CA1231052A - Vehicle suitable for use in medicinal preparations - Google Patents
Vehicle suitable for use in medicinal preparationsInfo
- Publication number
- CA1231052A CA1231052A CA000460030A CA460030A CA1231052A CA 1231052 A CA1231052 A CA 1231052A CA 000460030 A CA000460030 A CA 000460030A CA 460030 A CA460030 A CA 460030A CA 1231052 A CA1231052 A CA 1231052A
- Authority
- CA
- Canada
- Prior art keywords
- base formulation
- weight
- present
- base
- consisting essentially
- 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
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Medicinal Preparation (AREA)
Abstract
ABSTRACT
This invention relates to vehicles suitable for use in medicinal preparations, for example, preparations incorporating a steroid.
This invention relates to vehicles suitable for use in medicinal preparations, for example, preparations incorporating a steroid.
Description
I
This invention relates to vehicles suitable for use in medic canal preparations, for example, preparations incorporating a steroid.
BACKGROUND OF INVENTION
One of the oldest bases is an ointment prepared mainly from petrolatum and mineral oil to which a medicine is added. This type of ointment is greasy, not water washable and more importantly, has a limited ability to release medicine carried by the ointment to the skin to which the ointment and medicine are applied. A non-aqueous ointment of more recent origin incorporates polyethylene glycol. However this vehicle, although water washable has a greasy texture and does not provide an occlusive coating on a treated surface of skin.
United States Letters Patent 3,592,930 and 3,888,995 disclose vehicles for topical applications of medicines which vehicles consist of an essentially an hydrous water washable base comprising from 15 - 45 parts by weight saturated fatty alcohol having from 16 - 24 carbon atoms, from 45 - 80 parts by weight of a glycol solvent, O - 15 parts by weight of compatible plasticizer, and from O to 15 parts by weight of compatible coupling agent among other constituents.
The patents provide at column 3, lines 9-15 that:
"The plasticizer concentration can be within the range of from O to 15 percent. Concentrations above 15 percent may provide a composition which has a consistency unsuitable for normal applications or cause instability of the vehicle mixture and some separation of the components.
In general, the particular plasticizer concentration necessary to provide a desired consistency, degree of smoothness and plasticity will vary with the choice of the fatty alcohol component, the choice of glycol solvent, and the ratio of these components in the vehicle."
The proposed vehicles however have not proved satisfactory.
Over prolonged storage periods in some formulations the components ~Z3~1~5Z
1 slowly separated. Furthermore when applied by the patient administering his/her medication, such application causes the area of application to sting.
In an attempt to reduce stinging, bases incorporating substantial quantities of water have been tried. Depending on the medicine carried in the base, because of the water content and resultant pi of the base, the medicine carried in the base may be destroyed and the rate release pattern of the medicine will be substantially changed American Cyanamid Company has taken such an approach in Canadian Letters Patent 1,052,269. In this patent, a new composition of matter comprising a topical cream base is disclosed purporting to provide enhanced penetration of steroids comprising:
OW
Ethoxylated stroll alcohol 5 to 25 Bouncily alcohol 0.9 to 4 Isopropyl palpitate 1 to 10 Glycerin 2 to 10 Soribitol solution US 2 to 10 Lactic or other acid as to pi 3.0-7.0 Water quantity sufficient at 100 This base is described as being suitable for use with 0.005 to 5% (W/W) of a steroid wherein the steroid is selected from the group consisting of triamcinolone astound; triamcinolone astound-vale rate; 16~ , 17~ -cyclopentylidenediory-9~ -flyer ,12 dihydroxy-1,4-pregnadiene-3, Dunn; and 16~ , 17~ -cyclopentyl-idenediory-9~ -flour- , 21-dihydroxy-1, 4-pregnadiene-3, downstate. I am also aware of US. Letters Patent 3,342,676; 3,352,753; 3,472,931 and 3,551,554 and Canadian Letters Patent 1,103,159.
SUMMARY OF INVENTION
.
~LZ31(~S2 1 Unexpectedly, I have been able to provide a base which over-comes the aforementioned difficulties with the prior art formulations.
To this end my base formulation is an hydrous and comprises:
(a) a compatible fatty alcohol between 5 and 35% by weight of the base formulation, preferably between 10 and 25% by weight, (b) a compatible glycol component between 20 and 75% by weight and preferably between 30 and 55% by weight of the base formulation, and (c) a compatible plasticizer between about 20 and 35% (preferably between 25 and 35%) by weight of the base formulation.
Preferably the base formulation also comprises a compatible acidic coupling agent of from 0 to I by weight of the base formulation which agent modifies the pi of the base making it more compatible with the skin and, with respect to some steroids, for example fluocininide, triamcinalone astound, fluocinolone astound and, betamethasone-17-vale rate, provides a suitable acidic medium for stability.
A suitable fatty alcohol may for example be any saturated fatty alcohol having from about 12 to about 32 carbon atoms or mixtures thereof including laurel alcohol, Seattle alcohol, stroll alcohol, isocetyl alcohol, palmityl alcohol, and mixtures thereof.
A suitable glycol component may for example be propylene glycol such as 1,2 propylenediol; 1,3 propylenediol, ethylene glycol, dipropylene glycol and mixtures thereof.
A suitable plasticizer may comprise for example polyethylene glycol having a molecular weight between about 400 and about 25,000;
1,2,6-hexanetriol, sorbitol and glycerol (glycerin), and, preferably glycerin (glycerol).
A suitable coupling agent may include fatty acids having from about 12 to about 32 carbon atoms, for example, Laurie acid, Starkey acid, palmitic acid and bunk acid, and citric acid, and preferably ~'~3~5~
1 citric acid.
As a result of this invention, a base is provided which permits the medicine to be taken wholly into solution to provide more uniform mixtures of medicine and base, and which has improved plasticity and smoothness.
It also provides a base which reduces stinging of the patient (without the addition of water) when applying his/her medication thus making i-t easier for the patient to comply with the doctor's prescribed applications of the medicine.
DESCRIPTION OF EMBODIMENTS
The following embodiments of the invention were prepared as illustrative of the invention.
1) 5% Stroll alcohol 15 2) 60% Propylene glycol 3 3) 4.5% Polyethylene glycol-6000 3 Viscosity at 20 = 26,250 cups 4) 30% Glycerin 3 Runny lotion like.
5) 0.5% 1,2, 6-Hexanetriol 20 1) 10% Stroll alcohol
This invention relates to vehicles suitable for use in medic canal preparations, for example, preparations incorporating a steroid.
BACKGROUND OF INVENTION
One of the oldest bases is an ointment prepared mainly from petrolatum and mineral oil to which a medicine is added. This type of ointment is greasy, not water washable and more importantly, has a limited ability to release medicine carried by the ointment to the skin to which the ointment and medicine are applied. A non-aqueous ointment of more recent origin incorporates polyethylene glycol. However this vehicle, although water washable has a greasy texture and does not provide an occlusive coating on a treated surface of skin.
United States Letters Patent 3,592,930 and 3,888,995 disclose vehicles for topical applications of medicines which vehicles consist of an essentially an hydrous water washable base comprising from 15 - 45 parts by weight saturated fatty alcohol having from 16 - 24 carbon atoms, from 45 - 80 parts by weight of a glycol solvent, O - 15 parts by weight of compatible plasticizer, and from O to 15 parts by weight of compatible coupling agent among other constituents.
The patents provide at column 3, lines 9-15 that:
"The plasticizer concentration can be within the range of from O to 15 percent. Concentrations above 15 percent may provide a composition which has a consistency unsuitable for normal applications or cause instability of the vehicle mixture and some separation of the components.
In general, the particular plasticizer concentration necessary to provide a desired consistency, degree of smoothness and plasticity will vary with the choice of the fatty alcohol component, the choice of glycol solvent, and the ratio of these components in the vehicle."
The proposed vehicles however have not proved satisfactory.
Over prolonged storage periods in some formulations the components ~Z3~1~5Z
1 slowly separated. Furthermore when applied by the patient administering his/her medication, such application causes the area of application to sting.
In an attempt to reduce stinging, bases incorporating substantial quantities of water have been tried. Depending on the medicine carried in the base, because of the water content and resultant pi of the base, the medicine carried in the base may be destroyed and the rate release pattern of the medicine will be substantially changed American Cyanamid Company has taken such an approach in Canadian Letters Patent 1,052,269. In this patent, a new composition of matter comprising a topical cream base is disclosed purporting to provide enhanced penetration of steroids comprising:
OW
Ethoxylated stroll alcohol 5 to 25 Bouncily alcohol 0.9 to 4 Isopropyl palpitate 1 to 10 Glycerin 2 to 10 Soribitol solution US 2 to 10 Lactic or other acid as to pi 3.0-7.0 Water quantity sufficient at 100 This base is described as being suitable for use with 0.005 to 5% (W/W) of a steroid wherein the steroid is selected from the group consisting of triamcinolone astound; triamcinolone astound-vale rate; 16~ , 17~ -cyclopentylidenediory-9~ -flyer ,12 dihydroxy-1,4-pregnadiene-3, Dunn; and 16~ , 17~ -cyclopentyl-idenediory-9~ -flour- , 21-dihydroxy-1, 4-pregnadiene-3, downstate. I am also aware of US. Letters Patent 3,342,676; 3,352,753; 3,472,931 and 3,551,554 and Canadian Letters Patent 1,103,159.
SUMMARY OF INVENTION
.
~LZ31(~S2 1 Unexpectedly, I have been able to provide a base which over-comes the aforementioned difficulties with the prior art formulations.
To this end my base formulation is an hydrous and comprises:
(a) a compatible fatty alcohol between 5 and 35% by weight of the base formulation, preferably between 10 and 25% by weight, (b) a compatible glycol component between 20 and 75% by weight and preferably between 30 and 55% by weight of the base formulation, and (c) a compatible plasticizer between about 20 and 35% (preferably between 25 and 35%) by weight of the base formulation.
Preferably the base formulation also comprises a compatible acidic coupling agent of from 0 to I by weight of the base formulation which agent modifies the pi of the base making it more compatible with the skin and, with respect to some steroids, for example fluocininide, triamcinalone astound, fluocinolone astound and, betamethasone-17-vale rate, provides a suitable acidic medium for stability.
A suitable fatty alcohol may for example be any saturated fatty alcohol having from about 12 to about 32 carbon atoms or mixtures thereof including laurel alcohol, Seattle alcohol, stroll alcohol, isocetyl alcohol, palmityl alcohol, and mixtures thereof.
A suitable glycol component may for example be propylene glycol such as 1,2 propylenediol; 1,3 propylenediol, ethylene glycol, dipropylene glycol and mixtures thereof.
A suitable plasticizer may comprise for example polyethylene glycol having a molecular weight between about 400 and about 25,000;
1,2,6-hexanetriol, sorbitol and glycerol (glycerin), and, preferably glycerin (glycerol).
A suitable coupling agent may include fatty acids having from about 12 to about 32 carbon atoms, for example, Laurie acid, Starkey acid, palmitic acid and bunk acid, and citric acid, and preferably ~'~3~5~
1 citric acid.
As a result of this invention, a base is provided which permits the medicine to be taken wholly into solution to provide more uniform mixtures of medicine and base, and which has improved plasticity and smoothness.
It also provides a base which reduces stinging of the patient (without the addition of water) when applying his/her medication thus making i-t easier for the patient to comply with the doctor's prescribed applications of the medicine.
DESCRIPTION OF EMBODIMENTS
The following embodiments of the invention were prepared as illustrative of the invention.
1) 5% Stroll alcohol 15 2) 60% Propylene glycol 3 3) 4.5% Polyethylene glycol-6000 3 Viscosity at 20 = 26,250 cups 4) 30% Glycerin 3 Runny lotion like.
5) 0.5% 1,2, 6-Hexanetriol 20 1) 10% Stroll alcohol
2) 44% Propylene Glycol-6000 3
3) 4.5% Polyethylene glycol-6000 3 Viscosity at 20C = 42,500 cups
4) 30% Glycerin 3 soft cream
5) 0.5% 1,2,6 Hexanetriol 1) 15% Stroll alcohol 3 2) 50% Propylene glycol 3) 4.5% Polyethylene glycol-6000 3 Viscosity at 20C = 85,000 cups 4) 30% Glycerin 3 Elegant cream 5) 0.5% 1,2,6 Hexanetriol 3 sly 1) 20% Stroll alcohol 2) 45% Propylene glycol 3) 4.5% Polyethylene glycol-6000 ) Viscosity at 25C = 127,500 cups 4) 30% Glycerin ) Cream 5) 0.5% 1,2,6 - Hexanetriol l) 34% Stroll alcohol 2) 31.0% Propylene glycol 3) 4.5% Polyethylene glycol-6000 ) Viscosity at 20C = 230,000 cups 4) 30% Glycerin ) Thick cream 5) 0.5% 1,2,6 - Hexanetriol The stability of each of examples 2, 3, 4 and 5 was investigated.
Examples 2, 3, 4 and 5 were found very stable after more than two years of controlled room temperature (15 - 30C). The antimicrobial effective-news test as per US XX was performed on each of the examples and found satisfactory against Candid albicans Escherichia golf, Aspergillus Niger Pseudomonas aeruginosa and Staphylococcus Ayers. They met US
XX requirements for preservative bacteria challenge test. The primary dermal irritation study in albino rabbits was better with marketed product. A comparative study of the vasoconstrictor effect of Fluocinonide hydrophilic creams 0.05% employing a base formulation according to an embodiment of this invention and other bases was performed and it was found that the formulations employing base formulations according to embodiments of the invention compare favorably with other bases yet still provide the aforementioned advantages.
As many changes can be made to the embodiments of the invention without departing from the scope of the invention, it is intended that all material disclosed therein shall be interpreted as illustrative of the invention and not in a limiting sense.
Examples 2, 3, 4 and 5 were found very stable after more than two years of controlled room temperature (15 - 30C). The antimicrobial effective-news test as per US XX was performed on each of the examples and found satisfactory against Candid albicans Escherichia golf, Aspergillus Niger Pseudomonas aeruginosa and Staphylococcus Ayers. They met US
XX requirements for preservative bacteria challenge test. The primary dermal irritation study in albino rabbits was better with marketed product. A comparative study of the vasoconstrictor effect of Fluocinonide hydrophilic creams 0.05% employing a base formulation according to an embodiment of this invention and other bases was performed and it was found that the formulations employing base formulations according to embodiments of the invention compare favorably with other bases yet still provide the aforementioned advantages.
As many changes can be made to the embodiments of the invention without departing from the scope of the invention, it is intended that all material disclosed therein shall be interpreted as illustrative of the invention and not in a limiting sense.
Claims (40)
PROPERTY OR PRIVILEGE IS CLAIMED ARE AS FOLLOWS:
1. An anhydrous base formulation consisting essentially of:
(a) a compatible saturated fatty alcohol having from about 12 - 32 carbon atoms or mixtures thereof and being between 5 and 35% by weight of the base formulation;
(b) a compatible glycol component between 20 and 75% by weight of the base formulation; and (c) a compatible plasticizer between about 25 and 35% by weight of the base formulation.
(a) a compatible saturated fatty alcohol having from about 12 - 32 carbon atoms or mixtures thereof and being between 5 and 35% by weight of the base formulation;
(b) a compatible glycol component between 20 and 75% by weight of the base formulation; and (c) a compatible plasticizer between about 25 and 35% by weight of the base formulation.
2. The base formulation of Claim 1, wherein the plasticizer is present in an amount about 30% by weight of the base formulation.
3. The base formulation of Claim 1, wherein the plasticizer is selected from the group of polyethylene glycol having a molecular weight between about 400 and about 25,000, 1,2,6-hexanetriol, sorbitol and glycerol (glycerin) or combinations thereof.
4. The base formulation of Claim 1, wherein the plasticizer is glycerol (glycerin).
5. The base formulation of Claim 2, wherein the plasticizer is selected from the group of polyethylene glycol having a molecular weight between about 400 and about 25,000, 1,2,6-hexanetriol, sorbitol and glycerol (glycerin) or combinations thereof.
6. The base formulation of Claim 2, wherein the plasticizer is glycerol (glycerin).
7. The base formulation of Claim 1, further consisting essentially of a small but effective amount of acidic coupling agent up to 5% by weight of the base formulation.
8. The base formulation of Claim 2, further consisting essentially of a small but effective amount of acidic coupling agent up to 5% by weight of the base formulation.
9. The base formulation of Claim 3, further consisting essentially of a small but effective amount of acidic coupling agent up to 5% by weight of the base formulation.
10. The base formulation of Claim 4, further consisting essentially of a small but effective amount of acidic coupling agent up to 5% by weight of the base formulation.
11. The base formulation of Claim 5, further consisting essentially of a small but effective amount of acidic coupling agent up to 5% by weight of the base formulation.
12. The base formulation of Claim 6, further consisting essentially of a small but effective amount of acidic coupling agent up to 5% by weight of the base formulation.
13. The base formulation of Claim 7, wherein the fatty alcohol component is present between 10 and 25% by weight of the base formulation.
14. The base formulation of Claim 8, wherein the fatty alcohol component is present between 10 and 25% by weight of the base formulation.
15. The base formulation of Claim 9, wherein the fatty alcohol component is present between 10 and 25% by weight of the base formulation.
16. The base formulation of Claim 10, wherein the fatty alcohol component is present between 10 and 25% by weight of the base formulation.
17. The base formulation of Claim 7, wherein the glycol component is present between 30 and 55% by weight of the base formulation.
18. The base formulation of Claim 8, wherein the glycol component is present between 30 and 55% by weight of the base formulation.
19. The base formulation of Claim 9, wherein the glycol component is present between 30 and 55% by weight of the base formulation.
20. The base formulation of Claim 10, wherein the glycol component is present between 30 and 55% by weight of the base formulation.
THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE AS FOLLOWS:
THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE AS FOLLOWS:
21. An anhydrous base formulation consisting essentially of:
(a) a compatible alcohol having from about 12-32 carbon atoms or mixtures thereof and being between 5 and 35% by weight of the base formulation;
(b) a compatible glycol component between 20 and 75% by weight of the base formulation; and (c) a compatible plasticizer between about 20 and about 35% by weight of the base formulation.
(a) a compatible alcohol having from about 12-32 carbon atoms or mixtures thereof and being between 5 and 35% by weight of the base formulation;
(b) a compatible glycol component between 20 and 75% by weight of the base formulation; and (c) a compatible plasticizer between about 20 and about 35% by weight of the base formulation.
22. The base formulation of Claim 21, wherein the compatible alcohol is a compatible alcohol having from about 16-32 carbon atoms or mixtures thereof.
23. The base formulation of Claim 21, wherein the plasticizer is selected from the group of polyethylene glycol having a molecular weight between about 400 and about 25,000, 1,2,6-hexanetriol, sorbitol and glycerol (glycerin) or combinations thereof.
24. The base formulation of Claim 21, wherein the plasticizer is glycerol (glycerin).
25. The base formulation of Claim 22, wherein the plasticizer is selected from the group of polyethylene glycol having a molecular weight between about 400 and about 25,000, 1,2,6-hexanetriol, sorbitol and glycerol (glycerin) or combinations thereof.
26. The base formulation of Claim 22, wherein the plasticizer is glycerol (glycerin).
27. The base formulation of Claim 21, further consisting essentially of a small but effective amount of acidic coupling agent up to 5% by weight of the base formulation.
28. The base formulation of Claim 22, further consisting essentially of a small but effective amount of acidic coupling agent up to 5% by weight of the base formulation.
29. The base formulation of Claim 23, further consisting essentially of a small but effective amount of acidic coupling agent up to 5% by weight of the base formulation.
30. The base formulation of Claim 24, further consisting essentially of a small but effective amount of acidic coupling agent up to 5% by weight of the base formulation.
31. The base formulation of Claim 25, further consisting essentially of a small but effective amount of acidic coupling agent up to 5% by weight of the base formulation.
32. The base formulation of Claim 26, further consisting essentially of a small but effective amount of acidic coupling agent up to 5% by weight of the base formulation.
33. The base formulation of Claim 27, wherein the fatty alcohol component is present between 10 and 25% by weight of the base formulation.
34. The base formulation of Claim 28, wherein the fatty alcohol component is present between 10 and 25% by weight of the base formulation.
35. The base formulation of Claim 29, wherein the fatty alcohol component is present between 10 and 25% by weight of the base formulation.
36. The base formulation of Claim 30, wherein the fatty alcohol component is present between 10 and 25% by weight of the base formulation.
37. The base formulation of Claim 27, wherein the glycol component is present between 30 and 55% by weight of the base formulation.
38. The base formulation of Claim 28, wherein the glycol component is present between 30 and 55% by weight of the base formulation.
39. The base formulation of Claim 29, wherein the glycol component is present between 30 and 55% by weight of the base formulation.
40. The base formulation of Claim 30, wherein the glycol component is present between 30 and 55% by weight of the base formulation.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA000460030A CA1231052A (en) | 1984-07-30 | 1984-07-30 | Vehicle suitable for use in medicinal preparations |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA000460030A CA1231052A (en) | 1984-07-30 | 1984-07-30 | Vehicle suitable for use in medicinal preparations |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1231052A true CA1231052A (en) | 1988-01-05 |
Family
ID=4128428
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000460030A Expired CA1231052A (en) | 1984-07-30 | 1984-07-30 | Vehicle suitable for use in medicinal preparations |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA1231052A (en) |
-
1984
- 1984-07-30 CA CA000460030A patent/CA1231052A/en not_active Expired
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MKEX | Expiry |