WO2017091167A1 - Topical pharmaceutical composition comprising fusidic acid, isoconazole, dexpanthenol and hydrocortisone - Google Patents
Topical pharmaceutical composition comprising fusidic acid, isoconazole, dexpanthenol and hydrocortisone Download PDFInfo
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- WO2017091167A1 WO2017091167A1 PCT/TR2015/050207 TR2015050207W WO2017091167A1 WO 2017091167 A1 WO2017091167 A1 WO 2017091167A1 TR 2015050207 W TR2015050207 W TR 2015050207W WO 2017091167 A1 WO2017091167 A1 WO 2017091167A1
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- pharmaceutically acceptable
- acceptable salt
- pharmaceutical composition
- hydrocortisone
- isoconazole
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- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/575—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
-
- 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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/164—Amides, e.g. hydroxamic acids of a carboxylic acid with an aminoalcohol, e.g. ceramides
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/415—1,2-Diazoles
-
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/10—Antimycotics
Definitions
- Present invention relates to a novel pharmaceutical combination product comprising antibacterial agent, antifungal agent, a provitamin of B5 and corticosteroid, and pharmaceutical compositions thereof. More particularly present invention relates to a topical treatment of bacterial and/or fungal infections, skin inflammations or wounds by using a fixed-dose pharmaceutical combination product comprising fusidic acid, isoconazole, dexpanthenol and hydrocortisone or pharmaceutically acceptable salts thereof.
- Fusidic acid or pharmaceutically acceptable salt thereof is an antibacterial agent that is often used topically. It acts as a bacterial protein synthesis inhibitor by preventing the turnover of elongation factor G from the ribosome. Fusidic acid is effective primarily on gram-positive bacteria such as Staphylococcus species, Streptococcus species, and Corynebacterium species.
- Antifungals work by exploiting differences between mammalian and fungal cells to kill the fungal organism with fewer adverse effects to the host. Unlike bacteria, both fungi and humans are eukaryotes. Thus, fungal and human cells are similar at the biological level. This makes it more difficult to discover drugs that target fungi without affecting human cells. Isoconazol or pharmaceutically acceptable salts thereof is anantifungal agent with a highly effective antimycotic and gram positive antibacterial activity.
- Panthenol is the alcohol analog of pantothenic acid, and is thus a provitamin of vitamin B5. Panthenol comes in two enantiomers, D and L. Only D-panthenol (dexpanthenol) is biologically active. It has soothing, anti- inflammatory, wound healing as well as itch relieving property.
- Topical inflammatory treatment compositions typically employ corticosteroids; the active ingredients typically comprise corticosteroids such as hydrocortisone or pharmaceutically acceptable salts thereof.
- Various therapies are available for the skin disease treatment. Combination of fusidic acid and hydrocortisone and combination of hydrocortisone and panthenol are available in the market.
- EP 2419087 B l discloses a cream for topical treatment of bacterial infections and for wound healing, said cream contains Fusidic acid and a biopolymer, preferably chitosan.
- WO2012023082 discloses medicinal fusidic acid cream which contains Fusidic Acid as an antibacterial, Hydrocortisone acetate as a corticosteroid, Terbinafine Hydrochloride as an antifungal, and a biopolymer, preferably Chitosan.
- WO 2009063493 discloses a combination therapy of a topical antibiotic and a topical steroid for the treatment of inflammatory dermatoses associated with secondary bacterial infections.
- topical pharmaceutical compositions comprising a combination of Fusidic Acid and corticosteroid such as Mometasone propionate.
- Topical pharmaceutical combination of fusidic acid or a pharmaceutically acceptable salt thereof, isoconazole or a pharmaceutically acceptable salt thereof, dexpanthenol and hydrocortisone or a pharmaceutically acceptable salt thereof is effective in bacterial/fungal skin infections of varied etiology due to their antibacterial/antifungal/anti-inflammatory properties.
- a topical monotherapy has relatively slow onset of the effect.
- fusidic acid, isoconazole, dexpanthenol and hydrocortisone or pharmaceutically acceptable salts thereof collectively enhance the skin regenerative aspect and aids in faster healing. This ensures that the patient would benefit for the treatment of skin inflammations, wounds, and burns with bacterial and/or fungal infections.
- Another object of the present invention is to provide a fixed dose pharmaceutical combination product of fusidic acid, isoconazole, dexpanthenol and hydrocortisone or pharmaceutically acceptable salts thereof.
- Another object of the present invention is to provide a suitable topical pharmaceutical composition comprising fusidic acid, isoconazole, dexpanthenol and hydrocortisone or pharmaceutically acceptable salts thereof for the treatment of bacterial and/or fungal infections, skin inflammations or wounds.
- Present invention relates to a novel pharmaceutical combination product comprising fusidic acid or a pharmaceutically acceptable salt thereof, isoconazole or a pharmaceutically acceptable salt thereof, dexpanthenol and hydrocortisone or a pharmaceutically acceptable salt thereof.
- An objective of the present invention is to provide a fixed dose pharmaceutical combination product of fusidic acid, isoconazole, dexpanthenol and hydrocortisone or pharmaceutically acceptable saltsthereof.
- Another object of the present invention is to provide a suitable topical pharmaceutical composition comprising fusidic acid, isoconazole nitrate, dexpanthenol and hydrocortisone acetatefor the treatment of bacterial and/or fungal infections, skin inflammations or wounds.
- the present invention provides a novel pharmaceutical combination product comprising antibacterial agent, antifungal agent, provitamin of B5 and corticosteroid, and their pharmaceutical compositions.
- the antibacterial agent is fusidic acid or a pharmaceutically acceptable salt thereof
- the antifungal agent is isoconazole or a pharmaceutically acceptable salt thereof
- the provitamin of B5 is dexpanthenol
- the corticosteroid is hydrocortisone or a pharmaceutically acceptable salt thereof.
- the present invention provides a novel pharmaceutical combination product comprising fusidic acid or a pharmaceutically acceptable salt thereof,isoconazole or a pharmaceutically acceptable salt thereof, dexpanthenol and hydrocortisone or a pharmaceutically acceptable salt thereof.
- the present invention provides a suitable topical pharmaceutical composition
- a suitable topical pharmaceutical composition comprising fusidic acid, isoconazole, dexpanthenol and hydrocortisone or pharmaceutically acceptable salts thereof for the treatment of bacterial and/or fungal infections, skin inflammations or wounds.
- salts refers, but not limited to, base form, bromide, chloride, hydrohalides like hydrochloride; lower-alkyl sulfonic acid salts such as methanesulfonate, ethanesulfonate; arylsulfonic acid salts such as benzene sulfonate or p- toluenesulfonate; inorganic acids such as nitrate, perchloric acid salt; organic acid salts such as acetate, fumarate, succinate, citrate, ascorbate, tartrate, oxalate or maleate; or an amino acid salts such as glycine salt, lysine salt, arginine salt, ornithine salt, glutamic acid salt or aspartic acid salt.
- antifungals examples include, but are not limited to isoconazole, isoconazole nitrate, terbinafine hydrochloride, oxiconazole nitrate, clotrimazole, miconazole nitrate, ketoconazole, and the like.
- Topical antifungals are intended to target skin for fungal infections caused by fungi such as Tinea pedis, Tinea cruris, and Tinea corporis. Fungal infections are generally manifested with itching at the site. Antifungals act by altering the permeability of the fungal membrane by inhibiting the synthesis of sterols.
- Topical corticosteroids are a powerful tool for treating skin diseases.
- Corticosteroids include drugs such as hydrocortisone, hydrocortisone acetate, dexamethasone acetate, betamethasone dipropionate, beclomethasone dipropionate, clobetasol propionate, clobetasone butyrate, halobetasol propionate, mometasone furoate, halcinonide, fluocinonide, triamcinolone acetonide, fluticasone propionate, amcinonide, diflorasone diacetate, prednicarbate, etc.
- drugs such as hydrocortisone, hydrocortisone acetate, dexamethasone acetate, betamethasone dipropionate, beclomethasone dipropionate, clobetasol propionate, clobetasone butyrate, halobetasol propionate, momet
- Topical corticosteroids are classified by their potency, ranging from weak to extremely potent, they include weak potent steroids, moderate potent steroids, potent steroids, very potent steroids and extremely potent steroids, the high potency steroids include betamethasone dipropionate, betamethasone valerate, diflorasone diacetate, clobetasol propionate, halobetasol propionate, desoximetasone, fluocinonide, mometasone furoate, triamcinolone acetonide, etc.
- low potency topical steroids include desonide, fluocinolone acetate, and hydrocortisone acetate, etc. topical corticosteroid is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
- Topical antibacterials are intended to target skin for bacterial infections caused by Staphylococcus aureus, Staphylococcus epidermidis, Methicillin Resistance Staphylococcus Aureus (MRSA) etc.
- Antibacterials act by inhibiting cell wall synthesis by combining with bacterial ribosomes and interfering with mRNA ribosome combination.
- antibacterials induce ribosomes to manufacture peptide chains with wrong amino acids, which ultimately destroy the bacterial cell.
- topical antibacterials examples include, but are not limited to bacitracin, erythromycin, gentamicin sulfate,neomycin, polymyxin b, fusidic acid, silver sulfadiazine, mafenide, mupirocin and like.
- the novel topical pharmaceutical combination product of the present invention can be formulated in the form of but not limited to cream, lotion, ointment, emulsion or solution.
- the present invention provides a novel pharmaceutical combination product wherein, fusidic acid or a pharmaceutically acceptable salt thereof is present in an amount from about 0.1% (w/w) to about 15% (w/w), preferably from about 1.0% (w/w) to about 6% (w/w), and more preferably about 2.00 % (w/w); the topical corticosteroid hydrocortisone or a pharmaceutically acceptable salt thereof is present from about 0.001% (w/w) to about 5% (w/w), preferably from about 0.01%(w/w) to about 3.0% (w/w) and more preferably about 1.00% (w/w); isoconazole or a pharmaceutically acceptable salt thereof is present from about 0.3%(w/w) to about 6.0%(w/w), preferably from about 0.5%(w/w) to about 3.0% (w/w)
- the present invention provides a fixed dose pharmaceutical composition
- a fixed dose pharmaceutical composition comprising 2.0%(w/w) fusidic acid or a pharmaceutically acceptable salt thereof, 1.0%(w/w) isoconazole or a pharmaceutically acceptable salt thereof, 5.0%(w/w) dexpanthenol and 1.0% (w/w) hydrocortisone or a pharmaceutically acceptable salt thereof by weight based on the total weight of the composition with pharmaceutically acceptable adjuvants, diluents and/or carriers.
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Abstract
The present invention relates to the novel topical pharmaceutical combination product comprising fusidic acid or a pharmaceutically acceptable salt thereof, isoconazole or a pharmaceutically acceptable salt thereof, dexpanthenol and hydrocortisone or a pharmaceutically acceptable salt thereof.
Description
TOPICAL PHARMACEUTICAL COMPOSITION COMPRISING FUSIDIC ACID, ISOCONAZOLE, DEXPANTHENOL AND HYDROCORTISONE
FIELD OF THE INVENTION
Present invention relates to a novel pharmaceutical combination product comprising antibacterial agent, antifungal agent, a provitamin of B5 and corticosteroid, and pharmaceutical compositions thereof. More particularly present invention relates to a topical treatment of bacterial and/or fungal infections, skin inflammations or wounds by using a fixed-dose pharmaceutical combination product comprising fusidic acid, isoconazole, dexpanthenol and hydrocortisone or pharmaceutically acceptable salts thereof.
BACKGROUND OF THE INVENTION
Use of antibacterial agents, antifungal agents, anti-inflammatory agents and corticosteroids individually for the skin disease treatment is well known in the art.
Fusidic acid or pharmaceutically acceptable salt thereof is an antibacterial agent that is often used topically. It acts as a bacterial protein synthesis inhibitor by preventing the turnover of elongation factor G from the ribosome. Fusidic acid is effective primarily on gram-positive bacteria such as Staphylococcus species, Streptococcus species, and Corynebacterium species.
Antifungals work by exploiting differences between mammalian and fungal cells to kill the fungal organism with fewer adverse effects to the host. Unlike bacteria, both fungi and humans are eukaryotes. Thus, fungal and human cells are similar at the biological level. This makes it more difficult to discover drugs that target fungi without affecting human cells. Isoconazol or pharmaceutically acceptable salts thereof is anantifungal agent with a highly effective antimycotic and gram positive antibacterial activity.
Panthenol is the alcohol analog of pantothenic acid, and is thus a provitamin of vitamin B5. Panthenol comes in two enantiomers, D and L. Only D-panthenol (dexpanthenol) is biologically active. It has soothing, anti- inflammatory, wound healing as well as itch relieving property.
Topical inflammatory treatment compositions typically employ corticosteroids; the active ingredients typically comprise corticosteroids such as hydrocortisone or pharmaceutically acceptable salts thereof.
Various therapies are available for the skin disease treatment. Combination of fusidic acid and hydrocortisone and combination of hydrocortisone and panthenol are available in the market.
EP 2419087 B l discloses a cream for topical treatment of bacterial infections and for wound healing, said cream contains Fusidic acid and a biopolymer, preferably chitosan. WO2012023082 discloses medicinal fusidic acid cream which contains Fusidic Acid as an antibacterial, Hydrocortisone acetate as a corticosteroid, Terbinafine Hydrochloride as an antifungal, and a biopolymer, preferably Chitosan.
WO 2009063493 discloses a combination therapy of a topical antibiotic and a topical steroid for the treatment of inflammatory dermatoses associated with secondary bacterial infections. In particular it relates to topical pharmaceutical compositions comprising a combination of Fusidic Acid and corticosteroid such as Mometasone propionate.
Various topical therapies are available for the treatment of bacterial and fungal infections and reduce skin inflammation. However there is no effective fixed-dose combination therapy for the treatment of bacterial and/or fungal infections, skin inflammations or wounds. To overcome the problem in the prior art and to bring affordable and safe therapy to the dispersed segment of population, a therapy with unique combination of fusidic acid or a pharmaceutically acceptable salt thereof, isoconazole or a pharmaceutically acceptable salt thereof,dexpanthenol and hydrocortisone or a pharmaceutically acceptable salt thereof is proposed by inventors of the present invention.
Topical pharmaceutical combination of fusidic acid or a pharmaceutically acceptable salt thereof, isoconazole or a pharmaceutically acceptable salt thereof, dexpanthenol and hydrocortisone or a pharmaceutically acceptable salt thereof is effective in bacterial/fungal skin infections of varied etiology due to their antibacterial/antifungal/anti-inflammatory properties. A topical monotherapy has relatively slow onset of the effect.
The properties of fusidic acid, isoconazole, dexpanthenol and hydrocortisone or pharmaceutically acceptable salts thereof collectively enhance the skin regenerative aspect and aids in faster healing. This ensures that the patient would benefit for the treatment of skin inflammations, wounds, and burns with bacterial and/or fungal infections.
Therefore it is an objective of the present invention to provide a fixed dose pharmaceutical combination product of fusidic acid, isoconazole, dexpanthenol and hydrocortisone or pharmaceutically acceptable salts thereof.
Another object of the present invention is to provide a suitable topical pharmaceutical composition comprising fusidic acid, isoconazole, dexpanthenol and hydrocortisone or pharmaceutically acceptable salts thereof for the treatment of bacterial and/or fungal infections, skin inflammations or wounds.
SUMMARY OF THE INVENTION
Present invention relates to a novel pharmaceutical combination product comprising fusidic acid or a pharmaceutically acceptable salt thereof, isoconazole or a pharmaceutically acceptable salt thereof, dexpanthenol and hydrocortisone or a pharmaceutically acceptable salt thereof.
An objective of the present invention is to provide a fixed dose pharmaceutical combination product of fusidic acid, isoconazole, dexpanthenol and hydrocortisone or pharmaceutically acceptable saltsthereof.
Another object of the present invention is to provide a suitable topical pharmaceutical composition comprising fusidic acid, isoconazole nitrate, dexpanthenol and hydrocortisone acetatefor the treatment of bacterial and/or fungal infections, skin inflammations or wounds.
DETAILED DESCRIPTION OF THE INVENTION
In one embodiment, the present invention provides a novel pharmaceutical combination product comprising antibacterial agent, antifungal agent, provitamin of B5 and corticosteroid, and their pharmaceutical compositions. In an aspect, the antibacterial agent is fusidic acid or a pharmaceutically acceptable salt thereof, the antifungal agent is isoconazole or a pharmaceutically acceptable salt thereof, the provitamin of B5 is dexpanthenol and the corticosteroid is hydrocortisone or a pharmaceutically acceptable salt thereof.
In another embodiment, the present invention provides a novel pharmaceutical combination product comprising fusidic acid or a pharmaceutically acceptable salt thereof,isoconazole or a pharmaceutically acceptable salt thereof, dexpanthenol and hydrocortisone or a pharmaceutically acceptable salt thereof.
In another embodiment, the present invention provides a suitable topical pharmaceutical composition comprising fusidic acid, isoconazole, dexpanthenol and hydrocortisone or
pharmaceutically acceptable salts thereof for the treatment of bacterial and/or fungal infections, skin inflammations or wounds.
The term "pharmaceutically acceptable salts" refers, but not limited to, base form, bromide, chloride, hydrohalides like hydrochloride; lower-alkyl sulfonic acid salts such as methanesulfonate, ethanesulfonate; arylsulfonic acid salts such as benzene sulfonate or p- toluenesulfonate; inorganic acids such as nitrate, perchloric acid salt; organic acid salts such as acetate, fumarate, succinate, citrate, ascorbate, tartrate, oxalate or maleate; or an amino acid salts such as glycine salt, lysine salt, arginine salt, ornithine salt, glutamic acid salt or aspartic acid salt.
Examples of antifungals, which may be used, include, but are not limited to isoconazole, isoconazole nitrate, terbinafine hydrochloride, oxiconazole nitrate, clotrimazole, miconazole nitrate, ketoconazole, and the like.
Topical antifungals are intended to target skin for fungal infections caused by fungi such as Tinea pedis, Tinea cruris, and Tinea corporis. Fungal infections are generally manifested with itching at the site. Antifungals act by altering the permeability of the fungal membrane by inhibiting the synthesis of sterols.
Topical corticosteroids are a powerful tool for treating skin diseases. Corticosteroids include drugs such as hydrocortisone, hydrocortisone acetate, dexamethasone acetate, betamethasone dipropionate, beclomethasone dipropionate, clobetasol propionate, clobetasone butyrate, halobetasol propionate, mometasone furoate, halcinonide, fluocinonide, triamcinolone acetonide, fluticasone propionate, amcinonide, diflorasone diacetate, prednicarbate, etc. Topical corticosteroids are classified by their potency, ranging from weak to extremely potent, they include weak potent steroids, moderate potent steroids, potent steroids, very potent steroids and extremely potent steroids, the high potency steroids include betamethasone dipropionate, betamethasone valerate, diflorasone diacetate, clobetasol propionate, halobetasol propionate, desoximetasone, fluocinonide, mometasone furoate, triamcinolone acetonide, etc. low potency topical steroids include desonide, fluocinolone acetate, and hydrocortisone acetate, etc. topical corticosteroid is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
Topical antibacterials are intended to target skin for bacterial infections caused by Staphylococcus aureus, Staphylococcus epidermidis, Methicillin Resistance Staphylococcus Aureus (MRSA) etc. Antibacterials act by inhibiting cell wall synthesis by
combining with bacterial ribosomes and interfering with mRNA ribosome combination. In another hypothesis it is believed that antibacterials induce ribosomes to manufacture peptide chains with wrong amino acids, which ultimately destroy the bacterial cell.
Examples of topical antibacterials, which may be used, include, but are not limited to bacitracin, erythromycin, gentamicin sulfate,neomycin, polymyxin b, fusidic acid, silver sulfadiazine, mafenide, mupirocin and like.
The novel topical pharmaceutical combination product of the present invention can be formulated in the form of but not limited to cream, lotion, ointment, emulsion or solution. In another embodiment, the present invention provides a novel pharmaceutical combination product wherein, fusidic acid or a pharmaceutically acceptable salt thereof is present in an amount from about 0.1% (w/w) to about 15% (w/w), preferably from about 1.0% (w/w) to about 6% (w/w), and more preferably about 2.00 % (w/w); the topical corticosteroid hydrocortisone or a pharmaceutically acceptable salt thereof is present from about 0.001% (w/w) to about 5% (w/w), preferably from about 0.01%(w/w) to about 3.0% (w/w) and more preferably about 1.00% (w/w); isoconazole or a pharmaceutically acceptable salt thereof is present from about 0.3%(w/w) to about 6.0%(w/w), preferably from about 0.5%(w/w) to about 3.0% (w/w) , and most preferably about 1.0%(w/w); dexpanthenol is present in an amount from about l%(w/w) to about 10%(w/w) , preferably from about 3.0%(w/w) to about 8.0% (w/w), and most preferably about 5.0%(w/w) by weight based on the total weight of the composition. The various fixed dose combinations are possible based on these amounts of active substances.
In another embodiment, the present invention provides a fixed dose pharmaceutical composition comprising 2.0%(w/w) fusidic acid or a pharmaceutically acceptable salt thereof, 1.0%(w/w) isoconazole or a pharmaceutically acceptable salt thereof, 5.0%(w/w) dexpanthenol and 1.0% (w/w) hydrocortisone or a pharmaceutically acceptable salt thereof by weight based on the total weight of the composition with pharmaceutically acceptable adjuvants, diluents and/or carriers.
Claims
1. A topical pharmaceutical composition comprising antibacterial agent, antifungal agent, a provitamin of B5 and corticosteroid, wherein
• antibacterial agent is fusidic acid or a pharmaceutically acceptable salt thereof, · antifungal agent is isoconazole or a pharmaceutically acceptable salt thereof,
• provitamin of B 5 is dexpanthenol,
• corticosteroid is hydrocortisone or a pharmaceutically acceptable salt thereof.
2. A pharmaceutical composition according to claim 1, wherein, fusidic acid or a pharmaceutically acceptable salt thereof is present in an amount from about 0.1% (w/w) to about 15% (w/w), preferably from about 1.0% (w/w) to about 6% (w/w), and more preferably about 2.00 % (w/w) by weight based on the total weight of the composition.
3. A pharmaceutical composition according to claim 1, wherein, isoconazole or a pharmaceutically acceptable salt thereof is present from about 0.3%(w/w) to about 6.0%(w/w), preferably from about 0.5%(w/w) to about 3.0% (w/w) , and most preferably about 1.0%(w/w) by weight based on the total weight of the composition.
4. A pharmaceutical composition according to claim 1, wherein, dexpanthenol is present in an amount from about l%(w/w) to about 10%(w/w) , preferably from about 3.0%(w/w) to about 8.0% (w/w), and most preferably about 5.0%(w/w) by weight based on the total weight of the composition.
5. A pharmaceutical composition according to claim 1, wherein, hydrocortisone or a pharmaceutically acceptable salt thereof is present from about 0.001% (w/w) to about 5% (w/w), preferably from about 0.01%(w/w) to about 3.0% (w/w) and most preferably about 1.0% (w/w) by weight based on the total weight of the composition.
6. A pharmaceutical composition according to any of preceeding claim, wherein it is a fixed dose pharmaceutical composition comprising 2.0%(w/w) fusidic acid or a pharmaceutically acceptable salt thereof, 1.0%(w/w) isoconazole or a pharmaceutically acceptable salt thereof, 5.0%(w/w) dexpanthenol, 1.0% (w/w) hydrocortisone or a pharmaceutically acceptable salt thereof by weight based on the total weight of the composition and pharmaceutically acceptable adjuvants, diluents and/or carriers.
7. A pharmaceutical composition according to any of preceeding claims,which is in the form of cream, lotion, ointment, emulsion or solution.
A pharmaceutical composition according to any of preceeding claims, which is used for the treatment of topical bacterial and/or fungal infections, skin inflammations or wounds.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/TR2015/050207 WO2017091167A1 (en) | 2015-11-28 | 2015-11-28 | Topical pharmaceutical composition comprising fusidic acid, isoconazole, dexpanthenol and hydrocortisone |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/TR2015/050207 WO2017091167A1 (en) | 2015-11-28 | 2015-11-28 | Topical pharmaceutical composition comprising fusidic acid, isoconazole, dexpanthenol and hydrocortisone |
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|---|---|
| WO2017091167A1 true WO2017091167A1 (en) | 2017-06-01 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/TR2015/050207 WO2017091167A1 (en) | 2015-11-28 | 2015-11-28 | Topical pharmaceutical composition comprising fusidic acid, isoconazole, dexpanthenol and hydrocortisone |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109350619A (en) * | 2018-12-05 | 2019-02-19 | 烟台大学 | Application of amino-substituted fusidic acid derivatives in the preparation of antifungal drugs |
| RU2736940C2 (en) * | 2018-04-28 | 2020-11-23 | Акционерное Общество "Вертекс" | Combined pharmaceutical composition for external application |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2009062746A2 (en) * | 2007-11-17 | 2009-05-22 | Bayer Consumer Care Ag | Topical drugs for use in antifungal therapy |
| WO2009063493A2 (en) | 2007-09-10 | 2009-05-22 | Glenmark Pharmaceuticals Limited | Topical pharmaceutical composition for the combination of fusidic acid and a corticosteroid |
| WO2012023081A1 (en) * | 2010-08-17 | 2012-02-23 | Sulur Subramaniam Vanangamudi | A medicinal fusidic acid cream made using sodium fusidate and incorporating a biopolymer, a corticosteroid - hydrocortisone acetate, and an antifungal agent - oxiconazole nitrate, and a process to make it |
| WO2012023082A1 (en) | 2010-08-17 | 2012-02-23 | Sulur Subramaniam Vanangamudi | A medicinal fusidic acid cream made using sodium fusidate and incorporating a biopolymer, a corticosteroid - hydrocortisone acetate, and an antifungal agent - terbinafine hydrochloride, and a process to make it |
| EP2419087B1 (en) | 2009-04-13 | 2013-01-23 | Sulur, Vanangamudi Subramaniam | A medicinal fusidic acid cream made using sodium fusidate and incorporating a biopolymer and a process to make it |
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2015
- 2015-11-28 WO PCT/TR2015/050207 patent/WO2017091167A1/en active Application Filing
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| WO2009063493A2 (en) | 2007-09-10 | 2009-05-22 | Glenmark Pharmaceuticals Limited | Topical pharmaceutical composition for the combination of fusidic acid and a corticosteroid |
| WO2009062746A2 (en) * | 2007-11-17 | 2009-05-22 | Bayer Consumer Care Ag | Topical drugs for use in antifungal therapy |
| EP2419087B1 (en) | 2009-04-13 | 2013-01-23 | Sulur, Vanangamudi Subramaniam | A medicinal fusidic acid cream made using sodium fusidate and incorporating a biopolymer and a process to make it |
| WO2012023081A1 (en) * | 2010-08-17 | 2012-02-23 | Sulur Subramaniam Vanangamudi | A medicinal fusidic acid cream made using sodium fusidate and incorporating a biopolymer, a corticosteroid - hydrocortisone acetate, and an antifungal agent - oxiconazole nitrate, and a process to make it |
| WO2012023082A1 (en) | 2010-08-17 | 2012-02-23 | Sulur Subramaniam Vanangamudi | A medicinal fusidic acid cream made using sodium fusidate and incorporating a biopolymer, a corticosteroid - hydrocortisone acetate, and an antifungal agent - terbinafine hydrochloride, and a process to make it |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2736940C2 (en) * | 2018-04-28 | 2020-11-23 | Акционерное Общество "Вертекс" | Combined pharmaceutical composition for external application |
| CN109350619A (en) * | 2018-12-05 | 2019-02-19 | 烟台大学 | Application of amino-substituted fusidic acid derivatives in the preparation of antifungal drugs |
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