CN102083414A - 包含抗生素和皮质类固醇的组合物 - Google Patents
包含抗生素和皮质类固醇的组合物 Download PDFInfo
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- CN102083414A CN102083414A CN2009801255946A CN200980125594A CN102083414A CN 102083414 A CN102083414 A CN 102083414A CN 2009801255946 A CN2009801255946 A CN 2009801255946A CN 200980125594 A CN200980125594 A CN 200980125594A CN 102083414 A CN102083414 A CN 102083414A
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- ketone
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- 239000000203 mixture Substances 0.000 title claims abstract description 138
- 230000003115 biocidal effect Effects 0.000 title claims abstract description 51
- 239000003246 corticosteroid Substances 0.000 title claims abstract description 33
- 239000003242 anti bacterial agent Substances 0.000 title abstract description 3
- 235000014113 dietary fatty acids Nutrition 0.000 claims abstract description 31
- 239000000194 fatty acid Substances 0.000 claims abstract description 31
- 229930195729 fatty acid Natural products 0.000 claims abstract description 31
- 150000004665 fatty acids Chemical class 0.000 claims abstract description 30
- 238000000034 method Methods 0.000 claims abstract description 6
- 239000003814 drug Substances 0.000 claims abstract description 5
- 150000003839 salts Chemical class 0.000 claims description 77
- -1 Fluoronaphthalene pyridine ketone Chemical class 0.000 claims description 40
- 239000012453 solvate Substances 0.000 claims description 37
- 229910052731 fluorine Inorganic materials 0.000 claims description 27
- 239000011737 fluorine Substances 0.000 claims description 27
- VLCMRTMCMQJSKM-UHFFFAOYSA-N phenyl-[4-phenyl-8-(trifluoromethyl)quinolin-3-yl]methanone Chemical compound C=1C=CC=CC=1C(=O)C1=CN=C2C(C(F)(F)F)=CC=CC2=C1C1=CC=CC=C1 VLCMRTMCMQJSKM-UHFFFAOYSA-N 0.000 claims description 26
- POULHZVOKOAJMA-UHFFFAOYSA-N dodecanoic acid Chemical compound CCCCCCCCCCCC(O)=O POULHZVOKOAJMA-UHFFFAOYSA-N 0.000 claims description 24
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- SMNDYUVBFMFKNZ-UHFFFAOYSA-N 2-furoic acid Chemical compound OC(=O)C1=CC=CO1 SMNDYUVBFMFKNZ-UHFFFAOYSA-N 0.000 claims description 17
- ZQPPMHVWECSIRJ-KTKRTIGZSA-N oleic acid Chemical compound CCCCCCCC\C=C/CCCCCCCC(O)=O ZQPPMHVWECSIRJ-KTKRTIGZSA-N 0.000 claims description 16
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- QSBYPNXLFMSGKH-UHFFFAOYSA-N 9-Heptadecensaeure Natural products CCCCCCCC=CCCCCCCCC(O)=O QSBYPNXLFMSGKH-UHFFFAOYSA-N 0.000 claims description 11
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- JUJWROOIHBZHMG-UHFFFAOYSA-N pyridine Substances C1=CC=NC=C1 JUJWROOIHBZHMG-UHFFFAOYSA-N 0.000 claims description 10
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- MYSWGUAQZAJSOK-UHFFFAOYSA-N ciprofloxacin Chemical compound C12=CC(N3CCNCC3)=C(F)C=C2C(=O)C(C(=O)O)=CN1C1CC1 MYSWGUAQZAJSOK-UHFFFAOYSA-N 0.000 claims description 4
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- MPORYQCGWFQFLA-ONPDANIMSA-N 7-[(7s)-7-amino-5-azaspiro[2.4]heptan-5-yl]-8-chloro-6-fluoro-1-[(1r,2s)-2-fluorocyclopropyl]-4-oxoquinoline-3-carboxylic acid;trihydrate Chemical compound O.O.O.C([C@H]1N)N(C=2C(=C3C(C(C(C(O)=O)=CN3[C@H]3[C@H](C3)F)=O)=CC=2F)Cl)CC11CC1.C([C@H]1N)N(C=2C(=C3C(C(C(C(O)=O)=CN3[C@H]3[C@H](C3)F)=O)=CC=2F)Cl)CC11CC1 MPORYQCGWFQFLA-ONPDANIMSA-N 0.000 claims description 2
- GSDSWSVVBLHKDQ-UHFFFAOYSA-N 9-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid Chemical compound FC1=CC(C(C(C(O)=O)=C2)=O)=C3N2C(C)COC3=C1N1CCN(C)CC1 GSDSWSVVBLHKDQ-UHFFFAOYSA-N 0.000 claims description 2
- DPSPPJIUMHPXMA-UHFFFAOYSA-N 9-fluoro-5-methyl-1-oxo-6,7-dihydro-1H,5H-pyrido[3,2,1-ij]quinoline-2-carboxylic acid Chemical compound C1CC(C)N2C=C(C(O)=O)C(=O)C3=C2C1=CC(F)=C3 DPSPPJIUMHPXMA-UHFFFAOYSA-N 0.000 claims description 2
- RUXPNBWPIRDVTH-UHFFFAOYSA-N Amifloxacin Chemical compound C1=C2N(NC)C=C(C(O)=O)C(=O)C2=CC(F)=C1N1CCN(C)CC1 RUXPNBWPIRDVTH-UHFFFAOYSA-N 0.000 claims description 2
- SPFYMRJSYKOXGV-UHFFFAOYSA-N Baytril Chemical compound C1CN(CC)CCN1C(C(=C1)F)=CC2=C1C(=O)C(C(O)=O)=CN2C1CC1 SPFYMRJSYKOXGV-UHFFFAOYSA-N 0.000 claims description 2
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- AIJTTZAVMXIJGM-UHFFFAOYSA-N Grepafloxacin Chemical compound C1CNC(C)CN1C(C(=C1C)F)=CC2=C1C(=O)C(C(O)=O)=CN2C1CC1 AIJTTZAVMXIJGM-UHFFFAOYSA-N 0.000 claims description 2
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Abstract
本发明涉及包含抗生素(一般是喹诺酮或萘啶酮)、皮质类固醇和有机酸(一般是脂肪酸)的组合物(例如,耳用组合物)。本发明也涉及使用该组合物的治疗方法,该组合物制备药物的应用,以及包含该组合物的治疗试剂盒。
Description
发明领域
本发明涉及包含抗生素(一般是喹诺酮或萘啶酮(naphthyridinone))、皮质类固醇和有机酸(一般是脂肪酸)的组合物。本发明也涉及使用该组合物的治疗方法,该组合物制备药物的应用,以及包含该组合物的治疗试剂盒.
发明背景
US专利申请公开2006-0122159讨论了治疗动物感染、特别是耳部感染的药物制剂。该组合物一般描述为包含皮质类固醇、抗生素和***。它们包括,例如包含一水合糠酸莫米松、奥比沙星和泊沙康唑的混悬液。在US专利申请公开2006-0122159所述的一种具体制剂如表1所示:
表1
US专利申请公开2006-0122159的实施例1的制剂
申请人观察到,当在室温下贮存上述制剂时,随着时间至少一种莫米松降解产物会增加。申请人还观察到,该制剂中的奥比沙星加速了降解产物的形成。通过在较冷温度(例如,5℃)下贮存该制剂一般可以减少降解产物的形成。但是,人们需要一种在更高温度(例如,室温)下仍能保持稳定的制剂。本发明提供了这样的制剂。
发明简述
简言之,本发明一般涉及包含皮质类固醇和抗生素的组合物(例如,混悬液)。这些组合物一般在室温或更高温度(例如,50℃)下在较长时间(例如,5个月)是稳定的。这些稳定的组合物的优点典型地包括,例如省去了与冷藏有关的费用和人力,消除了由于冷藏失败导致的产品损耗的风险,并消除了未冷藏的不当贮存后施用降解后产品的风险。
因此,本发明部分涉及一种药物组合物。该组合物包含皮质类固醇、抗生素和有机酸。所述有机酸一般包含脂肪酸,所述脂肪酸包含约3-约18个碳原子并具有不超过约60℃的熔点。在一些实施方案中,所述抗生素包含喹诺酮(特别是氟喹诺酮、氟喹诺酮的盐或者氟喹诺酮或其盐的溶剂化物)。在其他实施方案中,所述抗生素包含萘啶酮(特别是氟萘啶酮、氟萘啶酮的盐或者氟萘啶酮或其盐的溶剂化物)。
本发明也部分涉及一种治疗动物感染的方法,包括将上述组合物施用于该动物。
本发明也部分涉及上述组合物在制备治疗动物感染的药物中的应用。
本发明也部分涉及一种治疗试剂盒。该试剂盒包含上述组合物和其他组件。所述其他组件可以是例如诊断工具、洗耳溶液、清洁耳部的装置、将该组合物施用于动物的说明书或将该组合物施用于动物的工具。
通过阅读本说明书,本申请人的发明的其他益处对于本领域技术人员将是显而易见的。
优选实施方案的详述
优选实施方案的详述仅是用于使本领域其他技术人员熟悉本申请人的发明、其原理和其实际应用,以使本领域其他技术人员可以以很多方式适应和应用本发明,因为他们最需要实际应用。尽管描述了本发明的优选实施方案,但该详述及其具体实施例仅是用于解释的目的。因此,本发明并不限于在本说明书中所述的优选实施方案,可以进行很多改动。
I.组合物
本发明的药物组合物一般包含皮质类固醇、抗生素和有机酸。首先,应当认识到,各成分的这种列举并不是详尽的。因此,该组合物可以(而且一般也会)包含其他成分。这些其他成分可以包括,例如一种或多种其他皮质类固醇、抗生素和/或有机酸。同时,如下文的更详细讨论,其他成分可以包含一种或多种其他活性成分。同时,如下文所讨论,其他成分可以(而且一般也)包含一种或多种赋形剂。
一般而言,该组合物可以是各种形式,特别是非固体的形式。例如,该组合物可以是混悬液、溶液、乳剂、软膏等形式。在一些实施方案中,该组合物是混悬液的形式。
A.皮质类固醇
皮质类固醇一般是由下丘脑-垂体前叶(anterior pituitary)-肾上腺皮质轴(也称作脑下垂体腺)分泌的激素的天然和合成类似物。皮质类固醇(特别是糖皮质激素)公知是有效的抗炎剂。它们也典型地显示止痒和血管收缩活性。各种皮质类固醇,例如用于局部治疗皮质类固醇-应答性皮肤病,例如牛皮癣和特异性皮炎。
皮质类固醇的例子包括表2所示的化合物(和这些化合物的盐,以及这些化合物和盐的溶剂化物):
表2
皮质类固醇的例子
在一些实施方案中,该组合物中包含的皮质类固醇是选自表2的化合物、它们的盐以及这些化合物和它们的盐的溶剂化物的皮质类固醇。
在其他实施方案中,所述皮质类固醇包含莫米松、莫米松的盐或者莫米松或莫米松盐的溶剂化物。莫米松是一种合成的糖皮质激素,对应于下列结构:
在其他实施方案中,所述皮质类固醇包含莫米松酯、莫米松酯的盐或者莫米松酯或莫米松酯盐的溶剂化物。在一些这样的实施方案中,莫米松酯包含糠酸莫米松。糠酸莫米松对应于下列结构:
它的化学名是9,21-二氯-11(β),17-二羟基-16(α)-甲基孕-1,4-二烯-3,20-二酮17-(2糠酸酯)。糠酸莫米松是例如洗剂、乳膏和软膏的活性组分,可以从Schering-PloughCorporation(Kenilworth,NJ)购得。
皮质类固醇可以存在各种对映体形式。它们也可以存在各种晶体形式。例如,如上所述,可以使用糠酸莫米松的溶剂化物。在一些实施方案中,例如所述溶剂化物包含水合物。该水合物可以是例如,一水合物。
在一些实施方案中,所述皮质类固醇包含莫米松、糠酸莫米松或者莫米松或糠酸莫米松的溶剂化物(例如,一水合糠酸莫米松)。
一般而言,该组合物中皮质类固醇的总浓度足以使以一定剂量施用的组合物中皮质类固醇是治疗有效的。在一些实施方案中,在该组合物中皮质类固醇(例如,莫米松、糠酸莫米松和/或莫米松或糠酸莫米松的溶剂化物)的总浓度是至少约0.01%(重量)。在一些这样的实施方案中,例如,所述总浓度是约0.01-约1.0%(重量)。
B.抗生素
在一些实施方案中,所述抗生素包括喹诺酮。一般而言,所述喹诺酮包括氟喹诺酮、氟喹诺酮的盐或者氟喹诺酮或其盐的溶剂化物。氟喹诺酮类抗生素包括例如,6-氟喹啉-4(1H)-酮,6-氟喹啉-4(1H)-酮的盐以及6-氟喹啉-4(1H)-酮和它们的盐的溶剂化物。6-氟喹啉-4(1H)-酮的例子包括表3所示的那些:
表3
6-氟喹啉-4(1H)-酮的例子
6-氟喹啉-4(1H)-酮的其他例子包括表4所示的那些:
表4
6-氟喹啉-4(1H)-酮的其他例子
参见Chu等人,″Minireview:Structure-Activity Relationshipsof the Fluoroquinolones,″Antimicrobial Agents and Chemotherapy,33(2),pp.131-135(Feb.1989).
在一些实施方案中,所述抗生素包含选自下列的抗生素:表3所示的6-氟喹啉-4(1H)-酮、6-氟喹啉-4(1H)-酮的盐和这些6-氟喹啉-4(1H)-酮和它们的盐的溶剂化物。
在一些实施方案中,所述抗生素包含选自下列的抗生素:氨氟沙星、巴洛沙星、环丙沙星、克林沙星、氟罗沙星、加诺沙星、加替沙星、格帕沙星、洛美沙星、莫西沙星、诺氟沙星、培氟沙星、普多沙星(pradofloxacin)、西他沙星、司帕沙星和替马沙星;这些6-氟喹啉-4(1H)-酮的盐;和这些6-氟喹啉-4(1H)-酮和它们的盐的溶剂化物。
在一些实施方案中,所述抗生素包括选自下列的抗生素:达氟沙星、二氟沙星、恩氟沙星和沙氟沙星;这些6-氟喹啉-4(1H)-酮的盐;和这些6-氟喹啉-4(1H)-酮和它们的盐的溶剂化物。
在一些实施方案中,所述抗生素包括选自下列的抗生素:表4所示的6-氟喹啉-4(1H)-酮、6-氟喹啉-4(1H)-酮的盐和这些6-氟喹啉-4(1H)-酮和它们的盐的溶剂化物。
在一些实施方案中,所述抗生素包含奥比沙星、奥比沙星的盐或者奥比沙星或奥比沙星盐的溶剂化物。奥比沙星是一种已知的合成型有效和广谱抗菌剂,可以安全和有效地用于治疗疾病,特别是用于狗和猫。
在一些实施方案中,所述抗生素包含6-氟喹啉-4(1H)-酮,所述化合物包含三个稠合在一起的环。在一些这样的实施方案中,例如,抗生素包含选自下列的抗生素:氟甲喹、依巴沙星、左氧氟沙星、那氟沙星、氧氟沙星、帕珠沙星、普卢利沙星和芦氟沙星;这些6-氟喹啉-4(1H)-酮的盐;和这些6-氟喹啉-4(1H)-酮和它们的盐的溶剂化物。在其他实施方案中,抗生素包含马波沙星、马波沙星的盐或者马波沙星或马波沙星盐的溶剂化物。
在其他实施方案中,所述抗生素包含萘啶酮。一般而言,所述萘啶酮包含氟萘啶酮、氟萘啶酮的盐或者氟萘啶酮或其盐的溶剂化物。所述氟萘啶酮类抗生素包括例如,6-氟-1,8-萘啶-4(1H)-酮、6-氟-1,8-萘啶-4(1H)-酮的盐以及6-氟-1,8-萘啶-4(1H)-酮和它们的盐的溶剂化物。6-氟-1,8-萘啶-4(1H)-酮的例子包括表5所示的那些:
表5
6-氟-1,8-萘啶-4(1H)-酮的例子
在一些实施方案中,所述抗生素包含选自下列的抗生素:表5所示的6-氟-1,8-萘啶-4(1H)-酮类、这些6-氟-1,8-萘啶-4(1H)-酮类的盐以及这些6-氟-1,8-萘啶-4(1H)-酮类和它们的盐的溶剂化物。
在一些实施方案中,抗生素包含包括选自下列的抗生素:依诺沙星、吉米沙星、托氟沙星和曲伐沙星;这些6-氟-1,8-萘啶-4(1H)-酮类的盐;和这些6-氟-1,8-萘啶-4(1H)-酮类和它们的盐的溶剂化物
6-氟-1,8-萘啶-4(1H)-酮类的其他例子包括:
参见Chu等人,Antimicrobial Agents and Chemotherapy,第132页。在一些实施方案中,抗生素包括该化合物、它的盐或者它或其盐的溶剂化物。
一般而言,该组合物中抗生素的浓度足以使以一定剂量施用的组合物中抗生素是治疗有效的。在一些实施方案中,该组合物中抗生素的浓度(即,该组合物中所有抗生素的总浓度)是至少约0.01%(重量)。在一些实施方案中,所述浓度是约0.01-约30%(重量),约0.1-约10%(重量)或约0.5-约5%(重量)。
C.有机酸
有机酸一般包括脂肪酸。所述脂肪酸优选包含至少约3个碳原子。在一些实施方案中,例如,所述脂肪酸包含约3-约18个碳原子。在其他实施方案中,所述脂肪酸包含约4-约18个碳原子。在其他实施方案中,所述脂肪酸包含约7-约18个碳原子。
所述脂肪酸可以是自然产生的脂肪酸或合成的酸。它也可以是饱和或不饱和的。在一些实施方案中,所述脂肪酸包括无支链的脂肪链,包含至少约4个碳原子,是饱和或不饱和的。优选地,所述脂肪酸具有不超过约60℃的熔点。
在该组合物的使用温度下,所述脂肪酸优选溶于或可混溶于该组合物中存在的载体中。在该组合物的贮存温度下,所述脂肪酸也优选溶于或可混溶于该组合物中存在的载体中。因此,在其中该组合物是包含矿物油载体的混悬液的一些实施方案中,所述脂肪酸在室温(即约20-约25℃)下可混溶到矿物油中。在这样的实施方案中,在可以使用或贮存该组合物的更冷或更高温度下,所述脂肪酸也优选可混溶到矿物油中。
在一些实施方案中,所述脂肪酸包含丙酸(具有3个碳原子)。在其他实施方案中,所述脂肪酸包括肉豆蔻酸(具有14个碳原子)。在其他实施方案中,所述脂肪酸包括月桂酸(具有14个碳原子)。在其他实施方案中,所述脂肪酸包含油酸(具有18个碳原子)。应当认识到,该组合物可以包含超过一种类型的脂肪酸。例如,在一些这样的实施方案中,该组合物包含油酸和月桂酸。
一般而言,该组合物中脂肪酸的浓度足以在至少15℃,至少20℃,至少25℃,至少40℃,或至少50℃下贮存于具有低密度聚乙烯(“LDPE”)瓶盖的高密度聚乙烯(“HDPE”)塑料瓶中时,在至少1个月,至少2个月或至少5个月里有效减少(并优选基本上或完全抑制)至少一种皮质类固醇(例如,莫米松或糠酸莫米松)降解产物的产生。在一些实施方案中,所述脂肪酸的浓度是至少约0.01%(重量)。在一些这样的实施方案中,例如,所述浓度是约0.01-约5.0%(重量)。在其他实施方案中,所述浓度是约0.1-约2.0%(重量)。在一些实施方案中,该组合物包括油酸,且该组合物中油酸的浓度是约0.1-约2.0%(重量)。在其他实施方案中,该组合物包含月桂酸,且月桂酸的浓度是约0.1-约1.0%(重量)。
D.该组合物中的其他成分
如上所述,本发明的组合物可以(而且一般也)包含其他成分。这些成分可以是,例如一种或多种其他活性成分和/或一种或多种赋形剂。
i.其他活性成分
应当注意,除了皮质类固醇和抗生素外,可以将各种活性成分掺入到本发明的组合物中。任意这样的活性成分优选适合其中使用该组合物的环境,并且不会显著妨害皮质类固醇和抗生素的活性。
在一些实施方案中,该组合物包含抗真菌剂。在一些这样的实施方案中,例如,抗真菌剂包含咪唑、咪唑的盐或者咪唑或其盐的溶剂化物。所述咪唑包括例如,表6所示的那些:
表6
抗真菌咪唑类的例子
在一些实施方案中,所述抗真菌剂包含下列抗真菌剂:表6所示的咪唑、这些咪唑的盐以及这些咪唑和它们的盐的溶剂化物。
在其他实施方案中,所述抗真菌剂包含***、***的盐或者***或其盐的溶剂化物。所述***包括,例如,表7所示的那些::
表7
抗真菌***类的例子
在一些实施方案中,所述抗真菌剂包含选自下列的抗真菌剂:表7所示的***、这些***的盐或者这些***和它们的的溶剂化物。
在一些实施方案中,所述抗真菌剂包含泊沙康唑、泊沙康唑的盐或者泊沙康唑或其盐的溶剂化物。在一些这样的实施方案中,例如,抗生素包含泊沙康唑。泊沙康唑已知具有抗真菌活性,可以对抗范围广泛的真菌,包括曲霉(Aspergillis)、念珠菌(Candida)、隐球菌(Cryptococcus)、镰刀菌(Fusarium)和其他机会真菌。有关泊沙康唑的讨论可以参见,例如,US专利5,661,151;5,834,472;和5,846,971。
在一些实施方案中,所述抗真菌剂包含制霉菌素、制霉菌素的盐或者制霉菌素或制霉菌素盐的溶剂化物。制霉菌素对应于下列结构:
一般而言,该组合物中抗真菌剂的浓度足以使以一定剂量施用的组合物中抗真菌剂是治疗有效的。当该组合物中存在一种以上的抗真菌剂时,所有抗真菌剂的总浓度足以使以一定剂量施用的组合物中组合抗真菌剂是治疗有效的。在一些实施方案中,该组合物中所述抗真菌剂的浓度(即,该组合物中所有抗真菌剂的总浓度)是至少约0.01%(重量)。在一些这样的实施方案中,例如,所述浓度是约0.01-约1.0%(重量)。
在一些实施方案中,该组合物包含一种或多种抗生素(除了喹诺酮类或萘啶酮类抗生素以外)。这些抗生素可以包括,例如,下列抗生素(以及它们的盐、它们的溶剂化物和它们的盐的溶剂化物):
A.氯霉素、甲砜霉素以及氯霉素和甲砜霉素的含氟类似物(例如,氟苯尼考或D-(苏)-1-对甲磺酰苯基-2-二氟乙酰胺基-3-氟-1-丙醇)。
B.四环素类,例如金霉素和土霉素。
C.阿莫西林、氨苄西林、三水氨苄西林、氨苄青霉素钠、阿帕西林、阿扑西林、阿洛西林、巴氨西林、羧苄西林、羧苄西林钠、卡非西林、卡茚西林、环己西林、氯唑西林钠、苄星邻氯青霉素、双氯西林、双氯西林钠、氟氯西林、海他西林、仑氨西林、美西林、美坦西林、甲氧西林、美洛西林、萘夫西林、萘夫西林钠、苯唑西林、青霉酸、青霉素G、苄星青霉素G、青霉素G钾、青霉素G钠、青霉素V、苯氧乙基青霉素、苯氧乙基青霉素钾、哌拉西林、哌拉西林钠、匹氨西林、磺苄西林、舒他西林、酞氨西林、替卡西林、头孢克洛、头孢羟氨苄、单水合头孢羟氨苄、头孢孟多、头孢孟多锂、头孢孟多酯钠、头孢孟多钠、头孢氮氟、头孢西酮、头孢唑啉、头孢唑啉钠、头孢林定、头孢地尼、头孢吡肟、头孢他美、头孢克肟、头孢瑞南、头孢甲肟、头孢美唑钠、头孢地嗪、头孢尼西、头孢哌酮、头孢哌酮钠、头孢雷特、头孢噻利、头孢噻肟、头孢噻肟钠、头孢替安、头孢唑兰、头孢咪唑、头孢咪唑钠、头孢匹胺、头孢匹罗、头孢泊肟、头孢丙烯、头孢喹肟、头孢沙定、头孢磺啶、水合头孢磺啶钠、头孢他啶、五水合头孢他啶、头孢替唑、头孢布烯、头孢噻林、头孢唑肟、头孢曲松、头孢曲松二钠盐、头孢曲松钠、头孢呋辛、头孢唑南、头孢乙腈、头孢氨苄、头孢噻啶、头孢菌素C、头孢噻吩、头孢噻吩钠、头孢匹林、头孢匹林钠、头孢雷定、氯碳头孢、头孢拉宗、头孢西丁、头孢西丁钠、头孢米诺、头孢美唑、头孢替坦,单独或与β-内酰胺酶抑制剂例如克拉维酸、克拉维酸钾、舒巴坦lodopenicillanic acid,6-溴青霉烷酸、橄榄酸和他唑巴坦合用。
D.大环内酯类抗生素,例如阿奇霉素、布雷菲德菌素、克拉霉素、红霉素、依托红霉素、乙基红霉素琥珀酸酯、红霉素硬脂酸盐、交沙霉素、吉他霉素、托拉菌素和替米考星。
在一些实施方案中,除皮质类固醇以外该组合物包含一种或多种抗炎成分。这些抗炎成分包括,例如,一种或多种非甾体抗炎药(“NSAIDs”)。NSAIDs包括例如,水杨酸盐类、芳基链烷酸类、2-芳基丙酸类(或“profens”)、N-芳基邻氨基苯甲酸、吡唑烷衍生物、苯并噻嗪类、COX-2抑制剂、磺酰替苯胺类和利克飞龙。在一些实施方案中,所述NSAID包含阿司匹林、布洛芬或萘普生。抗炎成分也可以包括,例如,抗组胺剂。抗组胺剂包括例如,H1-受体激动剂、H2-受体激动剂、H3-受体激动剂、H4-受体激动剂、肥大细胞稳定剂和维生素C。
ii.赋形剂
所关注的本发明组合物中的赋形剂包括,例如,液体赋形剂(liquidvehicles)、增粘剂(viscosity-enhancing agents)、表面活性剂、防腐剂、稳定剂、树脂、填充剂、粘合剂、润滑剂、助流剂、崩解剂、共溶剂和药品级的染料或色素。
在一些实施方案中,本发明的组合物是混悬液的形式。这些组合物一般包括液体赋形剂(或“载体”),例如水、石油、动物油、植物油、矿物油或合成油。也可以包括生理盐水溶液或二醇(例如,乙二醇、丙二醇或聚乙二醇)。在一些实施方案中,所述液体赋形剂包含矿物油。
本发明的组合物典型地包含一种或多种增粘剂(或“增稠剂”)。该组合物中增粘剂的浓度一般是至少约0.1%(重量)。例如,在一些实施方案中,所述浓度是约0.1-约15%(重量)。在一些这样的实施方案中,例如,所述浓度是约0.1-约5%。在其他实施方案中,所述浓度是约2-约10%(重量)或约4-约8%(重量)。在一些实施方案中,所述增粘剂包含聚乙烯。聚乙烯是一种具有高分子量和高熔点的惰性烃。它可以用作增稠剂来增强例如矿物油载体的粘性。在一些实施方案中,聚乙烯是以50W(购自Bristol-Myers Squibb)的形式引入到该组合物中。50W包含在95%矿物油中的5%聚乙烯。也(或可替代地)可以使用其他关注的增粘剂。在一些实施方案中,例如,增粘剂包括,例如甲基纤维素、羧甲基纤维素钠、羟丙基甲基纤维素、羟丙基纤维素、海藻酸钠、卡波姆、聚维酮、***胶、瓜尔胶、黄原胶或西黄蓍胶。在其他实施方案中,所述增粘剂包含甲基纤维素、卡波姆、黄原胶、瓜尔胶、聚维酮、羧甲基纤维素钠或硅酸镁铝。在其他实施方案中,所述增粘剂包含羧乙烯聚合物;角叉菜胶;羟乙基纤维素;laponite;和纤维素醚的水溶性盐例如羧甲基纤维素钠和羧甲基羟乙基纤维素钠。在其他实施方案中,所述增粘剂包含天然胶,例如梧桐胶、黄原胶、***胶和西黄蓍胶。在其他实施方案中,所述增粘剂包含胶体硅酸镁铝或精细粉碎的硅石,它们可以用作增稠剂的一部分,以进一步改善构成。在其他实施方案中,所述增粘剂包含丙烯酸与季戊四醇的烷基醚或蔗糖的烷基醚或卡波姆类交联的均聚物。卡波姆类可以系列购自B.F.Goodrich。在一些实施方案中,所述卡波姆是934,940,941,956或其混合物。丙交酯和乙角酯的共聚物可以用于递送活性物质,特别是共聚物的分子量在约1,000-约120,000(数平均)的范围。这些聚合物在U.S.专利5,198,220;5,242,910和4,443,430中进行了描述。
所关注的表面活性剂包括,例如聚氧乙烯山梨糖醇酐脂肪酸酯;聚氧乙烯单烷基醚;蔗糖单酯;羊毛脂酯和醚;烷基硫酸盐;和脂肪酸的钠、钾和铵盐。
所关注的防腐剂包括,例如苯酚;对羟基苯甲酸的烷基酯(例如,对羟基苯甲酸甲酯(或“尼泊金甲酯”)和对羟基苯甲酸丙酯(或“尼泊金丙酯”));山梨酸;邻苯基苯酚苯甲酸或其盐;三氯叔丁醇;苯甲醇;硫柳汞;醋酸苯汞或硝酸苯汞;硝甲酚汞、苯扎氯铵;和西吡氯铵。特别关注的防腐剂是山梨酸。在一定程度上,本发明的组合物包含防腐剂,该组合物中防腐剂的浓度一般不大于约5%(重量)。在一些实施方案中,例如,所述防腐剂浓度是约0.01-约5%(重量).
所关注的稳定剂包括例如,螯合剂例如依地酸钠。所关注的稳定剂也包括例如,抗氧化剂例如丁羟茴醚和硫代甘油钠。
所关注的粘合剂包括例如,明胶、***胶和羧甲基纤维素。
所关注的润滑剂包括例如,硬脂酸镁、硬脂酸和滑石。
所关注的崩解剂包括例如,玉米淀粉和海藻酸。
如果需要,一般可以将其他惰性成分加入到该组合物中。应当关注的是,这些可以包括,例如,乳糖、甘露醇、山梨糖醇、碳酸钙、碳酸钠、三碱磷酸钙、二碱磷酸钙、磷酸钠、高岭土、可压缩糖、淀粉、硫酸钙、右或微晶纤维素、胶体二氧化硅、淀粉、淀粉羟乙酸钠、交聚维酮、交联羧甲基纤维素钠、微晶纤维素、西黄蓍胶、羟丙基纤维素、预胶化淀粉、聚维酮、乙基纤维素、羟丙基纤维素、羟丙基甲基纤维素和甲基纤维素。
E.盐
如上所述,本发明的组合物中存在的很多化合物可以是盐的形式。例如,很多上述的抗生素、皮质类固醇和抗真菌剂可以是盐的形式。盐可能是有利的,这是因为其具有的一种或多种物理性质,例如在不同温度和湿度下的药学稳定性;结晶性质;和/或在水、油或其他溶剂中令人期望的溶解性。通过例如使用本领域各种已知方法将化合物分别与酸或碱混合,可以形成酸或碱盐。一般而言,当为得到治疗益处而意欲将本发明的组合物体内施用(即,给予动物)时,该组合物中的所有盐都优选是药学可接受的。
可以通过游离碱化合物与适当化学量的无机或有机酸的反应来制备酸加成盐。用于制备药学可接受的盐的通常适当的无机酸的例子包括盐酸、氢溴酸、氢碘酸、硝酸、碳酸、硫酸和磷酸。用于制备药学可接受的盐的通常适当的有机酸的例子一般包括例如,脂肪、环脂肪、芳香、芳香脂肪、杂环、羧酸和磺酸类的有机酸。通常适当的有机酸的具体例子包括胆酸、山梨酸、月桂酸、乙酸、三氟乙酸、甲酸、丙酸、琥珀酸、羟乙酸、葡糖酸、二葡糖酸、乳酸、苹果酸、酒石酸、柠檬酸、抗坏血酸、葡糖醛酸、马来酸、延胡索酸、丙酮酸、门冬氨酸、谷氨酸、芳基羧酸(例如,苯甲酸)、邻氨基苯甲酸、甲磺酸、硬脂酸、水杨酸、对羟基苯甲酸、苯乙酸、双羟萘酸(巴莫酸)、烷基磺酸(例如,乙磺酸)、芳基磺酸(例如,苯磺酸)、泛酸、2-羟基乙磺酸、磺胺酸、环己基氨基磺酸、β-羟基丁酸、粘酸、半乳糖醛酸、己二酸、海藻酸、丁酸、樟脑酸、樟脑磺酸、环戊丙酸、十二烷基硫酸、糖庚酸、甘油磷酸、庚酸、己酸、烟酸、2-萘磺酸、草酸、巴莫酸、果胶酯酸、3-苯基丙酸、苦味酸、新戊酸、硫氰酸、对甲苯磺酸和十一烷酸。
一般而言,可以通过游离酸化合物与适当化学量的无机或有机碱的反应来制备碱加成盐。碱加成盐的例子包括例如,金属盐和有机盐。金属盐例如,包括碱金属(Ia族)盐、碱土金属(IIa族)盐和其他生理可接受的金属盐。这些盐可以由铵、钙、锂、镁、钾、钠和锌。例如,游离酸化合物可以与氢氧化钠混合,以形成这样的碱加成盐。有机盐可以由胺例如三甲胺、二乙胺、N,N′-二苄乙二胺、氯普鲁卡因、乙醇胺、二乙醇胺、乙二胺、葡甲胺(N-甲基葡萄糖胺)和普鲁卡因来制备。碱性包含氮的集团可以用试剂例如C1-C6-烷基卤化物(例如,甲基、乙基、丙基和丁基的氯化物、溴化物和碘化物)、二烷基硫酸酯(例如,二甲基、二乙基、二丁基和二戊基硫酸酯)、长链卤化物(例如,癸基、月桂基、肉豆蔻基和硬脂基的氯化物、溴化物和碘化物)、芳烷基卤化物(例如,苄基和苯乙基溴化物)和其他物质来季化。
II.本发明的组合物的制备
本发明的组合物一般可以使用例如本领域公知的技术来制备。典型地,将用于该组合物的任意载体(或这些载体的一部分)加入到配药容器中,然后加入剩余的赋形剂、活性物质和脂肪酸。一般而言,各组分加入到容器中的顺序并不是关键性的。
III.使用本发明的组合物的治疗方法
本发明的组合物一般用于动物感染。应当关注的是,该组合物可以用于治疗一定范围的动物,特别是哺乳动物。这些哺乳动物包括例如,人。其他哺乳动物包括例如,农场类或家畜类哺乳动物(例如,猪、牛、羊、山羊等)、实验室哺乳动物(例如,小鼠、大鼠、沙鼠等)、伴侣型哺乳动物(例如,狗、猫、马等)以及野生型和动物园哺乳动物(例如,水牛、鹿等)。在一些实施方案中,该组合物用于治疗犬科动物(例如,狗)。在其他实施方案中,该组合物用于治疗猫科动物(例如,驯养的猫)。应当关注的是,该组合物也适合治疗非哺乳动物类,例如鸟类(例如,火鸡、鸡等)和鱼(例如,鲑鱼、鳟鱼、鲤鱼等)。
一般而言,本发明的组合物以一定剂型施用,以向感染部位提供治疗有效量的组合物(特别是活性成分)。对于抗炎剂(例如,皮质类固醇,如一水合糠酸莫米松),“治疗有效量”是足以在靶组织中缓解、抑制或根除目标炎症,或发挥止痒或血管收缩作用的量。对于抗感染药(例如,抗生素或抗真菌剂),“治疗有效量”是足以缓解、抑制或根除目标病原体感染。在一些实施方案中,施用足够量的组合物以达到一定的抗生素浓度,所述浓度至少等于抗生素对目标病原体的MIC90水平(最小抑制浓度,即抑制90%目标病原体生长的浓度)。在一定程度上,该组合物包含对所期望靶组织或病原体具有合用效果的多种活性成分,构成“治疗有效量”的各成分的量是这样的量,即当与其他活性成分合用时会对靶组织或病原体产生期望的效果。
应当注意的是,本发明的组合物可以经直肠、经***、通过吸入(例如通过喷雾或气溶胶)、透皮(例如,通过透皮贴剂)或胃肠外(例如,皮下注射、静脉注射、肌内注射等)施用。同时应当注意的是,该组合物可以口服。例如,该组合物可以直接或作为预混合物的一部分加入到预期的动物受者的食物中;或者作为分离的剂型。
在一些实施方案中,本发明的组合物用于治疗耳部感染。在一些这样的实施方案中,耳部感染发生在狗中。在其他实施方案中,所述耳部感染发生在猫中。当用于治疗耳部感染时,本发明的组合物典型地施用于该动物被感染的耳部。尽管优选每日单次剂量,应当注意的是,该组合物可以每日多次剂量施用。在很多情况下,一次剂量足以治疗感染,特别是当该组合物包含例如,一水合糠酸莫米松、奥比沙星和泊沙康唑的时候更是如此。但是,在一些情况下可能需要(或者必须)在例如首次剂量后48小时施用第二剂量,以完全治疗该动物(或确保治疗完成)。在其他情况下,该组合物可以每日施用最多达7天(或更长)。
确定适当的剂量一般在本领域的技术范围内。精确剂量取决于各种因素。这些因素可以包括,例如预期受者的类型(例如,物种和族类)、年龄、大小、性别、饮食、活动能力和情况;药理学考虑,例如所施用的特定组合物的活性、效力、药代动力学和毒理学性质;以及该组合物是否作为与一种或多种活性成分的联合治疗的一部分施用。例如,在其中本发明的组合物用于治疗狗的耳部感染的一些实施方案中,剂量是约1-约10滴。在其中本发明的组合物用于治疗狗的耳部感染的其他实施方案中,剂量是约25-约500mg。在一些这样的实施方案中,例如,剂量是约25-约250mg。
IV.治疗试剂盒
本发明也涉及试剂盒,其例如,适合在实施上述治疗方法中使用。一般而言,这种试剂盒包含治疗有效量的本发明的组合物和一种或多种其他组件。所述一种或多种其他组件可以是例如下列的一种或多种:诊断工具、施用该组合物的说明书或施用该组合物的工具(例如,注射器或挤压瓶)。在耳部治疗的一些实施方案中,该试剂盒包含本发明的组合物并与例如,洗耳的工具和/或洗耳溶液组合。所关注的洗耳工具包括擦布(例如,干布或含醇的垫子)或动力洁耳器(例如Schering-PloughCorp.销售的System)。所关注的洗耳溶液的例子包括Virbac Animal Health′s溶液(包含丙二醇二辛酸酯/二癸酸酯、苯甲醇、芳香剂和丁羟甲苯)、Pfizer Inc.′s Oti-溶液(包含丙二醇-苹果酸、苯甲酸和水杨酸)、Vet Solutions洗耳溶液(包含丙二醇、芦荟凝胶、Sd醇40-2、乳酸、甘油、磺琥辛酸钠、水杨酸、芳香剂、苯甲酸和苯甲醇),和IVX Animal Health′s溶液(包含磺琥辛酸钠、水杨酸、乳酸、苯甲酸和芦荟)。
实施例
下列实施例仅是说明性的,而非以任何方式限制公开内容的其余部分。
实施例1.使用油酸或月桂酸稳定混悬液
本实验的目的是证明在包含一水合糠酸莫米松和奥比沙星的组合的混悬液中油酸或月桂酸可以减少至少一种莫米松降解产物的形成。在本实验中,混悬液具有如表8所示的组成:
表8
包含莫米松化合物和氟喹诺酮抗生素的混悬液
将该混悬液分成小份。各小份都加入油酸,以达到特定的油酸浓度(0.1%,0.2%,0.5%,1.0%或2.0%);加入月桂酸,以达到特定的月桂酸浓度(0.1%,0.2%,0.5%或1.0%);或不加入油酸或月桂酸(即,对照组)。将各小份装入具有LDPE盖的7.5g HDPE塑料瓶中,然后以直立位置于稳定贮存器上。为避免由标签引入任何污染物,各包装都不含商业标签。各瓶都在下列条件之一下贮存:(a)温度40℃,相对湿度75%,或(b)50℃,在环境条件下。
在实验开始时用HPLC评价样品,然后在之后的1个月,2个月和5个月的时间点确定莫米松降解产物的浓度。所观察到的莫米松降解产物的浓度如表9所示:
表9
在不同条件和不同油酸和月桂酸浓度下,经时所观察到的莫米松降解产物浓度
在表9中,“ND”是指什么都检测不到。可以看出,任何试验水平的这两种酸的存在在40℃和75%相对湿度下以及50℃和环境条件下抑制莫米松降解产物的形成长达5个月。申请人也没有观察到样品物理形态的任何变化,也没有检测到由于加入油酸或月桂酸而出现任何新的降解产物。
实施例2.包含油酸的说明性耳用制剂
下表10说明的是包含油酸的本发明的组合物。
表10
包含油酸的说明性耳用制剂
实施例3.包含月桂酸的说明性耳用制剂
下表11说明的是包含月桂酸的本发明的组合物。
表11
包含油酸的说明性耳用制剂
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词语“包含”和“含括”解释为包含性的,而非排他性的。这种解释与这些词语在美国专利法律中给出的解释是相同的、
术语“药学可接受的”作为形容词是用于指其所修饰的名词适合在药品中使用。当用于例如,描述盐或赋形剂时,其表征的是该盐或赋形剂与该组合物的其他成分是相容的,对于预期接受的动物在一定程度上是无害的,其中这种无害效果要比该盐或赋形剂的益处更重要。
在本专利中引用的所有参考文献都通过参考引入本专利。对优选实施方案的上述详述仅是意欲使本发明所述领域的其他技术人员熟知其原理和实际应用,以使本领域其他技术人员可以以很多方式适应和应用本发明,因为他们最需要实际应用。因此本发明并不仅限于上述实施方案,而且可以做出各种的改变。
Claims (18)
1.一种药物组合物,其中:
所述组合物包含:
皮质类固醇,
抗生素,和
脂肪酸;
抗生素包含:
氟喹诺酮,氟喹诺酮的盐,或者氟喹诺酮或其盐的溶剂化物,或
氟萘啶酮,氟萘啶酮的盐,或者氟萘啶酮或其盐的溶剂化物;
脂肪酸:
包含约3-约18个碳原子,和具有不超过约60℃的熔点。
2.根据权利要求1的组合物,其中所述组合物是混悬液的形式。
3.根据权利要求1或2的组合物,其中皮质类固醇包括莫米松、糠酸莫米松或者莫米松或糠酸莫米松的溶剂化物。
4.根据权利要求3的组合物,其中皮质类固醇包括一水合糠酸莫米松。
5.根据权利要求1至4的任一项的组合物,其中所述抗生素包括6-氟喹啉-4(1H)-酮、6-氟喹啉-4(1H)-酮的盐或者6-氟喹啉-4(1H)-酮或其盐的溶剂化物。
6.根据权利要求5的组合物,其中所述6-氟喹啉-4(1H)-酮包括选自下列的6-氟喹啉-4(1H)-酮:氨氟沙星、巴洛沙星、环丙沙星、克林沙星、氟罗沙星、加诺沙星、加替沙星、格帕沙星、洛美沙星、莫西沙星、诺氟沙星、培氟沙星、普多沙星、西他沙星、司帕沙星、替马沙星、达氟沙星、二氟沙星、恩氟沙星、沙氟沙星、氟甲喹、依巴沙星、左氧氟沙星、那氟沙星、氧氟沙星、帕珠沙星、普卢利沙星、芦氟沙星和马波沙星。
7.根据权利要求5的组合物,其中所述6-氟喹啉-4(1H)-酮包括奥比沙星。
8.根据权利要求1至7的任一项的组合物,其中所述组合物还包含抗真菌剂。
9.根据权利要求8的组合物,其中所述抗真菌剂包括***、***的盐或者***或其盐的溶剂化物。
10.根据权利要求9的组合物,其中所述***包含选自下列的***:氟康唑、伊曲康唑、沙康唑、特康唑和伏立康唑。
11.根据权利要求9的组合物,其中所述***包括泊沙康唑。
12.根据权利要求1至11的任一项的组合物,其中所述脂肪酸包括月桂酸。
13.根据权利要求1至11的任一项的组合物,其中所述脂肪酸包括油酸。
14.根据权利要求1至13的任一项的组合物,其中所述组合物还包含矿物油。
15.一种治疗动物感染的方法,其中所述方法包括将权利要求1-14任一项的组合物施用于所述动物。
16.根据权利要求15的方法,其中所述感染包括狗的耳部感染。
17.权利要求1至14的任一项的组合物在制备治疗动物感染的药物中的用途。
18.一种治疗试剂盒,其中所述试剂盒包含:
权利要求1-14任一项的组合物,和
其他组件,选自:
诊断工具,
洗耳溶液,
清洁耳部的装置,
将该组合物施用于动物的说明书,和
将该组合物施用于动物的工具。
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US5794008P | 2008-06-02 | 2008-06-02 | |
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PCT/EP2009/056751 WO2009147144A2 (en) | 2008-06-02 | 2009-06-02 | Composition comprising an antibiotic and a corticosteroid |
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BR (1) | BRPI0913297B8 (zh) |
CA (1) | CA2726074C (zh) |
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CN101039668A (zh) * | 2004-08-13 | 2007-09-19 | 先灵-普劳有限公司 | 包含抗菌素、***和皮质类固醇的药物制剂 |
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EP2502616A1 (fr) * | 2011-03-21 | 2012-09-26 | Matthew Krayenbuhl | Composition pharmaceutique nasale |
PL2802209T3 (pl) * | 2012-01-10 | 2021-07-05 | Entrx LLC | Preparaty do uszu |
US9849126B2 (en) | 2013-01-03 | 2017-12-26 | Entrx LLC | Sterile otic formulations |
WO2017216722A2 (en) * | 2016-06-13 | 2017-12-21 | Vyome Biosciences Pvt. Ltd. | Synergistic antifungal compositions and methods thereof |
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ES2436193T3 (es) | 2013-12-27 |
WO2009147144A3 (en) | 2010-09-16 |
CN102083414B (zh) | 2013-10-23 |
AU2009253956A1 (en) | 2009-12-10 |
RU2010154083A (ru) | 2012-07-20 |
EP2293778A2 (en) | 2011-03-16 |
EP2293778B1 (en) | 2013-09-18 |
TW201010708A (en) | 2010-03-16 |
RU2496501C2 (ru) | 2013-10-27 |
AR071988A1 (es) | 2010-07-28 |
HK1156876A1 (en) | 2012-06-22 |
BRPI0913297B1 (pt) | 2019-01-29 |
AU2009253956B2 (en) | 2016-05-12 |
US20120046259A1 (en) | 2012-02-23 |
WO2009147144A2 (en) | 2009-12-10 |
CA2726074C (en) | 2016-07-19 |
US10045940B2 (en) | 2018-08-14 |
US20100087409A1 (en) | 2010-04-08 |
CA2726074A1 (en) | 2009-12-10 |
JP2011521999A (ja) | 2011-07-28 |
BRPI0913297A2 (pt) | 2016-01-26 |
JP5674648B2 (ja) | 2015-02-25 |
BRPI0913297B8 (pt) | 2020-09-15 |
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