JP5992324B2 - 脂肪酸モノグリセリド組成物 - Google Patents
脂肪酸モノグリセリド組成物 Download PDFInfo
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- JP5992324B2 JP5992324B2 JP2012500982A JP2012500982A JP5992324B2 JP 5992324 B2 JP5992324 B2 JP 5992324B2 JP 2012500982 A JP2012500982 A JP 2012500982A JP 2012500982 A JP2012500982 A JP 2012500982A JP 5992324 B2 JP5992324 B2 JP 5992324B2
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- 229960002132 pyrrolnitrin Drugs 0.000 description 1
- 150000003242 quaternary ammonium salts Chemical class 0.000 description 1
- MCJGNVYPOGVAJF-UHFFFAOYSA-N quinolin-8-ol Chemical class C1=CN=C2C(O)=CC=CC2=C1 MCJGNVYPOGVAJF-UHFFFAOYSA-N 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- WKEDVNSFRWHDNR-UHFFFAOYSA-N salicylanilide Chemical compound OC1=CC=CC=C1C(=O)NC1=CC=CC=C1 WKEDVNSFRWHDNR-UHFFFAOYSA-N 0.000 description 1
- 229950000975 salicylanilide Drugs 0.000 description 1
- 229950008379 siccanin Drugs 0.000 description 1
- 229960003600 silver sulfadiazine Drugs 0.000 description 1
- UEJSSZHHYBHCEL-UHFFFAOYSA-N silver(1+) sulfadiazinate Chemical compound [Ag+].C1=CC(N)=CC=C1S(=O)(=O)[N-]C1=NC=CC=N1 UEJSSZHHYBHCEL-UHFFFAOYSA-N 0.000 description 1
- 239000002356 single layer Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 235000002639 sodium chloride Nutrition 0.000 description 1
- FQENQNTWSFEDLI-UHFFFAOYSA-J sodium diphosphate Chemical compound [Na+].[Na+].[Na+].[Na+].[O-]P([O-])(=O)OP([O-])([O-])=O FQENQNTWSFEDLI-UHFFFAOYSA-J 0.000 description 1
- GCLGEJMYGQKIIW-UHFFFAOYSA-H sodium hexametaphosphate Chemical compound [Na]OP1(=O)OP(=O)(O[Na])OP(=O)(O[Na])OP(=O)(O[Na])OP(=O)(O[Na])OP(=O)(O[Na])O1 GCLGEJMYGQKIIW-UHFFFAOYSA-H 0.000 description 1
- 235000019982 sodium hexametaphosphate Nutrition 0.000 description 1
- JXKPEJDQGNYQSM-UHFFFAOYSA-M sodium propionate Chemical compound [Na+].CCC([O-])=O JXKPEJDQGNYQSM-UHFFFAOYSA-M 0.000 description 1
- 235000010334 sodium propionate Nutrition 0.000 description 1
- 239000004324 sodium propionate Substances 0.000 description 1
- 229960003212 sodium propionate Drugs 0.000 description 1
- 229940100459 steareth-20 Drugs 0.000 description 1
- 239000008117 stearic acid Substances 0.000 description 1
- 235000019330 stearyl citrate Nutrition 0.000 description 1
- 229960005322 streptomycin Drugs 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 229960002607 sulconazole Drugs 0.000 description 1
- 229960002673 sulfacetamide Drugs 0.000 description 1
- SKIVFJLNDNKQPD-UHFFFAOYSA-N sulfacetamide Chemical compound CC(=O)NS(=O)(=O)C1=CC=C(N)C=C1 SKIVFJLNDNKQPD-UHFFFAOYSA-N 0.000 description 1
- 229940032330 sulfuric acid Drugs 0.000 description 1
- 230000001629 suppression Effects 0.000 description 1
- 229920003002 synthetic resin Polymers 0.000 description 1
- 239000000454 talc Substances 0.000 description 1
- 229910052623 talc Inorganic materials 0.000 description 1
- ZLOXYEZYWCTXHU-UHFFFAOYSA-N tenonitrozole Chemical compound S1C([N+](=O)[O-])=CN=C1NC(=O)C1=CC=CS1 ZLOXYEZYWCTXHU-UHFFFAOYSA-N 0.000 description 1
- 229960004480 tenonitrozole Drugs 0.000 description 1
- BWMISRWJRUSYEX-SZKNIZGXSA-N terbinafine hydrochloride Chemical compound Cl.C1=CC=C2C(CN(C\C=C\C#CC(C)(C)C)C)=CC=CC2=C1 BWMISRWJRUSYEX-SZKNIZGXSA-N 0.000 description 1
- 229960000699 terbinafine hydrochloride Drugs 0.000 description 1
- FBWNMEQMRUMQSO-UHFFFAOYSA-N tergitol NP-9 Chemical compound CCCCCCCCCC1=CC=C(OCCOCCOCCOCCOCCOCCOCCOCCOCCO)C=C1 FBWNMEQMRUMQSO-UHFFFAOYSA-N 0.000 description 1
- IWVCMVBTMGNXQD-UHFFFAOYSA-N terramycin dehydrate Natural products C1=CC=C2C(O)(C)C3C(O)C4C(N(C)C)C(O)=C(C(N)=O)C(=O)C4(O)C(O)=C3C(=O)C2=C1O IWVCMVBTMGNXQD-UHFFFAOYSA-N 0.000 description 1
- 229960002180 tetracycline Drugs 0.000 description 1
- 229930101283 tetracycline Natural products 0.000 description 1
- 235000019364 tetracycline Nutrition 0.000 description 1
- 150000003522 tetracyclines Chemical class 0.000 description 1
- UWHCKJMYHZGTIT-UHFFFAOYSA-N tetraethylene glycol Chemical compound OCCOCCOCCOCCO UWHCKJMYHZGTIT-UHFFFAOYSA-N 0.000 description 1
- 235000019818 tetrasodium diphosphate Nutrition 0.000 description 1
- 239000001577 tetrasodium phosphonato phosphate Substances 0.000 description 1
- 150000003558 thiocarbamic acid derivatives Chemical class 0.000 description 1
- 239000005028 tinplate Substances 0.000 description 1
- 239000004408 titanium dioxide Substances 0.000 description 1
- 239000011732 tocopherol Substances 0.000 description 1
- 235000010384 tocopherol Nutrition 0.000 description 1
- 229930003799 tocopherol Natural products 0.000 description 1
- 229960001295 tocopherol Drugs 0.000 description 1
- 229960004880 tolnaftate Drugs 0.000 description 1
- FUSNMLFNXJSCDI-UHFFFAOYSA-N tolnaftate Chemical compound C=1C=C2C=CC=CC2=CC=1OC(=S)N(C)C1=CC=CC(C)=C1 FUSNMLFNXJSCDI-UHFFFAOYSA-N 0.000 description 1
- 239000012049 topical pharmaceutical composition Substances 0.000 description 1
- 229910052723 transition metal Inorganic materials 0.000 description 1
- 150000003624 transition metals Chemical class 0.000 description 1
- ILJSQTXMGCGYMG-UHFFFAOYSA-N triacetic acid Chemical compound CC(=O)CC(=O)CC(O)=O ILJSQTXMGCGYMG-UHFFFAOYSA-N 0.000 description 1
- 229960002117 triamcinolone acetonide Drugs 0.000 description 1
- YNDXUCZADRHECN-JNQJZLCISA-N triamcinolone acetonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@H]3OC(C)(C)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O YNDXUCZADRHECN-JNQJZLCISA-N 0.000 description 1
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 1
- KRSIWAJXDVVKLZ-UHFFFAOYSA-H tricalcium;2,4,6,8,10,12-hexaoxido-1,3,5,7,9,11-hexaoxa-2$l^{5},4$l^{5},6$l^{5},8$l^{5},10$l^{5},12$l^{5}-hexaphosphacyclododecane 2,4,6,8,10,12-hexaoxide Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P1(=O)OP([O-])(=O)OP([O-])(=O)OP([O-])(=O)OP([O-])(=O)OP([O-])(=O)O1 KRSIWAJXDVVKLZ-UHFFFAOYSA-H 0.000 description 1
- 229960003500 triclosan Drugs 0.000 description 1
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 description 1
- 229960000281 trometamol Drugs 0.000 description 1
- LEHFPXVYPMWYQD-XHIJKXOTSA-N ulobetasol Chemical compound C1([C@@H](F)C2)=CC(=O)C=C[C@]1(C)[C@]1(F)[C@@H]2[C@@H]2C[C@H](C)[C@@](C(=O)CCl)(O)[C@@]2(C)C[C@@H]1O LEHFPXVYPMWYQD-XHIJKXOTSA-N 0.000 description 1
- 229960002703 undecylenic acid Drugs 0.000 description 1
- MYPYJXKWCTUITO-LYRMYLQWSA-N vancomycin Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1OC1=C2C=C3C=C1OC1=CC=C(C=C1Cl)[C@@H](O)[C@H](C(N[C@@H](CC(N)=O)C(=O)N[C@H]3C(=O)N[C@H]1C(=O)N[C@H](C(N[C@@H](C3=CC(O)=CC(O)=C3C=3C(O)=CC=C1C=3)C(O)=O)=O)[C@H](O)C1=CC=C(C(=C1)Cl)O2)=O)NC(=O)[C@@H](CC(C)C)NC)[C@H]1C[C@](C)(N)[C@H](O)[C@H](C)O1 MYPYJXKWCTUITO-LYRMYLQWSA-N 0.000 description 1
- 229960003165 vancomycin Drugs 0.000 description 1
- MYPYJXKWCTUITO-UHFFFAOYSA-N vancomycin Natural products O1C(C(=C2)Cl)=CC=C2C(O)C(C(NC(C2=CC(O)=CC(O)=C2C=2C(O)=CC=C3C=2)C(O)=O)=O)NC(=O)C3NC(=O)C2NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(CC(C)C)NC)C(O)C(C=C3Cl)=CC=C3OC3=CC2=CC1=C3OC1OC(CO)C(O)C(O)C1OC1CC(C)(N)C(O)C(C)O1 MYPYJXKWCTUITO-UHFFFAOYSA-N 0.000 description 1
- MECHNRXZTMCUDQ-RKHKHRCZSA-N vitamin D2 Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)/C=C/[C@H](C)C(C)C)=C\C=C1\C[C@@H](O)CCC1=C MECHNRXZTMCUDQ-RKHKHRCZSA-N 0.000 description 1
- 235000001892 vitamin D2 Nutrition 0.000 description 1
- 239000011653 vitamin D2 Substances 0.000 description 1
- 235000019165 vitamin E Nutrition 0.000 description 1
- 229940046009 vitamin E Drugs 0.000 description 1
- 239000011709 vitamin E Substances 0.000 description 1
- HLDCSYXMVXILQC-UHFFFAOYSA-N xenysalate Chemical compound CCN(CC)CCOC(=O)C1=CC=CC(C=2C=CC=CC=2)=C1O HLDCSYXMVXILQC-UHFFFAOYSA-N 0.000 description 1
- 229960003434 xenysalate Drugs 0.000 description 1
- 239000011787 zinc oxide Substances 0.000 description 1
- XOOUIPVCVHRTMJ-UHFFFAOYSA-L zinc stearate Chemical compound [Zn+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O XOOUIPVCVHRTMJ-UHFFFAOYSA-L 0.000 description 1
- XDWXRAYGALQIFG-UHFFFAOYSA-L zinc;propanoate Chemical compound [Zn+2].CCC([O-])=O.CCC([O-])=O XDWXRAYGALQIFG-UHFFFAOYSA-L 0.000 description 1
- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 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
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K31/05—Phenols
-
- 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
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N31/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic oxygen or sulfur compounds
- A01N31/08—Oxygen or sulfur directly attached to an aromatic ring system
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/517—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
-
- 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
-
- 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
- A61K9/10—Dispersions; Emulsions
- A61K9/12—Aerosols; Foams
-
- 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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7015—Drug-containing film-forming compositions, e.g. spray-on
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Dispersion Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Dermatology (AREA)
- Emergency Medicine (AREA)
- Pest Control & Pesticides (AREA)
- Agronomy & Crop Science (AREA)
- Plant Pathology (AREA)
- Dentistry (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- Environmental Sciences (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Description
−C(O)−C7H15(オクタン酸からのC8)
−C(O)−C8H17(ノナン酸からのC9)
−C(O)−C9H19(デカン酸からのC10)
−C(O)−C10H21(ウンデカン酸からのC11)
−C(O)−C11H23(ドデカン酸からのC12)
−C(O)−C12H25(トリデカン酸からのC13)、および
−C(O)−C13H27(テトラデカン酸からのC14)
からなる群から選択される、8〜14個の炭素原子を有する直鎖アシル基である。
−C(O)−C7H15(オクタン酸からのC8)
−C(O)−C8H17(ノナン酸からのC9)
−C(O)−C9H19(デカン酸からのC10)
−C(O)−C10H21(ウンデカン酸からのC11)
−C(O)−C11H23(ドデカン酸からのC12)
−C(O)−C12H25(トリデカン酸からのC13)、および
−C(O)−C13H27(テトラデカン酸からのC14)
からなる群から選択される、8〜14個の炭素原子を有する直鎖アシル基である。
一つの実施形態によると、医薬組成物は、少なくとも1つの揮発性溶媒およびフィルム形成成分をさらに含む。この実施形態によると、組成物は、ネイルラッカーである。ネイルラッカーの局所適用は、いったん揮発性溶媒が蒸発してしまうと、可撓性フィルムが患部に付着するのを可能にする。この可撓性フィルムは、患部を、環境ストレスおよび/または衣類から保護し、有効成分の貯蔵所として働く。
本発明のネイルラッカーは、1つまたは複数の揮発性溶媒を含む。したがって、ネイルラッカーを患者の爪および周囲の皮膚に適用すると、揮発性溶媒の蒸発により、有効成分の基質が、爪および周囲の皮膚の表面上のフィルム形成成分内に残る。これが、今度は、有効成分の爪および皮膚内への迅速な浸透を可能にする。
本発明の実施形態によると、フィルム形成成分は、フィルム形成ポリマーである。適当なフィルム形成ポリマーには、ヒドロキシプロピルメチルセルロース、ヒドロキシプロピルセルロース、ポリビニルピロリドン、カルボマー、PVM/MAデカジエンクロスポリマー、ヒドロキシプロピルグアー、オクチルアクリルアミドアクリレートコポリマー、アミノアルキルメタクリレートコポリマー、アンモニオメタクリレートコポリマー、PVP/VAコポリマー、PVA、PVM/MAコポリマーのC2−C4アルキルエステル、シェラック、またはそれらの組み合わせもしくは混合物が含まれる。
一つの代替実施形態によると、医薬組成物は、水、界面活性剤成分および噴霧剤をさらに含む。この実施形態によると、組成物は、エアロゾル泡組成物である。
本発明の実施形態によると、医薬組成物は、第2の医薬活性剤を含んでもよい。
本医薬組成物は、当技術分野で既知の追加の添加剤を含んでもよい。適切には、添加剤は、pH調整剤、湿潤剤、フィルム増量剤、キレート剤、酸化防止剤、保存剤、可塑剤、浸透促進剤、芳香剤、着色剤、界面活性剤、皮膚軟化剤、ゲル化剤、ラジカル捕捉剤、またはそれらの組み合わせもしくは混合物から選択される。
本医薬組成物は、pH調整剤をさらに含んでもよい。一実施形態では、pH調整剤は、塩基である。適当なpH調整塩基には、アミン、重炭酸塩、炭酸塩、およびアルカリまたはアルカリ土類金属水酸化物などの水酸化物、ならびに遷移金属水酸化物が含まれる。別の実施形態では、pH調整剤は、酸、酸性塩、またはそれらの混合物である。また別の実施形態によると、pH調整剤は、緩衝液である。適切には、緩衝液は、クエン酸塩/クエン酸、酢酸塩/酢酸、リン酸塩/リン酸、ギ酸塩/ギ酸、プロピオン酸塩/プロピオン酸、乳酸塩/乳酸、炭酸塩/炭酸、アンモニウム/アンモニア、エデト酸塩/エデト酸、またはそれらの組み合わせもしくは混合物から選択される。
本医薬組成物は、湿潤剤をさらに含んでもよい。この点について有用な湿潤剤の非限定的例としては、グリセロール、ソルビトール、マルチトール、ポリデキストロース、トリアセチン、プロピレングリコール、ステアリン酸PEG−20、ステアリン酸PEG−40、ステアリン酸PEG−150、ジステアリン酸PEG−150およびステアリン酸PEG−100を含むポリエチレングリコール(PEG)エステル、ラウレス−12、セテアレス−20、ラウレス−23、グリセレス−7、グリセレス−12、グリセレス−26、PEG−4、PEG−6、PEG−8、PEG−12、PEG−32、PEG−75、PEG−150を含むアルコキシル化アルコール、またはそれらの組み合わせもしくは混合物が挙げられる。好ましい実施形態では、湿潤剤は、グリセロールである。
本医薬組成物、特にネイルラッカー組成物は、少なくとも1つのフィルム増量剤をさらに含んでもよい。この点について有用なフィルム増量剤の非限定的例としては、炭酸カルシウム、リン酸カルシウム、ステアリン酸カルシウム、ステアリン酸マグネシウム、ステアリン酸亜鉛、硫酸カルシウム、コロイド状二酸化ケイ素、カオリン、炭酸マグネシウム、ケイ酸マグネシウム、フマル酸ステアリルナトリウム、タルク、二酸化チタン、酸化亜鉛、またはそれらの組み合わせもしくは混合物が挙げられる。一つの実施形態では、フィルム増量剤は、約0.1重量%〜約2重量%の量で存在する。
本医薬組成物は、キレート剤をさらに含んでもよい。この点について有用なキレート剤の非限定的例としては、クエン酸、(モノ)クエン酸イソプロピル、クエン酸ステアリル、クエン酸レシチン、グルコン酸、酒石酸、シュウ酸、リン酸、ピロリン酸四ナトリウム、モノリン酸カリウム、ヘキサメタリン酸ナトリウム、ヘキサメタリン酸カルシウム、ソルビトール、グリシン(アミノ酢酸)、メチルグルカミン、トリエタノールアミン(トロラミン)、EDTA、DEG(ジヒドロキシエチルグリシン)、DPTA(ジエチレントリアミン五酢酸)、NTA(ニトリロ三酢酸)、HEDTA(N−(ヒドロキシエチル)−エチレントリアミン三酢酸)、アミノカルボキシラート、ジメルカプロール(dimercaprol)(BAL)、ラリキシン酸(マルトール)、単座配位子(フッ化物イオンおよびシアン化物イオン)、ジフェニルチオカルバゾン、o−フェナントロリン、ジフェニルアミンスルホン酸バリウム、グルコヘプトン酸ナトリウム、8−ヒドロキシキノリン、オレフィン錯体(ジシクロペンタジエニル鉄など)、ポルフィリン、ホスホナート、またはそれらの組み合わせもしくは混合物が挙げられる。一つの実施形態では、キレート剤は、約0.1重量%〜約1重量%の量で存在する。
本医薬組成物は、酸化防止剤をさらに含んでもよい。本明細書で酸化防止剤として機能し得る物質の非限定的例としては、ブチル化ヒドロキシトルエン、ブチル化ヒドロキシアニソール、トコフェロール、没食子酸プロピル、ビタミンE、TPGS、またはその組み合わせもしくは混合物が挙げられる。一つの実施形態では、本組成物は、約0.001重量%〜約1重量%の量の酸化防止剤を含む。
本医薬組成物は、保存剤をさらに含んでもよい。本明細書で保存剤として機能し得る物質の非限定的例としては、ベンジルアルコール、ジアゾリジニル尿素、メチルパラベン、エチルパラベン、プロピルパラベン、ブチルパラベン、フェノキシエタノール、ソルビン酸、安息香酸、それらの塩、またはそれらの組み合わせもしくは混合物が挙げられる。一つの実施形態では、本組成物は、約0.01重量%〜約2重量%の量の保存剤を含む。
治療の方法
本組成物は、特定の皮膚糸状菌Trichophyton rubrumの治療に特に有効である。一つの実施形態によると、本発明は、Trichophyton rubrum感染症により引き起こされる真菌性疾患を治療する方法に関する。一実施形態では、真菌性疾患は、爪真菌症、足白癬(水虫)、股部(鼠径部)白癬、および皮膚糸状菌症(輪癬)からなる群から選択される。一実施形態によると、真菌性状態は、爪真菌症である。本組成物はまた、Trichophyton mentagrophytesおよびEpidermophyton floccosumにより引き起こされる真菌性状態の治療にも有効である。
別の実施形態では、本組成物を、真菌性状態の治療を促進するために追加の(別の)剤形と組み合わせて使用してもよい。この追加の剤形は、本組成物と同時に適用または使用(すなわち同時適用または使用)してもよい。あるいは、本組成物および追加の剤形の一方を朝に投与し、他方を夕方に投与してもよい(またはその逆でもよい)。
本明細書で使用する場合、「投与(administered、administeringおよびadministration)」という用語は、健全な医療行為において、治療効果をもたらす方法で患者に組成物を送達する任意の方法をいう。
(実施例1−ブロス液分析)
種々の試験剤の最小発育阻止濃度(MIC)を、2種の皮膚糸状菌、Trichophyton rubrumおよびTrichophyton mentagrophytesに対して標準的プロトコルで試験した。
1.シクロピロックス
2.テルビナフィンHCl
3.硝酸エコナゾール
4.チオコナゾール
5.ケトコナゾール
6.フザリン酸
7.1−モノカプリン(1−デカノイル−rac−グリセロール)
以下の実施例は、市販のコンパレーター、すなわちPENLAC(登録商標)ネイルラッカーと、表1a)による組成物の有効性の比較を提供する。
(実施例3−1−モノカプリンネイルラッカー)
以下の実施例は、本発明のネイルラッカー組成物を説明し、w/w%で与えられる。
1.撹拌しながらエタノール溶媒に1−モノカプリンを溶解させる(次いで、該当する場合には、第2の活性成分をエタノール溶媒に溶解させる)。
2.活性成分が完全に溶解したら、撹拌しながら酢酸エチル溶媒を添加する。
3.撹拌しながらGantrez ES−425を添加し、透明な溶液が得られるまで撹拌する。
以下の実施例は、本発明によるエアロゾルエマルジョン泡組成物を説明する。この泡は、爪真菌症の一次治療に、または維持療法として適している。
1.透明な溶液が得られるまで、1−モノカプリン(2%)をセトマクロゴール1000(0.5%)とともに加温する。
2.熱水(47.5w/w)をステップ1からの透明な溶液に添加し、半透明のかすかにオパール色の溶液を得る。
3.冷水(50%w/w)を添加し、泡ベースを示すよりオパール色の溶液を得る。
泡ベースをエアロゾル容器へ移し、バルブを挿入し、エアロゾル容器を真空圧着し、適当な炭化水素噴霧剤を添加してエアロゾル泡組成物を得る。
Claims (26)
- 一般式Ia:
- 一般式Ia:
- 前記グリセロールの脂肪酸モノエステルが、0.1重量%〜20重量%の量で存在する、請求項1または2に記載の組成物。
- 前記グリセロールの脂肪酸モノエステルが、1重量%〜10重量%の量で存在する、請求項1〜3のいずれか一項に記載の組成物。
- 前記組成物が、ネイルラッカー、エナメル、塗料、溶液、ローション、クリーム、ゲル、エアロゾル泡、およびエアロゾルスプレーからなる群から選択される局所投与剤形である、請求項1〜4のいずれか一項に記載の組成物。
- 前記組成物が、ネイルラッカーである、請求項5に記載の組成物。
- 前記組成物が、ネイルラッカーであり、少なくとも1つの揮発性溶媒およびフィルム形成成分をさらに含む、請求項5または6に記載の組成物。
- 前記少なくとも1つの揮発性溶媒が、エタノール、プロピルアルコール、イソプロピルアルコール、n−ブチルアルコール、t−ブチルアルコール、ブトキシエタノール、アセトン、酢酸エチル、および酢酸ブチルからなる群から選択される、請求項7に記載の組成物。
- 前記少なくとも1つの揮発性溶媒が、イソプロピルアルコールおよびエタノールの混合物である、請求項7または8に記載の組成物。
- 前記少なくとも1つの揮発性溶媒が、酢酸エチルおよびエタノールの混合物である、請求項7または8に記載の組成物。
- 前記フィルム形成成分が、ヒドロキシプロピルメチルセルロース、ヒドロキシプロピルセルロース、ポリビニルピロリドン、カルボマー、PVM/MAデカジエンクロスポリマー、ヒドロキシプロピルグアー、オクチルアクリルアミドアクリレートコポリマー、アミノアルキルメタクリレートコポリマー、アンモニオメタクリレートコポリマー、PVP/VAコポリマー、PVA、PVM/MAコポリマーのC2-C4アルキルエステル、シェラック、およびそれらの混合物からなる群から選択される、請求項7〜10のいずれか一項に記載の組成物。
- 前記フィルム形成成分が、PVM/MAコポリマーのブチルエステルである、請求項7〜11のいずれか一項に記載の組成物。
- 前記組成物が、エアロゾル泡である、請求項5に記載の組成物。
- 前記組成物が、エアロゾル泡であり、水、界面活性剤成分、および噴霧剤をさらに含む、請求項13に記載の組成物。
- 前記水が、80重量%〜96重量%の量で存在する、請求項14に記載の組成物。
- 前記水が、90重量%〜95重量%の量で存在する、請求項14または15に記載の組成物。
- 前記界面活性剤成分が、親水性界面活性剤を含み、親油性界面活性剤を含まないまたは実質的に含まない、請求項14〜16のいずれか一項に記載の組成物。
- 前記親水性界面活性剤が、非イオン性親水性界面活性剤である、請求項17に記載の組成物。
- 前記界面活性剤成分が、0.1重量%〜10重量%の量で存在する、請求項14〜18のいずれか一項に記載の組成物。
- 前記界面活性剤成分が、0.25重量%〜2重量%の量で存在する、請求項14〜19のいずれか一項に記載の組成物。
- 前記噴霧剤が、炭化水素、クロロフルオロカーボン、ジメチルエーテル、ハイドロフルオロカーボン、およびそれらの混合物からなる群から選択される、請求項14〜20のいずれか一項に記載の組成物。
- 前記噴霧剤が、炭化水素の混合物である、請求項14〜21のいずれか一項に記載の組成物。
- 前記噴霧剤が、5重量%〜10重量%の量で存在する、請求項14〜22のいずれか一項に記載の組成物。
- 前記組成物が、pH調整剤、湿潤剤、フィルム増量剤、キレート剤、酸化防止剤、保存剤、可塑剤、浸透促進剤、芳香剤、着色剤、界面活性剤、皮膚軟化剤、ゲル化剤、およびラジカル捕捉剤からなる群から選択される1つまたは複数の添加剤をさらに含む、請求項1〜23のいずれか一項に記載の組成物。
- 前記真菌性疾患が、足白癬、股部白癬、皮膚糸状菌症、および爪真菌症からなる群から選択される、請求項1〜24のいずれか一項に記載の組成物。
- 前記真菌性疾患が、爪真菌症である、請求項25に記載の組成物。
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CA2775393C (en) * | 2012-05-02 | 2014-04-29 | Samy Saad | Topical non-aqueous pharmaceutical formulations |
US9446131B2 (en) | 2013-01-31 | 2016-09-20 | Merz Pharmaceuticals, Llc | Topical compositions and methods for making and using same |
US8778365B1 (en) | 2013-01-31 | 2014-07-15 | Merz Pharmaceuticals, Llc | Topical compositions and methods for making and using same |
US9433680B2 (en) | 2013-01-31 | 2016-09-06 | Merz Pharmaceuticals, Llc | Topical compositions and methods for making and using same |
US9452173B2 (en) | 2013-01-31 | 2016-09-27 | Merz Pharmaceuticals, Llc | Topical compositions and methods for making and using same |
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EP3468544A2 (en) * | 2016-06-13 | 2019-04-17 | Vyome Therapeutics Limited | Synergistic antifungal compositions and methods thereof |
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EP4076391A1 (en) * | 2019-12-20 | 2022-10-26 | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | Topical pharmaceutical compositions for treating onychomycosis |
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EA022569B1 (ru) | 2016-01-29 |
CL2011002302A1 (es) | 2012-06-22 |
CN102368904B (zh) | 2014-03-26 |
WO2010108060A1 (en) | 2010-09-23 |
CN102368904A (zh) | 2012-03-07 |
IL214887A (en) | 2015-09-24 |
US20180360791A1 (en) | 2018-12-20 |
JP2012521351A (ja) | 2012-09-13 |
CA2756047C (en) | 2016-04-26 |
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