propyl)-3,3-dimethylbutyramide may also be added to the mixture obtained in step c, usually in an amount of about 0.5 weight percent.
Gentamycin sulfate is usually added in an amount equivalent to 35000 IU/lOOg of ointment and vitamin A
palmitate, in an amount equivalent to 30000 IU/lOOg of the ointment.
According to the invention, there is also provided a medicinal ointment useful for the treatment of psoriasis comprising an ointment vehicle derived from an oil in water emulsion which has been homogenized and cooled, said ointment vehicle containing two corticosteroids effective in the treatment of psoriasis and salicylic acid or a derivative thereof.
The corticosteroids may comprise 9-fluoro-11-.:
17,21-trihydroxy-16-methyl pregna-1,4-dien-3,20-dion-17,21-dipropionate and 6,9-difluoro-11,16,17,21-tetrahydroxy-pregna-1,4-dien-3,20,21-acetate-16,17-acetonide, usually in a 1:1 weight ratio, as pointed out above.
The medicinal ointment according to the invention may also comprise an antibiotic, such as a gentamycin, preferably gentamycin sulfate. It may also comprise a vitamin, such as vitamin A palmitate. It may also comprise
It is well known that skin diseases are as old as the human ~ace and that people have been trying to find curative agents for these diseases ever since the advent of man. Plant extracts as well as drugs of both organic and non-organic origin have been used extensively. Nowadays, there are about 2000 preparations used all over the world for the treatment of psoriasis most of which are based on the use of corticosteroids, combinations of corticosteroids or combinations of antibiotics and salicylates.
The main disadvantages of the preparations mentioned above a~e secondary effects after local application of corticosteroids, such as skin ~ecrosis, steroidal dermatitis and, in some cases, secondary effects on the adrenal gland (e.g. suppression).
It is an object of the present invention to over-come the above disadvantages, and more particularly, the activity of the steroids on the endocrine system.
It is another object of the present invention to provide a medicinal agent based on - corticosteroids, salicylates and antibiotics, using catalyst belonging to the group of highly purified proteins, which would clear the skin from psoriasis effectively, the most quickly and without endangering the integrity of healthy organs and skin regions and the reiapses approximate to zero point.
` According to the invention, there is provided a process for makiny a preparation useful for the treatment of psoriasis which comprises 1 3~4960 a. adding an oil phase to de~lineralized water while constantly stirring to obtain an oil in water emulsion, b. successively adding solutions of at least two corticosteroids effective in the treatment of psoriasis, to said oil in water emulsion, c. adding salicylic acid or a derivative to mixture obtained in b., d. homogenizing and cooling mixture obtained in c.
to provide a medicinal ointment.
In accordance with a preferred embodiment of the invention, the oil phase is prepared by melting an ointment grease vehicle, permanently homogenizing it at a temperature of about 150C, Gooling it to about 85C - 90C while stirring, the melting, homogenizing and cooling lasting about 20 minutes.
Pre~erably, the oil phase is added to previously sterilized water for about 10 minutes and the oil in water emulsion is sterilized for about 30 minutes, followed by cooling to about 60C. Normally, there is added about 7 weight percent of salicylic acid or derivative thereof to the mixture obtained in step b.
The two preferred corticosteroids successively added to the oil in water emulsion comprise 9-fluoro-11-17,21-trihydroxy-16-methyl pregna-1,4-dien-3,2~-dion-17,21-dipropionate and 6,9-difluoro-11,16,17,21-tetrahydroxy-pregna-1,4-dien-3,20,21-acetate-16,17-acetonide, and they are usually added in a 1:1 weight ratio.
An antibiotic such as a gentamycin, preferably gentamycin sul~ate, may also be added to the mixture obtained in step c. before proceeding to step d.
The process according to the invention may also involve adding a vitamin to the mixture obtained in step c.
before proceeding to step d. The vitamin may comprise vitamin A palmitate.
According to the invention, 2,4-dihydroxy-N-(3-hydroxy-propyl)-3,3-dimethylbutyramide may also be added to the mixture obtained in step c, usually in an amount of about 0.5 weight percent.
Gentamycin sulfate is usually added in an amount equivalent to 35000 IU/lOOg of ointment and vitamin A
palmitate, in an amount equivalent to 30000 IU/lOOg of the ointment.
According to the invention, there is also provided a medicinal ointment useful for the treatment of psoriasis comprising an ointment vehicle derived from an oil in water emulsion which has been homogenized and cooled, said ointment vehicle containing two corticosteroids effective in the treatment of psoriasis and salicylic acid or a derivative thereof.
The corticosteroids may comprise 9-fluoro-11-.:
17,21-trihydroxy-16-methyl pregna-1,4-dien-3,20-dion-17,21-dipropionate and 6,9-difluoro-11,16,17,21-tetrahydroxy-pregna-1,4-dien-3,20,21-acetate-16,17-acetonide, usually in a 1:1 weight ratio, as pointed out above.
The medicinal ointment according to the invention may also comprise an antibiotic, such as a gentamycin, preferably gentamycin sulfate. It may also comprise a vitamin, such as vitamin A palmitate. It may also comprise
2,4-dihydroxy-N-(3-hydroxy-propyl)-3,3-dimethylbutyramide.
In accordance with a preferred emhodiment, the ointment may comprise a 1:1 weight ratio of the two steroids comprising 9-fluoro-11,17,21-trihydroxy-16-methyl pregna~
1,4-dien-3,20-dion-17,21-dipropionate and 6,~-difluoro-11, 16,17,21-tetrahydroxy-pregna-1,4-dien-3,20,21-acetate-16,17-acetonide, about 7 weight percent of salicylic acid or derivative thereof, 35000 IU/lOOg of ointment of gentamycin sulfate, 30000 IU/lOOg of ointment of vitamin A palmitate, and 0.5 weight percent of 2,4-dihydroxy-N-(3-hydroxy-propyl)~3,3-dimethylbutyramide.
This preparation according to the invention desin-tegrates all kinds of crusts thereby avoiding skin necrosis and, by neutralization of the sugilation and subfusion processes, it induces the vasoconstrictive effects on periph-eral blood circulation and, therefore, enhances recovery. The adequateiuse of the drug, that is, the adequate combination of the application of the drug and a certain hygienic and ; dietetic treatment as well as the maintenance of a certain state of mind (psychic peace) is conducive to very rare relapses into the illness.-The invention will now be illustrated with refer-ence to an example without the intention to be limited thereto.
Example : The weighted components normally used in the preparation of the so-called, greasy vehicle, are melted, while being permanently homogenized, at 150C and, while stirring, it is cooled to 85C - 90C the total preparation phase lasting about 20 minutes. The filtered and melted phase is added, while constantly stirring, into demineralized water, which has been previously sterilized for 10 minutes, after which the resulting emulsion is sterilized for 30 minutes at 85C - 90C.
-The emulsion is then cooled to 60C and the pre-viously prepared solutions of the active ingredients are added while stirring. The solutions of active ingredients are added in the followin~ order:
- 9-fluoro-11-17,21-trihydroxy-16-methyl pregna-1,4-dien-3, 20-dion-17,21-dipropionate - 6,9-difluoro-11,16,17,21-tetrahydroxy-pregna-1,4-dien-3,20-21-acetate-16,17-acetonide, the ratio of the two corticosteroids being 1:1, after which, while constantly stirring, there are added gentamycin sulphate in an amount equivalent to at least 35000 IU/lOOg of the ointment, vitamin A palmitate in an amount equivalent to 30000 IU~lOOg of the ointment and, finally, 0.5 g of 2,4-dihydroxy-N-(3-hydroxy-propyl)-3,3-dimethylbutyramide.
After stirring and homogenization, salicylic acid is added in an amount representing 7~ of the ointment and the emulsion is then again subjected to homogenization and cooling.
During the manufacture of this preparation enough homogenizer should be provided for the component and the preparation of the vehicle as well as for sterilization, vacuuming, micronization, i.e., for obtaining a maximally homogenized mixture.
The corticosteroids used as the active ingredients should be dissolved in suitable solvents, by an aseptic procedure, at a temperature providing stability to the dissolved substances.
The preparation, when adequately applied and with the addition of vitamins and with certain diet treatment, has proved to be very effective not only in the cure of psoriasis but in significant decrease of the number of relapses as well.
In accordance with a preferred emhodiment, the ointment may comprise a 1:1 weight ratio of the two steroids comprising 9-fluoro-11,17,21-trihydroxy-16-methyl pregna~
1,4-dien-3,20-dion-17,21-dipropionate and 6,~-difluoro-11, 16,17,21-tetrahydroxy-pregna-1,4-dien-3,20,21-acetate-16,17-acetonide, about 7 weight percent of salicylic acid or derivative thereof, 35000 IU/lOOg of ointment of gentamycin sulfate, 30000 IU/lOOg of ointment of vitamin A palmitate, and 0.5 weight percent of 2,4-dihydroxy-N-(3-hydroxy-propyl)~3,3-dimethylbutyramide.
This preparation according to the invention desin-tegrates all kinds of crusts thereby avoiding skin necrosis and, by neutralization of the sugilation and subfusion processes, it induces the vasoconstrictive effects on periph-eral blood circulation and, therefore, enhances recovery. The adequateiuse of the drug, that is, the adequate combination of the application of the drug and a certain hygienic and ; dietetic treatment as well as the maintenance of a certain state of mind (psychic peace) is conducive to very rare relapses into the illness.-The invention will now be illustrated with refer-ence to an example without the intention to be limited thereto.
Example : The weighted components normally used in the preparation of the so-called, greasy vehicle, are melted, while being permanently homogenized, at 150C and, while stirring, it is cooled to 85C - 90C the total preparation phase lasting about 20 minutes. The filtered and melted phase is added, while constantly stirring, into demineralized water, which has been previously sterilized for 10 minutes, after which the resulting emulsion is sterilized for 30 minutes at 85C - 90C.
-The emulsion is then cooled to 60C and the pre-viously prepared solutions of the active ingredients are added while stirring. The solutions of active ingredients are added in the followin~ order:
- 9-fluoro-11-17,21-trihydroxy-16-methyl pregna-1,4-dien-3, 20-dion-17,21-dipropionate - 6,9-difluoro-11,16,17,21-tetrahydroxy-pregna-1,4-dien-3,20-21-acetate-16,17-acetonide, the ratio of the two corticosteroids being 1:1, after which, while constantly stirring, there are added gentamycin sulphate in an amount equivalent to at least 35000 IU/lOOg of the ointment, vitamin A palmitate in an amount equivalent to 30000 IU~lOOg of the ointment and, finally, 0.5 g of 2,4-dihydroxy-N-(3-hydroxy-propyl)-3,3-dimethylbutyramide.
After stirring and homogenization, salicylic acid is added in an amount representing 7~ of the ointment and the emulsion is then again subjected to homogenization and cooling.
During the manufacture of this preparation enough homogenizer should be provided for the component and the preparation of the vehicle as well as for sterilization, vacuuming, micronization, i.e., for obtaining a maximally homogenized mixture.
The corticosteroids used as the active ingredients should be dissolved in suitable solvents, by an aseptic procedure, at a temperature providing stability to the dissolved substances.
The preparation, when adequately applied and with the addition of vitamins and with certain diet treatment, has proved to be very effective not only in the cure of psoriasis but in significant decrease of the number of relapses as well.
Claims (26)
1. Process for making a preparation useful for the treatment of psoriasis which comprises a. adding an oil phase to demineralized water while consistantly stirring to obtain an oil in water emulsion, b. successively adding solutions of at least two corticosteroids effective in the treatment of psoriasis, to said oil in water emulsion, c. adding salicylic acid or a derivative to mixture obtained in b., d. homogenizing and cooling mixture obtained in c.
to provide a medicinal ointment.
to provide a medicinal ointment.
2. Process according to claim 1, which comprises melting an ointment grease vehicle, permanently homogenizing same at a temperature of about 150°C, cooling same to about 85°C - 90°C while stirring, said melting, homogenizing and cooling lasting about 20 minutes, thereby obtaining said oil phase.
3. Process according to claim 1, wherein step a.
comprises adding said oil phase to previously sterilized water for about 10 minutes and the oil in water emulsion is sterilized for about 30 minutes, followed by cooling to about 60°C.
comprises adding said oil phase to previously sterilized water for about 10 minutes and the oil in water emulsion is sterilized for about 30 minutes, followed by cooling to about 60°C.
4. Process according to claim 1, which comprises adding about 7 weight percent of salicylic acid or derivative thereof to the mixture obtained in step b.
5. Process according to claim 17 wherein the two corticosteroids successively added to the oil in water emulsion comprise 9-fluoro-11,17,21-trihydroxy-16-methyl pregna-1,4-dien-3,20-dion-17,21-dipropionate and 6,9-di-fluoro-11,16,17,21-tetrahydroxy-pregna-1,4-dien-3,20,21-acetate-16,17-acetonide.
6. Process according to claim 5, wherein the two corticosteroids are added in a 1:1 weight ratio.
7. Process according to claim 1, which comprises adding an antibiotic to mixture obtained in step c. before proceeding to step d.
8. Process according to claim 7, wherein said antibiotic comprises a gentamycin.
9. Process according to claim 8, wherein said gentamycin comprises gentamycin sulfate.
10. Process according to claim 1, which comprises adding a vitamin to mixture obtained in step c. before proceeding to step d.
11. Process according to claim 10, wherein said vitamin comprises vitamin A palmitate.
12. Process according to claim 1, which comprises adding gentamycin sulfate and vitamin A palmitate to mixture obtained in step c. before proceeding to step d.
13. Process according to claim 12, which comprises also adding 2,4-dihydroxy-N-(3-hydroxy-propyl)-3,3-dimethyl-butyramide to mixture obtained in step c.
14. Process according to claim 13, which comprises adding about 0.5 weight percent of said 2,4-dihydroxy-N-(3-hydroxy-propyl)-3,3-dimethylbutyramide.
15. Process according to claim 14, which comprises adding gentamycin sulfate in an amount equivalent to 35000 IU/100g of ointment and vitamin A palmitate in an amount equivalent to 30000 IU/100g of the ointment.
16. Process for making a preparation useful for the treatment of psoriasis which comprises melting an ointment grease vehicle, permanently homogenizing same at a temperature of about 150°C, cooling same to about 85°C - 90°C
while stirring, said melting, homogenizing and cooling lasting about 20 minutes, thereby obtaining an oil phase, adding said oil phase to previously sterilized water for about 10 minutes while constantly stirring to obtain an oil in water emulsion, and sterilizing said oil in water emulsion for about 20 minutes, followed by cooling to about 60°C, successively adding a first and a second corticosteroid solution, said first corticosteroid solution containing 9-fluoro-11,17-21-trihydroxy-16-methyl pregna-1,4-dien-3,20-dion-17,21-dipropionate and said second corticosteroid solution containing 6,9-difluoro-11,16,17,21-tetrahydroxy-pregna-1,4-dien-3,20,21-acetate-16,17-acetonide, said first and second solutions containing said corticosteroids in 1:1 weight ratio, thereafter successively adding salicylic acid or a derivate thereof in an amount of about 7 weight percent, 0.5 weight percent of 2,4-dihydroxy-N-(3-hydroxy-propyl)-3,3-dimethylbutyramide gentamycin sulfate and vitamin A
palmitate respectively in an amount equivalent to 35000 IU/100g of ointment and 30000 IU/100g of ointment, and homogenizing and cooling the mixture obtained to provide a medicinal ointment.
while stirring, said melting, homogenizing and cooling lasting about 20 minutes, thereby obtaining an oil phase, adding said oil phase to previously sterilized water for about 10 minutes while constantly stirring to obtain an oil in water emulsion, and sterilizing said oil in water emulsion for about 20 minutes, followed by cooling to about 60°C, successively adding a first and a second corticosteroid solution, said first corticosteroid solution containing 9-fluoro-11,17-21-trihydroxy-16-methyl pregna-1,4-dien-3,20-dion-17,21-dipropionate and said second corticosteroid solution containing 6,9-difluoro-11,16,17,21-tetrahydroxy-pregna-1,4-dien-3,20,21-acetate-16,17-acetonide, said first and second solutions containing said corticosteroids in 1:1 weight ratio, thereafter successively adding salicylic acid or a derivate thereof in an amount of about 7 weight percent, 0.5 weight percent of 2,4-dihydroxy-N-(3-hydroxy-propyl)-3,3-dimethylbutyramide gentamycin sulfate and vitamin A
palmitate respectively in an amount equivalent to 35000 IU/100g of ointment and 30000 IU/100g of ointment, and homogenizing and cooling the mixture obtained to provide a medicinal ointment.
17. A medicinal ointment useful for the treatment of psoriasis comprising an ointment vehicle derived from an oil in water emulsion which has been homogenized and cooled, said ointment vehicle containing two corticosteroids effective in the treatment of psoriasis and salicylic acid or a derivative thereof.
18. A medicinal ointment according to claim 17, wherein said corticosteroids comprise 9-fluoro-11,17-21-trihydroxy-16-methyl pregna-1,4-dien-3,20-dion-17,21-dipro-pionate and 6,9-difluoro-11,16,17,21-tetrahydroxy-pregna-1,4-dien-3,20,21-acetate-16,17-acetonide.
19. A medicinal ointment according to claim 18, which comprises said corticosteroids in a 1:1 weight ratio.
20. A medicinal ointment according to claim 19, which also comprises an antibiotic.
21. A medicinal ointment according to claim 20, wherein said antibiotic comprises a gentamycin.
22. A medicinal ointment according to claim 21, wherein said gentamycin is gentamycin sulfate.
23. A medicinal ointment according to claim 20, which also comprises a vitamin.
24. A medicinal ointment acording to claim 23, wherein said vitamin comprises vitamin A palmitate.
25. A medicinal ointment according to claim 23, which also comprises 2,4-dihydroxy-N-(3-hydroxy-propyl)-3,3-dimethylbutyramide.
26. A medicinal ointment useful for the treatment of psoriasis comprising an ointment vehicle derived from an oil in water emulsion which has been homogenized and cooled, said ointment vehicle comprising a 1:1 weight ratio of the two steroids comprising 9-fluoro-11,17,21-trihydroxy-16-methyl pregna-1,4-dien-3,20-dion-17,21-dipropionate and 6,9-difluoro-11,16,17,21-tetrahydroxy-pregna-1,4-dien-3,20,21-acetate-16,17-acetonide, about 7 weight percent of salicylic acid or derivative thereof, 35000 IU/100g of ointment of gentamycin sulfate, 30000 IU/100g of ointment of vitamin A
palmitate, and 0.5 weight percent of 2,4-dihydroxy-N-(3-hydroxy-propyl)-3,3-dimethylbutyramide.
palmitate, and 0.5 weight percent of 2,4-dihydroxy-N-(3-hydroxy-propyl)-3,3-dimethylbutyramide.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA 565548 CA1324960C (en) | 1988-04-29 | 1988-04-29 | Procedure for obtaining the preparation for the treatment of the disease psoriasis drug for the treatment of psoriasis and its application |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA 565548 CA1324960C (en) | 1988-04-29 | 1988-04-29 | Procedure for obtaining the preparation for the treatment of the disease psoriasis drug for the treatment of psoriasis and its application |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1324960C true CA1324960C (en) | 1993-12-07 |
Family
ID=4137934
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA 565548 Expired - Fee Related CA1324960C (en) | 1988-04-29 | 1988-04-29 | Procedure for obtaining the preparation for the treatment of the disease psoriasis drug for the treatment of psoriasis and its application |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA1324960C (en) |
-
1988
- 1988-04-29 CA CA 565548 patent/CA1324960C/en not_active Expired - Fee Related
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